best biotech business plan

How to Write a Business Plan for Your Biotech Startup

Last Updated on 

August 9, 2022

Do you always need a written business plan? Keeping track of every part of your business in your head is an impossible task, and the components of cash flow–sales, costs, expenses, assets, liabilities, capital, and profits–are much easier to understand and manage when laid out in an organized way.

Not only that, having everything documented will help show others that you have a good idea on your hands, one worthy of investment—whether that be labor or capital.

There are many different types of business plans, however, each type generally falls under one of two categories: traditional or lean startup. Whichever you choose, writing a business plan can give you a roadmap, guiding you through each stage of starting and managing your company, and can help convince people to invest in or lend to you.

That said, does a business plan guarantee success? Sadly, it does not. If all you needed to succeed was a business plan, then everyone with a business plan would be successful. Nonetheless, it is an excellent exercise and decision-making tool, and will help you flesh out a solid business strategy. In fact, scientific studies have shown that many successful businesses planned ahead.

In this article, we’ll review the traditional business plan format used to outline the company’s mission statement, structure, products or services, growth strategy, and more—information that will all be necessary if you’re going to secure outside investment, such as investor funding and business loans. Furthermore, we’ll provide a few examples of business plan templates we stand behind.

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How Does a Business Plan Help?

If you’e starting a small business, your business plan can be a highly useful tool to help you run your business. It can be the blueprint for how you structure, run, and grow your company.

They’re also an excellent way to flesh out key elements of your company, such as capital needs, product-to-market fit, competition, marketing plans, and potential to make a profit. Documenting all this will give you a much better grasp on your chances for success.

Most importantly, traditional business plans are an essential part to securing funding or bringing on new business partners. By providing in-depth detail on how you plan to operate your business, you make it that much more attractive to prospective investors or lenders.

This is because any investor is more likely to put their money and resources into someone who has made the effort to think out and document how the business will run—the business owner is more likely to be viewed as committed, thoughtful, and strategic.

Furthermore, creating a business plan lets you spot opportunities and challenges as you grow. This is due, in large part, to the fact that business plans have become less static.

(It used to be the case that many business plans were long, formal, and static documents that did not change much.)

Nowadays, many business owners revisit and revise their business plan as the company grows, as they gather new and different information and experience, and as the market changes. This allows for more flexibility and strategic planning and pivoting.

Now, some people may see writing a business plan as a chore or necessary “evil” required to attract financing or investors.

It may be seen as a chore, but it should also be seen as a low-cost—if not free—way to explore the viability of your potential business and avoid costly mistakes. At the end of the day, it’s not just about funding, it’s about the process.

By writing a plan out, you show not only yourself but those around you that you have a good idea on your hands, one worthy of time, effort, and money.

What Does Your Business Plan Need to Include?

Traditional business plans, or standard business plans, are highly detailed and provide a comprehensive look at the inner workings of your business.

These types of plans are necessary when requesting funding from an prospective investor or lender. They can be dozens of pages long, and usually take more time to write than other types of business plans, such as a lean startup plan.

Lean startup plans are typically shorter, focusing on key elements from a high-level. They are useful tools for measuring performance regularly and tracking your financials and milestones against what you projected so you can respond to opportunities and react to challenges quickly.

This type of business plan is faster to write, but doesn’t always provide enough information to potential investors or lenders. Nonetheless, it is a great option for startups looking to move quickly and decisively.

When writing a traditional business plan, the outline should include these topics:

Executive summary

Company description.

• Company structure & management
• Products or services
• Market analysis
• Sales & marketing plan
• Funding request
• Financial plan & projections

The order in which the topics are included is not incredibly important. The level of detail is what investors are looking at. Let’s briefly review each section.

This is one of the most important sections of your business plan, as many investors will make a decision to invest in your business based on this summary.

Often, these investors won’t read the rest of the business plan unless your executive summary is convincing enough. It shouldn’t be longer than one page, and should provide a high-level overview of your business idea that persuades an investor to continue reading.

Your executive summary should include every section described below, but condensed to include the most important information so a busy reviewer can get the idea quickly.

This is where you’ll go into detail about your business concept and company, explaining what you do, why you do it, and the problems you plan to solve.

You should include information regarding your business’s structure, goals and objectives, as well as the consumers or businesses you plan on serving. You can also include your cultural philosophy, principles, and ideals.

All this should be written to explain why your business is a good investment bet.

Company Structure & Management

If you plan on raising money from investors, they will want to know how you structure your business and who runs it. This means determining how your business is structured legally, and including that information in your business plan.

State whether or not you are or plan to incorporate as a C-corporation, S-corporation, or limited liability company (LLC), and show who will be running each part of the business and describe how each member will contribute to the company..

Documenting the legal structure and management team in your business plan regardless of fundraising strategies will ultimately be helpful, as you will have all your business entity information recorded for any future needs.

Products or Services

Explain what you plan to sell and why. How will it benefit your customers or the businesses you plan to serve? In the life sciences sector, sharing how you plan to handle intellectual property is incredibly important.

If you’re performing research and development, you’ll want to include comprehensive details.

Market Analysis

Many investors will want to know an analysis of your target market, the size and growth of that market, and why you’re targeting it.

Market research—specifically, researching your competitors—should give you a good idea of what your target industry and market looks like. It will show you what other businesses are doing and whether or not it’s working.

This type of competitive analysis will also help you understand their strengths and weaknesses, and how you can position yourself.

Looking for themes and trends can help you get an idea of what successful companies do, why they do it, and how you can improve on it. Including this information in your business plan will help investors see how your business fits into the target market, and whether or not you have any competitive advantages.

Sales & Marketing Plans

Creating these two documents is extremely important because it will define how exactly you will market to customers, as well as how you will convince them to purchase the product or service you’re offering.

While sales strategies and marketing strategies are somewhat different, they are often talked about together, as sales and marketing departments work closely to achieve business goals.

Although there is no single way to approach creating a marketing strategy, there are some best practices that many entrepreneurs in various industries typically follow. These best practices include:

Include your marketing and sales strategy in your business plan by outlining your current marketing plan. Explain what your ideal customer demographics are and why, show how your strategy fits that actual or potential customer, and include your value propositions. Incorporate how you plan to attract and retain their business as well.

As well, this section should also describe how you’ll actually make a sale. Refer back to this section when describing your financial projections.

Funding Requests

If you’re looking for outside investments to fund or finance your company, you’ll need to include a funding request section. If you’re not planning to ask, you can skip this section entirely.

Although investors are an excellent resource (large cash injections, wide network to leverage), there are other ways to fund your business without using investors.

Use this section to include important information on your business’s funding needs, as well as future financial plans and projections.

Include how much funding you may need and when you’ll need it, whether you prefer equity or debt, the terms you’d like, and the length of time this request will cover. Furthermore, describe how you’ll use your funds.

Specify whether it’s for hiring and salaries, equipment and supplies, or bills that need to be paid. (It could be for all of these.)

Include a description of your future financial plans. It should include any loan repayment schedules and plans to sell the business. You’ll also want to include your exit strategy , letting investors know how they will be able to exit the deal should they wish.

An exit strategy can be a number of things, from initial public offering (IPO) or merger and acquisition (M&A) to a management buyout.  

Financial Plan & Projections

The financial plan section is used to illustrate your projected financial position, as well as a number of financial statements.

It can be used to supplement your funding request and should show your company’s stability.

You’ll want to include the most important views of your financials, to showcase your business’s financial health. If you have income statements , balance sheets , and cash flow statements you can provide, make sure you do.

Depending on your audience, it may also be helpful to provide a financial forecast for the next five years. Include projected income statements, balance sheets, cash flow statements, and capital expenditure budgets, and describe your projected cash-flow statement.

It can identify gaps or negative cash flow, helping you adjust your operations accordingly. Lastly, match these projections with your requested funding so investors understand why you’re requesting that specific amount.

Business Plan Template Examples

You can use a business plan template to write an effective business plan. These templates typically provide step-by-step instructions, or enough detail about each section, to help guide you through the process.

We’ve gone ahead and collected a few resources we believe in, and have provided them here for you:

• USBA Business Plan Template
• Bplans Business Plan Template for Small Business and Entrepreneurs
• Shopify Free Business Plan Template
• My Own Business Free Business Plan Template
• Score Business Plan Template for Startup Businesses

In conclusion

As tedious as it may sound, writing a great business plan can help convince others that you have a viable business idea on your hands.

With an excellent business plan, you’ll likely have an easier time getting people to work with you, whether as a fellow founder, an employee, or as an investor.

Lastly, even if you’re not actively seeking out funding, it’s an excellent exercise that will leave you understanding your business inside and out.

These articles are designed to be informational and do not represent legal advice. Before making any legal or financial business decisions, you should consult with a professional who can advise you based on your individual situation.

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Home » Sample Business Plans » Technology

A Sample Biotech Company Business Plan Template

Are you about starting a biotech company? If YES, here is a complete sample biotech business plan template & feasibility report you can use for FREE . Okay, so we have considered all the requirements for starting a biotech company.

We also took it further by analyzing and drafting a sample biotech company marketing plan template backed up by actionable guerrilla marketing ideas for biotech companies. So let’s proceed to the business planning section.

Why Start a Biotech Company?

No matter the profession you find yourself in, you can still become your own boss, as there are several business opportunities available in your field of study / training. In essence, if you are a scientist and you wish to start your own business, you can decide to start your own biotech company; it is an industry that is still green and open to creative scientist cum investors.

Starting a biotech company requires trainings, experience, creativity, reasonable startup capital, license and detailed business plan. The truth is that you can’t just wake up and launch your own biotech company; you must follow establish protocols.

This industry is highly regulated because of the potential risk involved; it is all about making use of living organism and system to develop new products. To start with, one might want to ask, what does biotech companies produce?

There are several fields that need the input of biotech companies. Fields like medicine and pharmacy, agriculture (hybrid food production, hybrid bird production and hybrid animal production et al.) and non-food industries (used in the production of biodegradable plastics and bio – fuels et al).

Although some people still have their reservation when it comes to the use biotechnology in agriculture, but the fact remains that it has contributed in no smaller measure in the increase and ease of cultivating crops and rearing of birds and animals.

If you are sure this type of business is what you truly want to do after you must have undertaken your research, the next step to follow is to write a good business plan. Below is a sample biotech company business plan template that will help you successfully write yours without much stress;

1. Industry Overview

Companies that operate in the Biotechnology industry primarily make use of living organisms or molecular and cellular techniques to provide chemicals, food and services that meet human needs. It is important to state that the Biotechnology industry does not include companies that are involved in developing small-molecule pharmaceuticals, performing contract research or manufacturing biological equipment.

A close study of the Biotechnology industry shows that the industry is growing rapidly, with revenue increases over the last five years driven by rising use of ethanol, demand for improved crop yields and the increasing medical needs of an aging population.

Even though the industry has grown, a consolidation trend has emerged as large pharmaceutical companies have increasingly targeted industry firms for acquisition, to expand their product portfolios ahead of impending patent expirations. Sustained spending on research and development, including by the federal government, will benefit the industry going forward, driving growth in revenue generation and of course profit.

The Biotechnology Industry is indeed a thriving sector of the economy of countries like Israel, Japan, India, China, United Kingdom, Germany and the united states of America. Statistics has it that in the United States alone, the industry generates a whooping sum of well over $109 billion annually from more than 2,230 registered and licensed biotechnology companies scattered all around the United States of America.

The industry is responsible for the employment of well over 218,610 people. Experts project the industry to grow at a 1.8 percent annual rate from 2011 to 2016. AbbVie, Amgen Inc., Genentech Inc., Monsanto and Gilead, have the lion share of the available market in the Biotechnology industry in the United States of America.

A recent report published by IBISWORLD shows that in the Biotechnology industry’s short history, its diversity of product offerings, markets, company sizes and funding sources have largely buffered it against major volatility from market fluctuations.

The report further stated that, high labor costs and the need for significant upfront investment in research and development (R&D) render the industry somewhat vulnerable to declines in venture capital and government funding. In the years following the recession, cutbacks across these funding sources caused industry revenue to fall.

However, growth boomed in 2015 as companies began to experience returns on their research, which can take years to develop into fully approved products. Capital markets have recovered from the recession, moderately improving the availability of industry investment capital.

The bottom line is that; the Biotechnology industry is still very much open for new entrant; the competition within the industry is not as stiff as similar industry. If your product is good, it can gain fair share of the available market in any country or region you intend launching the business.

2. Executive Summary

Bennie Polestar® Biotechnology, LLC is a licensed and standard generic biotechnology company that will be located in an industrial area in Saint Paul – Minnesota. We have been able to secure a long-term lease agreement for a facility in a strategic location with an option of a long-term renewal on an agreed terms and conditions that is favorable to us.

The facility has government approval for the kind of production business we want to run and the facility is easily accessible and we are deliberate about that because we want to facilitate easy movement of raw materials and finished products.

Bennie Polestar® Biotechnology, LLC is in the biotechnology industry to make use of living organisms or molecular and cellular techniques to provide chemicals, food and services that meet human needs. We will engage in DNA coding, mapping and sequencing, processing biotechnologies, sub cellular organisms engineering, cell and tissue culture engineering, protein sequencing, and synthesis and engineering.

We are also in business to make profits at the same to give our customers value for their money; we want to give people and businesses who patronize our biotech products the opportunity to be part of the success story of our brand.

We are aware that there are several big scale and small scale biotechnology companies scattered all around the United States and Canada whose products can be found in every nooks and crannies of The United States and Canada, which is why we spent time and resources to conduct our feasibility studies and market survey so as to enable us locate the business in an area that can easily accept our products and brand.

We ensured that our facility is easy to locate and we have mapped out plans to develop a far-reaching distribution network for wholesalers of biotech products all around Saint Paul – Minnesota and throughout the United States of America.

Much more than producing quality, effective and safe biotech products, our customer care is going to be second to none. We know that our customers are the reason why we are in business which is why we will go the extra mile to get them satisfied when they purchase any of our biotech product and also to become our loyal customers and ambassadors.

Bennie Polestar® Biotechnology, LLC will ensure that all our customers (wholesale distributors) are given first class treatment whenever they visit our factory. We have a CRM software that will enable us manage a one on one relationship with our customers (wholesale distributors) no matter how large the numbers of our customer base may grow to.

We will ensure that we get our customers involved when making some business decisions that will directly or indirectly affect them.

Bennie Polestar® Biotechnology, LLC is a family business that will be owned and managed by Dr. Bennie Polestar (PhD) and his immediate family members.  Dr. Bennie Polestar who is the Chief Executive Officer of the Company has PhD in Biotechnology.

He has well over 20 years of experience working in related industry as a senior production manager prior to starting Bennie Polestar® Biotechnology, LLC. He will be working with a team of professionals to build the business and grow it to enviably height.

3. Our Products and Services

Bennie Polestar® Biotechnology, LLC is going to run a standard and licensed biotechnology company whose products will not only be sold in Saint Paul – Minnesota but also throughout the United States of America and Canada. We are in the Biotechnology industry to make profits and also to give our customers value for their money.

We will ensure that we do all that is permitted by the law in the United States of America to accomplish our business goal and objective. These are some of the products that we will be offering;

• DNA coding, mapping and sequencing
• Processing biotechnologies
• Sub cellular organisms engineering
• Cell and tissue culture engineering
• Protein sequencing, synthesis and engineering
• Human health technologies
• Animal health, marine and terrestrial microbial technologies
• Environmental remediation and natural resource recovery
• Agriculture and aquaculture technologies
• Industrial technologies

4. Our Mission and Vision Statement

• Our vision is to establish a standard Biotechnology Company whose products will be not only be sold in Saint Paul – Minnesota, but also throughout the United States of America and Canada.
• Our mission is to establish a standard and world class Biotechnology Company / brand that in our own capacity will favorably compete with leaders in the industry. We want to build a business that will be listed amongst the top 20 biotechnology companies in the United States of America and Canada.

Our Business Structure

Bennie Polestar® Biotechnology, LLC is a business that is established with the aim of competing favorably with other leading biotech product brands in the industry. This is why we will ensure that we put the right structure in place that will support the kind of growth that we have in mind while setting up the business.

We will ensure that we only hire people that are qualified, honest, hardworking, customer centric and are ready to work to help us build a prosperous business that will benefit all the stake holders (the owners, workforce, and customers).

As a matter of fact, profit-sharing arrangement will be made available to all our senior management staff and it will be based on their performance for a period of five years or more depending how fast we meet our set target. In view of that, we have decided to hire qualified and competent hands to occupy the following positions;

• Chief Executive Officer (Owner)

Senior Research Fellow / Biotech Scientist

Human Resources and Admin Manager

Merchandize Manager

Sales and Marketing Manager

• Laboratory Assistant / Plant Breeder / Glass washer
• Accountants / Cashiers
• Customer Care Executive
• Distribution Truck Driver

5. Job Roles and Responsibilities

Chief Executive Officer – CEO (Owner):

• Increases management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities.
• Creates, communicates, and implements the organization’s vision, mission, and overall direction – i.e. leading the development and implementation of the overall organization’s strategy.
• Responsible for fixing prices and signing business deals
• Responsible for providing direction for the business
• Responsible for signing checks and documents on behalf of the company
• Evaluates the success of the organization.
• Responsible for research and development in collaboration with others on projects. He or she makes detailed observations, analyzes data, and interprets results. Research associates prepare technical reports, summaries, protocols, and quantitative analyses. An incumbent maintains familiarity with current scientific literature and contributes to the process of a project within his or her scientific discipline, as well as investigating, creating, and developing new methods and technologies for project advancement.
• Responsible for identifying patentable inventions and acting as principal investigator in conducting his or her own experiments.
• Performs a variety of greenhouse research tasks and experiments. He or she may be required to make detailed observations, detecting horticultural or pest problems, and instituting corrective action.
• Determine optimal cultural requirements and perform tasks related to disease and pest prevention; they often are required to collect, record, and analyze data, as well as interpret results. In addition, a greenhouse assistant may be called upon to perform troubleshooting and equipment maintenance.
• Participates in scientific conferences and contribute to scientific journals.
• Ensures operation of equipment by completing preventive maintenance requirements; calling for repairs.
• Ensures that the plant meets the expected safety and health standard at all times.
• Responsible for overseeing the smooth running of HR and administrative tasks for the organization
• Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
• Defines job positions for recruitment and managing interviewing process
• Carries out staff induction for new team members
• Responsible for training, evaluation and assessment of employees
• Oversees the smooth running of the daily office and factory activities.
• Manages vendor relations, market visits, and the ongoing education and development of the organizations’ buying teams
• Responsible for the purchase of raw materials and packaging materials
• Responsible for planning sales, monitoring inventory, selecting the merchandise, and writing and pricing orders to vendors
• Ensures that the organization operates within stipulated budget.
• Manages external research and coordinate all the internal sources of information to retain the organizations’ best customers and attract new ones
• Model demographic information and analyze the volumes of transactional data generated by customer purchases
• Identifies, prioritize, and reaches out to new partners, and business opportunities et al
• Responsible for supervising implementation, advocate for the customer’s needs, and communicate with clients
• Develops, executes and evaluates new plans for expanding increase sales
• Document all customer contact and information
• Represents the company in strategic meetings
• Helps to increase sales and growth for the company

Accountant / Cashier

• Responsible for preparing financial reports, budgets, and financial statements for the organization
• Provides managements with financial analyses, development budgets, and accounting reports; analyzes financial feasibility for the most complex proposed projects; conducts market research to forecast trends and business conditions.
• Responsible for financial forecasting and risks analysis.
• Performs cash management, general ledger accounting, and financial reporting
• Responsible for developing and managing financial systems and policies
• Responsible for administering payrolls
• Ensures compliance with taxation legislation
• Handles all financial transactions for the organization
• Serves as internal auditor for the organization

Client Service Executive

• Welcomes guests and clients by greeting them in person or on the telephone; answering or directing inquiries.
• Ensures that all contacts with clients (e-mail, walk-In center, SMS or phone) provides the client with a personalized customer service experience of the highest level
• Through interaction with clients on the phone, uses every opportunity to build client’s interest in the company’s products and services
• Manages administrative duties assigned by the manager in an effective and timely manner
• Consistently stays abreast of any new information on the company’s products, promotional campaigns etc. to ensure accurate and helpful information is supplied to clients
• Receives parcels / documents for the company
• Distributes mails in the organization
• Handles any other duties as assigned by the line manager

Laboratory Assistant/ Plant Breeder / Glass washer:

• Responsible for performing a wide variety of research laboratory tasks and experiments, making detailed observations, analyzing data, and interpreting results. He or she maintains laboratory equipment and inventory levels for laboratory supplies. He or she may also write reports, summaries, and protocols regarding experiments.
• Performs limited troubleshooting and calibration of instruments.
• Responsible for the design, development, execution, and implementation of plant breeding research projects in collaboration with a larger research team. He or she may be responsible for project planning and personnel management within the project. Plant breeders may use exotic germ plasma and work with various mating systems and integrate them with biotechnology as needed to enhance selection methods and accelerate product development.
• A plant breeder’s diverse responsibilities can include making contributions to and developing good public relations with scientific and other professional communities. He or she may also act as an adviser to company management about long-range goals for a plant breeding department. He or she may participate in the development of patents or proposals and assist with the management and development of a plant breeding group.
• Performs routine maintenance of glass-washing equipment and performs other related duties as required

Distribution Truck Drivers

• Assists in loading and unloading biotech products
• Maintains a logbook of their driving activities to ensure compliance with federal regulations governing the rest and work periods for operators.
• Keeps a record of vehicle inspections and make sure the truck is equipped with safety equipment
• Assists the transport and logistics manager in planning their route according to a delivery schedule.
• Local-delivery drivers may be required to sell products or services to pharmaceutical stores and businesses on their route, obtain signatures from recipients and collect cash.
• Transport finished goods and raw materials over land to and from manufacturing plants or retail and distribution centers
• Inspect vehicles for mechanical items and safety issues and perform preventative maintenance
• Complies with truck driving rules and regulations (size, weight, route designations, parking, break periods etc.) as well as with company policies and procedures
• Collect and verify delivery instructions
• Reports defects, accidents or violations

6. SWOT Analysis

We are quite aware that there are several biotechnology companies both large and small in the United States of America and Canada which is why we are following the due process of establishing a business so as to compete favorable with them. We know that if a proper SWOT analysis is conducted for our business, we will be able to position our business to maximize our strength, leverage on the opportunities that will be available to us, mitigate our risks and be welled equipped to confront our threats.

Bennie Polestar® Biotechnology, LLC employed the services of an expert HR and Business Analyst with bias in start – up business to help us conduct a thorough SWOT analysis and to help us create a Business model that will help us achieve our business goals and objectives.

This is the summary of the SWOT analysis that was conducted for Bennie Polestar® Biotechnology, LLC;

Part of what is going to count as positives for Bennie Polestar® Biotechnology, LLC is the vast experience of our management team, we have people on board who are highly experienced and understands how to grow business from the scratch to becoming a national phenomenon.

So also, our state of the art biotech machines and equipment, the wide varieties of biotech products that we produce, our large national distribution network and of course our excellent customer service culture will definitely count as a strong strength for the business.

A major weakness that may count against us is the fact that we are a new biotech company in the United States and we don’t have the financial capacity to engage in the kind of publicity that we intend giving the business especially when big names like AbbVie, Amgen Inc., Genentech Inc., Monsanto and Gilead et al are already determining the direction of the market both in the United States and in the global market.

• Opportunities:

The opportunities available to biotech companies with a wide range of products that cuts across many industries are enormous. As a result of that, we were able to conduct a thorough market survey and feasibility studies so as to position our business to take advantage of the existing market for biotech products and also to create our own new market. We know that it is going to requires hard work, and we are determined to achieve it.

We are quite aware that just like any other business, one of the major threats that we are likely going to face are economic downturn and unfavorable government policies. It is a fact that economic downturn affects purchasing power. Another threat that may likely confront us is the arrival of a new biotech company in same location where ours is located and where our target market exists.

7. MARKET ANALYSIS

• Market Trends

A close study of the trends in the Biotechnology industry shows that the industry is growing rapidly, with revenue increases over the last five years driven by rising use of ethanol, demand for improved crop yields and the increasing medical needs of an aging population.

The fact that there are several fields that need the input of biotech companies boost production makes it an industry that is worth paying attention to. Fields like medicine and pharmacy, agriculture (hybrid food production, hybrid bird production and hybrid animal production et al.) and non-food industries (used in the production of biodegradable plastics and bio – fuels et al).

8. Our Target Market

When it comes to selling biotech products, there is indeed a wide range of available customers. In essence, our target market can’t be restricted to just an industry, but all the industries that make use of biotech products. In view of that, we have conducted our market research and we have ideas of what our target market would be expecting from us.

We are in business to engage in developing and producing biotech products, marketing and distributing biotech products and gaining regulatory approval for biotech products. Hence our target markets are;

• Medicine and pharmaceutical manufacturing companies
• Hybrid food processing and production companies
• Hybrids crops cultivators
• Hybrid animal breeders
• Hybrid bird / poultry farmers
• Non – food industries (used in the production of biodegradable plastics and bio – fuels et al).

Our competitive advantage

A close study of the biotech industry reveals that the market has become much more intensely competitive over the last half decade. As a matter of fact, you have to be highly creative, customer centric and proactive if you must survive in this industry.

We are aware of the stiffer competition and we are well prepared to compete favorably with other biotech companies in Saint Paul – Minnesota and throughout the United States and Canada. Bennie Polestar® Biotechnology, LLC is launching a standard biotech product brand that will indeed become the preferred choice of residence of Saint Paul – Minnesota and every city where our biotech product will be sold.

Part of what is going to count as competitive advantage for Bennie Polestar® Biotechnology, LLC is the vast experience of our management team, we have people on board who are highly experienced and understands how to grow business from the scratch to becoming a national phenomenon.

So also, our state of the art biotech production machines and equipment, the wide varieties of biotech products that we produce our large and far reaching national distribution network and of course our excellent customer service culture will definitely count as a strong strength for the business.

Lastly, our employees will be well taken care of, and their welfare package will be among the best within our category (startups biotech companies) in the biotechnology industry, meaning that they will be more than willing to build the business with us and help deliver our set goals and achieve all our aims and objectives. We will also give good working conditions and commissions to freelance sales agents that we will recruit from time to time.

9. SALES AND MARKETING STRATEGY

• Sources of Income

Bennie Polestar® Biotechnology, LLC is established with the aim of maximizing profits in the biotech industry in both the United States of America and Canada and we are going to go all the way to ensure that we do all it takes to sell a wide range of biotech products to a wide range of customers.

Bennie Polestar® Biotechnology, LLC will generate income by selling the following biotech products;

10. Sales Forecast

One thing is assured when it comes to biotech company, if your products are meet the expected industrial standard and if your production plant is centrally positioned and easily accessible, you will always attract customers cum sales and that will sure translate to increase in revenue generation for the business.

We are well positioned to take on the available market in Saint Paul – Minnesota and every city where our biotech products will be sold and we are quite optimistic that we will meet our set target of generating enough income / profits from the first six month of operations and grow the business and our clientele base.

We have been able to critically examine the biotechnology industry and we have analyzed our chances in the industry and we have been able to come up with the following sales forecast. The sales projections are based on information gathered on the field and some assumptions that are peculiar to similar startups in Saint Paul – Minnesota.

Below is the sales projection for Bennie Polestar® Biotechnology, LLC, it is based on the location of our business and other factors as it relates to small scale and medium scale biotech company start – ups in the United States;

• First Fiscal Year-: $250,000
• Second Fiscal Year-: $550,000
• Third Fiscal Year-: $950,000

N.B : This projection is done based on what is obtainable in the industry and with the assumption that there won’t be any major economic meltdown and there won’t be any major competitor manufacturing same biotech products and customer care services as we do within same location. Please note that the above projection might be lower and at the same time it might be higher.

• Marketing Strategy and Sales Strategy

Before choosing a location for Bennie Polestar® Biotechnology, LLC and also the kind of biotech products we will produce, we conduct a thorough market survey and feasibility studies in order for us to be able to be able to penetrate the available market in our target market locations.

We have detailed information and data that we were able to utilize to structure our business to attract the numbers of customers we want to attract per time and also for our products to favorable compete with other leading biotech brands in the United States of America and Canada.

We hired experts who have good understanding of the biotechnology industry to help us develop

In other to continue to be in business and grow, we must continue to sell our biotech products to the available market which is why we will go all out to empower or sales and marketing team to deliver our corporate sales goals. In summary, Bennie Polestar® Biotechnology, LLC will adopt the following sales and marketing approach to sell our biotech products;

• Introduce our biotech products brand by sending introductory letters to Medicine and pharmaceutical manufacturing companies, Hybrid food processing and production companies, Hybrids crops cultivators, Hybrid animal breeders, Hybrid bird / poultry farmers, and Non – food industries (used in the production of biodegradable plastics and bio – fuels et al) and other stakeholders in Saint Paul – Minnesota and other cities both in the United States of America and Canada
• Engage in road show in targeted communities from time to time to market our products
• Advertise our products in community based newspapers, local TV and radio stations
• List our business and products on yellow pages ads (local directories)
• Leverage on the internet to promote and market our biotech product brands
• Engage in direct marketing and sales
• Encourage the use of Word of mouth marketing (referrals)
• Join local chambers of industry and commerce with the aim of networking and marketing our products.

11. Publicity and Advertising Strategy

In spite of the fact that our biotech manufacturing plant is a standard one with a wide range of biotech products that in few years from now will favorably compete with other leading brands in the industry like AbbVie, Amgen Inc., Genentech Inc., Monsanto and Gilead we will still go ahead to intensify publicity for all our products and brand. We are going to explore all available means to promote Bennie Polestar® Biotechnology, LLC.

Bennie Polestar® Biotechnology, LLC has a long-term plan of distributing our biotech products in various locations all around the United States of America and Canada which is why we will deliberately build our brand to be well accepted first in Saint Paul – Minnesota before venturing out. As a matter of fact, our publicity and advertising strategy is not solely for selling our products but to also effectively communicate our brand.

Here are the platforms we intend leveraging on to promote and advertise Bennie Polestar® Biotechnology, LLC;

• Place adverts on both print (community based newspapers and magazines) and electronic media platforms
• Sponsor relevant community programs
• Leverage on the internet and social media platforms like; Instagram, Facebook, twitter, et al to promote our biotech product brand
• Install our Bill Boards on strategic locations all around major cities in the United States of America and Canada
• Engage in road show from time to time in targeted communities
• Distribute our fliers and handbills in target areas
• Position our Flexi Banners at strategic positions in the location where we intend getting customers to start patronizing our products.
• Ensure that our products are well branded and that all our staff members wear our customized clothes, and all our official cars and distribution vans are customized and well branded.

12. Our Pricing Strategy

When it comes to pricing for products such as biotech products, there are two sides to the coin. We are aware of the pricing trend in the biotech industry which is why we have decided to produce various sizes of biotech products as regulated by the industry.

In view of that, our prices will conform to what is obtainable in the industry but will ensure that within the first 6 to 12 months our products are sold a little bit below the average prices of various biotech product brands in the United States of America. We have put in place business strategies that will help us run on low profits for a period of 6 months; it is a way of encouraging people to buy into our generic pharmaceutical product brands.

• Payment Options

The payment policy adopted by Bennie Polestar® Biotechnology, LLC is all inclusive because we are quite aware that different customers prefer different payment options as it suits them but at the same time, we will ensure that we abide by the financial rules and regulation of the United States of America.

Here are the payment options that Bennie Polestar® Biotechnology, LLC will make available to her clients;

• Payment via bank transfer
• Payment with cash
• Payment via credit cards / Point of Sale Machines (POS Machines)
• Payment via online bank transfer
• Payment via check
• Payment via mobile money transfer
• Payment via bank draft

In view of the above, we have chosen banking platforms that will enable our client make payment for biotech products purchase without any stress on their part. Our bank account numbers will be made available on our website and promotional materials to clients who may want to deposit cash or make online transfer for the purchase of our products.

13. Startup Expenditure (Budget)

Starting a standard biotech company is indeed a capital – intensive business. This is so because the amount required in setting up a biotech production plant is not a piecemeal. The bulk of the start – up capital will be sent on leasing or acquiring a facility, acquiring license and in purchasing biotech lab machines and equipment.

Aside from that, you are not expected to spend much except for purchase and servicing of distribution trucks, purchasing raw materials, paying of your employees and utility bills. These are the key areas where we will spend our start – up capital;

• The total fee for registering the Business in the United States of America – $750.
• Legal expenses for obtaining licenses and permits as well as the accounting services (software, P.O.S machines and other software) – $1,300.
• Marketing promotion expenses for the grand opening of Bennie Polestar® Biotechnology, LLC in the amount of $3,500 and as well as flyer printing (2,000 flyers at $0.04 per copy) for the total amount of – $3,580.
• The cost for hiring Business Consultant – $2,500.
• The cost for insurance (general liability, workers’ compensation and property casualty) coverage at a total premium – $2,400.
• The cost for payment of rent for 12 months at $1.76 per square feet in the total amount of $105,600.
• The cost for construction of a standard biotech lab / production plant – $100,000.
• Other start-up expenses including stationery ( $500 ) and phone and utility deposits ( $2,500 ).
• Operational cost for the first 3 months (salaries of employees, payments of bills et al) – $100,000
• The cost for start-up inventory (mixing, blending, compounding and packaging equipment, raw materials, and packaging materials et al) – $80,000
• Cost for store equipment (cash register, security, ventilation, signage) – $13,750
• Cost of purchase of distribution vans – $60,000
• The cost for the purchase of furniture and gadgets (Computers, Printers, Telephone, Fax Machines, tables and chairs et al) – $4,000.
• The cost of launching a website – $600
• The cost for our opening party – $10,000
• Miscellaneous – $10,000

We would need an estimate of $500,000 to successfully set up our biotech company in Saint Paul – Minnesota. Please note that this amount includes the salaries of all the staff for the first 3 month of operation.

Generating Funds / Startup Capital for Bennie Polestar® Biotechnology, LLC

Bennie Polestar® Biotechnology, LLC is a family business that is owned and financed by Dr. Bennie Polestar (PhD) and his immediate family members. They do not intend to welcome any external business partner which is why he has decided to restrict the sourcing of the start – up capital to 3 major sources.

These are the areas we intend generating our start – up capital;

• Generate part of the start – up capital from personal savings and sell of stocks
• Source for soft loans from family members and friends
• Apply for loan from my Bank

N.B: We have been able to generate about $200,000 ( Personal savings $150,000 and soft loan from family members $50,000 ) and we are at the final stages of obtaining a loan facility of $300,000 from our bank. All the papers and document have been signed and submitted, the loan has been approved and any moment from now our account will be credited with the amount.

14. Sustainability and Expansion Strategy

The future of any business lies in the numbers of loyal customers that they have the capacity and competence of the employees, their investment strategy and the business structure. If all of these factors are missing from a business (company), then it won’t be too long before the business close shop.

One of our major goals of starting Bennie Polestar® Biotechnology, LLC is to build a business that will survive off its own cash flow without the need for injecting finance from external sources once the business is officially running. We know that one of the ways of gaining approval and winning customers over is to sell our biotech products a little bit cheaper than what is obtainable in the market and we are well prepared to survive on lower profit margin for a while.

Bennie Polestar® Biotechnology, LLC will make sure that the right foundation, structures and processes are put in place to ensure that our staff welfare are well taken of. Our company’s corporate culture is designed to drive our business to greater heights and training and re – training of our workforce is at the top burner.

As a matter of fact, profit-sharing arrangement will be made available to all our management staff and it will be based on their performance for a period of three years or more. We know that if that is put in place, we will be able to successfully hire and retain the best hands we can get in the industry; they will be more committed to help us build the business of our dreams.

Check List / Milestone

• Business Name Availability Check: Completed
• Business Registration: Completed
• Opening of Corporate Bank Accounts: Completed
• Securing Point of Sales (POS) Machines: Completed
• Opening Mobile Money Accounts: Completed
• Opening Online Payment Platforms: Completed
• Application and Obtaining Tax Payer’s ID: In Progress
• Application for business license and permit: Completed
• Purchase of Insurance for the Business: Completed
• Leasing of facility and construction of standard biotech lab / production plant: In Progress
• Conducting Feasibility Studies: Completed
• Generating capital from family members and friends: Completed
• Applications for Loan from the bank: In Progress
• writing of business plan: Completed
• Drafting of Employee’s Handbook: Completed
• Drafting of Contract Documents and other relevant Legal Documents: In Progress
• Design of the Company’s Logo: Completed
• Graphic Designs and Printing of Packaging Marketing / Promotional Materials: In Progress
• Recruitment of employees: In Progress
• Purchase of the needed biotech machines and equipment, furniture, racks, shelves, computers, electronic appliances, office appliances and CCTV: In progress
• Creating Official Website for the Company: In Progress
• Creating Awareness for the business both online and around the community: In Progress
• Health and Safety and Fire Safety Arrangement (License): Secured
• Opening party / launching party planning: In Progress
• Establishing business relationship with Medicine and pharmaceutical manufacturing companies, Hybrid food processing and production companies, Hybrids crops cultivators, Hybrid animal breeders, Hybrid bird / poultry farmers, and Non – food industries (used in the production of biodegradable plastics and bio – fuels et al): In Progress

More on Technology

Business Plan Template for Biotech Startups

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Business Plan Template for Biotech Startups Benefits

A Business Plan Template for Biotech Startups provides numerous benefits for founders and entrepreneurs in the biotech industry, including:

• Streamlining the process of creating a comprehensive business plan specifically tailored for the biotech sector
• Ensuring all essential components, such as scientific discoveries, R&D plans, and commercialization strategies, are included
• Helping founders present a clear and compelling case to potential investors, increasing the likelihood of securing funding
• Assisting in the validation of business ideas and strategies, setting the foundation for successful execution
• Providing a framework for financial projections, enabling founders to make informed decisions and attract necessary resources.

Main Elements of Biotech Startups Business Plan Template

ClickUp's Business Plan Template for Biotech Startups provides a comprehensive framework to help you outline your scientific discoveries, research and development plans, and commercialization strategies. Here are the main elements of this template:

• Custom Statuses: Track the progress of each section of your business plan with statuses like Complete, In Progress, Needs Revision, and To Do, ensuring that you stay on track and meet your goals.
• Custom Fields: Use custom fields such as Reference, Approved, and Section to add important details and categorize information within your business plan, making it easy to track and organize.
• Custom Views: Access five different views, including Topics, Status, Timeline, Business Plan, and Getting Started Guide, to visualize your business plan from different angles and gain valuable insights into its progress and overall structure.

With ClickUp's Business Plan Template for Biotech Startups, you can confidently present your ideas and strategies to investors, securing the resources needed to bring your biotech venture to life.

How To Use Business Plan Template for Biotech Startups

If you're a biotech startup looking to create a comprehensive business plan, follow these four steps using ClickUp's Business Plan Template:

1. Define your vision and mission

Start by clearly defining your vision and mission for your biotech startup. What problem are you aiming to solve? What is your long-term goal? This will help guide your business plan and provide a clear direction for your company.

Use the Docs feature in ClickUp to write down your vision and mission statements.

2. Identify your target market and competitors

Next, conduct thorough market research to identify your target market and understand your competitors in the biotech industry. Determine your unique selling proposition (USP) and how you can differentiate yourself from other companies.

Create tasks in ClickUp to track your market research and competitor analysis.

3. Develop your product or service

Outline the details of your biotech product or service in your business plan. Explain how it addresses the needs of your target market and how it provides a solution to their problems. Include information about your technology, intellectual property, and any regulatory considerations.

Use the Table view in ClickUp to create a detailed product development plan and track key milestones.

4. Create a financial plan

Finally, develop a comprehensive financial plan for your biotech startup. Include projected revenue, expenses, and cash flow projections. Identify potential funding sources and outline your plan for profitability and growth.

Use the Goals feature in ClickUp to set financial targets and track your progress towards them.

By following these steps and utilizing ClickUp's Business Plan Template, you can create a well-structured and comprehensive business plan for your biotech startup.

Get Started with ClickUp’s Business Plan Template for Biotech Startups

Biotech startup founders and entrepreneurs can use the Business Plan Template for Biotech Startups in ClickUp to streamline the process of creating a comprehensive business plan that will attract investors and secure resources for their ventures.

To get started, hit “Add Template” to sign up for ClickUp and add the template to your Workspace. Make sure you designate which Space or location in your Workspace you’d like this template applied.

Next, invite relevant members or guests to your Workspace to start collaborating.

Now you can take advantage of the full potential of this template to create a winning business plan:

• Use the Topics View to organize your plan into different sections, such as scientific discoveries, research and development plans, target markets, commercialization strategies, and financial projections.
• The Status View will help you track the progress of each section, with statuses like Complete, In Progress, Needs Revision, and To Do.
• The Timeline View will allow you to visualize the timeline of your business plan and set deadlines for each section.
• The Business Plan View will give you an overview of your entire plan, allowing you to easily navigate between sections and make updates.
• Use the Getting Started Guide View to access helpful resources and tips on how to create a successful business plan.
• Customize the template by adding custom fields like Reference, Approved, and Section to provide additional context and information.
• Collaborate with team members and stakeholders to gather input and feedback on each section of your business plan.
• Monitor and analyze progress to ensure that your business plan is comprehensive, compelling, and investor-ready.
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Guide to the ALM Capstone Project

Customstyles.

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Capstone Idea Generation

Business plan.

Think about how your idea for a new company, drug, diagnostic, or medical device could be described in a one-page executive summary. This will serve as the introductory section of your soon-to-be developed business plan. It will include a description of the idea, possible source(s) of funding, market demand, competition, and growth potential. A good summary will describe why your idea has potential for profit and success, and how it will solve a problem related to human health.

From the summary, you'll need to develop a “pitch” to potential investors. Think about how to attract interest for start-up capital from a financial investor or scientist. In other words, you should not only think about the scientific relevance for your idea, but how to convince others that your innovation is worthy of financial support. Remember that the audience for the pitch are likely those who have limited scientific training; therefore, you'll need to ensure that you use persuasive language in layman's terms.

For an overview of biotechnology business plans, we recommend that you visit Nature.com link, Writing Your Business Plan

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• Intellectual Property Rights in Biotech

/ Article

Building effective business development in pharma.

By  Mark Lubkeman ,  André Kronimus , and  Filip Hansen

At a time of rapidly evolving scientific breakthroughs and, coincidentally, of the expiration of many blockbuster drug patents, the key to innovation and revenue growth is pharmaceutical business development. While some innovation and new revenue can come from internal pipelines and assets, business development teams are under intense pressure at most companies to supplement internal efforts with external licensing agreements and M&A. Unfortunately, those teams are frequently unable to deliver the transactions needed for innovation and growth.

Often a major reason for this shortfall is that executive team members are not fully aligned on the role of business development in achieving the company’s strategic priorities. They may agree in theory that business development should pursue partnerships, ecosystems, and collaborations, but that consensus falls apart when it comes to making decisions about specific deals.

We have identified six success factors that enable more rapid and effective decision making, which, in turn, will lead to substantially enhanced business development performance.

Subscribe to our Biopharma E-Alert.

Biopharma m&a and licensing remain strong.

Biopharma M&A deal value more than doubled between 2017 and 2019, from $138 billion to $336 billion, and valuations reached all-time highs. Most of those deals involved midsized biotech companies, for which the average premium paid was close to 70%, with an average EV/sales multiple of nearly 8x. All in all, close to 60% of new therapeutic drugs in the last five years have been externally sourced.

The COVID-19 pandemic slowed biopharma M&A activity in 2020, especially in the first half of the year. But since the core drivers of deals remain intact—scientific breakthroughs, expiring patents, and an increasing focus on key therapeutic areas or on modalities such as cell and gene therapy—deal activity will continue to rebound. A recent example is AstraZeneca’s acquisition in late December of Alexion for $39 billion.

Moreover, biopharma companies can finance transactions cheaply with today’s very low interest rates. They also have significant financial resources to pursue business development. BCG’s ValueScience team estimates that the top 20 biopharma companies have more than $700 billion in cash, short-term investments, and additional debt capacity. But as a result, many companies are pursuing the same assets, driving up valuations and the risk of overpaying.

Six Success Factors for Pharma Business Development While we focus here on M&A, the six success factors we have identified will enable business development teams to create value through both M&A and licensing. (See Exhibit 1.)

1. Prioritize what business development needs to accomplish for the company. Executive team members often have differing views about how to prioritize business units, technology areas, and technology platforms and what types of deals to pursue (early- versus late-stage R&D deals, for example, or transformative versus tuck-in acquisitions). To ensure alignment, it’s critical that team members agree on how and where they want to create value. Will they use business development to generate near-term revenues or to build the pipeline for future innovation? Will they seek to maximize the core, expand into adjacent markets, or explore new frontiers? (See Exhibit 2.)

As part of this prioritization process, the executive team needs to regularly review and agree on how much revenue growth the current internal portfolio or pipeline will deliver. Only then can it determine the revenue gaps that business development needs to address in which specific therapeutic areas or modalities—and with what urgency. It’s astonishing how often management teams are misaligned on this simple setting of objectives, which often results in business development teams wasting time assessing opportunities that are fundamentally unattractive to the executive team and will never get approved. To avoid such situations, the team should ask itself two key questions about every transaction early on: What revenue gap will the transaction fill? And who on the executive committee will champion the transaction from start to finish? By forcing these decisions early, the team can avoid a lot of wasted time.

2. Build relationships with prospective targets. Executive teams should commit to building relationships with potential partners or acquisition targets for two or three years. Proactive sourcing, screening, and relationship building are far better for deal execution than simply showing up at the target’s headquarters with a banker and an offer. An established relationship will give a prospective buyer an edge over other bidders, perhaps even preempting the bidding process altogether. Such relationships can also accelerate due diligence.

Active engagement with potential targets over several years also gives companies a better grasp of the range of potential deals available. It might, for example, make a pharmaceutical company more likely to take small equity stakes in a number of promising biotechs, perhaps supporting Phase 1 trials with its own clinical and regulatory expertise.

3. Agree on how to assess value. Depending on one’s assumptions when valuing a target, the same transaction may seem spectacularly attractive or exceptionally unattractive. So teams need to agree about how they will value all aspects of each deal and then apply that valuation with discipline. Too often, companies end up redoing their analysis and engaging in repetitive decision making because they haven’t agreed on valuation approaches or metrics from the start.

One common valuation pitfall is to focus only on core asset value, that is, the value of the cash flow generated by current and future products in the market. Valuation models need a wider lens, encompassing multiple dimensions of value, including the following:

• Synergies. What is the value of cost, revenue, and capability synergies across the value chain—for example, in R&D, manufacturing, and sales?
• Platform Value. What is the value of the future products a technology platform might make possible?
• Strategic Value. What is the value of preempting a competitor from acquiring an asset, gaining access to a large proprietary data set, or being recognized as a leader in an emerging field?

Because these advantages are less tangible than core assets, large swings in valuation are possible depending on the underlying assumptions. We have found that companies with a clearly defined and endorsed valuation approach are able to use a common “language” in their deliberations, leading to better, faster decision making. These advantages are amplified when the company is highly transparent about the underlying assumptions and entertains a range of scenarios and associated probabilities.

4. Define integration issues early. Executive and business development teams are frequently so focused on due diligence and valuation that they don’t consider the integration process until after a term sheet has been signed. Integration issues should be considered at the outset, when assessing the deal’s attractiveness and viability, and in parallel with due diligence. Teams should ask such questions as: Will the acquired company be a distinct entity or be integrated into the acquiring company? What governance will be applied to the acquired assets? How will cost synergies factor into the valuation?

Knowing the answers to these questions early on is critical to realizing the full potential of the transaction. Our research shows that successful integration can drive 8% to 10% more value compared with the average transaction. Planning for that success right from the start is essential.

5. Enable agile business development teaming and governance. Even when a company has a clear vision for the transaction, it still needs an agile process and governance to execute the deal quickly and effectively. But because the business development process is highly cross-functional (and often involves many junior-level people), it can be unclear who has the authority to make decisions and who will provide the necessary analytical resources. In addition, preexisting governance committees (such as executive committees) often meet too infrequently to keep up with the fast pace of business development decision making.

To address these challenges, we recommend three best practices:

• Designate resources. Within each function, several senior staff members with business development experience and authority should be on call. This will help build continuity and organizational learning.
• Establish clear processes and responsibilities. All members of a business development project team should be aligned on processes, deliverables, and timelines. That should include who is responsible for what and who has what decision rights. For example, who in R&D will calculate the probability of success of a specific asset under review?
• Create nimble governance. A few members of key governance committees should meet more frequently than the entire group (perhaps even on a weekly basis, depending on deal volume) and have the authority to mobilize the entire committee within 24 or 48 hours if there’s an urgent issue to be addressed.

6. Design an organizational structure suited to strategic priorities. Because companies have different revenue gaps and objectives and use business development in different ways, there is no single “right” organizational structure. One company might focus on early-stage and another on late-stage acquisitions. One company might be looking for deals to strengthen the core business, another to build up new therapeutic areas. A company’s business development organization must be suited to its strategic purpose, whatever that may be. There are three main approaches (with various permutations) to consider:

• Centralize business development in one group. A central function maximizes scale, alignment of activities, and resource prioritization. This setup works well for companies looking to make relatively few late-stage or transformative acquisitions.
• Separate R&D and commercial transactions. Assessing an early-stage R&D acquisition requires a different mix of expertise than assessing a late-stage, commercial acquisition. When a company intends to pursue both types of transactions, it’s best to keep at least some of these due diligence activities separate. But such companies can still centralize certain functions—valuation modeling, for example—in order to maximize scale.
• Separate by business lines or therapeutic areas. It can be sensible to separate business development activities by business lines or therapeutic areas at different levels of maturity. This arrangement works well if a company has a mature business area looking for transformative deals and a smaller business unit looking for technology platform acquisitions. Here again, certain aspects of the business development process, such as valuation modeling, can be centralized for scale and efficiency.

Current market conditions present unique opportunities to tap into external innovation and drive revenue growth, but the inherently complex and cross-functional nature of business development makes it difficult for many pharmaceutical companies to execute effectively. As a result, these companies are not winning the transactions necessary for future success. We believe that the six success factors described above can significantly improve business development capabilities and are worth serious consideration by management teams.

Managing Director & Senior Partner

ABOUT BOSTON CONSULTING GROUP

Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders—empowering organizations to grow, build sustainable competitive advantage, and drive positive societal impact.

Our diverse, global teams bring deep industry and functional expertise and a range of perspectives that question the status quo and spark change. BCG delivers solutions through leading-edge management consulting, technology and design, and corporate and digital ventures. We work in a uniquely collaborative model across the firm and throughout all levels of the client organization, fueled by the goal of helping our clients thrive and enabling them to make the world a better place.

© Boston Consulting Group 2024. All rights reserved.

For information or permission to reprint, please contact BCG at [email protected] . To find the latest BCG content and register to receive e-alerts on this topic or others, please visit bcg.com . Follow Boston Consulting Group on Facebook and X (formerly Twitter) .

What Is Next

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Biotech Business Plan Sample

Published Jul.15, 2016

Updated Apr.19, 2024

By: Noor Muhammad

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Table of Content

Biotechnology has helped to improve the lives of millions if not billions of people from all across the globe. The high demand for biotech products and services has resulted in an influx in the number of individuals want to venture into this industry. If you are planning to travel this road, it is important that you hire an expert to write a professional business plan for biotech for you.

For many years, OGSCapital has been helping entrepreneurs like you who have a goal and a dream to run a profitable business succeed. One of the corner pillars that our biotech startup business plan service packages are founded on is professionalism. Over the years, we have worked smart to come up with a set of protocols and processes that enable us to deliver nothing but the best biotech startup business plans to our clients. Our team undertakes regular training courses that help them to stay abreast of the new business plan writing techniques. Unlike other business writing firms, we do not use or have any business templates in our possession. Instead, we use our deep understanding of the business world and inherent ability to write quality biotechnology business plans.

Here are the primary reasons why you need an expertly written biotechnology business plan.

Scale up existing business.

If you already have a business already, but you want to focus on biotechnology to scale it to greater heights, you can do that by using a business plan as the roadmap to your success. The plan will clearly articulate the specific amount of resources that you should allocate to the new business as well help you create a winning strategy to help you achieve your short and long-term goals and objectives. Our professional business analysts, researchers, and writers will come together and write a quality business plan that will elevate the business to the next level.

Support Loan Application

Submitting loan application forms to the financial institution or individual lender does not guarantee you financing. You need to show the bank or investor that you have what it takes to ensure that the biotech business takes off successfully and becomes profitable. Ultimately, the bank will need you to service the loan, and the investors will want a return on the investment group with a business plan after a given period.

When you contact us, we will carefully evaluate your business proposal and come up with a plan that you can present to the finances as proof that you are committed and capable of establishing and running the business like a professional in the biotech industry. The business plan for biotech company will cover all the main point and explain why your idea is feasible to the investors.

Chronologic Steps of Creating a New Business

One of the major hurdles that companies are faced with when launching a new business is knowing the specific steps that they should take to avoid pitfalls and regrets along the way. By trusting a legally accredited and reputable business writer with your plan, you will be able to identify the right steps that you should take during the initial stages and even after the business is fully operational. For instance, we will use of expertise, knowledge, and skills to determine the specific resources that you will need at every stage of the business. We will also go an extra mile and explain to you some of the scenarios that you can expect along the way and how you should respond to them.

Guidance When Hiring Professionals

It is not possible to biotech company on your own. You need to have a team of experts to help you make solid decisions that will catapult and point your business in the right direction. For example, you need accountants to help you budget and file tax returns at the end of the financial year correctly. The company will also need a group of legally accredited and reputable attorneys to deal with all legal matters. With a group of committed, highly trained and well-educated business plan biotech writers and consultants on your side, you will be able to know the professionals that you should hire.

The plan will also give you clear guidelines on how to go about the hiring process to get the best candidates from the job market. If you need expert assistance to interview applicants, our experts can come to your rescue and conduct the interviews for you without charging you a fortune.

Bring On Board Business Partners

If you want to scale up the business faster and more conveniently, it is recommended to look for business partners who can work with you to establish and grow the business. The ideal partners should have similar business goals and objectives as you, and committed to ensuring that the business achieves the set goals and objectives. With a biotech startup business plan roadmap, you will be able to discuss all the business strategies with the partners before signing the agreement. To avert any inconveniences along the way, our team can come in and collect all the views and recommendations put across by the partners and use them to come up with a comprehensive and implementable plan for the company.

Cementing New Business Deals and Alliances

Once the business is up and running, many enterprises will present proposals to join you as business partners. It is paramount to make sure that such alliances are made diligently and carefully to ensure that all the decisions agreed upon in the boardroom meets are informed and incapable of spelling doom for your business.

We take pride in the fact that we have a task force of professionals who have the past helped oversee alliance business meetings. Using their vast knowledge and understanding of the process, they will help you make intelligent decisions. We will also give you a detailed plan on how to set targets for the new partnerships as well as recommend the most appropriate channels that you should use to communicate with the alliances to foster good co-existing and a favorable working environment.

Propose Professional Ways of Dealing with Displacement

Displacement is a valuable and an essential business concept that you need to understand and deal with professionally at different stages of the business growth. Our business experts will help you to understand the plausible active and negative impacts that this concept could have on your business. They will also give you a set of clear recommendations to help you deal with displacement like a professional. All this information will be chronologically included in the business plan. For more details about this practical business concept, contact us today. We will also give you a few biotechnology business plan examples to help you understand the concept better and how it can affect your business.

Raising enough capital to meet all the business operating costs is a major problem to most startup in the biotechnology industry. We can assist you to jump this hurdle by not only giving you ideas on where you can get financing. Our financial experts will also help you manage the capital that you get from investors and financial institutions in form of loans well.

Here are tips for raising startup capital for your new biotech startup business. We have tested and used them in the recent past to secure capital for our clients.

Get to Know the Investor Audience

This is one of the most crucial yet a staggering number of people who want to venture into the biotechnology pay little attention to. The two ways of knowing your audience are by evaluating the investor’s firm and the partner which in this case is you. The ideal investment firm should have at least managed to raise a fund over the last four years or so. If not, there is a high probability that they are just out to meet you to stay relevant and credible in the market. Our professionals will give you a list of investment firms that are trusted and reliable. We also help you write a credible business plan to increase your chances of getting funding.

Understand your Strengths and Weakness

Excellent work.

excellent work, competent advice. Alex is very friendly, great communication. 100% I recommend CGS capital. Thank you so much for your hard work!

The most successful companies in the world today are owned and managed by business experts who understand their strengths and weaknesses. You need to have a vivid mental picture and understanding of what you are and what you are not. Trying to do everything in this industry is counterproductive and will most likely result in wastage of resources. Focus on one thing and be true to it. Unlike other business writing firms that shoehorn business plan biotechnology templates to a conventional biotech startup script with the hope that it will appeal the investors is a prescription for failure.

Our expert business plan writers will help you to discover your strengths and weakness. They will work smart and hard to come up with a script that is based on an in-depth understanding of the target audience and your capabilities.

Base your Business Valuation Expectations on the Current Economy

Just a few years ago, the world economy collapsed and depressed virtually all valuations of biotech startups business. Luckily, the current lively IPO market is encouraging investors to channel money to the future biotech businesses across the globe. The current market clearing price is the right valuation for your startup. That said; it is important to note that the current market trends are very volatile. They can change at any time, and so it is imperative to put in place plans for ensuring that your business stands the test of time when the economic tide changes course. We will help you come up with an accurate valuation that will promote sustainability of your business. To do this, our professionals will spend time evaluating the current economy and the various factors that have a direct impact on the success of companies in this niche.

How you introduce the Business to Venture Firms Matters

Gone are the days when cold calling would help a new business to get funding. Another strategy that is no longer relevant is hiring an investment advisory firm to help you raise your first round of financing in a bid to get to the top level venture firms. Use your creativity and zeal to come up with a unique and exciting way of introducing your business idea to the trading partners or investment firms that you want. This being probably your first time to try this new method of presenting your company to venture firms, it is understandable to be confused at first. However, that should not hold you back. We will help place you miles ahead of the competition by giving you tested and proven ways of introducing yourself to venture firms.

Consider the Long Term Capital Needs of your Business and its Liquidity Paths

If you look at the biotech startup business plan example that we sent you, you will clearly see the great lengths that our teams go to create a long-term business plan for our clients. In addition, we make sure that the plan puts into consideration the liquidity paths. One of the strategies that we use to ensure that the plan is as close to reality or the situation on the ground as possible is by coming up with plausible descriptive scenarios of a liquidity event that could rock your business such as an IPO. Our business consultants will carry out liquidity and funding analysis and use the results to come up with a solid plan that you can count on to safeguard the financial stability of your business.

Focus on Science and Research Studies Data

One of the main reasons why most biotech business plans fall short of expectations is because they concentrate on discussing why particular conditions such as heart failure and Alzheimer are “big” diseases that need to be resolved. The venture firms that you want to engage most likely have this information. To avoid your proposal being rejected, you should focus more on the investment decisions. The investor needs to know that the company will have a real positive impact on patients. We will help you do this by professionally framing your business plan. We will also collect, analyze, and layout the data supporting your business idea in a thoughtful and easy to understand way.

Take Legal Advice Seriously

Skimping on legal advice when laying out the foundations for your business will make it difficult to achieve your entrepreneurial skills. Nothing compromises a new biotech business fundraising momentum during the initial stages than weak corporate fundamentals, cap tables, unusual structures, and poorly designed licensed agreements. By hiring us, we will make sure that all legal matters are well-taken care of. Over the years, we have fostered good working relationships with experts in the biotechnology industry whom we reach out to for advice when writing business plans.

Also, our legal team of experts will carefully review the options and the proposed license framework before submitting it to the venture firms to ensure that it meets all the requirements. Doing so will greatly help in ensuring that your business succeeds and eliminate unnecessary hurdles along the way.

Laser Sharp Understanding of Risk Management and Mitigation Mechanisms

Just like any other business venture, you will need to take calculated risks once in a while. Knowing how to mitigate the risks will help your business to stand the test of time. Our risk management experts will help you come up with the plans. We will also create a “de-risking” timeline to encourage investors to come on board and invest in your company before the next risk reduction phase. Concisely, we will craft a business plan that will paint a thoughtful image of your company to the venture firms.

In a nutshell, here is what you can expect from us:

• A team of hired trained business consultants and business plan writers who are committed and determined to ensure that you succeed
• Unbiased, professional, and diligent engagement
• Accurate and implementable recommendations
• Timely completion and submission of the business plan to investors
• In-depth research and market analysis before we make any recommendations or embark on writing the business plan

Indeed, when starting a biotech business, it is paramount to have a team of reliable, experienced, and professional business consultants, OGSCapital, on your side to make the right decisions. We do not outsource projects to third parties as we have the skills and ability to get the job done not only within the agreed timeframe but also correctly. For more details about the company and the services that we offer, do not hesitate to contact our able support team by filling the contact us form. Feel free also to request for a biotechnology business plan example to get a clearer understanding of our capabilities.

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• v.25(21); 2014 Nov 1

How to start a biotech company

The spirit of life science entrepreneurship is alive and well, with outstanding innovation hubs arising throughout the country and the world. Of note, many of these hubs flourish in close proximity to research universities. If universities are the engine for discovery, then startups are the vehicle for innovation. The creativity and drive of young researchers has the potential to explore novel or underserved applications and revolutionize industries.

INTRODUCTION

With the current exuberant energy surrounding biotech entrepreneurship, it is hard to believe that the industry is close to 50 years old. Much has changed since Herb Boyer, a professor at the University of California, San Francisco (UCSF), and Bob Swanson, a young entrepreneur and aspiring venture capitalist, started Genentech in 1976, giving rise to the entire biotechnology industry. Back then, spinning out a company was limited to faculty members or experienced biotechnology professionals. Today, the democratization of life science entrepreneurship is allowing graduate students and postdocs to apply their scientific expertise toward the commercialization of newly developed technologies. Much like the path of a PhD project, the life of a science startup is not straightforward, but there are some common milestones from birth to growth and success ( Figure 1 ).

Life of a science startup.

THE BIRTH OF A STARTUP

In 2009, Dan Widmaier was a fifth-year graduate student at UCSF in the area of synthetic biology. His research was centered on engineering Salmonella to produce and secrete spider silk. Spider silk protein has incredible tensile strength, being stronger than steel and tougher than the body armor and tire material Kevlar. Despite these properties, the silk extraction process has remained incredibly labor-intensive for hundreds of years, limiting its use mostly to luxury textiles. Dan saw an opportunity to use synthetic biology to streamline the production and extraction of spider silk. He convinced his lab-mate and collaborator Ethan Mirsky and microfluidics expert David Breslauer, then a graduate student at the University of California, Berkeley, to join him in creating a new company, and Refactored Materials was born in 2009. The team successfully applied for small business grants from the National Science Foundation and Department of Defense with their proposal for producing spider silk from engineered microbes for ballistic armor and medical device applications. The company started their operations out of a single bench in an incubator space at UCSF called the QB3 Garage. Since then, Refactored Materials has successfully raised two venture rounds and is going after the textile market, a much larger market than originally anticipated that has seen little innovation since Lycra in the 1950s. In a few years, expect your athletic clothes to be more breathable, your socks to be softer, and your silk garments to be more durable, all thanks to three grad students with a vision to change the world, one spider dissection at a time.

TURNING RESEARCH INTO AN AGENT OF CHANGE

There is no question that having a meaningful impact on society is a powerful driver for scientists. It is not surprising that so many of the discoveries that have improved our society by increasing efficiency, adding capabilities, and bettering health have come from basic research done in universities. Universities, however, are not equipped to fully translate technologies out of the academic lab into the market, and a separate vehicle is needed to truly fulfill the promise of societal impact. Certain efficiencies in the industry environment are rare in academia. This has been the case since Genentech's inception and remains true today, a reminder for young scientists and future entrepreneurs that industry is the conduit for translational applications.

Startups are the vehicle needed for this translation for three key reasons. First, startups can address key technical risks and arrive at go/no-go decision points with relatively low amounts of capital and close to no overhead. Of importance, thinly capitalized startups are incentivized to listen to their investors and advisors and act swiftly, a feat that is easily said but more rarely achieved in the academy. If the startup wishes to survive, the achievement of milestones is not optional. Thus every experiment is tailored at answering go/no-go questions. Data must be not only publication worthy, but, more important, worth millions of investors' dollars and years of work. Second, founders must constantly assess risk, and a thorough study is essential to select the best market for a technology with several potential applications. The selective pressures for an early stage startup are extremely high when all the contributors to a viable business model are considered. These pressures enable a competitive marketplace for the best ideas. In such a marketplace, the startup structure allows for the ability to “pivot”—to remain nimble as the business model evolves. Startup founders can ensure that the technology has a viable market and create a validated plan to get there. Third, startups allow the correct alignment of incentives for their founders in terms of real-world impact and financial return. Students and postdocs are at a point in their careers at which they can dedicate the time to build this opportunity, something that faculty founders usually cannot do. Science startups often involve the original inventors behind the innovation—postdocs or graduate students who can easily address key proof-of-concept questions and develop the original technology. In most cases, it was at the hands of these young scientists that the invention materialized, so the sense of ownership is strong, and they remain very passionate and motivated to see their work address a real-world need (and reap the benefits of their effort).

ADVICE POINTS

At QB3, the California Institute of Quantitative Biosciences, we have helped more than 200 teams of scientists start companies through the Startup in a Box Program. Of these teams, 65 have successfully raised funds within the first 18 months of coming to QB3 for help. Two-thirds of the teams come directly from academia, with postdocs or graduate students at the helm. Following are some lessons for the life science entrepreneur-to-be.

Identify the unmet need that your technology addresses

The best way to articulate your solution and the value of your approach is to clearly state the problem you are solving. It is important to solve a problem you are passionate about, but there must be a large enough market for this technology; in other words, make sure that there are enough people who care about this problem enough to pay for your solution. Going after a small or niche market is acceptable, too, but your sources of capital will be fewer, and you will need to clearly articulate how your company can even recover its costs. When looking for your market, “don't be a hammer in search of a nail”; that is, be objective when identifying a need instead of trying to make your special interest into a market that might never exist.

Build a high-quality, well-rounded team

No startup was ever created by a single person. When starting a company, find one or more cofounder(s) with complementary skill sets. For example, if you are a cancer biologist and your idea is to develop new cancer therapeutics, find someone with pharmacology or drug development experience. If you have a clinical background and want to develop a medical device, find an engineer. In the case of Refactored Materials, Dan had the chemistry know-how, Ethan brought in the electrical engineering and operational expertise, and David was able to spin fibers thanks to his microfluidics background. Having a cofounder has multiple benefits, from expanding the company's skillset, to having a sounding board and accountability partner, to showing investors that you can work with others.

Having a well-rounded team with the best people you can recruit is a key asset for a startup. Faculty cofounders commonly remain involved as advisors or board members. If your team is made up of academics, it can be extremely helpful to find an experienced entrepreneur or executive with startup experience. A youthful team is great, but an experienced person will help anchor the team and give you credibility in front of investors. The same goes for qualified mentors and advisors: everyone in your team should be passionate about the company's vision and mission.

Understand incentives, and use them to drive your company to success

Once you have put your all-star team together, make sure the people involved are incentivized to do their best work for the company. At the very early stage, you will not have the funding needed to steal your colleagues away from a salary in industry, consulting, or any salary for that matter. Therefore you give equity or shares in your company tied to a vesting schedule, allowing your cofounders and early employees to participate in the ownership of your company. Initially these company shares will be worth very little, but the idea is to incentivize high-quality work that will drive up the value of the shares with a large potential up-side to the shareholders. Equity is also a vehicle to recruit an experienced entrepreneur, senior advisor, or consultant with unique expertise to help your company.

Get quality legal advice

A good lawyer will become a key advisor in the early stages of your company, so it is crucial to seek out quality legal advice in the field of your startup (a lawyer with experience in real estate can help little when it comes to a company inventing cardiovascular implants). Yes, it is pricey, but you really get what you pay for, so it is worth spending slightly more to set up the foundation of your company correctly. Many large law firms have special incentives for startups, often with fees deferred until a funding event happens. In terms of company formation, make sure you choose the company structure that fits your business model best. For example, if you will need to incentivize early advisors with equity and if you will need to seek private capital to bring your product to market, a C-corporation makes more sense. If you will be operating as a service and do not depend on raising investor dollars, you might consider a Limited Liability Corporation (LLC). A “quick and dirty” online site to register your company may seem appealing now, but try to avoid it—fixing all the problems later will cost more money, and it will create unnecessary paperwork and transactions.

Your intellectual property (IP) is also one of your most valuable assets, so make sure you secure it early and well. If you are filing your own patent, craft the claims so that your technology is protected as broadly as possible; if you are licensing IP (for example, from a university), do this early and seek your lawyer's counsel to make sure the license terms are acceptable.

Money, money, money—search under every rock

There are many sources of early-stage funding: Small Business Innovation Research (SBIR)/Science and Technology Translation Research (STTR) and other federal grants, angels, venture capital (VC), foundations, crowd funding, friends, and family. Explore them all, but be prepared to roll up your sleeves and write some grants. SBIRs and STTRs are grants by any federal government agency that has an annual budget larger than $100 million. Familiar sources such as the National Institutes of Health, National Science Foundation, Department of Defense, and Department of Energy participate and provide these types of grants. The process is involved and competitive, but many successful companies, including Refactored Materials, started on the backs of these grants. Most VCs and angels have moved farther down the pipeline to where the technology has been de-risked, so government grants are certainly worth your time and effort. As an example, one-third of Startup in a Box graduates started operations on the back of SBIRs.

Finally, leave no rock unturned. It is always helpful to start building relationships with your potential future investors to understand what is needed for a “yes” later on and ask for advice before asking for money (the old adage, “if you want money, ask for advice,” is certainly true in the early-stage investment world).

Respect your investors

Research your investors before meeting with them. Find out what their investment interests are and in which space they usually participate. This will help you spin your story appropriately in terms of specific application (if you have several possible ones), amount to ask for (some large investors cannot give you seed money), and your use of the funds.

Sooner or later, you will run into the rumor that you should not talk science with investors. Know that this is just a myth; sophisticated life science investors will want to understand the technology into which they are putting their cash. In the words of engineer and statistician William Edwards Deming, “In God we trust, all others must bring data.”

Your investors will know more about the market than you will. This means that you do not need to dwell on the point that cancer is an important problem. Listen to your investors' advice even before they become your investors. Their insight can help you identify opportunities and refine your strategic thinking.

Be unfocused at the beginning, but learn to identify opportunities

This advice applies to technologies with more than one application, such as platform technologies; in such situations, it might be difficult to pick which application or market to pursue first. It is useful to think of having a strategy that includes an earlier or easier path to revenue. Large markets may be alluring as a first battlefield, but they are often plagued with regulatory and market risks. Find out whether there is a better route to establish your proof of concept, even if it is in a smaller market. Having a direct path to market will allow you to move quicker on fewer funds; this will make it easier to tackle the larger and more challenging market later on. Refactored Materials realized that ballistic armor and medical devices would be challenging markets to crack, and they received much interest from the textile industry. The door is open to come back to the other applications in the future, but the silk textile market is primed for disruption.

Identify your white-hot risk, and use your time wisely

There are many risks in the way of taking a scientific technology to market: technical/scientific risk, regulatory risk, market risk. Higher risk in any of these areas correlates directly with the difficulty of getting money (since the uncertainty of return on investment for investors is higher). Convincing investors to accept these risks strongly affects early stage companies, as they have the largest number of unknowns. Your goal as an entrepreneur is to focus on answering the questions that will help you address and decrease those risks. Understand what the major risks are that stand between you and getting to market, and focus your time on them.

Test and build your business model—no, you do not need a business person—yes, you can use a scientific approach, too

As a startup, one of your most important tasks will be to discover your business model, that is, how your company fits into the market. What is your value proposition? Who are your customers and partners? Do you understand how your product fits into the entire process or patient care procedure? If you are developing a diagnostic for a disease that has no current therapy, why will people be inclined to use (and pay for) your product? You might have answers to all these questions, but at the moment they are really just hypotheses. The best way to validate these and develop your business model is to talk to relevant partners directly in a process developed by Steve Blank and called “customer discovery” ( Blank and Dorf, 2012 ). The founders are the best people to do this validation, since they have a deep understanding of the technology and can make changes to the model (or pivot) if necessary. So, in Blank's words, “Get out of the building!”

Money is the lifeline of a startup, and you will never have enough. You must use it wisely when you have it, and take it whenever you can. Make a budget and prioritize to ensure that your resources are going toward your key activities, and follow this plan with superb execution: in other words, be a lean startup . For example, you do not need to hire a full-time business person from the beginning; instead find someone who is willing to work with your company as an advisor or interim CEO in exchange for equity and reduced (or no) pay. If they believe in your company, they will be incentivized to help the company grow.

When being lean, you often need to find a middle ground that allows you to focus on your core skills. Trying to save some money by attempting to cram “Accounting 101” might not be a wise use of your time. Conversely, you do not need to hire a full-time accountant; outsource the company's accounting work, and pay by the hour or service.

Tell a story without giving away your secrets

An idea alone is not enough to make a company; you need execution and feedback from others. You will need to learn how to talk about your idea without revealing the “secret sauce” with investors and potential partners: in fancy terms, this is called having a nonconfidential discussion. While you are in the process of filing a patent to protect your IP, it is useful to learn how to describe the problem you are solving and your approach without revealing confidential details. Being able to describe your idea in nonconfidential terms will also allow you to avoid having to ask for a nondisclosure agreement (NDA) when you have an introductory discussion with a potential partner. Oh, and whatever you do, don't ask VCs for an NDA for an initial pitch: they will not sign them, and it makes you seem naive.

Inform yourself

Staying informed is the key to success: talk to entrepreneurs in the field, and find resources at your institution (career office, technology transfer office, entrepreneurship groups) that can help you learn about entrepreneurship and connect with alumni who have started their company or joined a startup. Reach out to faculty who have founded companies, and try to get connected with the entrepreneurs that drove their company.

Do not give up, and get ready for the best roller coaster ride!

Despite the plethora of (at times daunting) things to think about, I have not yet met a single entrepreneur who regrets starting a company. There will be ups and downs, much as in academic science, but as with any goal worth pursuing, it will all be worth it. In the case of Refactored Materials, it will be revolutionizing a centuries-old industry by enabling spider silk production for multiple applications at a large scale and in an environmentally conscious way.

Acknowledgments

I acknowledge Douglas Crawford, Regis Kelly, Richard Yu, and Filip Ilievski for constructive discussions and thoughtful feedback on this Perspective.

Abbreviations used:

DOI:10.1091/mbc.E14-06-1162

• Blank S, Dorf B. The Startup Owner's Manual: The Step by Step Guide for Building a Great Company. Pescadero, CA: K&S Ranch Press; 2012. [ Google Scholar ]

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• Strategic Planning
• Published: June 2002

Writing your business plan

• Lorin Cohen 1  

Nature Biotechnology volume  20 ,  pages BE33–BE35 ( 2002 ) Cite this article

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Lorin Cohen describes what you need to include in your business plan to ensure that it is an effective tool for fundraising.

You have full access to this article via your institution.

After three years in the laboratory, your research team has made an unprecedented scientific breakthrough. Further evaluation confirms the value of this discovery, the potential of which is even greater than you first expected. In fact, the research has so much potential, you are certain investors and angels will be falling over themselves to fund your work and turn it into a commercial venture. Think again.

Like many other bioentrepreneurs, you are now about to experience one of the most challenging aspects of product development—securing the capital and resources needed to bring a technology to market. Although there will always be investors interested in exciting opportunities, you will have to be well prepared and patient to successfully raise capital today.

Commercialization of science, especially the development of a new drug, costs hundreds of millions of dollars and can take 15 years or more. The majority of these expenses are typically underwritten by outside sources, which must be solicited and secured by the management team. Whether you are soliciting venture capitalists, strategic partners, investment bankers, or private equity, you will need a business plan with which to initiate the dialogue.

However, most “professional” investors see more than a hundred plans every week—so if your plan does not grab the reader's interest, you may not even make it to the initial analysis round. To that end, it is imperative that your plan provide potential investors with confidence that your technology will lead to revenue, profit, and significant market share, based on the company's fundamentals and the marketplace.

Although each plan is as unique as the business it describes, there are key elements that should be present in any plan. Here we offer an overview of the most common topics and key strategic elements that should be included in your business plan. These suggestions are based upon a proven methodology that has been used to successfully complete hundreds of business plans over the past two decades (see also “ Business plan do's and don'ts ”).

Executive summary

Your plan should start with a brief (two- to five-page) summary providing the reader with a solid overview of your business. The opening paragraph should be strong, giving the reader an instant understanding of your ultimate goals. An effective summary should be able to stand alone, and should entice the reader without giving too much proprietary detail away. Specifically, an executive summary should include an overview of the technology, the company's near- and long-term objectives, the key points of the strategic plan achieve those goals, the revenue model, and summary financial projections.

The market section should discuss the parameters of the key sector in which the company operates. There may be many potential applications of your innovation, but if your parameters are too broad, most investors will see the flip side—that you will be spread so thin that you will not have enough resources to apportion a sufficient amount to each goal. Therefore, limit your efforts to one or two objectives in the near term.

It is also important that these sectors be well defined. Is the target market substantial and sustainable? Who are the customers—are they patients, doctors, drug manufacturers, clinical research organizations (CROs)? What trends and regulations might influence this sector in the future: for example, are certain brand-name pharmaceuticals soon to come off patent?

If there are no figures available for the size of the market in question, you can lead the reader to the appropriate conclusion using anecdotal information. For example, a client developing a new diagnostic for Alzheimer's disease cited the increasing size of the population of people over 65 years of age, as baby boomers reach the age of onset of the disease, as an indicator of the projected market.

Competition

Investors will expect you to be well informed about the competitive environment. Do not make the mistake of stating that you have no competitors—you certainly do. Your customers are already meeting their needs in some manner, even though they may not be achieving the level of satisfaction or efficacy that your new solution will provide. For example, the drug they take today may provide some relief for their symptoms, whereas your pill will eliminate them. Perhaps your diagnostic is accurate in 98% of cases, as compared with the competition's 87% accuracy rate.

Your objective in the business plan is to illustrate the current unmet need within the market and how your product fills this gap. Specifically, explain how your product is, for example, faster, more reliable, and more cost-effective than what is already available and how those advantages will benefit the user and other members of the market, making a clear case that there is a demand for this benefit. For example, you would not be justified in taking five years and $100 million to develop a digital thermometer for consumers that is accurate to the thousandth of a degree. It is also important that you indicate how long you anticipate maintaining your competitive advantage; for example, you may hold a patent that puts you 18 months ahead of the competition.

You are probably thinking, “At last, science, that's the easy part”; but remember your audience. You are writing a business plan, not a white paper or peer-reviewed journal article. Whereas you want to generate interest in, and support for, your work, the readers of this business plan are looking for evidence that your technology could generate income—the more, and the sooner, the better.

You will certainly need to describe your technology within the business plan; however, it should be explained in clear, familiar terms. Like most bioentrepreneurs, you are likely quite passionate about your technology, having lived with it for quite some time. It might be best to have a “detached” party read the science section before you submit your plan. Make sure they can understand it and can recount it to you accurately.

A strategy for growth

The strategy for the growth of the company is the essence of your business plan. How are you going to achieve your goals? How will you differentiate your product from the competition? What efforts are you going to undertake in the pursuit of these objectives? Common activities include the sale of a product in less regulated international markets, pursuit of licensing agreements in unrelated sectors, securing “fee-for-service” research contracts, establishing joint ventures with strategic partners, and the like. Each campaign must be geared toward achieving the company's long-term objectives.

Be specific—establish milestones that can be measured. Investors will want to know how long their financial contributions will last you, and what they will be used for. Your chance of success with investors improves substantially if they feel you can account for the funds. Thus, if you tell investors you need $2 million to hire a manager to take a product into phase 3 trials, recruit patients, and commence manufacturing of the product for these trials, and you achieve those objectives within the budget, they are far more likely to provide you with additional capital when you move on to the next phase of development. If you miss the mark and do not accomplish your goals, you will have to return to your supporters hat in hand, and spend much time explaining your shortcomings rather than your successes.

Investors will also want a detailed account of how much capital you need, the timing of the infusions, and your intentions for “their” money. Be sure that all items discussed in your growth strategy are accounted for in the projections. What will additions to the management team cost (e.g., benefits, stock options, advisor fees)? What are the expenses associated with engaging an experienced CRO? What type of travel will be required to oversee your operations in, say, the Pacific Rim? What will it cost you to manufacture your product under Good Manufacturing Practice guidelines so that you can complete phase 3 trials? If you are fortunate enough to have an application that is or will soon be generating revenue, what is or will be your revenue model (product sales, licensing fees)?

Often the best way to get a handle on these expenses is to tie them together in a flow chart. Map out each of the activities necessary to achieve your goal and assign a cost to every one. This will enable you to visualize and prioritize all the efforts that must be undertaken to reach your goals. Do not forget to include the day-to-day expenses, or “burn rate,” associated with running your operation. Often companies underestimate these needs during a time of growth. How much space will you need for another laboratory to initiate testing of a new compound, and can a team of three truly oversee your national sales drive effectively?

It may be a cliché, but it is true that whereas some investors bet on the horse, others bet on the jockey. You should therefore show that you have a management team with the skill set necessary to execute the action plan, and that they have the necessary commitment to succeed. Provide short biographies of key members of senior management and key advisors, including all relevant experience and associations. It is not, however, necessary to provide a 12-page résumé on each board member; that information can be forwarded to interested parties on request.

Financial projections

The financial projections essentially present your business plan in dollars and cents. You should include three- to five-year “Statements of Operations and Cash Flow.” If your company is beyond the research and development stage (that is, it is operational and is generating revenue), you will also want to include a balance sheet.

Potential investors will want to see financial projections; however, they may be equally interested in the underlying assumptions. An investor reviewing your plan may have questions regarding your projections, and if they have to contact you to ask questions and review figures, that may be enough of an inconvenience to stop the process. It therefore is critical that your plan include a comprehensive overview of the factors used to generate your projections. These figures do not need to be refined down to the cent, but they should enable the reader to determine, for example, your pricing, units sold, operating expenses, and items included in research and development costs.

This information enables the reader to challenge the projections provided, adjusting the assumptions based on their own experience. For instance, a potential strategic partner might evaluate your projections differently knowing that their purchasing capabilities would reduce the price of raw materials by 25%.

Final thoughts

Raising capital is a difficult and time-consuming task. Investors will not typically provide you with funding much beyond a 12–18 month horizon. They will likely feel that their funds will perform better under their own management rather than in your bank account. Because the expenses associated with the commercialization of a new technology typically range into the hundreds of millions of dollars, it is likely that you will have to go back to the “well” several times during your development process. Even if you find a powerful strategic partner with deep pockets, you will regularly have to justify your budgets. This process can be daunting, even for experienced business professionals, but a clear and concise business plan will serve you well in many ways. The mere exercise of creating one should provide you with insight into your company's strengths and weaknesses.

Be sure to get the input of key personnel in the various divisions of your business in writing the business plan, because if they do not “buy into” the plan, your chances of success are reduced. If you do not feel that your team is capable of developing an effective plan in a timely manner, do not hesitate to contract a professional to manage the project on your behalf. Professionally written plans are common within all industries and will serve you far better than an internally generated plan that is incomplete.

Finally, remember that this is a business plan —it is not scientific document and it is not written in stone. With an open mind and an aptitude for flexibility, you will be able to raise capital and pursue viable opportunities. The resulting document not only will be a valuable tool in raising capital, it can be used to secure strategic partners, recruit, and serve as an internal roadmap for growth.

Box 1: Business plan do's and don'ts

• Highlight the business opportunities associated with the venture's science

• Be realistic in establishing milestones

• Create the plan around “moderate” assumptions

• Plan an infrastructure that will accommodate growth

• Write clearly and use graphics when appropriate

• Mistake an exciting technology for a business

• Ignore the weaknesses in your company or plan

• Overlook the competition

• Include untruths, semi-truths, or wishful thinking

• Write anything you cannot defend in meetings with investors

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Cohen, L. Writing your business plan. Nat Biotechnol 20 (Suppl 6), BE33–BE35 (2002). https://doi.org/10.1038/nbt0602supp-BE33

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• Best Products

Best 20 Biotechnology Business Ideas with High Profit

• November 19, 2023
• by Next What Business Research Team

Biotechnology, a transformative field at the intersection of biology and technology, is driving innovation and reshaping industries. Entrepreneurs keen on venturing into the dynamic realm of biotechnology have a spectrum of opportunities to explore. From healthcare breakthroughs to sustainable solutions, here are some of the best biotechnology business ideas poised to make a significant impact:

What is Biotechnology?

Biotechnology is a dynamic and interdisciplinary field. It harnesses the principles of biology and technology to manipulate living organisms, cells, and biological systems for the betterment of humanity. The field of biotechnology involves a wide spectrum of applications, ranging from healthcare and agriculture to industry and the environment. Here’s an overview of the fundamental aspects of biotechnology:

a) Genetic Manipulation

Biotechnology often involves the alteration of genetic material, whether in microorganisms, plants, or animals. This can be achieved through techniques like genetic engineering, CRISPR-Cas9, and gene cloning.

b) Cell Culture and Tissue Engineering

Biotechnologists cultivate and manipulate cells in controlled environments to study their behaviour or create tissues for medical applications. This is crucial in regenerative medicine and the development of artificial organs.

c) Protein Expression

Biotechnology plays a vital role in the expression and production of proteins, including enzymes and therapeutic proteins. Recombinant DNA technology is commonly used to introduce foreign genes into host organisms for protein synthesis.

Applications of Biotechnology

Some of the major applications of biotechnology are the following:

• Pharmaceuticals: Biotechnology contributes to the development of biopharmaceuticals, including vaccines, monoclonal antibodies, and gene therapies.
• Diagnosis and Treatment: Molecular diagnostics, personalized medicine, and targeted therapies are outcomes of biotechnological advancements.

Agriculture

• Genetically Modified Organisms (GMOs): Biotechnology enhances crop traits for improved yield, resistance to pests, and adaptation to environmental conditions.
• Biofertilizers and Biopesticides: Microbial biotechnology provides eco-friendly solutions for soil fertility and pest management.
• Enzyme Technology: Industrial processes benefit from biocatalysts, such as enzymes, for efficient and sustainable production.
• Bioprocessing: Fermentation and other bioprocessing techniques are employed for the production of biofuels, chemicals, and materials.

Environmental Management

• Bioremediation: Biotechnological approaches aid in the cleanup of pollutants and contaminants in soil, water, and air.
• Waste Treatment: Microbial biotechnology contributes to the treatment of wastewater and the conversion of organic waste into useful products.

Research and Development

• Genomic Studies: Biotechnology facilitates genomic research, allowing scientists to sequence, analyze, and understand the genetic makeup of organisms.
• Stem Cell Research: Advances in biotechnology play a crucial role in stem cell research, with implications for regenerative medicine.

Why Start a Biotechnology Business?

Starting a biotechnology business is not merely a business venture. It is a commitment to shaping the future of science, healthcare, and sustainability. Entrepreneurs in the biotechnology sector are driven by a confluence of factors that make this field uniquely compelling. Here are compelling reasons to consider starting a biotechnology business:

• Biotechnology has the power to revolutionize industries
• Provide medical solutions
• Biotechnology in agriculture offers solutions for sustainable farming, crop improvement, and environmentally friendly practices.
• Provide cleaner, greener Solutions
• Biotechnology businesses can contribute to global health by developing vaccines, treatments, and diagnostic tools that address prevalent diseases and health disparities.
• Intellectual Satisfaction
• High growth potential

List of 20 Biotechnology Business Ideas

1. genetic testing services.

Offering genetic testing services that provide individuals with insights into their genetic makeup, health risks, and ancestry. This can include testing for hereditary diseases, personalized nutrition plans, and even genealogy services.

• Empower individuals to make informed health decisions.
• Taps into the growing interest in personalized medicine.

2. Precision Medicine Development

You can focus on the development of precision medicine, tailoring medical treatments to individual characteristics. It can be genetic makeup and targeted therapies for cancer and other diseases.

• Enhances treatment efficacy while minimizing side effects.
• Positions the business at the forefront of medical innovation.

3. Agri clinic

A small-scale Agri clinic or agribusiness centre is one of the best businesses in the biotechnology industry to start on agricultural land. Establishing agri clinics that provide agricultural consultancy services to farmers. This can include crop management advice, soil testing, nutrient deficiency charts, seed testing, pest control strategies, and the introduction of innovative farming techniques.

• Supports farmers with expert guidance.
• Creates a channel for disseminating agricultural innovations.

4. Biopharmaceutical Manufacturing

Establishing a biopharmaceutical manufacturing unit to produce biologics, including monoclonal antibodies, vaccines, and other therapeutic proteins. This is a critical sector within the pharmaceutical industry.

• Addresses the increasing demand for biologically derived drugs.
• Offers opportunities for collaboration with pharmaceutical companies.

5. Biodegradable Plastics Production

Leveraging biotechnology to develop and produce biodegradable plastics as an eco-friendly alternative to traditional plastics. This contributes to the reduction of plastic pollution.

• Aligns with global sustainability goals.
• Addresses environmental concerns associated with plastic waste.

6. Biofertilizer Manufacturing

This is one of the best-emerging businesses in the biotechnology industry. Biofertilizers are living microorganisms of bacterial, fungal, and algal origin. The awareness of using biofertilizers, among farmers is increasing rapidly. Biofertilizer manufacturing is very popular among profitable biotech business ideas in the agriculture sector. Apart from this, biofertilizers are essential items for organic farming. Some of the most popular biofertilizers are Rhizobium, Azotobacter, Azospirillum, Blue-green Algae, Phosphate solubilizing microorganisms, etc.

• Improves soil health and fertility.
• Reduces reliance on chemical fertilizers.

7. Biopesticide Manufacturing

Biopesticides are Plant Protection Products that contain Biological Control Agents (BCAs) as microbial, pheromones, and plant extracts. They are typically used in combination with conventional chemical pesticides in the framework of the Pest Integrated Management (IPM) to safeguard the health of the roots, the plant growth, and the quality of the crop, to reduce the occurrence of resistance and to lower residue levels.

• Addresses environmental concerns associated with chemical pesticides.
• Promotes integrated pest management.

8. Compost Fertilizer Production

You can initiate a compost fertilizer production unit in small towns, rural areas, and urban areas. You can start this business with crop waste, vegetable waste, and kitchen waste. Additionally, you can start the unit with a small capital investment. Read More…

• Converts organic waste into valuable fertilizer.
• Enhances soil structure and water retention.

9. Synthetic Biology Applications

Exploring synthetic biology applications to engineer biological systems for various purposes, such as biofuel production, industrial processes, and environmental remediation.

Offers innovative solutions to complex challenges. Explores the potential of bioengineering in diverse industries.

10. Stem Cell Therapy Clinics

Establishing clinics that specialize in stem cell therapies for various medical conditions. This includes regenerative medicine applications for tissue repair and disease treatment.

• Capitalizes on the growing interest in regenerative medicine.
• Addresses a range of medical conditions with innovative therapies.

11. Bioinformatics Services

Overview: Providing bioinformatics services that analyze and interpret biological data, especially in genomics and proteomics. This can include data management, analysis, and interpretation for research institutions and biotech companies.

Supports advancements in genomics and personalized medicine. Serves as a crucial component in drug discovery and development.

12. Agricultural Biotechnology Solutions

Developing biotechnology solutions for agriculture, such as genetically modified crops for enhanced yield, disease resistance, and nutritional value. This can also include sustainable agricultural practices.

Addresses food security challenges. Promotes environmentally friendly farming practices.

13. Microbial Bioremediation Services

Offering services that utilize microbial bioremediation to clean up environmental pollutants. This can include the remediation of oil spills, wastewater treatment, and soil restoration.

• Provides eco-friendly solutions to environmental challenges.
• Aligns with sustainability and corporate responsibility initiatives.

14. Neurotechnology Innovations

Venturing into neurotechnology to develop innovations such as brain-machine interfaces, neurostimulation devices, and diagnostic tools for neurological disorders.

• Contributes to advancements in neuroscience and neurology.
• Addresses the growing prevalence of neurological conditions.

15. Biodiesel Production

Bio-diesel production units can be established on a small-scale basis at any place where the main raw material Jatropha oil is easily available. Setting up a biodiesel production unit that utilizes crops or waste to produce biofuels. This promotes sustainable energy sources and reduces dependence on fossil fuels.

• Contributes to renewable energy solutions.
• Utilizes agricultural resources efficiently.

16. Food Processing

You can consider integrating biotechnological processes into food processing units. This can include developing genetically modified crops for enhanced nutritional content or using enzymes for food preservation.

17. Hybrid Seeds

The production of high-yield seeds is one of the most profitable businesses in the biotechnology industry. Good quality vegetable seeds, fruit seeds, and flower seeds are in high demand.

• Addresses the demand for high-yielding and resilient crop varieties.
• Supports sustainable agriculture practices.

18. Specialty Medicine Manufacturing

A Medicinal product is defined as any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances that may be administered to human beings to make a medical diagnosis or to restore, correct, or modify physiological functions in human beings is likewise considered a medicinal product.

• Provides targeted healthcare solutions for livestock.
• Explores the potential of biopharmaceuticals in animal health.

19. Vaccine Manufacturing

You can think of establishing a vaccine manufacturing unit for livestock to prevent and control diseases. This contributes to the overall health and productivity of agricultural animals. This business demands substantial capital investment even to start on a small scale.

• Enhances animal welfare and productivity.
• Addresses health challenges in the agricultural sector.

20. Vermicompost Production

You can Create a vermicompost production facility that utilizes earthworms to convert organic waste into nutrient-rich vermicompost. This supports organic farming practices. It is sometimes superior to chemical fertilizers for better crop growth and safe food production. The business is very profitable. You can start with a small capital investment.

• Produces high-quality organic fertilizer.
• Promotes sustainable waste management.

Related:  Top Agriculture Business Ideas 

Frequently Asked Questions

What qualifications or expertise do i need to start a biotechnology business.

Answer: While a background in biology, biochemistry, or related fields is advantageous, an entrepreneurial spirit and a passion for innovation are key. Collaborating with experts and staying informed about the latest advancements in biotechnology is essential.

How can I secure funding for a biotechnology startup?

Explore various funding options, including venture capital, government grants, angel investors, and partnerships with research institutions. A robust business plan outlining the potential impact of your biotechnology solution can attract investors.

Are there regulatory considerations for launching a biopharmaceutical manufacturing unit?

Yes, regulatory compliance is crucial. Work closely with regulatory authorities to ensure adherence to safety, quality, and ethical standards. Engage with professionals experienced in navigating the regulatory landscape.

What challenges might I face in the production of biodegradable plastics?

Challenges may include finding sustainable raw materials, achieving cost-effective production, and ensuring the biodegradability of the final product. Research and development are key to overcoming these challenges.

How can I stay updated on the latest advancements in bioinformatics for my services?

Subscribe to scientific journals, attend conferences, and engage with online forums and communities in the field of bioinformatics. Establish collaborations with researchers and institutions to stay at the forefront of advancements.

Is there public acceptance of genetically modified crops in agriculture?

Public acceptance can vary. Transparent communication about the benefits, safety measures, and ethical considerations of genetically modified crops is essential. Engaging with communities and addressing concerns contributes to public trust.

What are the ethical considerations in stem cell therapy clinics?

Ethical considerations include informed consent, patient privacy, and responsible use of stem cells. Adhere to ethical guidelines and collaborate with healthcare professionals to ensure ethical practices in stem cell therapies.

How can I ensure the environmental safety of microbial bioremediation services?

Conduct thorough research on the specific microorganisms used in bioremediation, their environmental impact, and potential risks. Collaborate with environmental scientists and regulatory bodies to implement safe and effective bioremediation solutions.

Are there intellectual property considerations in biotechnology businesses?

Yes, protecting intellectual property is crucial. Consider patents for novel inventions, trademarks for branding, and trade secrets for confidential processes. Consult with intellectual property professionals to safeguard your innovations.

How can I navigate the challenges of launching neurotechnology innovations?

Neurotechnology faces challenges related to ethical concerns, regulatory approval, and the complexity of the human brain. Collaborate with neuroscientists, ethicists, and regulatory experts to address these challenges responsibly.

• Seed & Series A pitch decks
• Series B pitch decks
• Late-stage funding rounds

See the presentations that cutting-edge biotech companies have used to raise millions from top investors

• Biotech startups have raised billions of dollars in an effort to transform medicine.
• Despite an economic downturn, biotechs are still getting interest from investors.
• Here are the presentations that biotechs used to win over investors and raise millions.

In 2020 and 2021 the pandemic fueled a massive boom in biotech investing — but 2022 was a different story. While funding for biotech companies soared in 2021 to nearly $47 billion, a record for the industry, 2022  marked a slowdown .

As the global economy becomes more uncertain, venture capitalists have become cautious about investing in startups of all kinds — including biotech firms . Some private biotechs are delaying going public , and even preparing to raise down rounds . By the end of 2022, the SPDR S&P Biotech ETF, a leading biotech index, was down 19% compared to the beginning of the year. 

Despite the market downturn, some companies are still raising sizable funding rounds. Investors have told Insider that they're favoring startups that have a solid plan to bring in revenue over companies that have cool but vague ideas. And some companies, like those based on gene-editing , are still thriving thanks to a breakneck speed of scientific discoveries. 

One key for all companies who want investor interest is a great pitch deck, the presentation that companies use to solicit funding from investors. Pitch decks, also known as slide decks, usually lay out the company's history, its achievements, and where it's heading.

Insider rounded up all the biotech pitch decks we've published, from those seeking early-stage funding to presentations for late-stage rounds, that have helped companies raise money from investors. 

In seed and Series A funding rounds, startups raise money to test their ideas

Seed and Series A funding rounds come at the early stages of a biotech company. The company may have an idea or some preliminary clinical data, but it still needs to vet its science more thoroughly. 

Some companies, such as 64x Bio, have newly identified a problem — in 64x Bio's case, drug-manufacturing bottlenecks — and have an idea for a plan that could fix it. This is the 10-slide presentation the company used to quickly raise $55 million .

Other startups, like the cancer-metabolism company Faeth Therapeutics, have shown promising results in lab tests and mice but not yet in humans. Check out the company's 17-slide presentation it used to raise $47 million .

Oftentimes, companies raising early funding rounds, like the biosensor company Monod Bio, hope the money can fund trials that will prove their science works. Monod used this 12-slide pitch deck to raise $25 million from investors .

See the 25-slide pitch deck a Baltimore biotech used to raise $56 million to develop a blood test that detects recurring cancer

A healthcare startup that wants to offer personalized treatments for depression just used this presentation to raise $14 million

See the 14-slide pitch deck that Meliora Therapeutics used to raise $11 million toward its search for more precise and effective cancer treatments

See the 23-slide pitch deck a software startup used to raise $6 million for its mission to make science faster, cheaper, and more transparent

A biotech trying to bring back the woolly mammoth just launched its first spinout company. See the 15-slide pitch deck Form Bio used to raise $30 million.

See the 11-slide presentation that sold General Catalyst on a 21-year-old founder's at-home lab-testing platform for Latin America

See the 27-slide presentation a secretive biotech startup backed by Sean Parker used to raise $40 million and 'open a new universe' in cancer immunotherapy

This 10-slide presentation convinced top VC firm NEA to invest $20 million in its first clinical-operations startup

See the presentation microbiome startup Seed Health used to raise $40 million

Related stories

See the 10-slide presentation a Mark Cuban-backed startup used to raise $20 million to develop a vertigo headband

By Series B funding rounds, biotech companies are trying to start human studies

By Series B rounds, startups are often raising large sums of money and focused on growth. Many times, the companies will use new capital to hire more employees or continue to bring drugs through clinical development. 

For instance, the Belgian biotech AgomAb told Insider it planned to use its new funds to extend the company's cash runway into 2024. Here's the 21-slide pitch deck the company used to raise $144 million from investors .

And the genetics startup Camp4 used an 18-slide pitch deck to raise $100 million and plans to start human testing in 2023. 

The cancer startup Affini-T Therapeutics also plans to have two treatments in human testing in 2023. Here's the 24-slide pitch deck the company used to raise $175 million from investors like Leaps by Bayer. 

A Y Combinator-backed startup just raised $39 million to develop new psychedelic treatments for depression

See the 13-slide pitch deck a biotech used to raise $120 million and write the next chapter in mRNA medicines

See the pitch deck a doctor used to sell his vision for an entirely new way of testing experimental drugs and win a $250 million valuation

See the 20-slide presentation this biotech startup used to raise $75 million for a way to treat blindness with CRISPR

Late-stage funding rounds prepare biotech startups to go public 

Series C, D, and even E funding rounds can help private biotechs get a reserve of cash before a public debut. The presentations used in these rounds often highlight the company's science and show investors what lies ahead. 

The funding rounds, such as Moderna's pitch to investors in 2017, can come shortly before plans to go public . Moderna made its public debut in 2018.

Some companies, like the cell-therapy startup Aurion, are almost ready to file for regulatory approval in certain countries. Here is the 24-slide pitch deck the company used to raise $120 million  and prepare for regulatory approval in Japan.  

In late-stage funding rounds, the investors might also be different or used to backing bigger companies. This is the 15-slide presentation that Deep Genomics used to secure $180 million funding from blue-chip investors, including SoftBank. 

A former Harvard chemist just raised $178 million for a biotech startup that plans to treat previously untreatable cancers

This 31-year-old CEO says staying focused on one disease was the key to helping his company raise $120 million in a frozen biotech market

See the 12-slide pitch deck a Flagship startup just used to raise $121 million to build an 'unlimited platform' for making new drugs

See the 14-slide pitch deck a French biotech just used to raise $86 million to pursue a twist on one of the hottest ideas in cancer research

See the 24-slide pitch deck a biotech startup used to sell investors on a new approach to AI in medicine and raise $110 million

See the 22-slide presentation an Israeli startup used to raise $45 million for an easier way to treat migraines

• Main content

Everything You Need to Know About Biotech Business Models

What’s my business model? Who do I partner with? How do I scale up? These are typical strategic questions a young biotech will regularly face.

The business model of a biotech company can determine its long-term trajectory to success. In this article, we’ll focus on a typical ‘platform’ biotech company in the biopharma sector whose intellectual property can be applied to a wide range of R&D programs.

These principles apply to a range of technologies including protein therapeutics, targeted drug delivery, computational drug discovery, gene therapy, RNA therapeutics, and stem cells , as well as platforms that unlock new insights into disease pathophysiology or novel drug targets.

Pure Play Models

Broadly speaking, a founder could adopt any one of these three pure play business models:

• Technology partnering: licensing your platform and providing related services to a biopharma company, which in turn uses your help to create, develop, and commercialize pharmaceutical products.
• Asset creation and out-licensing: using your platform to create a pipeline of proprietary assets, be it candidate drugs in the case of therapeutics or prototype formulations in the case of drug delivery. Once there is scientific proof-of-concept for an asset, it can be licensed to a biopharma company, which in turn develops it into a product for regulatory approval and subsequent marketing.
• Product development and commercialization: creating your own pharmaceutical assets and taking care of the whole development process until commercialization.

When adopting either the second or third approach, there is always the option to conduct a joint effort with a large biopharma, small biotech, or academic partner on a project-by-project basis. While these are the three key business models in biotech, in practice many established companies end up operating with a hybrid of all the above approaches.

Technology partnering

Once your technology has evolved sufficiently to reliably contribute to pharmaceutical R&D projects, you can generate immediate and significant income by licensing your platform and providing related services to the projects of better-funded biopharma companies. If you have limited financial resources or a low-risk appetite, this is your best option for getting started.

This is also the fastest route to validating your platform with both the investor and biopharma communities; an initial technology partnering deal with a well-known biopharma early in your company’s life will immeasurably enhance your credibility and bargaining power. An example is Mogrify, a UK-based startup developing stem cell technology. Just about a year after its seed round in 2019, the company signed a collaboration and exclusive licensing deal with Sangamo Therapeutics.

If you follow the model of technology partnering, your partner absorbs all the financial risk — the upfront licensing fee, fee-for-service revenue, and near-term preclinical milestone payments are earned irrespective of whether the project eventually results in an approved pharmaceutical product. While your partner will own any pharmaceutical assets and marketing authorizations that emerge from the project, you can typically earn small single-digit royalties on future sales of these products.

Asset creation and out-licensing

If you invest your own funds upfront to create proprietary pharmaceutical assets, you can then issue exclusive licenses to larger biopharma companies. The latter then becomes fully responsible for completing late-stage clinical trials, manufacturing scaleup, obtaining regulatory approval, and commercialization. A good example is Numab, a Swiss company that earlier this year, signed its second licensing deal with Japanese firm Ono Pharmaceutical, giving the company exclusive access to a cancer antibody treatment currently in development.

A key advantage of out-licensing, compared to technology partnering, is that the return on investment is higher if successful. The upfront fee and milestone payments are higher, and these deals often involve significant double-digit royalties on future product sales.

With appropriately negotiated deal terms, the upfront fee alone can recover most of your initial cash outlay for the asset, and the milestone payments can ensure a small positive return even if the subsequent commercial performance is not to expectations. Furthermore, this business model lets you leverage your partner’s late-stage development and commercial expertise, while transferring the cost and risk for these much more expensive stages to the partner.

In situations where your company is facing other competing technologies, creating your own pharmaceutical assets may be essential to differentiate yourself in a crowded arena. For example, in the area of targeted drug delivery, you might apply your technology to an off-patent active pharmaceutical ingredient, such as ibuprofen, to demonstrate superior performance compared to existing medicines. While this scenario generates a lower standalone financial return compared to novel applications, you may need successful projects of this type to support fundraising and attract more lucrative partnering opportunities on novel applications.

On the downside, this path takes more time, costs more money, and exposes you to a greater risk of financial loss compared to technology partnering. This model also requires significant expertise in disease biology and pharmacological screening. These can be obtained through in-house investment, external contract research organizations, or company acquistions.

An alternative option is to collaborate with another biotech or pharma company that has complementary capabilities and shares the cost and risk. For example, the UK-based biotechs Kymab and Heptares are collaborating to co-discover new cancer therapeutics using their complementary technologies.

Product development and commercialization

If you choose to develop a pharmaceutical asset on your own, you retain full ownership and prevent handing it over to another party. This business model requires either substantial investor backing or a well-established revenue stream, often coming from a sizeable portfolio of historical technology partnering and asset out-licensing deals.

The total financial return of this route is hugely greater if successful. Of course, the financial burden and risk exposure is also bigger. And even some well-established companies may lack the necessary expertise for late-stage clinical development, manufacturing scale-up, regulatory approval, payer reimbursement negotiations, commercial brand management and sales promotion. Most biotechs taking this approach mitigate these gaps with strategic alliances — for example, the one between the Belgian biotech Galapagos and big pharma Gilead to co-develop and co-promote the antiinflammatory drug filgotinib.

Hybrid approaches

Most young biotechs start with either the technology partnering or the asset creation and out-licensing approach. The former generates revenue faster with lower financial risk. With higher investor funding and a greater risk appetite, the latter generates a much better return if successful. In addition, this second option might be essential in a very competitive situation where you initially have to demonstrate technological superiority with your own pharmaceutical assets.

An increasing number of research-stage companies operate a hybrid business model that combines both these two approaches. For example, the US-Israeli company Intec Pharma offers technological partnerships around its drug delivery platform while in parallel developing its own pharmaceutical assets by applying the technological platform to established medicines.

Once you become more established, successful, and well-funded, you might want to gradually transition over time to the product development and commercialization model, as giants such as Genmab in Denmark and MorphoSys in Germany have done.

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Create An Effective Biotech Pitch Deck (Updated Dec, 2023) | Startup Guide + Template

December 26, 2023

Presentation and Pitch Expert. Ex Advertising.

$100mill In Funding. Bald Since 2010.

Picture this: a room full of eager investors, their pockets practically spewing money, waiting to be wowed by the latest and greatest in biotech.

You saunter towards the podium, armed with nothing but your wit, charm, and…a biotech pitch deck?

That’s right, folks!

It’s time to take your spectacular, groundbreaking discovery from the depths of your laboratory to the grand stage of high-stakes investment. It’s simple, really. 

To dazzle these deep-pocketed patrons, you need a biotech pitch deck that’s equal parts fascinating and persuasive. After all, the perfect concoction of cutting-edge science, lofty aspirations, and good old-fashioned showmanship can work wonders in securing that elusive funding.

But worry not, my brilliant, bio-savvy friends, for we have concocted the ideal recipe to create a pitch deck that will leave your audience enamoured, enthralled, and, most importantly, reaching for their check-books. 

Whassup, I’m Viktor, a  pitch deck expert ,  creative strategist  and burger lover. I’ve been a pitch deck expert for the past 10 years and helped clients raise millions and win pitches, with my unique approach to creating pitch decks.

I’ve had my fair share of pitching my own startups and know how difficult and time consuming can get, particularly if you don’t have a good presentation in your tool box.

With this short guide, you’ll be able to create a bulletproof SaaS pitch deck that makes a bigger kick than any anti viral cure out there in the market (too far?).

Let’s begin.

Book a free personalized pitch deck consultation and save over 20 hours of your time.

Join hundreds of successful entrepreneurs who’ve transformed their pitch decks with my help.

Let me develop an investor ready deck by using my hands-off approach, which includes: market research, copy, design, financials, narrative and strategy.

One week turnaround time.

The least you will get is 10 actionable tips & strategies to own that next presentation, worth $599, for free.

What Is A Biotech Pitch Deck Presentation?

A biotech pitch deck presentation is a visual, slide-based, communication tool that entrepreneurs use to persuade investors and other potential stakeholders to support their biotechnology start-up.

The pitch deck includes essential components, such as the problem that the biotech company aims to solve, the proposed product or service, the target market, the revenue model, and the financial projections.

Biotech pitch decks need to communicate complex scientific concepts and technical jargon effectively, highlight the potential of the company’s technology to change the market, and demonstrate the competence of the team in executing their business plan successfully.

A well-crafted pitch deck may attract funding from venture capital firms, angel investors or strategic partners, which can enable biotech start-ups to grow and develop their products more efficiently.

What Does A Biotech Pitch Deck Presentation Consist Of?

A Biotech pitch deck presentation typically consists of about 10-20 slides that provide an overview of the company’s technology, team, market opportunity, and financial projections. In general, the presentation:

• Starts with a compelling and concise introduction that grabs the attention of potential investors or partners
• Covers the company’s background and its value proposition, highlighting how its technology or product addresses an unmet need in its targeted market
• Includes details about the company’s management team, its scientific advisors, and any partnerships or collaborations it has established
• Wraps up with a financial overview, projecting the company’s revenue and expenses for the next few years, including any expected milestones or inflection points which could drive value for investors

What’s The Goal Of A Biotech Pitch Deck?

The goal of a Biotech pitch deck presentation is to provide a clear and compelling picture of how the company’s technology or product can deliver significant value to its target market and generate strong returns for its investors.

How To Create An Effective Biotech Pitch Deck? 11 Tips

Creating an effective biotech pitch deck requires strategic planning and attention to detail.

• Identify your audience
• Communicate your unique value proposition clearly and concisely
• Introduce your target market
• Highlight the problem you aim to solve
• Present your solution 
• Provide evidence of market demand and competition
• Highlight your competitive advantage 
• Focus on the science and technology behind your product and provide clear and compelling data
• Include a clear roadmap for the development and commercialization of your product or service
• Break down your financial projections
• Outline your team’s expertise and experience

A well-executed pitch deck can capture investors’ interest and help your biotech company secure funding.

Crucial Slides That Should Be Included In Your Biotech Pitch Deck Presentation

When creating a Biotech pitch deck presentation, there are certain slides you need to include to make the presentation effective such as:

Title Slide:

• Company Name and Logo
• Tagline or Slogan
• Presenter’s Name and Title

Slide 1: The Problem

• Define the challenges or gaps in the current biotech or life sciences industry
• Highlight the pain points experienced by your target patients or customers
• Use statistics or real-life examples to emphasize the magnitude of the issue

Slide 2: The Solution

• Introduce your biotech product, service, or technology as the answer to the problem
• Describe its unique features and benefits
• Explain how it differentiates from existing solutions in the market

Slide 3: Market Opportunity

• Present the size of the target biotech market
• Explain the growth potential and trends within the industry
• Identify your target customer segments

Slide 4: Business Model

• Describe how your company generates revenue
• Outline your pricing strategy and sales channels
• Provide an overview of any partnerships or strategic alliances

Slide 5: Regulatory Compliance and Intellectual Property

• Detail the relevant regulations, certifications, and licensing requirements for your business
• Explain your strategy for maintaining compliance and managing regulatory risks
• Highlight any patents, trademarks, or other intellectual property held by your company

Slide 6: Traction and Milestones

• Share key metrics that demonstrate market validation and traction
• Highlight notable customer successes or testimonials
• Outline significant milestones achieved and future milestones planned

Slide 7: Marketing and Sales Strategy

• Detail your customer acquisition strategy, including marketing channels and tactics
• Describe your sales process and customer retention initiatives
• Provide an overview of your marketing budget and expected return on investment

Slide 8: Competitive Landscape

• Identify your main competitors in the biotech industry
• Analyze their strengths and weaknesses
• Explain how your product, service, or technology differentiates from the competition

Slide 9: Management Team

• Introduce key team members, their roles, and their relevant experience
• Highlight any industry experts or advisors involved
• Describe how the team is positioned to lead the company to success

Slide 10: Financial Projections

• Provide a summary of key financial metrics (revenue, profit, expenses, etc.)
• Present a 3-5 year financial forecast
• Explain any assumptions or risks associated with your projections

Slide 11: Funding Request and Use of Funds

• State the amount of investment you are seeking
• Detail how the funds will be allocated (e.g., research and development, marketing, hiring, etc.)
• Explain how the investment will help your company achieve its goals

Slide 12: Exit Strategy

• Outline potential exit scenarios for investors (e.g., acquisition, IPO, etc.)
• Provide examples of recent exits within the biotech industry
• Estimate a timeline for a potential exit

Slide 13: Thank You and Contact Information

• Express gratitude for the audience’s time and consideration
• Provide contact details for further discussion or follow-up
• Include any relevant social media handles or website URLs

By including these slides, you can create a well-rounded pitch deck presentation that can help secure funding for your biotech project.

A Pitch Deck Idea To Inspire Your Inner Scientist

As always, here’s me with something I came up with while researching about a clients product once.

Slide 1: Title Slide

• Company Name: “GeneCure Therapeutics”
• Subtitle: “Revolutionizing Medicine Through Gene Therapy”

Slide 2: Biotech Concept

• Problem: Genetic disorders with limited treatment options and high medical costs.
• Solution: “GeneCure Therapeutics” is developing cutting-edge gene therapy treatments that address the root cause of genetic diseases, offering hope for patients and transforming healthcare.
• Key Focus: Precision medicine, gene editing technologies, and personalized therapies.

Slide 3: Target Market

• Patient Population: Specify the target patient population affected by the genetic disorders your gene therapy treatments address.
• Unmet Need: Highlight the lack of effective treatments or curative options for these genetic disorders.
• Market Size: Present market research data on the prevalence of the target genetic disorders and the potential market size.

Slide 4: Unique Selling Proposition (USP)

• USP: “GeneCure Therapeutics” combines breakthrough gene editing technologies, innovative delivery systems, and a patient-centered approach to provide targeted and long-lasting gene therapies.
• Competitive Advantage: Strong intellectual property portfolio, strategic partnerships, and a team of leading experts in gene therapy research.

Slide 5: Development Pipeline

• Outline the different gene therapy candidates in your development pipeline, along with their therapeutic indications and current stage of development.
• Highlight any regulatory milestones, successful preclinical studies, or ongoing clinical trials.

Slide 6: Monetization Strategy

• Licensing Partnerships: Collaborate with pharmaceutical companies to license and commercialize your gene therapy treatments.
• Royalties: Generate revenue through royalty agreements based on the successful commercialization of gene therapy products.
• Research Collaborations: Explore partnerships with research institutions to access funding, expertise, and shared resources.

Slide 7: Intellectual Property (IP)

• IP Portfolio: Highlight the patents, trademarks, and proprietary technologies that protect your gene therapy treatments.
• Competitive Landscape: Evaluate the IP landscape, highlighting any unique differentiators or advantages over competitors.

Slide 8: Regulatory Pathway

• Provide an overview of the regulatory process for gene therapy products, including interactions with regulatory agencies, FDA approvals, and compliance requirements.
• Detail any successful regulatory milestones achieved or ongoing discussions with regulatory authorities.

Slide 9: Clinical Data and Efficacy

• Showcase preclinical and early clinical data demonstrating the safety, efficacy, and potential benefits of your gene therapy treatments.
• Highlight any positive results, patient responses, or milestones achieved in clinical trials.

Slide 10: Next Steps

• Call to Action: Schedule a meeting to discuss potential collaborations, investment opportunities, or partnerships with pharmaceutical companies and research institutions interested in advancing gene therapy.

Remember, these examples are purely hypothetical, and you can adapt them to fit your unique biotech business idea. The key is to clearly communicate your biotech concept, identify the unmet medical need, showcase your unique selling proposition, and outline your development pipeline, monetization strategy, and regulatory pathway.

What To Keep In Mind When Creating Your Biotech Pitch Deck?

Creating a biotech pitch deck requires a clear understanding of the audience’s needs, as well as the key components necessary to create an exciting and compelling presentation.

One main thing to keep in mind when creating a biotech pitch deck includes providing a clear overview of your product, utilisation of visuals, and data.

It’s essential to articulate the core benefits of your product in a concise and straightforward manner, highlighting its unique features, and market advantage over competitors.

For instance, when presenting data, it’s crucial to ensure that the information presented is easy to digest, relevant, and compelling.

Hold on. You might want to check my list on the best presentation books. Why?

It’s 1O crucial books that will help you improve the design and structure of your presentations, besides improving its delivery. Check it out below.

Furthermore, it is vital to include any potential risks or setbacks that may come with the product in the pitch.

Overall, a well-designed Biotech Pitch Deck can be the key tool to help your company gain investors, partners, or even FDA approval. 

The Template For Your Biotech Pitch Deck Presentation

Would you rather spend time improving and upgrading your life saving startup or spend time developing slides?

My biotech pitch deck template is an innovative solution for entrepreneurs and startups in the biotech industry who need to showcase their products, services, and business plans. 

This template is a ready-made, professional presentation that includes all the necessary slides typically included in a pitch deck, such as market analysis, financial projections, team bios, and milestones.

The benefit of this template is that it saves time in the design process, which can be crucial when time is limited or when you need to create multiple presentations for different audiences. Additionally, the template also ensures that the presentation is visually appealing, easy to navigate, and appealing to potential investors and partners.

You can find tons of templates on sites like Canva, Slidesgo and Google Slides, but none of them will align with the truth of the brand you represent precisely.

What will happen is you’ll need to spend hours adjusting these templates to fit your brand guidelines. 

There’s a better way.

My clients have used my written template to craft a stellar SaaS pitch deck in half the time and designed a deck that secured their new funding.

Other Questions Biotech Experts and Founders Ask:

What is a pitch deck for biotech startups .

A pitch deck for biotech startups is a presentation that highlights the key aspects of a biotech startup, including its technology, market, business plan, and team.

It’s meant to provide potential investors with a clear understanding of the startup’s potential value and how it plans to achieve success. 

The pitch deck typically includes slides covering the problem the startup solves, the product or service it offers, the target market, competition, business model, marketing strategy, revenue projections, and financials.

The pitch deck is a critical tool for biotech startups as they seek to raise funds and attract partners or customers.

A well-crafted pitch deck can help a biotech startup gain credibility and interest from potential investors, leading to further discussions and potential financing opportunities.

How do you make a biotech pitch deck?

Making a biotech pitch deck requires careful planning and attention to detail.

The essential elements of a successful pitch deck include a compelling elevator pitch, a clear problem statement, a description of the biotech product or service, and a detailed business model. It is important to clearly outline the competitive landscape and the product’s unique value proposition, highlighting key features and benefits.

Additionally, incorporating a well-designed visual aid, such as infographics or images, can help to clarify complex scientific concepts and create interest in the product.

As the biotech industry continues to grow and evolve, it is becoming increasingly important to incorporate innovative technology and strategic partnerships into the pitch deck, emphasizing the potential for long-term growth and sustainability.

With a well-crafted pitch deck, biotech startups have the potential to attract funding, gain industry recognition, and ultimately succeed in bringing their innovative products to market.

How do you pitch a biotech company?

Pitching a biotech company can be a complex and challenging task. The primary goal is to communicate the company’s vision, mission, and technology to potential investors or partners.

Firstly, it’s important to highlight the scientific innovation behind the technology and its potential impact on healthcare, industry or the environment. 

Secondly, the team behind the company should be emphasized to assure potential investors that the management has the necessary expertise and experience to execute the business plan. Thirdly, the market potential and potential customers or partners should be identified and explained in a clear and concise manner.

Finally, a well-prepared presentation that conveys the key messages and value proposition should be delivered effectively. Overall, a successful pitch results from a combination of compelling storytelling, scientific depth, and a sound business plan with a realistic roadmap to generate revenue and ROI.

To help you improve your narrative, check this selection on the best books for pitching . The authors have won billions in $ thanks to their ability to create stories when pitching and are sharing their methods with you.

What nobody will tell you: Crucial considerations to keep in mind when developing your Biotech pitch deck and business

10 insights. These are things no advisor, startup event organizer or coach will tell you for free. We’ve done the research and combined it with our experience to give you these insights with no strings attached.

Market Analysis and Trends in Biotech: Key to Crafting a Persuasive Pitch Deck

Understanding the Biotech Landscape:

• Global Market Insights: Biotech is a rapidly growing sector. A detailed analysis of the global biotech market size, growth rate, and projections helps in understanding the potential market for your innovation.
• Sub-sector Analysis: Biotech encompasses various sub-sectors like pharmaceuticals, biomedicine, genetic engineering, etc. Identifying trends in your specific sub-sector is crucial for tailoring your pitch to address current needs and future opportunities.

Why This Matters for Your Pitch Deck:

• Investor Relevance: Investors seek opportunities in thriving markets. Demonstrating knowledge of market trends shows that you understand where your innovation fits and its growth potential.
• Competitive Landscape: Knowledge of existing competitors and market gaps allows you to position your innovation more strategically, highlighting its unique value proposition.

Research and Data Insights:

• Utilize industry reports from sources like IBISWorld, Statista, or Frost & Sullivan for the latest market data.
• Refer to publications like Nature Biotechnology or BioSpace for insights into current research and development trends.
• Analyze investment patterns in biotech startups from databases like Crunchbase or PitchBook.

Actions to Take for Your Pitch Deck:

• Market Size and Growth: Include current market size and projected growth in your pitch deck to show the economic potential of your innovation.
• Target Market Segmentation: Clearly define your target market segment within biotech, providing data to support why this segment is ripe for your solution.
• Competitor Analysis: Present a well-researched competitor landscape, showing how your product or solution differs and offers additional value.
• Future Trends: Highlight emerging trends in biotech that align with your project, indicating foresight and long-term viability.
• Case Studies and Success Stories: Reference successful companies or products in your niche, drawing parallels to your own project to build credibility.

Regulatory Landscape and Compliance: Navigating Through Biotech’s Legal Framework

Understanding Biotech Regulations:

• FDA Regulations and Guidelines: The U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating biotech products, especially in pharmaceuticals, medical devices, and food safety. Familiarity with FDA approval processes is crucial.
• Global Regulatory Variations: Biotech companies often aim for a global market. Understanding regulatory differences in key markets like the EU, Asia, and others is vital for a global strategy.

Why Regulatory Knowledge is Crucial for Your Pitch Deck:

• Investor Confidence: Demonstrating a clear understanding of regulatory pathways reassures investors that you are prepared to navigate these complex processes.
• Risk Management: Highlighting how you plan to manage regulatory risks can set your pitch apart, showing foresight and preparedness.
• Stay updated with the latest FDA guidelines and case studies relevant to your biotech field.
• Utilize resources like the Biotechnology Innovation Organization (BIO) for insights into regulatory trends and challenges.
• Research past biotech startups’ regulatory paths to understand common hurdles and successful strategies.
• Regulatory Strategy: Articulate a clear regulatory strategy in your pitch deck, outlining steps to achieve compliance and market authorization.
• Timeline for Regulatory Approval: Provide a realistic timeline for navigating through the regulatory process, aligning it with your product development milestones.
• Expertise and Partnerships: Highlight any regulatory expertise within your team or external partnerships with regulatory consultants or legal advisors.
• Risk Assessment: Include a risk assessment regarding regulatory compliance, showing that you’ve considered potential obstacles and have a plan to address them.
• Case Studies of Regulatory Success: Reference biotech companies that successfully navigated the regulatory landscape, especially those in a similar domain as your project.

Intellectual Property Strategy: Securing Your Biotech Innovation

Significance of IP in Biotech:

• Protection of Unique Innovations: Biotech often involves novel discoveries and technologies. Patents and other IP rights protect these from competitors, ensuring you retain the exclusive right to capitalize on your innovations.
• Attracting Investment: Investors often evaluate the strength and security of a biotech startup’s IP portfolio. A well-defined IP strategy can significantly increase your venture’s attractiveness.

Why IP Strategy Matters in Your Pitch Deck:

• Demonstrating Competitive Edge: A robust IP strategy differentiates your biotech venture in a competitive market, showing investors that you have a unique and legally protectable asset.
• Long-term Value Creation: Effective IP management can be a key driver for long-term growth and value creation in biotechnology.
• Consult resources like the World Intellectual Property Organization (WIPO) for global IP trends in biotech.
• Analyze patent databases like the USPTO or EPO to understand the IP landscape in your specific biotech sector.
• Study IP strategies of successful biotech companies for insights and best practices.
• Outline Your IP Assets: Clearly identify what aspects of your innovation are patentable or have already been patented, including any pending applications.
• IP Strategy Roadmap: Present a roadmap of how you plan to develop and expand your IP portfolio, including future filings and international patent strategies.
• Freedom to Operate Analysis: Conduct and present a Freedom to Operate (FTO) analysis, ensuring your innovation does not infringe on existing patents.
• Licensing Strategies: If applicable, describe your strategy for licensing your IP to or from third parties, outlining how this adds value to your business.
• Case Studies of IP Leveraging: Cite examples of how effective IP management has contributed to the success of other biotech ventures, particularly in your niche.

Scientific and Technical Communication: Articulating Complex Biotech Concepts

Importance in Biotech Pitch Decks:

• Simplifying Complexity: Biotech often involves intricate scientific concepts and data. The ability to simplify these for a non-specialist audience, without losing the essence, is crucial for investor engagement.
• Building Credibility: Accurate and clear communication of scientific information builds credibility and trust with potential investors who may not have a deep scientific background.

Why Effective Communication is Crucial:

• Connecting with Investors: Investors need to understand the science behind your innovation to gauge its potential. Effective communication bridges this gap.
• Storytelling with Data: Using data effectively to tell a compelling story about your biotech innovation can significantly boost its appeal.
• Utilize resources like scientific communication workshops or courses tailored for biotech professionals.
• Review successful biotech pitch decks to understand how they present complex data and scientific concepts.
• Study principles of effective communication from sources like the Alan Alda Center for Communicating Science.
• Use Analogies and Metaphors: Employ analogies and metaphors to explain complex biotech processes, making them relatable and easier to understand.
• Visual Data Presentation: Incorporate clear, visually appealing graphics to represent scientific data, ensuring they are easy to interpret.
• Focus on the Problem and Solution: Clearly articulate the problem your innovation addresses and how it provides a solution, using scientific evidence to support your claims.
• Tailor the Level of Detail: Adjust the technical detail to suit your audience – detailed enough to be credible but not overwhelming.
• Storytelling Approach: Frame your scientific data and research within a narrative that outlines the journey of your discovery and its potential impact.

Investor Targeting and Fundraising Strategies: Aligning Biotech Innovation with the Right Investors

Critical Aspects in Biotech Pitch Decks:

• Identifying the Right Investors: Biotech projects often require investors who understand the long timelines and regulatory complexities involved. Identifying investors with experience in biotechnology is crucial.
• Effective Fundraising Approach: Developing a tailored fundraising strategy that aligns with the stages of your biotech venture’s development is essential to securing the right amount of funding at the right time.
• Strategic Alignment: Showing that you have identified investors who are a good fit for your project builds confidence in your business acumen.
• Demonstrating Realistic Funding Goals: Clearly articulating realistic funding goals and how you plan to use the capital shows investors that you have a solid plan for growth and scalability.
• Research the investment focus of venture capitalists and angel investors in the biotech sector.
• Utilize platforms like Crunchbase or PitchBook to analyze previous funding rounds in similar biotech startups.
• Study successful fundraising campaigns in biotech for strategies and best practices.
• Investor Profiles: Develop profiles of ideal investors for your biotech venture, including their investment history and interest in specific biotech sub-sectors.
• Fundraising Milestones: Set clear fundraising milestones that correlate with development stages such as research and development, clinical trials, or market entry.
• Use of Funds: Clearly articulate how you plan to use the funds, showing how each dollar will bring you closer to the next milestone.
• Success Metrics: Define what success looks like at each stage of your venture, providing potential investors with a clear vision of progress and growth.
• Exit Strategy: Outline potential exit strategies, such as acquisition or IPO, giving investors an understanding of how they can realize a return on their investment.

Case Studies of Successful Biotech Startups: Learning from Industry Triumphs

Relevance in Biotech Pitch Decks:

• Illustrating Real-world Success: Case studies provide concrete examples of how other biotech startups have successfully overcome hurdles, offering a roadmap of sorts.
• Building Credibility and Vision: Showcasing real-life success stories in biotech can build credibility for your approach and help investors visualize the potential of your venture.

Why This Is Crucial for Your Pitch Deck:

• Learning from Successes and Failures: Understanding what has worked (or not) for others can provide valuable lessons and strategies.
• Inspiring Confidence: Demonstrating awareness of the industry landscape and success patterns can inspire confidence in your knowledge and strategy.
• Select case studies of biotech startups that closely align with your field or have faced similar challenges.
• Utilize industry reports, biotech news platforms, and academic journals for comprehensive and credible case studies.
• Analyze the growth strategies, funding paths, regulatory navigation, and market entry tactics of these startups.
• Choose Relevant Case Studies: Select case studies that are relevant to your startup’s focus area and stage of development.
• Highlight Key Lessons: Extract and emphasize key lessons from these case studies, particularly those that apply to your startup’s strategy or challenges.
• Draw Parallels: Clearly draw parallels between these successes and your startup’s path, showing how these lessons have influenced your strategy.
• Discuss Adaptation Strategies: Explain how you would adapt the successful strategies from these case studies to fit your unique circumstances.
• Visual Storytelling: Use infographics or timelines to visually represent the journey of these startups, making the case studies more engaging and understandable.

Ethical Considerations and Social Impact: Responsibility and Vision in Biotech Innovation

Significance in Biotech:

• Ethical Responsibility: Biotechnology often deals with sensitive areas like genetic engineering, healthcare, and environmental interventions. Demonstrating ethical responsibility is crucial for building trust and credibility.
• Social Impact: Showcasing the potential social benefits of your biotech innovation can significantly strengthen your pitch by aligning with broader societal goals and values.

Why This is Key for Your Pitch Deck:

• Investor and Public Perception: Today’s investors and consumers increasingly value ethical practices and positive social impact. Highlighting these aspects can make your venture more appealing.
• Regulatory Smoothness: Ethical compliance can facilitate smoother regulatory approvals, as many biotech products require ethical considerations to be thoroughly addressed.
• Refer to ethical guidelines and frameworks specific to biotech, such as those provided by the National Institutes of Health (NIH) or the International Bioethics Committee (IBC).
• Analyze case studies where ethical considerations significantly impacted biotech ventures, either positively or negatively.
• Study social impact reports of biotech companies to understand how they communicate and measure their societal contributions.
• Articulate Ethical Practices: Clearly state the ethical standards and practices your company adheres to, especially in areas like clinical trials, data privacy, and genetic research.
• Showcase Social Benefits: Highlight the potential positive impacts of your innovation on society, such as improving health outcomes, environmental sustainability, or accessibility to healthcare.
• Engagement with Ethical Bodies: Mention any collaborations or consultations with ethical boards or committees, showing proactive engagement in ethical discourse.
• Risk Assessment: Include an ethical risk assessment, acknowledging potential ethical dilemmas and how you plan to address them.
• Metrics for Social Impact: Define how you will measure the social impact of your product or service, using clear, quantifiable metrics.

Go-to-Market Strategy for Biotech Products: Navigating the Path to Market Success

Essentiality in Biotech Ventures:

• Market Entry Planning: Biotech products often face unique market entry challenges, including regulatory hurdles, high development costs, and complex buyer landscapes. A GTM strategy outlines the pathway to navigate these challenges effectively.
• Differentiation and Positioning: In a competitive biotech landscape, how you position your product and differentiate it from others is key to capturing market attention and driving adoption.

Why a GTM Strategy is Vital for Your Pitch Deck:

• Investor Confidence: A clear GTM strategy demonstrates to investors that you have a well-thought-out plan for making your biotech product a commercial success.
• Market Readiness: It shows that you understand the market dynamics and are prepared for the practical aspects of product launch and scaling.
• Analyze market reports specific to your biotech sub-sector for insights into market size, growth rates, and trends.
• Study successful market entry strategies used by similar biotech products.
• Utilize resources from biotech industry associations for best practices in GTM strategies.
• Target Market Identification: Clearly define your initial target market, including demographics, geographies, and the specific needs your product addresses.
• Value Proposition Articulation: Craft a compelling value proposition that highlights what sets your product apart in the biotech market.
• Marketing and Sales Channels: Outline your planned marketing and sales channels, tailored to reach and influence your target market effectively.
• Regulatory Strategy Alignment: Ensure your GTM strategy aligns with the regulatory pathway, outlining how you plan to navigate approval processes.
• Milestones and Timelines: Set specific milestones for market entry and scaling, providing investors with a clear timeline of expected progress.

Building a Strong Team and Network: The Backbone of Biotech Success

Critical Importance in Biotech Ventures:

• Diverse Expertise: Biotech ventures require a blend of scientific, regulatory, business, and technical expertise. Showcasing a team that covers these areas demonstrates your project’s capability to tackle the industry’s multifaceted challenges.
• Industry Connections: Strong industry networks can facilitate partnerships, provide mentorship, and open channels for funding and collaboration, which are essential in the biotech sector.

Why This is Essential for Your Pitch Deck:

• Confidence in Execution: Investors are more likely to back a venture that has a competent and experienced team, confident in their ability to execute the business plan.
• Resource Accessibility: A well-connected network implies better access to resources, including funding, expertise, and critical industry insights.
• Identify key roles and expertise crucial for success in your specific biotech field.
• Research the backgrounds of successful biotech teams to understand the mix of skills and experience that contribute to success.
• Utilize networking platforms and industry associations to gauge the importance of different types of networks in biotech.
• Team Profiles: Highlight the qualifications, experience, and specific roles of your core team members, emphasizing how each contributes to the venture’s success.
• Advisory Board and Partnerships: If applicable, introduce your advisory board or strategic partners, showcasing their industry credentials and how they add value.
• Networking Strategy: Outline your strategy for expanding your industry network, including attending key biotech conferences, participating in industry forums, and engaging with professional groups.
• Talent Acquisition Plan: Detail your plan for attracting and retaining top talent as your venture grows, addressing key areas like culture, training, and development opportunities.
• Success Stories: Share any previous successes or achievements of your team members that are relevant to the biotech industry, illustrating a track record of capability and accomplishment.

Financial Projections and Valuation: Charting the Financial Future of Your Biotech Venture

• Long-term Financial Planning: Biotech ventures often have long development cycles with significant upfront investment. Accurate financial projections are critical to demonstrate sustainability and long-term viability.
• Valuation for Investors: A realistic valuation based on solid financial data is key for attracting investment. It gives investors an idea of the company’s worth and the potential return on their investment.

Why It’s Crucial for Your Pitch Deck:

• Investor Decision-making: Investors rely heavily on financial projections and valuation to make funding decisions. Clear, realistic projections can significantly boost your credibility.
• Resource Allocation: Demonstrating a well-thought-out plan for resource allocation reassures investors that their capital will be used effectively.
• Analyze financial models of successful biotech startups to understand revenue projections, cost structures, and burn rates.
• Study industry benchmarks and average valuations in your biotech sub-sector.
• Use tools and resources from financial advisory firms specializing in biotech for accurate modeling.
• Detailed Financial Projections: Include a 3-5 year financial projection, detailing revenue, costs, cash flow, and break-even analysis. Be realistic about the time and capital required for R&D, clinical trials, and market entry.
• Valuation Methodology: Explain the methodology used for your startup’s valuation, whether it’s based on discounted cash flows, comparables, or a cost-to-duplicate approach.
• Funding Stages and Use of Funds: Clearly articulate the stages of funding you anticipate, what each round of funding will achieve, and how the funds will be utilized at each stage.
• Risk Analysis: Include a financial risk analysis that considers various scenarios, such as delayed market entry or increased R&D costs.
• Exit Strategy: Outline potential exit strategies and how they align with the financial projections and valuation, offering investors a clear path to ROI.

Use these insights and make a winning pitch. If you want to talk about them, reach out to me and book a call.

How to creatively pitch your biotech startup? 24 Ways

Pitching a biotech startup requires a blend of creativity, scientific acumen, and storytelling skills. The goal is to captivate your audience right from the start, maintain their interest, and leave a lasting impression. Here are some novel and attention-grabbing ideas:

• Virtual Reality (VR) Demonstration: Utilize VR technology to give investors an immersive experience of what your biotech product does. For example, if your product is related to cellular therapy, let them “travel” inside a human cell.
• Live Experiment or Demo: Conduct a simple, safe experiment on stage to demonstrate a key aspect of your technology. This could be as simple as a chemical reaction that visualizes a concept.
• Patient Testimonials in Augmented Reality (AR): If applicable, use AR to project testimonials from patients or users who could benefit from your product, creating an emotional and personal connection.
• Interactive Data Visualization: Use interactive touch screens for presenting complex data. Let the investors interact with the data – like touching a graph to see more information about a specific metric.
• Storytelling with a Twist: Start your pitch with a compelling story – it could be a futuristic scenario where your product has changed lives, or a historical analogy that relates to your product’s significance.
• Holographic Projections: Use holographic displays to showcase your product or demonstrate how it works in a 3D space. This can be particularly effective for products with a physical component or complex structures.
• Theatrical Elements: Employ elements of theater such as costumes, props, or a short skit to illustrate your product’s journey, its development, and its potential impact.
• Gamification of the Pitch: Turn your pitch into an interactive game where investors make decisions based on scenarios you present, helping them understand the potential outcomes and impacts of your biotech solution.
• Scientific Art Exhibition: If your product involves visually striking scientific phenomena (like cellular structures or biotech materials), display these as art pieces around the presentation area.
• ‘Shark Tank’ Style Interaction: Encourage a dynamic Q&A session similar to a ‘Shark Tank’ pitch, where you actively engage with the audience, inviting them to challenge your ideas and thus demonstrating your product’s robustness. 
• Time Capsule Concept: Present your pitch as if opening a time capsule from the future, showcasing the long-term impact of your biotech innovation. Include predictions and potential headlines that your product could generate.
• Interactive Polls with Live Feedback: Use real-time digital polling during your pitch. Ask the audience questions related to the problem your product solves and display live feedback, creating an interactive and engaging experience.
• ‘Day in the Life’ Simulation: Create a short film or animation that portrays a day in the life of someone who benefits from your biotech product, highlighting its impact on everyday life.
• Collaborative Problem-Solving Session: Turn part of your pitch into a collaborative brainstorming session with the audience on a relevant topic, demonstrating the need for your solution and involving them in the process.
• Musical or Dance Interpretation: Incorporate a brief musical or dance performance that metaphorically represents the journey of your biotech product from conception to impact, adding an artistic flair to your presentation.
• Use of Scent and Sensory Elements: If applicable, introduce non-visual sensory elements like scents or textures that relate to your product, offering a multi-sensory experience to the audience.
• Flash Mob Style Presentation: Organize a flash mob to suddenly ‘appear’ and perform a coordinated act that creatively explains your product, surprising the audience and capturing their attention.
• Futuristic Fashion Show: If your product involves wearable biotech, host a mini fashion show demonstrating its use in a futuristic setting, showcasing practicality and style.
• Escape Room Challenge: Design an escape room scenario related to the problem your biotech product solves. Let a few audience members participate, with the solution being your product.
• 3D Printed Models: Use 3D printed models of molecules, cells, or other relevant structures to your biotech product. Hand them out to the audience or use them as visual aids during your pitch.
• Science Comedy Routine: Infuse humor into your presentation with a short, science-themed comedy routine that highlights the problem your product addresses, making the pitch both informative and entertaining.
• Guerrilla Marketing Tactic: Prior to your pitch, use guerrilla marketing tactics like mysterious messages, puzzles, or intriguing visuals around the venue that pique interest in your product.
• Biotech Food Tasting: If your product is related to food biotechnology, offer a tasting session of the product (if safe and feasible), giving the audience a literal taste of your innovation.
• Personal Story Journey: Share a personal story or journey that led to the development of your biotech product, making your pitch deeply personal and relatable.

The goal with these ideas is to break the mold of traditional pitches, creating a memorable and impactful presentation that goes beyond mere facts and figures, and truly engages the audience on multiple levels.

Last But Not Least, Some Examples:

Wrap-up on the biotech pitch deck presentation guide.

In conclusion, the biotech pitch deck presentation guide is an essential tool for any startup operating in the biotech industry. This guide provides a comprehensive framework for crafting a compelling pitch that not only demonstrates the potential of your product or service but also showcases your team’s expertise and passion.

From outlining the problem you are solving to discussing your business model and financial projections, the guide offers a step-by-step process to create a winning pitch.

Additionally, it emphasizes the importance of creating a visually appealing pitch deck to engage your audience and leave a lasting impression. By following this guide, you will be able to effectively communicate your biotech startup’s value proposition and secure potential investors and partners.

For more details about creating and structuring the ideal and effective deck, feel free to check out  the main page . I got tips, tricks, mistakes and more for you to use and abuse!

You got this!

But, if you’d rather focus on developing your life saving startup:

Consider doing what others like you did. Let me help you develop a killer pitch deck and save 10 hours of your time for a fraction of the cost. All it takes to start is a free 30 min call with me.

Additional Resources

Check my basic guide on pitch decks that helped my clients win more than $4mill in funding:

Startup Pitch Deck Guide: How To Create A Pitch Deck For Investors (Template Incl)

It includes :

• Step by step process on building each slide
• What investors are dying to see
• What a pitch deck has to be
• What a pitch deck can’t be
• Tips and tricks when creating a pitch deck

Or, check out all the other pitch deck guides here:

Also don’t miss out on my massive presentation specialist guide , last minute presentations and best business projector buyers guide.

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Table of Contents

Biotechnology funding, deals, and IPOs reached the highest levels worldwide in 2020, with venture-capitalist (VC) funding for biotech companies up more than 80 percent year-over-year, and IPO values increasing by more than 180 percent. The next waves of science and innovation are on the horizon, and the bio-revolution is well underway.

However, value creation is not guaranteed. Increasing complexity—scientific, supply chain, access, etc.—raises the bar for high-quality talent and successful execution. For example, less than 50 percent of biotech launches meet expected forecasts , and independent biotech companies launching by themselves the first time are typically less successful than experienced launchers.

McKinsey helps biotech companies across the entire value chain, from early-stage companies getting initial funding to established companies launching into international markets. We also drive transformations by bringing together the capabilities needed to help organizations grow and thrive in the digital age.

Developing equity stories and helping prepare financing rounds and IPOs Help biotech companies present equity stories—such as business models, competitive advantages, strategy, and market dynamics—in a compelling way that maximizes valuation in financing rounds and at IPO

Investing our people to build the next generation of innovators Align with clients to ensure there are shared objectives and key performance indicators. We invest our human capital—our capabilities, databases, people, and tools—in promising biotech companies to help them scale and achieve high ambitions, using our proven Leap by McKinsey  methodology. We invest in and innovate new delivery models that allow us to share risks and upsides, which is different from our more traditional project-based work

Corporate strategy and capital market Develop holistic corporate strategy to steer mid- to long-term direction, understand key value drivers from the investor’s view, and articulate compelling stories

Portfolio and platform strategy and asset optimization Maximize R&D platforms and portfolio value with unrivaled expertise in portfolio strategy, clinical development strategy, study design optimization, and clinical-operations acceleration

Launch and go-to-market Assess launch readiness and design differentiated go-to-market models, such as access, commercial, and medical while developing commercial organizations and building roadmaps with clear value propositions in market and competition

Operations Build the manufacturing plant of the future, integrate digital and analytics to achieve world-class productivity and quality

Strategic partnerships Support strategic partnerships by evaluating portfolio, value-chain strength, geographic trends, and strategic fit that inform partnering options and craft value-proposition stories

Future-proof organization Develop the organization of the future by considering rapidly evolving and growing organizational changes in external competition and commercial environments

International expansion Define the launch model for international markets based on an evaluation of the addressable patient population by market, and by assessing commercial and organization requirements

Eureka A groundbreaking initiative to advance and deploy state-of-the-art, AI-constructed drug discovery and development as part of outcome-based partnerships with our biopharmaceutical clients. Eureka brings the best of tools and talent from QuantumBlack, AI by McKinsey, with the distinctive data from our center of excellence in life-sciences data, where we have a number of strategic partnerships across geographies and therapeutic areas.

Examples of our work

Platform strategy for an early-stage biotech, ipo equity story, franchise strategy for a cross-border biotech, value-creation partnership, knowledge partnerships.

McKinsey is a knowledge partner for key industry conferences, including BioCentury in China and BioEquity Europe, HIMSS, and LSX. We convene experts across the world to share the latest thinking and research at hosted events, including our annual Early Stage Investor Conference, quarterly healthtech CEO and founder sessions, and regular biotech CEO and founder events.

We collaborate annually with BioCentury and the BayHelix Group to orchestrate the China Healthcare Summit, the “bridge to innovation,” as their insights partner. The conference is a combination of strategic panels and one-on-one meetings where we present our views on the evolution of the biopharma and medtech industries in China. Every conference publishes a McKinsey-authored report report on the latest in Chinese biotech and medtech ecosystems. We are also a knowledge partner with BioCentury’s European event, BioEquity.

Featured Insights

Accelerating clinical trials to improve biopharma R&D productivity

What early-stage investing reveals about biotech innovation

Digital diagnostics: A path forward for IVD

How biotech and collaboration can enable sustainable animal production

From bench to bedside: Transforming R&D labs through automation

Five ways biopharma companies can navigate the deal landscape

Europe’s Bio Revolution: Biological innovations for complex problems

The Helix report: Is biopharma wired for future success?

How the European biotech sector can navigate turbulent times

A biotech survival kit for a challenging public-market environment

Vision 2028: How China could impact the global biopharma industry

What are the biotech investment themes that will shape the industry?

CROs and biotech companies: Fine-tuning the partnership

How biotechs can rethink their strategies after the market downturn

Building a global biotech: Taking a first-time launch into international markets

What’s ahead for biotech: Another wave or low tide?

Featured experts.

Olivier Leclerc

Senior partnersouthern california.

Alexandra Zemp

Partnerzurich.

Fangning Zhang

Partnershanghai, related practices.

Life Sciences

McKinsey Digital

Contact us for any inquiries about biotech.

50 Best Biotech Business ideas You Can Start Today

By: Author Tony Martins Ajaero

Home » Business ideas » Technology Industry » Biotech Business

Do you want to start a biotech related business but lack ideas? If YES, here are 50 best profitable biotechnology small business ideas & opportunities.

Biotechnology businesses are businesses that harness biological processes to come up with new products and equipment in areas like medicine, agriculture, food production and environmental protection.

These businesses are getting all the attention and a lot of funding from angel investors and grants from the government right now because they are considered essential for improving the quality and continuous existence of human life.

However, to be able to harness these funds or profit from this industry, you need innovative business ideas . Here is a long list of lucrative business ideas in the biotechnology industry that you can choose from:

Best Biotech Business ideas

1. bio-fertilizer production.

Bio-fertilizers are favored among organic farmers because unlike other fertilizers that contain chemicals which may be harmful to health, bio-fertilizers contain living organisms which can help plants to grow and thrive without negatively impacting the health of consumers.

2. Bee Apiary

You can start a business that involves helping farmers with pollination through your apiaries. You can also harvest and sell honey from your bees.

Apart from harvesting and selling honey from bees, bee keepers also make money from other by-products from bees such as beeswax, bee pollen, bee venom, and royal jelly which are all used in diverse capacities to better human health.

3. Animal Feed Manufacturing

Humans keep a lot of pets and animals for commercial purposes. These animals need to consume balanced diets in order to grow and thrive properly. You can set up an animal feed manufacturing business where you can produce healthy animal feeds for fish, chicken, cattle, dogs, and birds amongst others.

4. Bird Hatchery

Commercial bird farmers cannot afford to wait for birds to hatch naturally so they rely on specially designed machinery created by biotechnologists to help hatch the eggs laid by their birds in a speedy and profitable manner.

If you live in an area where there are a lot of bird farmers, you can make a lot of money from setting up an industrial hatchery as not many of these farmers are able to afford their own hatching equipment.

5. Fish Hatchery

Fish hatchery is also very profitable. There is a high demand for fish in the market and there is only so much the ocean can supply so most fish marketing companies rely on bio-technologically engineered fish hatcheries to supply fingerlings in large quantities that they can now breed and sell.

6. Plant Protection Services

You can also start a pest surveillance, control and diagnostic service to help farmers monitor their plants and protect them from pesticides, fungicides and insects using advanced tools, and chemicals.

7. Plant Tissue Culture Laboratory

Another lucrative business idea to consider is cultivating plant tissues in laboratories. You would use your professional skills and knowledge to collect cells and tissues of plants and use it to produce cloned versions of plants through a method known as micropropagation.

These are some of the techniques that bio-technologists are using to prevent world hunger by ensuring that there’s always food crop for people to consume.

8. BioGas Production

We all know that traditional gas is expensive and created from materials that are at risk of depletion. Bio-gas on the other hand is made from fermenting organic waste which is less likely to go into extinction as long as humans and animals continue to exist.

Bio-gas is the future as predicted by a lot of industry experts so you might want to jump on the trend now that it is still fresh so that you can make a lot of money before the industry becomes over-saturated.

9. Bio-gas Equipment Manufacturing and Selling

If you don’t want to produce bio-gas, you can opt for selling bio-gas equipment such as biogas plant equipment, bio-gas stove, and other household or industrial equipment powered by biogas. You’ll make a lot of money especially from people looking to reduce the amounts they spend on gas every month.

10. Seed Processing Services

You can start manufacturing and selling bio-technologically engineered seeds to help farmers earn more profits from their business.

11. Soil Water Quality and Input Testing Laboratory

Soil and water play very important roles in determining the growth of crops so farmers always need the help of soil water quality and input testing professionals to help them decide on the best spots to plant their crops.

12. Bio-pesticide Manufacturing

You can start your own brand of plant protection products that contain biological control agents (BCAP) such as plant extracts, microbial extracts or pheromones. BCAP pesticides can help to enhance plant growth, and reduce resistance to pesticides in plants.

13. Compost Fertilizer Production

You can also consider starting a compost fertilizer production business which involves using human wastes to produce fertilizer.

14. Vaccine Manufacturing

Vaccines are very important for human survival as they help to prevent the spread of deadly diseases. There are hundreds of vaccines that you can start producing and you’ll earn a lot of money from supplying your products to the government who often buy these vaccines and give them to citizens for free.

15. Artificial Human Parts Production

You can start a business of manufacturing prosthetic hands, limbs and other human parts that can be biotechnologically engineered. You’ll be able to put a smile on the faces of people suffering from physical challenges, and also make money in the process.

16. 4D Ultrasound Laboratory

The latest technology in ultrasound for pregnant women is a 4D scan that can help expectant mothers see their developing babies in colors. 4D scans can help expectant parents prevent birth defects in their kids.

17. Cryobank

These days, assisted reproduction have become very popular especially amongst people with fertility problems, gay couples who cannot birth children naturally, or people who want children marital commitments. You can make a lot of money from starting a cryobank where sperm donors and egg donors can safeguard their eggs and sperm for future harvest.

18. Vegetable Processing Plant

A lot of people around the world consume vegetables on a daily basis because they are healthy and nutritious. However, farmers alone cannot handle the huge demand for these vegetable which is why there are a lot of vegetable and tomato processing plants to artificially cultivate these products for sale and supply to the market.

19. Blood Bank

A lot of people donate blood regularly which has to be kept in blood banks until it is needed by a patient. This type of business requires a huge capital outlay but you’ll earn a lot of profits from it.

20. Medical Transportation Services

Medical transportation services is usually done by biotechnologists because transporting human parts needed for transplants require professional skills and experience and a lot of equipment.

21. Equipment for the Visually Impaired

Another lucrative business idea is manufacturing and selling products for the visually impaired such as mounted magnifiers, braille creation machines, writing equipment, telephones and personal care equipment to make life easier for the visually impaired.

22. Handicapped Car Manufacturers

You can also consider a business of producing modified cars for the physically challenged or the visually impaired so that they can also have a chance to drive themselves.

23. Smart Wheelchairs

Gone are the days when wheelchairs were boring and required some measure of human assistance. These days, wheelchairs are created to be smart so that the physically challenged can take care of themselves without relying excessively on caregivers.

Smart wheelchairs come with buttons that allow the user control anything from light switches to cable televisions. You can start manufacturing or selling one of those.

24. Non-Invasive Diagnostic Tools

You can start manufacturing and selling tools that allow for non-invasive diagnosis such as Electrocardiograms (ECG), Computerized Axial Tomography (CAT) and MRI (Magnetic Resonance Imaging) scanning tools.

25. Food Supplements

Food supplements are very popular now because a lot of people now understand the importance of getting all the essential nutrients that the body requires, which they may not be getting enough from foods that they consume. The food supplement industry is worth $278 Billion and it still has a lot of room for new entrants.

26. Breast Implant Manufacturing

Breast silicone are selling fast now due to the increase in the number of people getting breast augmentation procedures. You’ll make a lot of money from selling or manufacturing and supplying breast implants.

27. Laser Hair Removal

Not very many people can stand painful hair waxing procedures. Laser hair removal is a less painful and more effective procedure that many people are opting for these days. You can set up your own laser hair removal clinic or start selling portable laser hair removal tools that people can use at home.

28. Platelet Rich Plasma Injections (PRP)

Speaking of hair, there is a group of people who need to grow their hair especially people suffering from alopecia. Scientists have discovered that Platelet rich injections can help to stimulate hair regrowth.

You can consider setting up a business that involves manufacturing or selling these injections. There are also a number of other hair regrowth technologies that you can make money from.

29. Stem Cell Processing Laboratory

Stem cells are used to treat a number of blood and bone marrow diseases. Recently, they have been used to carry out beauty procedures. You can start a stem cell laboratory to service this growing medical industry.

30. Minimally Invasive (Endoscopic) Surgical Equipment

Another way that biotechnologists have helped to advance the medical field is by inventing tools and equipment that make it possible for surgeons to perform surgical procedures without opening up a patient. You can starts manufacturing or selling such equipment.

31. Electrical Bone Simulation Devices

You can also consider a business of making or selling electrical bone stimulation devices that help to promote healing of bone fractures and spinal injuries.

32. Artificial Food Sweeteners

A lot of people are avoiding sugar and aspartame for sweetening their foods because they are considered unhealthy. You can consider setting up a business that involves manufacturing of genetically modified food sweeteners or healthy food sweeteners like Xylitol, Stevia, Erythritol, and Yacon Syrup. This is a very huge industry right now with a lot of profit potentials.

33. Genetically Modified (GMO) Food Processing

Another lucrative business idea is to start manufacturing and selling genetically modified foods like Sugar Beets, Soy, Milk, Corn, and Canola.

34. Consultancy Services

You can also consult for people who wish to invest in the biotechnological industry. You can make money off showing them lucrative ideas to invest in, help them write grant proposals or business plans to raise money from the government or other investors.

35. Bio-Feedback Therapy Services or Equipment Supply

Biofeedback therapy is used to help people regain control over normal involuntary functions by attaching electrodes or sensors to send signals to targeted organs in the body, in order to treat or prevent a number of health conditions including high blood pressure, incontinence, headaches, and other diseases.

Bio-feedback is a growing field in the biotechnological industry and you can make a lot of money from selling equipment or starting your own laboratory to offer therapy services to interested patients.

36. Water Extractors

There is an undeniable water crisis in the world with an estimated 1.2 billion people in the world living in areas prone to water scarcity. Devices like the water extractor are some of the innovations that bio-technologists have come up with to solve water scarcity problems.

Water extractors can help to extract water from the atmosphere so that people no longer have to rely on groundwater for survival. This is an emerging technology that you can invest in, and make money from.

37. Wastewater Treatment Plants

You can start your own wastewater treatment plant to remove solid and chemical wastes from water so that they can be recycled for reuse. This is another solution for world water scarcity.

38. Training School

You can consider the idea of setting up a training school to train students on how to research, develop tools and products in the emerging biotechnological industry.

39. Biodegradable Plastic Production

Biodegradable plastics are made from organic matter like non-castor plants and corns. Biodegradable plants are essential for solving world pollution problems because they can decompose faster, and be absorbed by the environment without causing harm.

40. Personal Testing Kits and devices

Self-testing kits are also a growing trend. People are able to use these kits and devices to monitor their health and perform emergency diagnostics. You can earn good income from manufacturing or selling test kits such as high blood pressure monitors, ovulation detector kits, HIV and STD test kits, pregnancy test strips, and alkaline test strips to mention few.

41. Biometric Capturing Centers

Biometric capturing is used across different business industries. You can make money from setting up your own biometric capturing center to capture and process biometric data on behalf of private clients or the government.

42. Lie Detecting Equipment

Biotechnology has also helped to improve crime fighting in the world especially through the creation of lie detectors that can help to determine when suspects are telling lies or saying the truth. You can start manufacturing, or selling these tools, or providing consultancy services to security agencies.

43. Forensic DNA Analysis Tools

You can also start a forensic analysis lab or start selling equipment to security agencies, and forensic analysis service providers.

44. Biotechnology Business Incubator

Yet another way to profit off the emerging biotechnology industry is to set up a business incubator to help people with brilliant biotech business ideas to find funding for brilliant business ideas and innovations.

45. Security Devices

You can start making and selling biotechnology devices that promote security such as fingerprint locks, eyelid scanners, and several others.

Related Posts:

• Biotech Company Business Plan [Sample Template]
• How to Start a Biotech Business

This free eBook goes over the 10 slides every startup pitch deck has to include, based on what we learned from analyzing 500+ pitch decks, including those from Airbnb, Uber and Spotify.

Top 8 Pitch Decks from Biotechnology Startups (2024)

Description

The Biotechnology industry is a growing sector, and startups around the world are trying to get a piece of the pie.

In this post, we’ve collected 8 pitch decks created by Biotechnology startups that raised funds in the last years.

8 Pitch Decks From Biotechnology Startups

List of startup investors in the FinTech industry, along with their Twitter, LinkedIn, and email addresses.

List of startup investors in the BioTech, Health, and Medicine industries, along with their Twitter, LinkedIn, and email addresses.

List of 250 startup investors in the AI and Machine Learning industries, along with their Twitter, LinkedIn, and email addresses.

Everything you need to raise funding for your startup, including 3,500+ investors, 7 tools, 18 templates and 3 learning resources.

Healx is transforming the rare disease treatment path for patients and their doctors by generating insights and enabling actionable recommendations that drive improved outcomes.

Details of the startup :

Business model:

Subscription

Details of the pitch deck :

Amount raised:

You can find more details about this startup here .

Theranos was a consumer healthcare technology company that developed proprietary technologies for detecting, treating, and preventing blood-borne diseases

VC, Corporate

Cyclica provides tools for the entire pre-clinical drug discovery process

ELXR is a personalized cloud sports club that aggregates all your sports data in one place, giving you actionable insights and delivering personalized experiences across your devices.

Undisclosed

Folia Water

Folia is a new class of high-performance fibers that can be produced at the low cost and large scale of paper mills, using conventional equipment.

Fyodor Biotechnologies

Fyodor Biotechnologies is a leading provider of innovative medical devices that change people’s lives.

Qualio is a scalable quality management platform for life sciences companies. Qualio helps you monitor quality levels across all stages of the development process.

Roam and Wander

R+W is a software creation studio specializing in custom web, mobile, and enterprise app development.

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• EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take, individually and collaboratively, to improve regulatory clarity, streamline regulatory oversight, reduce regulatory redundancies and gaps, and increase regulatory coordination for specific product categories and across the Coordinated Framework. The Plan identifies regulations and guidance documents that can be updated, streamlined, or clarified and identifies potential new guidance or regulations, where needed. These actions will focus on the following areas of biotechnology product regulation: modified plants; modified animals; modified microorganisms; human drugs, biologics, and medical devices; and cross-cutting issues.

As reported in our September 13, 2022, blog item , on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) issued a request for information (RFI) on behalf of the primary agencies that regulate the products of biotechnology — USDA, EPA, and FDA — requesting relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900 .

On November 13, 2023, USDA, EPA, and FDA posted the following documents on the Unified Website for Biotechnology Regulation :

• Report on Stakeholder Outreach Related to Ambiguities, Gaps, Uncertainties in Regulation of Biotechnology Under the Coordinated Framework (Report on Stakeholder Outreach) (Mar. 11, 2023); and
• The Coordinated Framework for the Regulation of Biotechnology: Plain language information on the biotechnology regulatory system (Plain Language Document) (Nov. 2023).

According to the Report on Stakeholder Outreach, in reviewing the comments on the RFI, several themes emerged: (1) requests for greater regulatory clarity; (2) requests for greater regulatory coordination and harmonization; (3) requests for regulatory reform or revision; and (4) comments on regulatory resources. The Report on Stakeholder Outreach summarizes comments representing each area.

Modified Plants

According to the Plan, commenters expressed various agency-specific and cross-agency concerns about the regulation of modified plants and plant products, including: cumbersome and lengthy regulatory processes; the scope of plant-incorporated protectants (PIP); lack of harmonization of approaches to the regulation of genome-edited plants and new varieties of previously reviewed plants; lack of alignment of timelines for reviews of products subject to regulation by more than one agency; food crops engineered to produce substances that could cause food safety concerns if they inadvertently enter the general food supply; duplicative regulation of genetically modified plants; and a need for recognition by agencies of each other’s expertise to promote predictability, reduce redundancy, and enable synchronous agency decisions.

The Plan states that agencies will identify ways to streamline review processes, including:

• USDA will identify ways to streamline its Regulatory Status Review (RSR) process: Modified plants that do not meet the criteria for exemption from USDA regulations have an opportunity for a regulatory off-ramp through the RSR process. To improve the predictability of this process (which is important for developers making business plans and decisions), in fiscal year (FY) 2024, USDA will review the RSR process to identify improvements that will bring processing times into greater alignment with the target timeframes specified in its biotechnology regulations. Following its review, USDA will continue implementing process improvements and track progress in shortening the time taken to complete reviews until it reaches full alignment with the timeframes specified in the biotechnology regulations.
• EPA will identify ways to streamline and ensure consistency across its PIP registration reviews: To improve the quality of materials received and the predictability of reviews of PIP registration applications under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is developing guidance documents on common data needs for PIPs for each of the three components of the risk assessment: molecular characterization, human health assessment, and ecological assessment. EPA will also develop internal guidance for PIPs related to technical screen checklists, study evaluation templates, and risk assessment templates to ensure consistency across reviews.
• FDA intends to develop procedural guidance for participants in its voluntary consultation program as resources allow. The guidance would provide clarity for stakeholders, making for a more efficient and timely voluntary consultation process. This guidance would help stakeholders better understand the food safety issues considered in the voluntary consultation process and thereby lead to higher quality submissions from program participants. This guidance may also provide business process improvements that enable FDA to respond to consultation submissions in a timelier way.

USDA will streamline its permitting process and update its user guides. Under USDA’s revised regulations, modified plants that do not meet the criteria for regulatory exemption and that have not successfully completed the RSR process require a permit for import, interstate movement, and environmental release. To improve consistency in oversight, the revised regulations adopted a single method to authorize regulatory activities using a permitting process. Separately, USDA adopted a new Web-based permitting system for a variety of different products, including but not limited to biotechnology products. According to the Plan, collectively, these actions added administrative steps related to biotechnology permit issuances for external and internal users, increasing processing times and impacting the predictability of the permitting process. To address these issues, beginning in the first quarter of FY 2024, USDA will take the following actions:

• In consultation with EPA and FDA, USDA will explore eliminating interstate movement permits for certain plants or establishing alternative import and interstate movement permit categories for certain plants with streamlined processes and permit conditions, while retaining inspection and recordkeeping requirements;
• USDA will streamline permit application reviews to remove identified redundancies within its permitting process, revise its confidential business information (CBI) review process, and conduct risk-based reviews of standard operating procedures (SOP) for which USDA has established standard supplemental permit conditions, including all interstate movement and importation permits for plants and for environmental releases for familiar crops ( e.g. , corn, soybean, cotton, potato, tomato, canola, and alfalfa) and traits. USDA will also consider issuing multi-year permits for all interstate movement and importation permits for plants and for environmental releases for familiar crops ( e.g. , corn, soybean, cotton, potato, tomato, and alfalfa) and traits;
• USDA will streamline Supplemental Permit Conditions to ensure it assigns permit conditions that meet USDA protection goals, are consistent among developers, and provide concise, plain-language requirements. According to the Plan, USDA is reviewing and revising current standard supplemental permit conditions for all movement types (importation, interstate movement, and environmental release). USDA will communicate key changes to stakeholders and complete its review and revisions during FY 2024;
• An update to the Permit User Guide to align with USDA’s revised regulations and Animal and Plant Health Inspection Service’s (APHIS) eFile permitting system; and
• A final Guide to Submitting Data for Reports and Notices that will provide information and instructions for permit holders on submitting reports and notices to maintain compliance with USDA regulations during regulated activities.

EPA and USDA will clarify and streamline PIP regulation. As reported in our June 2, 2023, memorandum , EPA issued a final rule on May 31, 2023, that exempts a class of PIPs created using genetic engineering from registration requirements under FIFRA and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). The Plan states that EPA plans to update existing guidance on small-scale field testing of PIPs to incorporate USDA’s containment measures and modify, as necessary, the list of containment measures intended to reduce the probability for PIP residues to enter the food and feed supply from small-scale field tests. To minimize duplicative regulation of products that are subject to EPA pesticide regulations, in FY 2024, USDA will clarify its exemption from permitting requirements for modified plants containing PIPs that are registered by EPA as pesticides and, in consultation with EPA, will explore additional mechanisms for minimizing duplicative regulation of such products. The Plan notes that in response to requests from developers, EPA intends to address the scope of plant regulator PIPs.

EPA, FDA, and USDA intend to clarify their regulatory approaches to genome-edited plants and ensure their regulatory approaches are risk proportionate. As reported in our February 29, 2024, blog item , FDA recently issued “ Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing ” that clarifies FDA’s current thinking on the safety and regulatory status of foods derived from genome-edited plant varieties in accordance with its 1992 policy on foods from new plant varieties. According to the Plan, USDA and EPA will solicit feedback on additional modifications in plants that can be exempt from their respective regulations. USDA will consider comments on a November 15, 2023, notice on additional modifications that plants, including polyploid plants, can contain and be exempt from its regulations, based on publicly available scientific information describing advances in conventional breeding techniques. More information on the notice is available in our November 16, 2023, blog item . The Plan states that EPA will similarly issue a notice to solicit feedback to identify new categories of PIPs that could meet the FIFRA and FFDCA statute requirements for exemption that could be added to the list of exempt genetically engineered PIPs in future rulemakings.

USDA will streamline the process to update the List of Bioengineered Foods maintained in accordance with the National Bioengineered Food Disclosure Standard. USDA’s Agricultural Marketing Service (AMS) works with APHIS, FDA, and EPA to identify foods that meet the definition of a bioengineered food. This list helps identify foods or ingredients that may be required to be labeled as bioengineered. USDA will publish an RFI rather than an advance notice of proposed rulemaking to start each cycle of list updates to accelerate the rulemaking process, while continuing to allow for critical stakeholder input and feedback. As reported in our April 4, 2024, blog item , AMS published an RFI on March 28, 2024.

According to the Plan, FDA and USDA intend to collaborate to consider mechanisms for stewardship of food crops engineered to produce substances that could cause food safety concerns, or other food crops where stewardship may be important, if they inadvertently enter the food supply. The Plan states that USDA and FDA have noted an increased interest in using genetic engineering to produce, in food crops, ingredients intended for specific food uses that may pose food safety issues if they enter the general food supply ( e.g. , allergenic ingredients not previously produced by those crops), as well as other food crops where stewardship may be important. The Coordinated Framework did not explicitly address this subset of genetically engineered food crops. FDA and USDA intend to consider mechanisms for stewardship of such crops to ensure they are directed toward their intended uses and to minimize, where relevant, the possibility that material from the crops inadvertently enters the general food supply. Such mechanisms may be led by developers or third parties with advice from USDA and FDA, as appropriate, and could be applicable to other situations in the future if relevant.

Modified Animals

The Plan states that commenters stressed the importance of providing clarity about the regulatory process for modified agricultural animals falling under the Coordinated Framework, noted the ongoing discussions between FDA and USDA, and encouraged the agencies to bring closure to discussions, noting the importance of streamlining rather than complicating the regulatory process, although commenters differed in their preferred outcome. Commenters also requested that FDA and USDA provide information on principles and process for implementing regulatory oversight of cultured animal cell foods per their March 2019 Formal Agreement. The regulatory process for modified insects and other invertebrates also remains unclear and duplicative in some circumstances.

The Plan states that FDA and USDA recently signed a Memorandum of Understanding (MOU) on information sharing and regulatory cooperation on heritable intentional genomic alterations in animals that are also subject to USDA oversight. The MOU establishes policies and procedures to enhance the exchange of information between the agencies; describes the regulatory roles of the agencies; and promotes coordination of regulatory responsibilities. It does not change or add regulatory requirements for developers.

FDA recently issued two companion guidance documents on heritable intentional genomic alterations (IGA) in animals:

• Guidance for Industry (GFI) #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” is a final guidance document describing FDA’s general approach to the oversight of heritable IGAs in animals. Under this approach, FDA may exercise enforcement discretion and not expect people or companies developing certain types of IGAs in animals to submit an application or get approval before marketing their products; and
• GFI #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process,” is a draft revised guidance document that describes how the FDA approval process applies to heritable IGAs in animals. According to the Plan, FDA is issuing GFI #187B as a draft guidance document to solicit comments that will enable the agency to update, and make as efficient as possible, the approval process for IGAs in animals.

The Plan states that FDA and USDA intend to clarify and provide guidance on the regulation of cultured animal cell foods. According to the Plan, FDA and USDA staff are in routine contact to ensure that oversight is implemented consistently with the roles and responsibilities described in the March 2019 Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species. FDA intends to issue draft guidance that would help manufacturers and other industry stakeholders understand the types of food safety issues they should consider when producing cultured animal cell foods and how to assemble and organize information that can support a firm’s conclusion about the safety of their food. The Plan notes that in 2024, USDA will propose new regulations pertaining to the labeling of meat and poultry products composed of or containing cultured cells derived from animals subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act. USDA will also issue labeling guidance for establishments producing these cell-cultured meat and poultry products.

EPA, FDA, and USDA intend to provide updated information on the regulation of modified insect and invertebrate pests and work together to streamline and coordinate the regulation of modified insects. According to the Plan, EPA will provide efficacy guidance on genetic modifications in pest animals intended for use as a pesticide. EPA requires scientific evidence that registered products sold to control pests known to impact public health (such as those that carry West Nile virus, Zika virus, and dengue) are effective against the target pest. The Plan states that given the unique parameters involved with field testing of modified mosquito products, EPA will develop efficacy guidance for modified mosquito products for population control.

Modified Microorganisms

According to the Plan, stakeholders commented that agency roles and responsibilities remain unclear for various microbial products ( e.g. , microbial inoculants/biostimulants used for plant growth promotion, plant pests, microbial biocontrol organisms, and microbial biomass used for human and animal feed). Stakeholders requested an integrated approach to improving regulatory clarity and harmonization, limiting duplicative oversight, and ensuring risk-proportionate regulation of engineered microbes. The Plan notes that greater agency coordination will minimize the potential for stakeholder confusion or conflicting regulatory requirements among the agencies.

EPA and USDA will clarify, and as possible harmonize, regulatory roles, processes, and information, data, and authorization requirements for environmental release of modified microbes. The agencies will undertake this effort to reduce regulatory duplication where possible, harmonize risk-based processes and requirements, and increase interagency communication, particularly regarding small-scale field trials.

USDA will clarify the modified microorganisms that are subject to regulation under its authority. Under USDA’s revised regulations, modified plant pests, microorganisms modified with DNA from a plant pest where the DNA can produce an infectious agent or compound that causes plant disease, and modified microorganisms that are used to control plant pests and could pose a plant pest risk require a permit for import, interstate movement, and environmental release. USDA will develop, publish, and maintain a list of plant pests. In the legacy biotechnology regulations, USDA maintained a regulatory listing of taxa to describe “organisms that are or contain plant pests” to aid developers in determining whether a modified organism required a USDA permit. When USDA updated its regulations in 2020, it removed this listing from the regulations because it had become out of date and agreed to post a list of taxa on its website that could be regularly reviewed and updated. The Plan states that USDA plans to begin developing the plant pest list in FY 2024 and will provide an opportunity for public comment on the list.

According to the Plan, USDA will explore mechanisms to exempt certain modified microorganisms from its regulation. USDA will explore potential regulatory changes that would exempt from USDA regulations, in whole or in part, modified biological control organisms that are not plant pests and that are registered with EPA as microbial pesticides or that are not EPA registered pesticides but are being transferred, sold, or distributed in accordance with EPA’s regulations at 40 C.F.R. Section 152.30.

The Plan states that USDA will explore potential pathways to commercialization, including mechanisms for risk-based deregulation, for non-plant organisms that could be proposed in future rulemaking, including by considering comments from stakeholders on the RFI issued in November 2022, further engaging impacted developers and other stakeholders, and consulting with EPA and FDA. According to the Plan, USDA will further streamline permit application and review processes to enable efficient movement of modified microbes between APHIS-approved containment facilities for contained research activities. USDA will streamline Supplemental Permit Conditions for microbe release permits to ensure it assigns permit conditions that meet its protection goals, are consistent among developers, and provide concise, plain-language requirements. USDA will further revise its draft microorganism permit guide. As reported in our October 20, 2023, blog item , in October 2023, USDA published a revised draft guide for submitting permit applications for modified microorganisms and a response to public comments on the initial draft guide issued in March 2023. As part of its ongoing commitment to clarify the guide further, after intra- and interagency consultation, USDA will publish a revised draft guide for public comment. The revised draft guide will provide information on USDA processes, criteria, and any associated data requirements for determining regulatory jurisdiction for microorganisms based on whether an organism is a plant pest or biocontrol organism that could pose a plant pest risk. It will harmonize, where possible, information and data requirements for modified and non-modified microbes subject to USDA regulation under the Plant Protection Act.

The Plan notes that biopesticides often have lower toxicity profiles, reduced worker re-entry intervals, and reduced pre-harvest intervals. They can also support climate change mitigation ( e.g. , by providing alternatives to ozone-depleting pesticides or reducing on-field applications and use of fossil fuels) and help advance environmental justice. The Plan states that considering these benefits, EPA will prioritize review of biopesticide applications, provide technical assistance to biopesticide developers, and seek to collaborate with state lead pesticide agencies to reduce the time to bring new and effective biopesticide tools to farmers, as resources allow and in alignment with the Pesticide Registration Improvement Act (PRIA 5).

Human Drugs, Biologics, and Medical Devices

According to the Plan, stakeholders commented that FDA should update or issue new guidance documents or regulations in areas related to human drugs and biologics, such as aseptic processing of sterile drug products, validation and testing procedures, quality metrics reporting, the manufacture of multiple products in a single facility, lot release and product characterization requirements, cross-referencing of drug master files, sterility assurance and contamination control, and certain animal testing requirements. A commenter requested that FDA rather than EPA oversee products with anti-biofilm claims. Another commenter recommended that the United States should foster the domestic manufacture of active pharmaceutical ingredients.

The Plan states that FDA intends to issue a proposed rule to revise regulations related to post-approval chemistry, manufacturing, and controls (CMC) changes for both drugs and biological products, and intends to issue draft guidance to provide greater clarity on its oversight of post-approval CMC changes for certain biotechnology products. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are developing a proposed rule to revise regulations related to post-approval CMC changes (21 C.F.R. Sections 314.70, 314.81, and 601.12) to facilitate further application of risk-based approaches, including the use of tools described in the internationally harmonized guidance International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In July 2023, CBER issued the draft guidance document Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (CGT products) to provide more guidance on post-approval changes in these products. CDER and CBER are also developing draft guidance on post-approval manufacturing changes to biosimilar and interchangeable biosimilar products to provide clarity on how to make post-approval changes for biosimilar products.

The Plan states that FDA is developing guidance on its oversight of certain genome-editing products, including use of a platform approach to such therapeutics. In January 2024, CBER issued a final draft of the guidance document Human Gene Therapy Products Incorporating Human Genome Editing . This guidance addresses development of human genome-editing products for clinical studies and licensure. The Plan notes that while the potential of such products for the treatment of human disease is clear, the potential risks are not as well understood. To assist in the translation of these products from the bench to clinical trials, the guidance includes recommendations for how to assess the safety and quality of these products and address the potential risks of these products. According to the Plan, as the field evolves, product design advances, and FDA gains information on the safety of human genome-edited products, FDA may revise its recommendations to consider such changes.

CDER and CBER plan to issue draft guidance to implement Section 2503 of the 2023 Consolidated Appropriations Act. According to the Plan, to implement this provision, FDA intends to establish a platform technology designation program. The guidance would describe the program and how interested persons can submit a request for a platform technology to be designated. If a platform technology designation request is granted, FDA may accept a request for expedited development for any subsequent application submitted under Sections 505(b) of FFDCA or 351(a) of the Public Health Service (PHS) Act that uses the platform technology. Expedited development for a subsequent application may include engaging in early interactions with sponsors to discuss the use of a platform technology and providing timely advice to and having additional engagement with the sponsor during the development program.

In January 2024, CBER issued a final draft of the guidance Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products . The guidance provides CAR T cell-specific recommendations regarding CMC, pharmacology and toxicology, and design of clinical studies for cancer indications. This guidance also provides recommendations for analytical comparability studies for CAR T cell products.

In December 2023, CBER updated the guidance Potency Assurance for Cellular and Gene Therapy Products . The revised draft guidance document updates FDA’s recommendations for potency assays for CGT products and further recommends a comprehensive approach to ensuring potency that is grounded in quality risk management.

According to the Plan, FDA will continue to partner, along with the National Institutes of Health and multiple public and private organizations, in the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium public-private partnership. The Partnership aims to develop platforms and standards that will speed the development and delivery of customized or “bespoke” gene therapies that could treat the millions of people affected by rare diseases.

Cross-Cutting Issues

The Plan states that commenters had many requests and suggestions for greater clarity on and assistance with the regulation of biotechnology products that fall under the Coordinated Framework. In addition to requests for increased clarity in specific product areas, commenters asked the agencies to provide simple, plain language information that clarifies agency responsibilities for different products, data requirements and regulatory processes, and the bases for decision-making. According to the Plan, commenters suggested using the Unified Website for Biotechnology Regulation to provide plain language summaries of regulations, as well as guidance and documents such as case studies, and as a one-stop shop for stakeholder questions and updates. Commenters asked the agencies to provide dedicated staff who would be directly available to provide regulatory assistance to developers. In addition to actions described above to increase regulatory clarity and assistance, EPA, FDA, and USDA will:

• Work together to provide plain language information on regulatory roles, responsibilities, and processes for products of biotechnology; and
• Develop and implement a mechanism for developers to submit information to, and request a meeting with, all three regulatory agencies, early in the product development process.

The Plan notes that commenters stressed the need for greater policy and process alignment across EPA, FDA, and USDA regarding regulation of biotechnology products to reduce uncertainties for developers and avoid unnecessary redundancies. Commenters urged the agencies to align definitions, regulatory exemptions, data and other information requirements, and timelines for reviews; to coordinate reviews and recognize their sister agencies’ expertise; and to establish a single point of entry into the regulatory system. Further, they asked for coordination across all federal agencies that touch products of biotechnology, from regulatory and trade agencies to administrative and security agencies, and made various recommendations for establishing a formal interagency coordinating body. The Plan states that EPA, FDA, and USDA intend to:

• Update and renew their information sharing MOU; and
• Work together to update the Coordinated Framework for the Regulation of Biotechnology by December 2024 .

The Plan is good news by any standard. The words “update,” “streamline,” and “clarify” are music to the ears of any innovator, registrant, or other stakeholder in this complicated and fast-evolving area of law, policy, and science. We noted the tremendous challenges stakeholders face with the lack of clarity among EPA, FDA, and USDA in our 2015 publication “ The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology ?,” published in the Woodrow Wilson International Center for Scholars Synthetic Biology Project Report . The report highlights just how porous the jurisdictional divide is among these agencies and the lack of clarity and direction for innovators in this space in terms of how to obtain approvals for products as a predicate to commercialization. We applaud the Plan and wholeheartedly support its goals. The hard part is executing on the plan and making the updating, streamlining, and clarifying part a reality, and soon!

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RIPE Publishing takes home top prize in Business Plan competition finale

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Eight businesses gave their final pitch before a panel of judges at the Modern Art Museum of Fort Worth as part of the Fort Worth Business Plan Competition May 9.

The Fort Worth Business Plan Competition is an annual celebration of the city’s entrepreneurs and small businesses. This was the 13th year for the program. 

Twenty businesses completed six weeks of business development training and coaching before applying those skills to their own written plans. After the plans were judged, the top eight finalists each made a three-minute pitch to the judges, followed by a two-minute round of questions and answers. 

This year, the grand prize of $10,000 in cash was taken home by Megan Jackson and Tneisha Brown of RIPE Publishing House, a company focused on serving authors and the community more effectively and equitably including through youth programming. 

RIPE Publishing House also won the “Perfect Pitch Prize” audience popular vote, receiving a $500 credit for custom merchandise for their business courtesy of sponsor Printed Threads.

Second prize — a check for $6,000 — went to Shawna Murphy from StyleSmart VA. A client of TechFW, StyleSmart VA matches beauty industry professionals with trained virtual assistants to provide them with administrative support.

The third-place prize of $4,000 went to Dee Henry of Champion Strength & Conditioning, a boutique personal training studio that offers tailored fitness programs to improve its clients’ health, wellness and performance.

This year’s Fort Worth Business Plan Competition included businesses from nine of Fort Worth’s 10 council districts. Council members Michael Crain, Janette Martinez and Chris Nettles attended the event. 

The emcee for the evening was Lauren Kutschke of Salted Pages, the 2022 grand prize winner of the competition. A special introduction was provided by Shalonda Burnside of Lil Pop Gourmet Popcorn, last year’s grand prize winner.

As in previous years, the Fort Worth Business Plan Competition was organized by the city of Fort Worth’s Economic Development Department and sponsored by Frost Bank.

A variety of supporting partners also helped provide coaching and mentorship to the participating businesses, including TechFW, HSC Next, SCORE Fort Worth, Tarrant County Small Business Development Center, Accelerate Fort Worth Foundation and Foundations EDC.

The additional businesses that pitched during the finale were:

• Brown Sugar Ice Cream Co., which specializes in organic, lactose-free frozen custard using local ingredients.
• Ca’Maire LLC, a local hair salon that offers tailored solutions to all hair textures and types.
• OnDa Spot Solutions, a company that provides commercial cleaning and disinfecting services to workplaces across the region.
• Shaman Systems LLC, a business that designs and sells electronic components for personal electric vehicles like e-bikes.
• Smackin Mac, a food truck that serves a variety of baked gourmet mac-and-cheese bowls with fresh ingredients.

La Pulga releases mezcal 

One year ago, three local entrepreneurs launched La Pulga Tequila, a new spirit produced and bottled in Mexico, but born in Fort Worth. As the company celebrates its one-year anniversary, it has expanded its portfolio to include a new ultra-premium mezcal, La Pulga Mezcal.

Now available across North Texas — and soon throughout the state — La Pulga officials report the mezcal is crafted in San Luís Potosí, Mexico, from wild harvested 100% agave salmiana, imparting a distinct and flavorful taste and aroma of green chili, citrus and green olives. La Pulga Mezcal is a joven, or unaged mezcal.

“Our mission — and our passion — at La Pulga is to handcraft the very best, most unique spirits of their kind. That’s what we did with our La Pulga tequilas, and now with our extraordinary new mezcal,” said Sarah Castillo, one of La Pulga’s three founders. “This is not your usual smoky mezcal.”

La Pulga Mezcal honors time-honored production methods passed down through generations, including meticulous roasting of the agave piñas — the sweet and juicy heart of the plant — which are then crushed to separate the agave juice from the fibers before fermentation and distillation.

The brand takes its name from the “Pulga” outdoor market on University Drive where it enters Fort Worth’s Northside; it is one of the oldest open-air flea markets in the U.S. 

The brand was founded by Castillo, a Fort Worth restaurateur; Andrew de la Torre, a club owner and the operator of the Pulga market; and Stephen Slaughter, a local entrepreneur and real estate developer.

La Pulga Mezcal and La Pulga Tequila are available through Republic National Distributing Co. at bars and restaurants throughout the metroplex and other select Texas markets, at spirits retailers and online . 

La Pulga Mezcal marks the first release in the brand’s new “Alebrijes” series, which refers to the Mexican folk art images of mystical animals that adorn La Pulga bottles. The animal spirit on La Pulga Mezcal is a coyote, native to the area around the distillery in San Luís Potosí.

Hillwood refinances industrial building 

Hillwood refinanced the construction debt on a recently completed industrial building within the developer’s AllianceTexas master-planned development. 

JLL  Capital Markets, the capital markets arm of JLL, a large commercial real estate services firm, arranged for the financing on behalf of Hillwood. 

The 1.2 million-square-foot property is fully leased to Southwire Co., one of the leading manufacturers of wire and cable based in Carrollton, Georgia.

The JLL Capital Markets team included Trey Morsbach, DJ Meagher, Ryan Pollack and Chad Lisbeth.

Do you have something for the Bob on Business column? Email Bob Francis as [email protected].

Bob Francis is business editor for the Fort Worth Report. Contact him at [email protected]. 

At the Fort Worth Report, news decisions are made independently of our board members and financial supporters. Read more about our editorial independence policy here .

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by Bob Francis, Fort Worth Report May 18, 2024

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Robert Francis is a Fort Worth native and journalist who has extensive experience covering business and technology locally, nationally and internationally. He is also a former president of the local Society... More by Bob Francis

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Endeavor's $13 billion deal highlights push to sidestep minority shareholders

The plan is the latest example of a company's controlling investors risking lawsuits to avoid paying a higher deal price.