business plan for small biotech

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.

Business Plan Template for Biotech Startups

• Ready-to-use, fully customizable Subcategory
• Get started in seconds

As a biotech startup founder, you understand the importance of a well-crafted business plan to secure the resources and funding needed to bring your scientific discoveries to life. That's why ClickUp's Business Plan Template for Biotech Startups is an essential tool for entrepreneurs like you!

With this template, you can easily outline your research and development plans, target markets, commercialization strategies, and financial projections in a comprehensive and professional manner. It's designed specifically for the biotech industry, so you can confidently present your ideas to investors and stakeholders.

Don't let the complexities of the biotech world hold you back. Use ClickUp's Business Plan Template for Biotech Startups to validate your business ideas and strategies, and take your venture to new heights!

Get started today and make your biotech dreams a reality.

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.
• Business Plan Template for Geneticists
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/ 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) .

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• Building a Business
• Published: 11 February 2022

BUILDING A BUSINESS

So you want to start a biotech company

• Sadhana Chitale 1 ,
• Colm Lawler 2 &
• Arthur Klausner 3  

Nature Biotechnology volume  40 ,  pages 296–300 ( 2022 ) Cite this article

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Commercializing research is fraught with pitfalls, but a thoughtful checklist can ensure you set off on the right path and give your fledgling business the best chance of success.

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Authors and affiliations.

Technology Operations and Ventures, NYU Langone Health, New York, NY, USA

Sadhana Chitale

Mass General Brigham, Boston, MA, USA

Colm Lawler

Goldilocks Therapeutics Inc, Bedford, NY, USA

Arthur Klausner

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Chitale, S., Lawler, C. & Klausner, A. So you want to start a biotech company. Nat Biotechnol 40 , 296–300 (2022). https://doi.org/10.1038/s41587-022-01239-9

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Crafting a Comprehensive Biotech Business Plan

Every entrepreneurial journey in biotechnology begins with a solid biotech startup business plan. Whether you aim to pioneer groundbreaking research, develop innovative products, or provide top-notch biotech services, an effective, well-articulated business plan is your first step toward achieving your goals.

Understanding the Biotech Industry

Definition and importance of biotechnology.

Biotechnology, fondly shortened as biotech, involves leveraging living systems and organisms to develop or produce beneficial products or technologies. Biotech is an omnipresent component of our daily lives, from enhancing agricultural yield to fabricating life-saving drugs and therapies. Its importance can’t be overstated—it shapes the world as we know it, promising a brighter, healthier future for all.

Exploring the Various Facets of Biotechnology

The intriguing world of biotech is not confined to a single segment. It encapsulates various fields, including agricultural biotech, industrial biotech, medical biotech, and environmental biotech. These branches harbor unique opportunities that can be harnessed for societal excellent and financial gain.

The Intrinsic Need for a Biotech Business Plan

Think of your biotech startup business plan as a roadmap or a GPS guiding your entrepreneurial journey. It outlines your current location (the concept) and pinpoints your destination (profitability). For aspiring entrepreneurs in the biotech market, formulating a robust business plan is more than an optional exercise—it’s a vital necessity.

Forging a Vision for Your Biotech Business

Every successful venture begins with a vision. This vision, integral to your biotech business model, is the northern star guiding your biotech startup. It represents your ultimate goals, the impact you aim to have, and the legacy you aspire to leave behind. A vision can vary from developing innovative therapeutics that save lives to creating sustainable biofuels that combat climate change.

Navigating the Biotech Market: Market Analysis

Identifying your target market.

The biotech market is as vast as it is diverse. Understanding your target market is a prerequisite to carve out a niche for your biotech startup. It’s about knowing who your potential customers are, what they require, how they operate, and where your product or service fits into their lives. Knowing your customers ‘ wants, needs, and expectations can guide your operations and strategies, whether your customers are pharmaceutical firms, hospitals, or the general public.

Understanding Your Competitors

Equally crucial to your biotech commercial planning is understanding your competition. A comprehensive competitive analysis affords you invaluable insights into current market trends, untapped opportunities, and potential hurdles.

Defining Your Biotech Product/Service

Describing your offering.

Are you developing a novel drug or devising an innovative gene-editing service? Whatever your unique selling proposition, you must be able to articulate what you offer clearly. This encompasses your biotech product or service, how it works, and how it benefits consumers.

Understanding Your Product/Service Lifecycle

Every product or service goes through a lifecycle—a series of stages from development to decline. Knowing where your product/service lies in this lifecycle helps you plan for future growth, manage resources effectively, and foresee potential challenges.

Building a Profitable Biotech Business Model

Whether you’re laying out a traditional biotech business model or a flexible virtual biotech business model, outlining how your business will generate revenue is vital. You could make money through direct sales, licensing agreements, strategic partnerships, or a combination. This financial planning for biotech executives is critical to ensure sustainability and attract investment.

Marketing and Sales Strategy: Reaching and Convincing Your Market

Having a revolutionary product or service is meaningless if your target market doesn’t know it exists or fails to understand its value. That’s where your marketing and sales strategy comes in. This plan outlines reaching your target market and persuading them to invest in your product or service.

Assembling Your Team and Structuring Your Management

In the high-stakes world of biotech, your team’s expertise and your management’s efficiency can spell the difference between success and failure. Your biotech startup business plan should thus delineate your team and management structure, capturing your key team members’ skills, experiences, and roles.

Creating Your Operational Biotech Business Plan

The operational plan functions as the engine room of your biotech startup. It details the nitty-gritty of your daily operations, from product development to delivery, regulatory compliance, and customer service.

Financial Projections: Painting a Picture of Financial Success

Financial projections are crucial elements of financial planning for biotech executives. These projections—revenue forecasts, operational costs, and profitability estimates—give potential investors a glimpse of your business’s economic potential.

Identifying Risks and Outlining Contingency Plans

Every business venture comes with its set of risks. For a biotech startup, these risks could include regulatory changes, scientific setbacks, market volatility, and financial challenges. Acknowledging these risks in your business plan and proposing realistic contingency measures enhances the plan’s credibility and prepares you to weather potential storms.

The Executive Summary In The Biotech Business Plan

While the executive summary is the first section potential investors read, it is often written last. This section snaps your business plan, highlighting the most critical points.

Tips for Creating a Robust Biotech Startup Business Plan

To make your business plan as effective as possible, keep it clear, concise, and fact-based. Use engaging, straightforward language, and remember that your business plan should evolve as your business grows.

Starting a biotech company can seem like a daunting task. However, with careful planning and strategic execution, it can become a rewarding journey. Crafting a comprehensive biotech business plan provides you with a roadmap for your startup and improves your odds of securing biotech startup funding, especially in the early stages of your business.

Remember, the road to success in the biotech industry may be winding and challenging. However, with a robust plan, the journey can become much more navigable.

Integrating Marketing & Business Development In Life Sciences

This article explores integrating Marketing & Business Development in Life Sciences and how to implement it in your business.

How To Define Your Target Audience in Pharma and Biotech

Understanding your target audience is crucial in the complex landscapes of pharmaceutical and biotechnology industries. Explore different strategies for three distinct groups: large pharmaceutical companies, mid-sized firms, and small biotech startups, ensuring successful engagements and long-term partnerships.

What is Biotech Business Development? 

Explore the integral role of biotech business development in merging science with commerce, the broad scope of life sciences, the varied roles of its professionals, and the significance of strategic planning for market success.

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Pharmaceutical Business Plan Template

Written by Dave Lavinsky

Pharmaceutical Business Plan

Over the past 20+ years, we have helped over 500 entrepreneurs and business owners create business plans to start and grow their pharmaceutical companies.

If you’re unfamiliar with creating a pharmaceutical business plan, you may think creating one will be a time-consuming and frustrating process. For most entrepreneurs it is, but for you, it won’t be since we’re here to help. We have the experience, resources, and knowledge to help you create a great business plan.

In this article, you will learn some background information on why business planning is important. Then, you will learn how to write a pharmaceutical business plan step-by-step so you can create your plan today.

Download our Ultimate Business Plan Template here >

What Is a Business Plan?

A business plan provides a snapshot of your pharmaceutical business as it stands today, and lays out your growth plan for the next five years. It explains your business goals and your strategies for reaching them. It also includes market research to support your plans.

Why You Need a Business Plan

If you’re looking to start a pharmaceutical business or grow your existing company, you need a business plan. A business plan will help you raise funding, if needed, and plan out the growth of your pharmaceutical company to improve your chances of success. Your business plan is a living document that should be updated annually as your company grows and changes.

Sources of Funding for Pharmaceutical Businesses

With regards to funding, the main sources of funding for a pharmaceutical business are personal savings, credit cards, bank loans, and angel investors. When it comes to bank loans, banks will want to review your business plan and gain confidence that you will be able to repay your loan and interest. To acquire this confidence, the loan officer will not only want to ensure that your financials are reasonable, but they will also want to see a professional plan. Such a plan will give them the confidence that you can successfully and professionally operate a business. Personal savings and bank loans are the most common funding paths for pharmaceutical businesses.

Finish Your Business Plan Today!

How to write a business plan for a pharmaceutical company.

If you want to start a pharmaceutical company or expand your current one, you need a business plan. The guide below details the necessary information for how to write each essential component of your pharmaceutical business plan.

Executive Summary

Your executive summary provides an introduction to your business plan, but it is normally the last section you write because it provides a summary of each key section of your plan.

The goal of your executive summary is to quickly engage the reader. Explain to them the kind of pharmaceutical business you are running and the status. For example, are you a startup, do you have a company that you would like to grow, or are you operating pharmaceutical companies in multiple markets?

Next, provide an overview of each of the subsequent sections of your plan.

• Give a brief overview of the pharmaceutical industry.
• Discuss the type of pharmaceutical business you are operating.
• Detail your direct competitors. Give an overview of your target customers.
• Provide a snapshot of your marketing strategy. Identify the key members of your team.
• Offer an overview of your financial plan.

Company Overview

In your company overview, you will detail the type of pharmaceutical company you are operating.

For example, you might specialize in one of the following types of pharmaceutical businesses:

• Generic Pharmaceutical Manufacturing : this type of pharmaceutical business develops prescription or over-the-counter drugs products that do not have patent protection.
• Vitamin & Supplement Manufacturing: this type of pharmaceutical company primarily develops products that contain ingredients intended to supplement the diet.
• Brand Name Pharmaceutical Manufacturing: this type of pharmaceutical business engages in significant research and development of patent-protected prescription and over-the-counter medications.

In addition to explaining the type of pharmaceutical business you will operate, the company overview needs to provide background on the business.

Include answers to questions such as:

• When and why did you start the business?
• What milestones have you achieved to date? Milestones could include the number of patents awarded, the extent of your product portfolio, reaching X number of distributors under contract, etc.
• Your legal business Are you incorporated as an S-Corp? An LLC? A sole proprietorship? Explain your legal structure here.

Industry Analysis

In your industry or market analysis, you need to provide an overview of the pharmaceutical industry.

While this may seem unnecessary, it serves multiple purposes.

First, researching the pharmaceutical industry educates you. It helps you understand the market in which you are operating.

Secondly, market research can improve your marketing strategy, particularly if your analysis identifies market trends.

The third reason is to prove to readers that you are an expert in your industry. By conducting the research and presenting it in your plan, you achieve just that.

The following questions should be answered in the industry analysis section:

• How big is the pharmaceutical industry (in dollars)?
• Is the market declining or increasing?
• Who are the key competitors in the market?
• Who are the key suppliers in the market?
• What trends are affecting the industry?
• What is the industry’s growth forecast over the next 5 – 10 years?
• What is the relevant market size? That is, how big is the potential target market for your pharmaceutical company? You can extrapolate such a figure by assessing the size of the market in the entire country and then applying that figure to your local population.

Customer Analysis

The customer analysis section of your business plan must detail the customers you serve and/or expect to serve.

The following are examples of customer segments: healthcare providers, chain pharmacies, independent retailers, and consumers.

As you can imagine, the customer segment(s) you choose will have a great impact on the type of pharmaceutical business you operate. Clearly, individuals would respond to different marketing promotions than hospitals, for example.

Try to break out your target customers in terms of their demographic and psychographic profiles. With regards to demographics, including a discussion of the ages, genders, locations, and income levels of the potential customers you seek to serve.

Psychographic profiles explain the wants and needs of your target customers. The more you can recognize and define these needs, the better you will do in attracting and retaining your customers.

Finish Your Pharmaceutical Business Plan in 1 Day!

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With Growthink’s Ultimate Business Plan Template you can finish your plan in just 8 hours or less!

Competitive Analysis

Your competitive analysis should identify the indirect and direct competitors your business faces and then focus on the latter.

Direct competitors are other pharmaceutical businesses.

Indirect competitors are other options that customers have to purchase from that aren’t directly competing with your product or service. This includes imported alternatives, herbal remedies, or customers’ nutritional self-care. You need to mention such competition as well.

For each such competitor, provide an overview of their business and document their strengths and weaknesses. Unless you once worked at your competitors’ businesses, it will be impossible to know everything about them. But you should be able to find out key things about them such as

• What types of products do they manufacture?
• What are their research and development capabilities?
• What is their pricing (premium, low, etc.)?
• What are they good at?
• What are their weaknesses?

With regards to the last two questions, think about your answers from the customers’ perspective. And don’t be afraid to ask your competitors’ customers what they like most and least about them.

The final part of your competitive analysis section is to document your areas of competitive advantage. For example:

• Will you provide product development?
• Will you offer products or services that your competition doesn’t?
• Will you provide better customer service?
• Will you offer better pricing?

Think about ways you will outperform your competition and document them in this section of your plan.  

Marketing Plan

Traditionally, a marketing plan includes the four P’s: Product, Price, Place, and Promotion. For a pharmaceutical company, your marketing strategy should include the following:

Product : In the product section, you should reiterate the type of pharmaceutical business that you documented in your company overview. Then, detail the specific products or services you will be offering. For example, will you manufacture patent-protected prescription medications, or a range of vitamins?

Price : Document the prices you will offer and how they compare to your competitors. Essentially in the product and price sub-sections of your plan, you are presenting the products and/or services you offer and their prices.

Place : Place refers to the site of your pharmaceutical business. Document where your company is situated and mention how the site will impact your success. For example, is your pharmaceutical company located in an industrial district, near a major medical and/or scientific hub, or near input markets? Discuss how your site might be the ideal location for your customers.

Promotions : The final part of your pharmaceutical marketing plan is where you will document how you will drive potential customers to your location(s). The following are some promotional methods you might consider:

• Advertise in local papers, radio stations and/or magazines
• Advertise in trade publications
• Reach out to websites
• Distribute flyers
• Engage in email marketing
• Advertise on social media platforms
• Improve the SEO (search engine optimization) on your website for targeted keywords

Operations Plan

While the earlier sections of your business plan explained your goals, your operations plan describes how you will meet them. Your operations plan should have two distinct sections as follows.

Everyday short-term processes include all of the tasks involved in running your pharmaceutical company, including meeting with potential customers, creating and distributing product information, developing and manufacturing products, etc.

Long-term goals are the milestones you hope to achieve. These could include the dates when you expect to produce your Xth product, or when you hope to reach $X in revenue. It could also be when you expect to expand your pharmaceutical business to a new city.  

Management Team

To demonstrate your pharmaceutical company’s potential to succeed, a strong management team is essential. Highlight your key players’ backgrounds, emphasizing those skills and experiences that prove their ability to grow a company.

Ideally, you and/or your team members have direct experience in managing pharmaceutical businesses. If so, highlight this experience and expertise. But also highlight any experience that you think will help your business succeed.

If your team is lacking, consider assembling an advisory board. An advisory board would include 2 to 8 individuals who would act as mentors to your business. They would help answer questions and provide strategic guidance. If needed, look for advisory board members with experience in managing a pharmaceutical business or successfully running a R&D company.  

Financial Plan

Your financial plan should include your 5-year financial statement broken out both monthly or quarterly for the first year and then annually. Your financial statements include your income statement, balance sheet, and cash flow statements.

Income Statement

An income statement is more commonly called a Profit and Loss statement or P&L. It shows your revenue and then subtracts your costs to show whether you turned a profit or not.

In developing your income statement, you need to devise assumptions including your sales projections. For example, will you manufacture a line of general sales products, or will you specialize in manufacturing controlled drugs? And will sales grow by 2% or 10% per year? As you can imagine, your choice of assumptions will greatly impact the financial forecasts for your business. As much as possible, conduct research to try to root your assumptions in reality.

Balance Sheets

Balance sheets show your assets and liabilities. While balance sheets can include much information, try to simplify them to the key items you need to know about. For instance, if you spend $50,000 on building out your pharmaceutical company, this will not give you immediate profits. Rather it is an asset that will hopefully help you generate profits for years to come. Likewise, if a lender writes you a check for $50,000, you don’t need to pay it back immediately. Rather, that is a liability you will pay back over time.

Cash Flow Statement

Your cash flow statement will help determine how much money you need to start or grow your business, and ensure you never run out of money. What most entrepreneurs and business owners don’t realize is that you can turn a profit but run out of money and go bankrupt.

When creating your Income Statement and Balance Sheets be sure to include several of the key costs needed in starting or growing a pharmaceutical company:

• Cost of equipment and supplies
• Payroll or salaries paid to staff
• Business insurance
• Other start-up expenses (if you’re a new business) like legal expenses, permits, computer software, and equipment

Attach your full financial projections in the appendix of your plan along with any supporting documents that make your plan more compelling. For example, you might include your facility blueprint or a list of products you manufacture.  

Writing a business plan for your pharmaceutical business is a worthwhile endeavor. If you follow the template above, by the time you are done, you will truly be an expert. You will understand the pharmaceutical company industry, your competition, and your customers. You will develop a marketing strategy and will understand what it takes to launch and grow a successful pharmaceutical company.  

Pharmaceutical Business Plan Template FAQs

What is the easiest way to complete my pharmaceutical business plan.

Growthink's Ultimate Business Plan Template allows you to quickly and easily write your pharmaceutical business plan.

How Do You Start a Pharmaceutical Business?

Starting a pharmaceutical business is easy with these 14 steps:

• Choose the Name for Your Pharmaceutical Business
• Create Your Pharmaceutical Business Plan
• Choose the Legal Structure for Your Pharmaceutical Business
• Secure Startup Funding for Your Pharmaceutical Business (If Needed)
• Secure a Location for Your Business
• Register Your Pharmaceutical Business with the IRS
• Open a Business Bank Account
• Get a Business Credit Card
• Get the Required Business Licenses and Permits
• Get Business Insurance for Your Pharmaceutical Business
• Buy or Lease the Right Pharmaceutical Business Equipment
• Develop Your Pharmaceutical Business Marketing Materials
• Purchase and Setup the Software Needed to Run Your Pharmaceutical Business
• Open for Business

Don’t you wish there was a faster, easier way to finish your Pharmaceutical business plan?

OR, Let Us Develop Your Plan For You

Since 1999, Growthink has developed business plans for thousands of companies who have gone on to achieve tremendous success.   Click here to see how Growthink’s business plan writers can create your business plan for you.

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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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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 ]

First-time launchers in the pharmaceutical industry

Imagine you’re the leader of a small biopharmaceutical company. As your new drug makes good progress through clinical trials, you face a moment of truth: Do you have what it takes to launch your product yourself?

Twenty years ago, the answer to that question would almost certainly have been “no.” Small biotechnology and biopharma companies followed a well-worn path for their assets and explored licensing, partnership, and outright acquisition as their means to product launches. But that pattern has shifted over the past decade or so as more small companies decide to launch their products themselves.

Globally, those first-time launchers account for more than a quarter of all new molecular entities submitted to the US FDA since 2016 (Exhibit 1). That share rises to more than a third when including subsequent launches from companies that launched their first product after 2001.

This article looks at the reasons for the shift in drug launches and identifies four areas of focus that can help first-time launchers maximize their chances of a successful launch.

Why is the number of first-time pharma-product launchers on the rise?

Three converging factors are swelling the ranks of first-time launchers of pharma products—the business cycle, the availability of talent, and the proliferation of vendors:

• Business cycle. For much of the past five years, small drug companies found it relatively easy to raise money. Economic growth was strong, interest rates were low, and venture-capital (VC) funding was flowing into healthcare, especially in late-round deals, which reached $4 billion in 2018. As M&A volumes grew , so did the valuation premium for small biotech companies, and large pharma companies tended to focus on megadeals (except for an overall drop in M&A activity, especially in the first half of 2020), with which premiums were easier to achieve through cost synergies.
• Talent. The intense M&A activity of large pharma companies has led to a substantial exodus of their talent—including experienced commercial leaders—to smaller companies, boosting the confidence of those smaller companies in launching for themselves. Additionally, the steady increase in the number of biopharma-related jobs has led to an increase in related training. The resulting access to ever-more qualified employees has also bolstered the confidence of first-time launchers. In the United States, for instance, R&D hubs in California and Massachusetts are rapidly becoming sources of seasoned commercial as well as research talent. Between 2000 and 2020, 31 out of 85 US small launchers originated from those two areas.
• Vendors. Today’s small pharma companies not only have more access to talent but also have more options to buy key commercialization capabilities. A growing list of vendors provide specialist support in functions such as manufacturing, sales, patient services, and pharmacovigilance. Almost half of all first-time launchers operate in specialty and rare market segments in which an in-depth understanding of the disease area is more important to success than is the ability to invest in a large commercial footprint. Using vendors allows first-time launchers to commercialize their assets without having to build large organizational footprints at a time when they are likely to lack the necessary capacity for investment.

What difficulties do first-time pharma-product launchers face?

Our analysis shows that many first-time launchers of pharma products struggle to maximize drug adoption and realize the expected value from their launches. Their share of successful launches is well below that of experienced launchers (Exhibit 2). Whereas almost half of launches from experienced launchers exceed analysts’ prelaunch forecasts, the share for first-timers is just 39 percent. The median first-time launcher reaches just 63 percent of expectations, compared with 93 percent for the experienced equivalent.

Why do first-time pharma-product launchers matter?

The next few years could transform the fortunes of innovative biopharma companies as their share of new launches increases. For instance, out of the 39 blockbuster launches (those with more than $1 billion in forecasted sales) due to take place between 2021 and 2025, 22 are expected to come from first-time launchers—a share of 56 percent (Exhibit 3). That would represent a sizeable increase over the period from 2016 to 2020, when less than 20 percent of blockbusters came, or were expected to come, from first-time launchers.

Although many of the new launchers may be destined to become acquisition targets for large pharma companies, the market shift from established to emergent players looks set to continue. That, in turn, will serve to heighten the interest of VC and other investors in biopharma and biotech.

How do first-time pharma-product launchers get it right?

Among the successful first-time launchers of pharma products that we studied, we have identified four broad areas of focus that could make all the difference in the lead-up to launch.

Expand the sources of insight

First-time launchers sometimes rely on relationships with a few key opinion and trial-site leaders to inform their thinking on pricing, sales-force deployment, and other critical decisions. That approach can leave them with blind spots and overoptimistic projections of how prescribers will react.

By contrast, successful launchers invest early to build deep understanding of the market in their disease areas, which helps them judge how to position their drugs among the therapies available. Similarly, they draw on a wide range of data sources to make rigorous assessments of how providers, patients, and payers are likely to react to their new product.

One first-time launcher used claim data to identify a set of smaller payers with a higher prevalence of the primary indication for its new drug so that it could engage with them early in the launch process. The company drew on the same data to articulate a value proposition geared to the broadest patient population and to identify a subset of 5,000 out of 95,000 healthcare professionals whose prescribing history suggested they might account for a large proportion—60 to 70 percent—of prescriptions for the drug. The targeted approach helped the company develop a realistic launch plan that was around 30 percent smaller than the original budget, freeing up resources that it then redeployed in other priority areas.

Invest for success

Many first-time launchers endure years of tight budgets while pouring every dollar into their development program, but they shouldn’t allow that mindset to deprive their launches of resources. Companies commonly spend more than ten times their expected first-year revenue during their launch years, and McKinsey research shows that dedicating a larger share of the budget to activities before and during launch is associated with a greater likelihood of meeting or exceeding sales targets. Our analysis of new launchers of pharma products between 2014 and 2017 showed that those in the top half of launch-year spending on selling, general, and administrative tasks were more than twice as likely as those in the bottom half to beat analyst forecasts with a success rate of 67 percent, compared with 29 percent. 1 McKinsey evaluated first-time pharmaceutical launches that occurred between 2014 and 2017 to calculate the share that exceeded the three-year net-sales forecasts from the year of launch (the forecasts used were from the pharmaceutical-data company Evaluate). Spending on selling, general, and administrative expenses in the launch year was calculated as a share of forecast sales for that year, and companies were divided into two groups: those spending more than ten times the launch-year forecast sales and those spending less.

Instead of starting by setting budgets, first-time pharma-product launchers would do better to begin by understanding the potential of their drug and then working to raise sufficient funds to provide appropriate support during launch. In other words, they should tailor their go-to-market approaches to their products, not their statures as small biotech companies. For instance, some small, US-based companies manage their home markets for themselves and raise funds and free up management attention by pursuing a partnership or licensing approach in other markets. In some cases, investors may have opportunities to step in and provide financing for first-time launchers.

One small pharma company was planning its first major launch in a highly competitive indication and needed a substantial sales force to reach primary-care providers. To ensure that its voice was heard above the noise from larger rivals, the company went back to investors and raised more than $1 billion to build the necessary sales force—and invest in best-in-class patient support, substantial direct-to-consumer marketing, and innovative engagement channels. That investment enabled the company to beat its sales forecast and carve out a leading position in its indication, despite head-to-head competition from established players.

Build the core team early

Some first-time launchers don’t start building their teams until they are well advanced in their launch planning. As a result, they may struggle to catch up in key activities that require long lead times, such as developing foundational insights, designing commercial strategy, and planning external engagement. Our experience suggests that companies would be wise to take early steps to identify the five to ten roles that are key to a successful launch and to fill them with top talent.

Leading pharma-product launchers begin building their team as early as 18 months before launch. They often start with external-facing medical and market-access roles so that they can begin engaging with key stakeholders to derive valuable insights and create excitement about their new products.

One small company identified its critical functions as medical affairs, market access, and analytics; defined job descriptions for the key roles; and put staff in place 24 months before launch. To maximize agility in other functions, it signed deals with contract sales organizations and third-party distributors. When the company’s launch was delayed, it was able to keep its core team in place and adjust vendor capacity instead. That flexibility prevented the whipsawing of layoffs and hiring and allowed the core team to keep working to maintain continuity as the company prepared for its deferred launch.

Track constantly and adjust quickly

Launches are complex, and first-time pharma-product launchers will have new functions that lack the experience an established pharma company would bring. Most companies will build detailed road maps for their launches, but they should take care not to let those plans lull them into complacency. If key functions drift behind schedule, critical activities could be put at risk, and the launch could be delayed.

Leaders must identify issues as they arise and empower a small team to resolve them rapidly. That done, team members can switch from tracking internal activities to monitoring the relevant markets for early signs from stakeholders. Any deviations from an expected launch trajectory need to be detected and addressed promptly.

When one small biotech company was preparing for its first launch, it set up a control tower to manage execution and track performance against the weekly objectives that led up to its launch goals. It also set up daily data feeds from distributors and third-party vendors so that it could swiftly shore up any areas of weakness that emerged. The control-tower team held a 15-minute stand-up huddle every morning to track progress in every function, and the company CEO made a point of dropping in to be briefed at the end of every week. When early data from medical engagement suggested that disease-state education wasn’t as effective as expected in a key European market, the company quickly stepped in to redesign material for the country concerned to address its particular needs better.

As the next generation of biopharma organizations evolve from their initial R&D focus to become integrated, end-to-end companies, which of them will rise to the challenges of becoming first-time product launchers? One thing is certain: the area isn’t just a matter of interest for leaders of small biopharma companies. Executives of large pharma companies looking for acquisition opportunities and VC firms with funds to invest in biotech will also pay close attention.

Eylul Harputlugil is an associate partner in McKinsey’s New Jersey office, Scott Hayton is an associate partner in the Toronto office, Joey Merrill is a senior capabilities and insight analyst at the Waltham Client Capability Hub, and Pablo Salazar is a partner in the Stamford office.

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5 ways for emerging biotechs to launch smarter

EY US Health Sciences & Wellness Commercial Strategy and R&D Lead

Works with clients to develop, launch and commercialize life sciences products. Interested in science, technology, new business models, diversity and women’s rights. Native of Sao Paulo, Brazil.

Principal, EY-Parthenon – Strategy, Life Sciences, Ernst & Young LLP

20+ years of experience in life sciences advising biopharma companies to support strategic growth. Supports bringing new products to market to enhance patient care.

Manager, Life Sciences Commercial Strategy Consulting, Ernst & Young LLP

Life sciences strategist. Global commercial strategy consultant with a cell biology and epidemiology background. Helping develop, launch, and commercialize life-changing medicines and therapies.

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5 ways for biotechs to launch smarter, how small and midsize biotech companies can seize on biopharma’s appetite for mature, de-risked acquisitions..

• While valuations for emerging biotech companies were high in early 2021, biopharma organizations today are more cautious about M&A. 
• At the same time, looming patent deadlines mean the biopharma industry’s innovation gap will continue to be a significant factor in the deal market.
• By developing and executing the right launch plan, small and midsize biotechs can demonstrate significant value in potential negotiations.

A mid evolving market conditions, small and midsize biotechnology (biotech) companies have been increasingly active in developing novel drugs and securing drug approvals from the Food and Drug Administration (FDA). Today, smaller companies (those with less than $1 billion in total sales) represent a significant share of new molecular entity (NME) market approvals and launches, growing from 10% in 2017 to 30% in 2021.[¹]  As a result, small and midsize biotech valuations have been rising, thereby making them less attractive for acquisition by larger players and forcing these biotech companies to launch on their own.

Launching a new drug can be challenging and complex, and more than two-thirds of biopharma products launched since January 2020 have failed to meet analyst expectations.² However, overall launch success has been disproportionately lower for biotechs in the last two years in the US, with 59% of those misses from companies with less than $1 billion in revenue.³

Only a small percentage of emerging biopharma companies exceeded sales expectations,⁴ further emphasizing how challenging commercial execution can be for small and midsize biotechs pursuing their first or second launch.

Current biopharma conditions

Traditionally, biotech M&A activity has occurred prior to product commercialization, often in Phase 2 or 3 of clinical development. However, in the first half of 2021, valuations for early-stage small and midsize biotechs reached historic levels⁵ due to increased interest in new technologies and therapeutic development amid a significant innovation deficit among large biopharmaceutical companies.

According to the 2022 EY M&A Firepower report , acquirers paid, on average, a 62% premium for public companies relative to their share price one month earlier. At the same time, funding alternatives such as IPOs and special purpose acquisition companies (SPACs) reached a fever pitch across the industry, providing these target biotech companies little financial pressure to sell and a stronger negotiating platform to demand higher deal premiums, especially if their drug belonged to a new therapeutic class expected to be important for future growth.

For these reasons, today’s biopharma acquirers are taking a more cautious approach and increasing their value expectations for drugs, devices, and diagnostics. Although larger biopharma companies are aggressive in their pursuit of external innovation to stay competitive, today’s acquirers prefer to engage in collaborative and strategic partnerships as they wait for biotechs and their products to mature, demonstrate potential value, and become de-risked.

Additionally, the need for external innovation to achieve future growth targets combined with the high price tags for M&A, further emphasizes the need for biotech to demonstrate value through launch success and accelerate partnering. Partnership and alliances remain strong in 2021, and it is notable that average upfront payment for biotech deals dropped from $84 million in 2020 to $53 million in 2021, signifying a shift toward smaller investments focused on hedging development risk.⁶ In addition, bolt-on deals comprised 88% of deal volume in 2021 — demonstrating an appetite for less risky deals among larger biopharma companies.⁷

Given these changing dynamics , small and midsize biotech companies must substantiate the value of lead and follow-on development programs to improve asset attractiveness for investment and acquisition through both a successful launch and recurring revenue of their products. Despite the urgent need for homegrown commercialization among biotechs, the launch process is often a new endeavour for these enterprises since they have been built and structured primarily to research and develop novel therapeutics. As a result, many emerging biotechs lack the infrastructure and capital necessary to build and execute successful launches. In addition, market access challenges and formidable competition, as well as other internal challenges, such as suboptimal skill-set alignment, often prevent these companies from effectively developing and executing launches on their own.

How EY can help

Strategy by ey-parthenon, the path forward for small and midsize biotechs.

Considering the conditions described above, we recommend that small and midsize biotech focus on the following five key pillars to prepare for and enable a successful launch.

1. Design an operating model that drives executional effectiveness​.

From market access to sales, supply chain, and regulatory, a cross-functional mindset is essential for a successful biotech launch. This involves building out a launch team with diverse skill sets and capabilities early on, particularly for biotechs launching a product for the first time with limited resources. Collaboration, accountability, and diversity of thinking inform a wide variety of critical launch-related activities, including pricing, marketing spend, and salesforce deployment.

Without proper planning and prioritization around key activities and resources, the launch team likely will find it difficult to execute an effective launch due to significant challenges in catching up on related tasks that require long lead times. It is critical for organizations to develop execution plans, to include associated investment that enable the launch team to build a deep understanding of the market and strategically position the company’s products for success.

2. Execute an effective and fit-for-purpose go-to-market plan. ​

Commercialization budgets are typically large, and their front spend is not at risk, assuming regulatory approval. Biotech companies have to utilize a fit-for-purpose, prioritized, and smaller budget, and yet they need to be able to execute competitively in the marketplace. Emerging biotechs should take advantage of the increasing role of medical affairs, advocacy, and potential provider partnerships in their go-to-market strategy. Innovative and effective plans to activate key opinion leaders prior to launch are fundamental to support a robust product introduction.

Relationships with advocates and influencers are essential in bolstering the clinical need and health-economic value of a new product relative to the standard of care or other interventions in the market. In addition to conveying a compelling value story, emerging companies should engage payers early to understand the drivers and potential barriers for product uptake, including non-traditional payers such as retail stakeholders.

Moreover, the COVID-19 pandemic has accelerated the shift beyond traditional face-to-face interactions to more digitally enabled communications. As such, biotech companies need to plan, build, and implement both an omnichannel engagement model to interact with customers and an end-to-end positive patient experience. It’s also important for these companies to understand which targeted stakeholders to engage, when to engage them, and which channel is most appropriate. This mindset is essential to drive a product’s success and penetration in the market upon launch.

3. Be strategic about market access and pricing​.

Another key pillar for successful launch, this approach involves carefully developing estimates for potential product value by applying risk scoring to assess pricing and guide strategic choices, building robust forecasting models, and establishing a methodology to evaluate the probability of technical, regulatory, and market access success for each product​. It’s critical for the launch team to develop an early understanding of how diverse stakeholder groups will perceive a product. This will enable the team to anticipate and plan for any potential obstacles or challenges that may arise during launch. The impact of not doing so can be significant, including underperformance and missed first-year forecasts.

​Small and midsize biotechs also need to understand the payer perspective on unmet need, comparators, and coverage and reimbursement processes early in the planning process so that the company can plan for and generate the appropriate evidence ahead of launch. The launch team also needs to assess the budget impact in the context of the treatment paradigm and outcomes when they establish the list price, net price, and coverage goal for the product. And because many of these tasks must be completed virtually, many companies also need to evaluate which payers to engage and how to engage them, including the pre-launch exchange of information, to articulate the value proposition of the product and potential negotiations at launch.

4. Prioritize data foundation, analytics, and monitoring​.

Strategically collecting, analyzing, and monitoring data is essential in establishing a solid foundation to deploy a smarter, more efficient go-to-market strategy with limited resources. Small and midsize biotech companies should leverage their internal data and external datasets to uncover market insights as well as physician and patient preferences and behaviors. Additionally, biotech companies are now applying machine learning and predictive analytics to a wide range of commercial use cases, including the identification of drivers for uptake and predictions on how providers, patients, and payers are likely to react to the entry of a new product. Using predictive analytics also can help launch teams anticipate pricing and reimbursement hurdles and understand how to improve patient access.

Advanced and predictive analytics can provide sales and marketing functions with real-time insights into content and channel preference based on the historical behavior of physicians and patients, increasing the likelihood that the right message will get to the right stakeholder through the optimal method. To maximize the effectiveness of the field force, organizations rely on clean and accurate customer data and performance metrics to properly align territories and incentivize sales representatives. All of these capabilities need to be “baked” into the strategic planning of any launch from the very beginning, as delayed decision-making around data and analytics considerations is a common industry pitfall that ultimately creates significant challenges in the later stages of product launch.

Implementing the foundation for a robust analytics and omnichannel model early will improve the quality of the insights extracted from data, increase overall organizational agility and establish effective closed-loop feedback mechanisms, resulting in quick adaption of messaging to customer preferences and seamless redeployment of resources. In addition, monitoring performance using consistent metrics across the product portfolio will help teams navigate a rapidly evolving landscape by identifying potential issues and enabling the team to course-correct early in the launch process.

5. Conduct market-shaping activities early.

Leveraging a multi-stakeholder approach to support market-shaping activities and increase awareness and adoption of new therapeutics begins far before launch. Collaborating with influential health and patient advocacy organizations, community leaders, and market influencers is especially important for new therapeutic indications, as shaping an unmet need with novel products in novel landscapes can take considerably longer than it does in previously established markets. To be successful at launch, it is essential that biotechs understand the nuances of the landscape, evaluate the market, and effectively communicate value and unmet needs throughout launch engagements.

Most successful companies begin these activities during the clinical development phase to transform disease perception and adjust the product profile before launch. The launch team will need to begin by forming strong partnerships and engaging early with patients, caregivers, and advocacy groups to understand their journey and the obstacles they may face in accessing treatment and help to address value gaps. Patient advocacy groups are tremendously influential in accelerating funding and access for innovative treatments by conveying their patients’ pressing needs to regulators, policymakers, and budget holders to drive maximum impact. 

In addition, building valuable relationships, deploying disease-state education programs, and priming the market can help stakeholders analyze data to source a stronger, more nuanced understanding of market and unmet patient needs. If market-shaping activities are executed effectively, biotechs will be able to transform existing market structures to improve therapy awareness and maximize patient access and uptake upon launch.

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A successful launch can establish value and change the narrative in negotiations for small and midsize biotechs. With over $1 trillion in collective firepower (i.e., capacity to fund transactions) in 2022 — amid looming loss-of-exclusivity concerns around patent expiration — biopharma is poised to invest in innovative products to fuel growth. Strategic partnerships offer significant value to biopharmas and allow small biotechs to focus on their core skills, including discovery, research, and development. However, biotech companies may not be able to rely only on M&A and will have to quickly learn how to launch products effectively and competitively before realizing an exit strategy.

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The 10 Must-Dos for an Effective Biotech Investor Plan

Posted on September 7th, 2021. Posted by ICR Westwicke

Why would anyone invest in a biotech or biopharma company? After all, most are development-stage companies based on complicated science that consume cash voraciously, have no revenue or earnings, and need to sell a dream that could be years away from commercialization.

The risks are enormous. Yet they attract investors because the payoff can be huge. Here are the 10 must-do items that all public biotech companies should address in an effective IR program in order to attract the right investors .

1. Under promise and over deliver. It’s a classic adage for a reason, but it’s even more important when you’re a biotech selling a dream or potential cure. Management credibility is key, so build in a safety cushion to your business plan so that you can meet or beat the timelines you provide to investors. Credibility can buy you time and the benefit of the doubt should things go wrong.

2. Quantify your commercial opportunity. Back up your estimates with facts and be upfront about your assumptions so analysts can run their own numbers and you’re not accused of hyping. Small-cap biotech companies can make the transition to large cap by developing products with significant commercial opportunity. Sell the dream, but back it up with the facts.

3. Right-size your investor presentation slide deck. Your investor deck must not be too long (25 to 30 slides is “normal”) and needs to be investor-centric. Investors aren’t as close to your subject as you are and can be sent to sleep or to checking email if you provide too much scientific information.

4. Talk about your funding runway. “We are funded for at least XX months” or “into 2023” are good approaches and are not too specific. It is always good to have at least a year of funding and to describe it in a way that does not tip your hand regarding future financing activity. Don’t ignore the subject. Investors will ask.

5. Try to look like peer companies. Follow best practices based on what your peers are doing . Too much quirkiness does not go down well. For every Richard Branson there are a thousand, respectable, solid, conformist CEOs. Wall Street doesn’t always like “odd” or “unique.”

6. Explain your intellectual property position and strategy in simple language. Have key patents been issued? What are they? What blocks competitors from doing what you are doing?

7. Talk about the origin of your technology. It could be based on the work of a founder, from academia, or from another company. If it was an acquisition, why did the people sell it and how are you developing it differently from the previous owners? Telling a coherent investment story is key for investors to buy into your ideas and your business plan.

8. Don’t take analyst recommendations personally. For every investor that buys your stock, there has to be a seller. A policy of not talking to an analyst that has a sell or neutral recommendation on your stock is pointless. You need different views to create a market, so engage with the negative analysts and, better still, prove them wrong!

9. Strike a balance between investor relations and running your company. You need to take part in investor calls, conferences, investor days, and non-deal road shows, but you also need to run your company. You don’t want to be too available or you might come across as a little desperate. Be mindful that having a scarcity factor could make you more desirable for a one on one investor meeting.

10. Articulate your milestones and catalysts. You have no revenues or profit. Consequently you need a series of ongoing events to keep Wall Street interested, and as a way for them to rate your execution capabilities and potentially increase your company valuation. Milestones for the next 12 months are typically in most investor presentations and include regulatory filings, clinical trial results, Orphan or Fast Track decisions, or acquisitions.

Explaining your investment thesis, underlying science and business strategy in an effective and concise manner is the goal. Remember, there are over 400 public biotech companies out there and if you don’t grab and keep the attention of Wall Street, investors have 399 other companies actively vying for their consideration. The attention span for investors is short, so once you have it, be ready to maximize the opportunity. Westwicke’ can help you execute a highly effective investor relations program.  Contact us if you’d like to discuss what we can do for your company.

ICR Westwicke is the largest healthcare focused investor relations firm in the country. We provide customized investor relations programs and independent capital markets advice to small and mid-cap healthcare companies.

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FREE 8+ Biotech Business Plan Samples in MS Word | Google Docs | Apple Pages | PDF

You, like many other bio entrepreneurs, are going to face one of the most difficult elements of product development : obtaining the finance and resources necessary to bring a technology to market. Despite the fact that investors will always be interested in interesting ideas, you will need to be well prepared and patient in order to obtain funds today. A new drug can cost hundreds of millions of dollars and take up to 15 years to develop. The majority of these costs are usually covered by outside sources, which the management team must seek out and secure. Most investors, on the other hand, examine over a hundred plans per week, so if yours does not pique the reader’s interest, you may not even make it to the first round of scrutiny. To that end, it’s critical that your business plan convinces potential investors that, based on the company’s fundamentals and the market, your technology will generate revenue, profit, and significant market share.

Biotech Business Plan

8+ biotech business plan samples, 1. biotech business plan template, 2. biotech business plan, 3. biotech startup business plan, 4. biotech executive business plan, 5. biotech development business plan, 6. biotech management business plan, 7. biotech career business plan, 8. biotech business continuity plan, 9. biotech final business plan, reasons why you need a biotech business plan, what are the aspects of your company that you should include in your business plan, why do we need a business plan.

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Biotechnology has made a difference in the lives of millions, if not billions, of people all over the world. The strong demand for biotech products and services has led to a surge in the number of people interested in working in this field. If you choose to go down this path, you should employ a specialist to draft a professional biotech business plan for you.

• It scales up existing business – If you already have a firm but want to focus on biotechnology in order to expand it to new heights, you may do it by employing a business plan as a road map to success. The plan will specify the number of resources you should devote to the new venture, as well as assist you in developing a winning approach to reach your short- and long-term goals and objectives . Our team of skilled business analysts, researchers, and writers will collaborate to create a high-quality business plan that will propel the company forward.
• It supports loan application – It is not a guarantee that submitting loan application papers to a financial institution or an individual lender will result in you being approved for a loan. You must demonstrate to the bank or investor that you have the necessary skills to ensure that the biotech firm succeeds and becomes profitable. Finally, the bank will expect you to service the loan, and the investors will expect a return on their investment in the form of a business plan after a certain amount of time.
• It has chronologic steps in creating a business – One of the most difficult challenges that businesses have when starting a new firm is determining the particular actions they need to follow to avoid errors and regrets along the way. You will be able to identify the proper measures to take throughout the first phases and even after the firm is fully operating if you entrust your plan to a legally authorized and respected business writer.
• It provides guidance when hiring professionals – It is impossible to start a biotech firm on your own. You’ll need a team of specialists to assist you in making sound judgments that will rocket and lead your company in the proper direction. To handle any legal concerns, the corporation will need a crew of legally licensed and renowned attorneys. You will be able to identify the pros you should hire if you have a team of dedicated, highly trained, and well-educated business plan biotech writers and consultants on your side.
• It brings more business partners – The perfect partners should share your business aims and objectives and be dedicated to ensuring that the company achieves its objectives. You’ll be able to discuss all of the business ideas with the partners before signing the agreement if you use a biotech startup business plan roadmap. Many businesses will approach you with offers to join you as business partners once your company is up and operating. It is vital to make sure that such partnerships are created methodically and properly to ensure that all the decisions decided upon in the boardroom meets are informed and incapable of spelling doom for your organization.
• You will get a chance to know the investor audience – This is one of the most important factors, but a surprising amount of people interested in biotechnology ignore it. The two techniques to determine your target audience are to assess the investor’s firm and the partner, in this example, you. Over the last four years or so, the ideal investment firm should have at least managed to establish a fund. If not, there’s a good chance they’re only looking to meet you in order to stay current and respectable in the market.
• It makes you understand your strengths and weaknesses – Today’s most successful businesses are owned and managed by business specialists who are familiar with their strengths and shortcomings. You must have a clear mental picture of yourself and know what you are and are not. In this sector, attempting to accomplish everything is unproductive and will almost certainly result in resource waste.

It includes opportunity, product, market, competition, IP, team, business model, exit strategy , and executive summary.

Your company’s business plans have both internal and external value. There are numerous values within the company. It enables you to have a solid plan in place that can propel a team forward rapidly while also allowing you to simply convey your priorities. A SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis should be included in any company plan.

The most common mistake in biotechnology business plans is a lack of quantification of market potential, as certain Biotech products have a very small market and investors are aware of this. Another significant impediment is a focus on deep technical elements without respect for the company’s business side, such as the commercialization of a go-to-market plan.

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Best 20 Biotechnology Business Ideas with High Profit

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:

Table of Contents

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.

Next What Business Research Team

The Editorial Staff at NextWhatBusiness is a team of Business Consultants having years of experience in small and medium-scale businesses.

2022 Biomedical Business Plan Challenge Showcases Promising Startups

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A promising venture that hopes to develop a new drug therapy for colorectal cancer won $50,000 in funding and recognition from experienced venture capitalists on May 26 at the annual Biomedical Business Plan Challenge.

The venture, Culnexin Therapeutics, is based on the work of Dr. Pengbo Zhou , a professor of pathology and laboratory medicine at Weill Cornell Medicine. Dr. Zhou is an expert on tiny enzymes called ubiquitin ligases, key components of a complex cellular housekeeping system that destroys proteins to keep their levels within normal limits. Dr. Zhou and his laboratory have uncovered evidence that a ubiquitin ligase called CUL4 regulates proteins that are particularly important in blocking cancers. The scientists have shown that cancers often get their start, or boost their growth, by upregulating CUL4—thus pushing down the levels of the anticancer proteins it regulates. By the same token, blocking CUL4 prevents tumor formation, or slows tumor growth, in multiple experimental settings.

For the past several years, Dr. Zhou, collaborating with Dr. Suman Lal, entrepreneur-in-residence at Weill Cornell Medicine’s BioVenture eLab , has been trying to turn his findings into a powerful new drug therapy for colorectal cancer, which remains one of the leading causes of cancer deaths. On May 26, their efforts were rewarded when their CUL4 project beat seven others to win the $50,000 first prize in Weill Cornell Medicine’s Biomedical Business Plan Challenge.

“This win is a nice validation of our technology, its potential to impact the lives of cancer patients, and of course its value as an investment opportunity,” Dr. Zhou said.

The annual Biomedical Business Plan Challenge, initiated in 2017, is meant to provide helpful funds for promising translational medicine startups and showcase the eLab’s work in incubating bench-to-bedside ventures. Led by Dr. Jahanara Ali, the eLab’s central mission is to connect Weill Cornell Medicine researchers with experienced entrepreneur-mentors who can guide the researchers on the epic and multifariously difficult journey from basic lab experiments through preclinical testing and into human clinical trials. This journey typically requires, among other challenges, convincing professional biotech investors to put up tens to hundreds of millions of dollars in funding.

“We are inspired every day to work with such talented, entrepreneurial colleagues, and we eagerly contribute our relevant curriculum and expertise on the journey to launching their startups,” said Loren Busby, a former life sciences venture capitalist who is one of the eLab’s entrepreneurs-in-residence.

The eLab was launched and is overseen by Weill Cornell’s Office of BioPharma Alliances and Research Collaborations, led by Managing Director Larry Schlossman. While other universities have programs designed to assist its faculty to form and spin off new companies to commercialize their research, eLab is unique for its specific laser focus on biomedical research.

“eLab is dedicated 100 percent to helping our scientists develop both the unique skill set and the mindset required for biomedical entrepreneurship, and to our knowledge it’s one of a very few with that tight biomedical focus,” Schlossman said.

Both eLab and BioPharma Alliances and Research Collaborations are part of Weill Cornell Medicine’s Enterprise Innovation, which provides end-to-end biotech and business development to Weill Cornell Medicine faculty and trainees from inception to commercialization.

The eight teams for this year’s challenge underwent nine weeks of mentoring, in which they learned about regulatory requirements for new drugs, typical costs of startup ventures, and how to pitch to investors. For the challenge, held in-person at Weill Cornell Medicine’s Griffis Faculty Club and via-Zoom audience, they made their 7-minute pitches before a judging panel of early-stage bioventure investors, including representatives from 2048 Ventures, Orbimed, Qiming Ventures, Bios Partners, Alexandria LaunchLabs, and Mission BioCapital.

Although the investor-judges awarded first prize to Drs. Zhou and Lal’s venture, they found two other projects worthy of recognition—and $25,000 each in funding—as runners-up.

The first of these, CARma Therapeutics, is a venture led by Dr. Nir Ben-Chetrit, research associate, and Dr. Dan Landau, an associate professor of medicine, both in the Division of Hematology and Medical Oncology. CARma’s aim is to develop therapies to reprogram tumor-associated macrophages, immune cells that are subverted by many tumors and help suppress local antitumor immune attacks. Without the cover provided by these cellular henchmen, tumors would be much more vulnerable to immune and other therapies—indeed, the scientists hope to reprogram tumor-associated macrophages not merely to cease their protection of tumors but to actively attack those tumors.

The other runner-up project, under a company called Mission-Driven Tech, is led by entrepreneur Eve McDavid and Dr. Onyinye D. Balogun, an assistant professor of radiation oncology at Weill Cornell Medicine. McDavid, a cervical cancer survivor and former Google executive, is also Dr. Balogun’s former patient, and their goal in this venture is to develop and market a better device for delivering radiation internally to cervical tumors. Brachytherapy, as this form of radiotherapy is called, is a common part of cervical cancer treatment. Mission-Driven Tech’s device is meant to improve patient comfort and reduce potentially costly side-effects—and possibly even boost brachytherapy’s potency.

The five remaining projects all seem highly promising and included efforts against multiple sclerosis and fatty liver disease, better platforms for research and drug discovery, and a system for improving communication between families and severely ill/isolated patients.

The first-prize winners, Drs. Zhou and Lal, plan to use the prize money to perform preclinical studies of the toxicity, bloodstream half-life, and other relevant properties of the small-molecule CUL4 inhibitors they are developing. If all goes well, they expect to start an initial small trial of a CUL4 inhibitor in human subjects in the next several years. And if their CUL4 inhibitor proves successful clinically, then in principle it could be used also against breast, lung, ovarian and other cancers—which often support themselves by upregulating CUL4.

“We’re currently in discussions with potential investors; we’re making progress by conducting key de-risking experiments; and we’re further expanding our team with drug development expertise,” Dr. Lal said.

Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosures public to ensure transparency. For this information, see Dr. Pengbo Zhou’s profile.

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Weill Cornell Medicine Office of External Affairs New York, NY --> Phone: (646) 962-9476

EU sets out plan to simplify biotech regulation and speed up approvals

Industry has welcomed the European Commission’s biotechnology and biomanufacturing initiative, but now wants to see some action

Margrethe Vestager presenting the Commission’s biotechnology and biomanufacturing initiative on 20 March. Photo credits: Aurore Martignoni / European Union

The European Commission is to look into how to speed up approvals for biotechnology, with a view to launching an EU Biotech Act in the next mandate, executive vice president Margrethe Vestager has announced.

“Europe will not be attractive to businesses worldwide if permitting and other administrative procedures take much longer than in other parts of the world,” she said, presenting the Commission’s biotechnology and biomanufacturing initiative on 20 March.

In the meantime, it will establish an EU biotech hub by the end of this year, “to enable biotech firms to better understand existing regulation,” she said. The sector is already set to benefit from streamlined permitting procedures under the Net-Zero industry Act .

Applications of biotechnology and biomanufacturing range from replacing fossil fuels, to the discovery and development of new drugs for rare diseases, and bio-based alternatives to plastic and other materials. The EU funds research in the sector predominantly through the Circular Bio-based Europe Joint Undertaking (CBE JU), and more support is needed to help innovators scale up their technologies in Europe.

Regulatory complexity is one of three key obstacles to European competitiveness the new plan aims to address, alongside access to finance, and difficulties moving from research to the market.

The Commission is promising to review its Bioeconomy Strategy by the end of 2025, which could include a stronger industrial dimension.

To help companies scale up, the Commission will advocate for the inclusion of specific challenges on biotech and biomanufacturing in the European Innovation Council (EIC) accelerator work programme for 2025.

“Europe cannot remain only a fantastic cradle of ideas for the rest of the world. What is born here should also have the opportunity to grow here,” Vestager said.

To support the uptake of bio-manufactured products, the Commission will conduct an impact assessment for bio-based requirements in public procurement. It will further develop methodologies to ensure a fair comparison between fossil-based and bio-based products, as the latter are usually more expensive and their environmental benefits are not always apparent to consumers.

The EU is also betting on the potential of artificial intelligence to help companies scale up their operations. The €500 million GenAI4EU initiative aims to stimulate the uptake of generative AI in industries including biotech and biomanufacturing, and the Commission wants to give biotech firms access to EuroHPC supercomputers.

“We want to make Europe a global biotech leader,” said Vestager. “With the potential to solve some of our most pressing problems, biotechnology also largely supports Europe’s economy, and it provides high-quality jobs.”

Biotechnology can also pose a risk due to its dual-use potential, and the Commission is working with member states to assess the risk of technology leakage.

“Biomanufacturing can be used to synthetically manufacture new molecules,” said Vestager. “These new molecules can have basic civilian uses, to produce sustainable pest repellents for instance. They can also be used in the military to produce new fuels for missiles.”

Great first step

The biotech industry welcomed the announcements, which, coming so close to the European elections, mostly amount to identifying the major challenges and promising to address them at some point in the future.

“To be competitive, the bio-based industries will require further action, including a sustainable supply of biomass and more stimulating measures for market uptake, such as bio-based content requirements under the new Ecodesign for Sustainable Products regulation,” said Rob Beekers, chair of the Bio-based Industries Consortium, which represents the private sector in the CBE JU.

“The new EU Parliament and EU Commission should make the bioeconomy and bio-based industries a political priority. Implementing the actions proposed in this communication would be a good start,” he said.

Pauline Grimmer, policy manager at international nonprofit and think tank the Good Food Institute Europe, was also pleased to see the Commission recognise the measures that are needed.

“While this is a great first step, for alternative protein startups to deliver on their potential to provide future-proof jobs and green growth, we now need to see this ambition translated into firm actions such as R&D funding, support to scale-up production and provide a clear and transparent regulatory framework,” she said.

Claire Skentelbery, director general of industry association EuropaBio, said the initiative shows the Commission has listened to the industry’s priorities. “I think it's as promising as it can be for something that is a theoretical exercise. It shows intent to pick this up in the next Commission,” she told Science|Business.

Clearer and faster regulatory pathways in the US are currently a major obstacle to European competitiveness. “If you've got investors within the EU, they are going to push you to launch in the US first,” Skentelbery said.

While a future EU Biotech Act is a positive long-term goal, “there’s a lot we can do in the short term that’s going to be more beneficial,” she added.

For example, the Commission and member states should work together on more standardised guidance for manufacturing using industrial biotechnology, while regulatory agencies are also in need of more resources to speed up approvals.

As the focus turns to implementation in the months and years ahead, EuropaBio wants to ensure any changes benefit startups and SMEs. “Because it’s frontier technology, it really lies with the small innovators that spin out and start up companies around scientific advances,” Skentelbery said.

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You might not want to think about estate planning, but as a financial planner, I know it's essential for small-business owners

Paid non-client promotion: Affiliate links for the products on this page are from partners that compensate us (see our advertiser disclosure with our list of partners for more details). However, our opinions are our own. See how we rate investing products to write unbiased product reviews.

• Estate planning may not be a topic you want to think about, but it's essential for small-business owners.
• Besides a will, you may also benefit from setting up a revocable living trust.
• Be sure to update things like beneficiary designations if you have a major life event.

Estate planning is a very sensitive, emotional topic, but as a financial planner, I believe it's essential to discuss. Estate planning should be a top priority — especially for Black business owners seeking to build generational wealth and preserve their legacies. Your business, likely your most valuable asset, deserves careful consideration within your estate plan to ensure a smooth transition of ownership and management in the event of incapacity or death.

As a business owner, there are more complexities and nuances to consider as it relates to estate planning. Therefore, it is critical to work with a qualified estate planning attorney who can help you create an estate plan that protects you, your business, and your heirs. As you navigate the estate planning process, consider these important items tailored to small business owners.

1. Last will and testament

One of the fundamental pieces to an effective estate plan is the last will and testament. This legal document is inexpensive and simple to set up.

This document serves as your voice beyond the grave, providing instructions to the state probate court regarding the distribution of your assets and the care of your dependents upon your passing. Without a will, your assets will be distributed according to state inheritance laws, which may not align with your wishes. In addition to personal assets, you may include business assets in your will.

A will may be amended during your lifetime and should be reviewed periodically, especially after major life events.

One thing to note is that a will does not avoid the probate process. While it provides guidance for asset distribution, your estate will still go through probate.

2. Revocable living trust

Establishing a revocable living trust is more complex and expensive than a will. Nevertheless, the advantages a living trust offers, especially for business owners, make it very attractive.

As a business owner, it is likely that most of your assets are tied to your business. A revocable living trust provides you with more control over these assets. Through a trust, you can appoint a trustee and provide them with specific instructions on how and when you want your business assets distributed. Moreover, you retain the flexibility and control to transfer assets into the trust and modify its terms during your lifetime.

One significant advantage of a trust is the protection it affords your assets from the probate process. By bypassing probate court proceedings, your estate information remains private, and your heirs save considerable time and money.

It is always a great idea to regularly update the assets in your living trust, as your business assets will change as your business grows over time.

3. Financial power of attorney

In most cases, as a small business owner, you are your business. If you become incapacitated, you want to ensure that you have someone you trust to handle your financial affairs. It is essential that you do not delay this task, as you must be legally competent to assign this role to someone. A financial power of attorney is a legal document that authorizes your selected agent to act on your behalf regarding certain financial matters of your choosing. Some of these matters may include:

• Paying your business bills
• Making business bank deposits and withdrawals
• Collecting and managing your self-employed retirement benefits
• Filing your business and personal taxes

There are different types of financial power of attorney that will determine how much power your agent holds and when their responsibilities take effect.

4. Succession plan

It is one thing to decide on how you want your business interests and assets to be distributed to your heirs. However, it is also critical to have an exit strategy for what happens to your business if you die or are incapacitated. Who do you want to run your business in your absence? Or do you want someone to be in charge of selling your business for a fair price?

Without an effective succession plan, your heirs may be forced to undersell your business, undermining all your hard work. An established succession plan will provide guidance on how to manage, sell, or pass on your business to new owners.

When developing your business succession plan, it is critical to work with a team of attorneys and CPAs. Not working with experienced professionals could create a significant tax bill for your heirs, eating into their inheritance.

Life happens, so make sure that you start working on your succession plan now.

5. Digital estate planning document

A common blind spot in estate planning is the digital asset space. So much of our lives are digital, but we often do not consider what happens to our digital assets if we were no longer here to manage them. As a small-business owner, it is critical to create a plan for your digital assets after you are gone to prevent any financial and sentimental harm.

The first step is to create a list of all the digital assets that you own. Some examples include email accounts, social media accounts, bank accounts, credit card accounts, and cellphones.

Digital estate planning will make it easier for your heirs to access your digital assets as needed. For example, there may be unpaid business invoices or bills that need to be taken care of.

I recommend that you consult with an attorney, as laws and regulations surrounding data and digital assets are constantly evolving.

6. Reviewing beneficiary designations

Most assets should be included in a will or trust to ensure these assets are distributed the way you want. An exception to this is any account where you are allowed to designate a beneficiary.

Example accounts include retirement plans , investment accounts, bank accounts , health savings accounts, UGMA or UTMA custodial accounts , and life insurance policies. These accounts will bypass probate and go directly to the beneficiaries listed on the account.

Typically, you are allowed to designate a primary and secondary beneficiary. In addition, you are allowed to make changes to these designations at any point. It is a good idea to reevaluate your designations after major life events.

7. Life insurance for estate liquidity

As mentioned above, life insurance proceeds avoid probate because of the beneficiary designations listed within the accounts.

Life insurance is designed to fill in financial gaps for your heirs. This is especially important for a business owner. There may be unpaid debts, payroll, or operating costs that need to be paid. Life insurance proceeds will help ease the pain of your heirs while they devote their time to sorting out other details.

• Main content

AI HRMS Revolutionizes HR Management With A Free Plan For Small Businesses

Singapore - March 25, 2024 —

AI HRMS introduces a free plan tailored for small businesses with less than 30 users, offering comprehensive HR management tools to streamline operations. With features such as automated expense management and employee performance reviews, AI HRMS empowers SMEs to manage their talent and drive organizational success efficiently.

"Small businesses often struggle to effectively manage their human resources due to limited resources and complex HR processes. This is where AI HRMS comes into the picture. The AI HRMS company addresses this challenge by offering a free plan tailored for small businesses with less than 30 users, providing comprehensive HR management tools to streamline operations," a representative said in a statement. 

AI HRMS simplifies HR operations for small and medium-sized organizations by offering a wide range of features, including employee onboarding, wellness programs, training modules, feedback mechanisms, leave applications, claims processing, and performance reviews.

AI HRMS was created with the goal of supporting millions of small and medium organizations worldwide with their human resource challenges. The representative added: "Our platform offers the best, simple-to-use AI HR software to help businesses better manage their talent."

Fully cloud-based, AI HRMS provides SMEs with the flexibility to customize the system according to their specific needs. AI HRMS has made a significant impact in a short period, being recognized as one of the Top 10 Best HRMS Software in Singapore.

"We are honored that our HRMS solution has been recognized as one of the Top 10 best HRMS software in Singapore by Singapore Brand, a testament to our commitment to innovation and excellence in human resource management software," the representative added. 

Automating tasks, improving HR decision-making

As businesses increasingly embrace digital transformation, AI-powered HRMS solutions are revolutionizing HR management practices. These solutions automate repetitive tasks, analyze data for actionable insights, and optimize workforce management, enhancing efficiency, accuracy, and strategic decision-making.

Key benefits of AI HRMS include automation of repetitive tasks, predictive analytics for talent management, personalized employee experiences, enhanced data security and compliance, and improved HR decision-making.

Using expense management software to automate the process can save time and money. Employees can use an expense management system to submit their expenses online, which are then processed automatically. This helps expedite the reimbursement process while ensuring all expenses are accounted for.

In addition to expense management, AI HRMS offers Employee Performance Reviews, assisting SMEs in providing goals, feedback, reviews, and one-on-one conversations with their employees. This feature streamlines the performance evaluation process, facilitating constructive feedback and fostering employee development.

Employee wellness, feedback

AI HRMS prioritizes employee onboarding, offering SMEs the best possible experience for new hires. With customizable profile templates and modules such as absence management, asset tracking, and employee onboarding, the platform streamlines the onboarding process for employers and new employees alike.

The platform also focuses on employee wellness, providing access to a comprehensive health program to maintain or improve well-being. Employers can disseminate information through various mediums, including wellness videos and pamphlets.

AI HRMS facilitates the creation of orientation plans to help new employees quickly adjust to their roles. Through thorough employee 360 feedback, the platform provides immediate feedback to help employees improve their performance instantly, eliminating the need for lengthy performance review cycles.

"AI HRMS serves as an ally of small and medium organizations in creating a productive workplace where their most valuable asset—their people—are managed effectively," added the representative. "As AI HRMS expands, new features will be added to enhance the user experience. We aim to be the best cloud-based HRMS solution worldwide, accessible and affordable for all SMEs."

Those ready to experience the revolution in HR management with AI HRMS may contact the team immediately to get started. To learn more about the platform and sign up for the free plan, visit  AIHRMS.com .

About AI HRMS:

AI HRMS is a leading human resource management software platform that supports small and medium-sized enterprises globally. With a focus on customization and innovation, AI HRMS aims to empower businesses to manage their talent and drive organizational success effectively.

Contact Info: Name: Stacey Email: Send Email Organization: AI HRMS Website: https://www.aihrms.com

Release ID: 89125234

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