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Home › Topics › Stages of Starting a Biotech Business › Set Up Your Business

Sarah Johnson

Biotech/Biomed Industry Unique Requirements

Topics Stages of Starting a Biotech Business Set Up Your Business Biotech/Biomed Industry Unique Requirements
Set Up Your Business

Establish the Business

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Registrations Required for Government Funding

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Biotech/Biomed Industry Unique Requirements

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Pitching Your Business

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Biotech/Biomed Industry Unique Requirements

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Learn the Requirements of Your Industry Sector

Different industries have their own requirements you must follow, in addition to the basic requirements for any business. For example, in the biomedical industry, many products must gain FDA approval.

U.S. Food and Drug Administration (FDA) Regulation

  • The FDA regulates:
    • Medical devices
    • Radiological health
    • Over-the-counter and prescription drugs
    • Biological therapeutics and biological products, including some human cell and tissue products, medical test kits, and drug products.
    • Products with color additives and new food additives.
  • Start learning about FDA approval early in your business planning. The FDA sponsors workshops, conferences, and training, and some NIH institutes, such as NCI, offer support for communications between small businesses and the FDA.
  • New drugs go through 3 phases of clinical trials. If the data shows the therapy is effective and safe, you submit a New Drug Application to the FDA.

Health Insurance Reimbursement

  • If your product is a biomedical treatment or device, make sure the health insurance companies will provide reimbursement for use of your product.
  • If a medical procedure is involved, you may need to secure a new procedural code so that healthcare providers can bill for it.

Planning Your Research Environment

Location for Life Science Research and Biotech/Biomedical Businesses

Consider locating your business near a center for life science research and biotechnology businesses, such as Boston, San Francisco, San Diego, or Research Triangle in NC, because it will facilitate hiring, networking, and collaborations. A lab location that all key personnel can access facilitates communication and productivity (Chitale et al., 2022).

Planning Your Lab

The following cost and time-saving options can help expedite getting your research started:

  • Renting bench space in an established lab during their off hours.
  • Renting lab space in an incubator, an organization that supports the growth and success of startups by providing physical workspace, shared facilities, guidance, and some funding.
  • Engaging a lab or a research organization to conduct all or part of the research for you.
  • For university employees or students: Universities may allow you to conduct sponsored research in your university lab (at some negotiated cost and with conflict of interest details worked out), which saves cost and effort.

Source:

Chitale S, Lawler C, Klausner A. So you want to start a biotech company. Nat Biotechnol. March 2022;40(3):296-300. doi:10.1038/s41587-022-01239-9.

Tips:
  • If your product needs FDA approval, seek help from attorneys and other expert consultants familiar with the process.
  • Show that you understand the regulatory pathway in your grant proposals.
  • Be sure to collect all of the data you will need for FDA approval or to support insurance reimbursement when you have the chance to collect it.
  • For medical devices or treatments, determine whether your product fits within existing clinic protocols or whether a clinical protocol change would be needed for your product to be adopted.
Read More:

Planning Your Research Environment

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Industry-Specific Requirements, Licenses, and Permits

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Challenge:

Which of the following products do you think are regulated by the U.S. Food and Drug Administration (FDA)? (Choose all that apply)

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Explore Motives & Skills Needed
3 Articles
Motivations for Starting a Business
Life Impact of Starting a Business
Skills Needed to Start a Business
Develop a Business Plan
12 Articles
1: Executive Summary, Company & Product Descriptions
2: Business and Management Structure
Part I: Business and Management Structure
Part II: Founding Team
3: Seek Professional Assistance
4: Market Research
5: Financial Analysis and Projections
6: SBIR/STTR and Other Seed Funding
Part I: SBIR/STTR & Other Seed Funding Overview and Getting Started
Part II: Writing and Submitting SBIR/STTR Grant Proposals
7: Venture Capital and Other Funding
8: Product Development and Marketing Plan
Set Up Your Business
4 Articles
Establish the Business
Registrations Required for Government Funding
Biotech/Biomed Industry Unique Requirements
Pitching Your Business
Return to Stages of Starting a Biotech Business

This project is funded by National Institute of General Medical Sciences (Grants 1R43 GM131458-01 & 2R GM131458-02)


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