Advice for Scientist Entrepreneurs

Planning an FDA Strategy

Written by Tamsen Valoir, PhD for Gaebler Ventures

Knowing these tips for getting FDA approval will come in handy if you are working on new drugs or medical devices.

Obtaining FDA approval for drugs and certain medical devices is an expensive process.

Founders will have to learn enough about the FDA rules to be conversant about the requirements and to decide on the most cost effective, least risky, approval strategy.

It is too complicated a subject to address adequately in this short article, but realize that the FDA is in one sense an advertising agency, and their goal is to ensure that product labels are not misleading to the public. Thus, a company can influence the difficulty of the FDA process by choosing WHICH medical claims to include on a label.

For example, proving safety and efficacy in breast cancer may be a significant endeavor, involving very large clinical trials. It might be easier to prove safety and efficacy in pancreatic cancer, which has no suitable treatment available, and thus expedited approval procedures may be available. Similarly, one could pursue an orphan drug designation, resulting in smaller study size and possibly faster approval.

In the device arena, a more modest claim may mean that a filing can be based on a existing similar device and avoid the need for clinical trials, whereas claiming more innovative uses may necessitate a full approval application with clinical trials being required. In each case, broader approvals can still be obtained after the more narrow use is approved or cleared, and this approach can decrease your time to market and make it much easier to obtain financing along the way.

At the same time, be cautious of choosing an indication that will be difficult or impossible to enroll patients, or an indication that has so little market potential as to discourage investors. Further, your drug or device will fare better in the marketplace if insurance companies, Medicare and Medicaid agree to reimburse it, and reimbursement should be a important consideration as you design an approval and marketing strategy.

Don't make the mistake of thinking that all you need are great clinical results to obtain FDA approval.

Manufacturing, packaging, storage and labeling are equally important to the FDA and it is likely that these functions will need to be outsourced to a company with significant experience in FDA regulated technology. Further, FDA obligations continue AFTER approval, and marketing a health care product requires clear policies and staff training to avoid off-label advertising or running afoul of the anti-kickback statute or foreign corrupt practices act, and similar Federal statutes.

A careful understanding of the FDA process, medical realities AND market considerations are all required to choose an optimal FDA approval strategy, and compliance with Federal regulations is even more important once a product enters the market.

More Tips for Scientist Entrepreneurs

To learn more about how to bring a product out of the laboratory and transition from the role of scientist to that of entrepreneur, please browse the rest of the tips for science entrepreneurs in this article series:

• Transitioning from Science to Sale - We introduce our 10 tips for entrepreneurial scientists who want to take their science to market.
• 1. Getting it in Writing - Before you get too far along in the process, it's imperative that you put together written contracts that define ownership rights, confidentiality and other important obligations and understandings.
• 2. Cultivating A Culture of Invention - Encouraging invention is the first step to creating valuable intellectual property. We look at what organizations must do in order to motivate employees to create proprietary science and apply for patents.
• 3. Getting Inventorship Right - Patent laws require that you get inventorship right. Get it wrong and you can lose the patent. Here are some simple ways to avoid making a mistake in the naming of inventors.
• 4. Using Hardbound Notebooks - Your lab notebook could end up being used as evidence to invalidate your patent claim. We discuss the proper use of hardbound lab notebooks to ensure proper IP protection.
• 5. Planning a Patent Strategy - Filing patents can be an intimidating endeavor, but there are some best practices for scientist entrepreneurs that you ought to know about.
• 6. Planning an FDA Strategy - Knowing these tips for getting FDA approval will come in handy if you are working on new drugs or medical devices.
• 7. Loosening the Reins - You can't do it all. Scientists entrepreneurs must know when to transition leadership and when it's time to bring in the pros.
• 8. Stirring Public Interest - Promoting your science before you commercialize can smooth the road to funding...but there are a few mistakes you can make if you are not careful.
• 9. Financing the Company - It takes money to make money. Here are a few things to know about the funding process.
• 10. Preparing for Due Diligence - Due diligence involves intense scrutiny of all of your documents. It's critical to keep your documents well-organized and readily accessible.

Tamsen Valoir, PhD is a partner in the Houston office of Baker & McKenzie, LLP. She has a JD and LLM in Intellectual Property, a doctorate in molecular biology from Rice University, and her practice is primarily in intellectual property in the life sciences. As a leading Houston patent attorney, she can assist scientists with patent preparation and prosecution, opinion writing, IP due diligence and licensing in the life sciences. She can be reached at [email protected] or by phone at (713) 427-5007.

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