Top 10 Legal Issues Biotech Start-Ups Must Address - Intellectual property and regulatory compliance strategies must be scalable to the business realities of the company - BioPharm International

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Top 10 Legal Issues Biotech Start-Ups Must Address
Intellectual property and regulatory compliance strategies must be scalable to the business realities of the company


BioPharm International
Volume 21, Issue 11

7) PLAN AHEAD

Certain regulatory requirements can be met in advance and allocating resources to identify must-have components of research agreements, informed consent documents, material transfer agreements, and authorizations can position the company well. If these requirements are not met when the company is poised to take-off, critical filings with the FDA and others could be in jeopardy.

8) PAPER TRAIL

Compliance is not just about what you do, it's also about what you say that you do. Basic policies and standard operating procedures are essential to memorialize the compliant practices to which the company is committed. If something goes wrong down the line, policies and procedures can be a useful mitigating strategy. In addition, simple documentation tools can routinize compliance to make it easier for employees to understand the compliance steps while at the same time doing double-duty as documentary confirmation that the employees have complied with the policy requirements.

9) READ ALL ABOUT IT

Product lines, success rates, business hazards, and timetables can all be very fluid for start-ups. This fluidity can continue even after the company goes public, especially if the product is not yet fully commercialized. A common trap for young companies is failure to invest in carefully drafted securities filings, press releases, and other public documents to eliminate misleading public statements about company's fiscal health, business plans, and risks.

10) PAYDAY

Although product approval by the FDA can seem like the ultimate goal, FDA approval just means you can sell your product. It does not guarantee that health plans will pay for it. Biotech start-ups often miss critical opportunities to engage with legal counsel to develop reimbursement strategies that maximize the chance that a product will be awarded a favorable code and quickly make its way into the marketplace.

In the everyday crunch to keep moving, generate market excitement, and strategically allocate resources, it can be difficult to plan ahead for the rainy day. Unfortunately, IP and regulatory compliance are long-term endeavors that require attention even when nothing is going wrong. IP and regulatory compliance strategies must be scaled, however, to the business realities of the company. The foregoing list is an attempt to identify 10 specific legal needs, out of the many legal needs a company might face, where an ounce of prevention is worth a pound of cure.

Jennifer S. Geetter, 202.756.8205,
Kelli Watson Francuzenko, 202.756.8351,
and Judith Toffenetti, 202. 756.8320,
are all partners at McDermott Will & Emery, Washington, DC.


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