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
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.
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, email@example.com
Kelli Watson Francuzenko, 202.756.8351, firstname.lastname@example.org
and Judith Toffenetti,
202. 756.8320, email@example.com
are all partners at McDermott Will & Emery, Washington, DC.