Advice for Biotech Entrepreneurs

From Sam English, founder of the Center for Innovation and Entrepreneurship, now CIE Partners:

Intellectual Property
Unless you have issued patents, patentability is essential.  Having a patent is good, but if you “overlap” (infringe) on someone else’s patent rights, that’s bad.  It’s not fatal, but the business just became much more complicated. 

Licensing rights from others can be acquired.  Iif you need to acquire rights or license your rights, please use a licensing professional.  Check AUTM or LES for more details. 

US rights are essential (assuming your market includes the US), but don’t forget the rest of the world.  If your exit strategy includes selling to someone who wants to sell your product outside the US, better plan on filing and prosecuting in those markets.  Don’t skimp on patenting.  At the end of the day, the R&D efforts should increase the value of the IP and justify these early expenses.

Proof of Concept
For a therapeutic product, if you want the interest of Big Pharma or VCs, you’ll need efficacy data from a Phase II clinical trial.  Angel investors, SBIR grants, and strategic partnerships are all good to help advance the development efforts  but the initial goal should be animal efficacy and safety.  FYI:  Pending legislation may increase the $ caps of a SBIR Phase I and Phase II grant awards.

Personal Goals
Consider these questions:  How does this endeavor fit with your personal goals?  Does it match your personal risk profile?

Your entrepreneurial effort will require significant commitment.  There is nothing wrong with discovering, inventing, and wanting the product to move forward while not wanting the risk (personal, financial, & professional).

If the risk does not match your appetite, then get your product into the hands of someone whose personal goals tolerate more risk.

I hope your readers will find my 2 cents useful.

Best regards,
Sam English, PhD

CIE Partners
416 Jefferson St., Suite 807
Roanoke, VA  24011
(540) 525-5493

CIE Partners is an independent Roanoke-based organization promoting innovation and assisting entrepreneurs, small businesses, and nonprofit organizations in the western region of Virginia.

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