22: FDA, Sirtris

Read note "U.S. Food and Drug Administration" (HBS 9-807-050). The article provides background information about the FDA, and discusses its approval process for drugs and devices. Pay particular attention to the “New Product Approval Process” (pp.4 ff) and consider how this may affect product development, venture financing and operational strategies of life science start-ups. Then, as you study today’s Sirtris case, think about how this article may apply to the case.

Read the “Sirtris Pharmaceuticals: Living Healthier, Longer”. Dr. David Sinclair and Dr. Christoph Westphal, co-founders of Sirtris, are faced with three strategic opportunities: (a) in-license compounds from a biotech company to diversify Sirtris’s drug development portfolio; (b) enter into a partnership with a large pharmaceutical firm; and/or (c) launch an over-the-counter nutraceutical product. Consider the following study questions in preparation for class discussion of the choices facing the co-founders:

• Should Sirtris do the deal with the pharmaceutical firm? Why or why not?
• Should Sirtris launch a SRT501 nutraceuticals business? Why or why not?
• Should Sirtris in-license additional compounds from an outside source? Why or why not?
• Should Sirtris pursue more than one of these opportunities concurrently? If so, what combination would you recommend and why?
• At the time Westphal joined Sirtris, what is your assessment of the odds that the company would ever generate substantial revenues? If you had been Westphal at that time, would you have left Polaris for Sirtris? Why?
• At the time of the case, Sirtris had a 27-member Scientific Advisory Board and an 11-member Board of Directors. What are the respective roles of these two bodies and in what way(s) are they each important to the success of Sirtris?

Be prepared to discuss these readings and other important elements of the case in class.

DUE:

Following the guidelines in the Case Method Overview (found in Canvas Files), write a concise 2-page essay addressing the question below:

In the case, Sirtris is facing three strategic options: pursue the neutraceuticals market, pursue the pharmaceutical deal, in-license to broaden their portfolio. Which would recommend they pursue right now (at the time of the case)? Explain.

Submit your essay on Canvas before class on Tuesday. All work must be your own, subject to the University’s Code of Academic Integrity.