With the inauguration of Donald Trump as president on January 20th, the editors asked some of our Xconomists to offer their thoughts on “How could the incoming administration significantly affect your industry?”
The life sciences industry has one problem: Lack of productivity. When it figures out how to consistently make a profit discovering and developing drugs on a meaningful scale, it will solve virtually all the major challenges it faces, from pricing to its poor public image.
President Trump is not going to fix that, but he can make it more difficult. The best thing that he and his friends can do is to get out of the way, and let the industry figure out how to make drugs themselves.
That doesn’t mean relaxing standards at the FDA, à la eteplirsen (Exondy 51), Sarepta’s drug for treating Duchene’s muscular distrophy.
I believe the agency wants to accelerate the development of new drugs. To do that, it needs to reduce the quantity of data required for approval. To do that, it must improve—not reduce—the quality of the data. If not, agency and industry alike face the inevitable trainwreck of death-by-drug on the front page of The New York Times.
Pharma will either price itself out of business or learn how to make drugs. The industry won’t get a second chance when Elizabeth Warren and the Democrats again take their turn driving the bus.
We don’t need handouts or political favors. To succeed at the drug discovery business, the pharmaceutical industry needs the courage to re-invent itself in partnership with the entrepreneurial community on an unprecedented scale. The less involved that Washington is in that process, the better.
[Editor’s note: You can read other responses to our questions here.]
Author: Standish Fleming
Standish Fleming is a 29-year veteran of early stage life sciences investing. He has helped raise and manage six venture capital funds totaling more than $500 million, and has served on the boards of 19 venture-backed companies, including Nereus Pharmaceuticals, Ambit Biosciences, Triangle Pharmaceuticals (acquired by Gilead Sciences) and Actigen/Corixa (now part of GSK).
He has extensive experience in all aspects of venture management and finance, including fund-raising, investor relations, operations and portfolio development. He has made investments, managed portfolio companies, raised funds, pursued business development, taken companies public and successfully exited investments through public-market sales and buyouts. In 1993, Mr. Fleming co-founded San Diego's Forward Ventures. He has made investments in almost every segment of the health-care industry, including pharmaceuticals, biologics, diagnostics, devices, services, and software. He has managed both platform and product companies, portfolio investments, and led or participated in financings at all levels, from pre-startup to PIPES in public companies, in both debt and equity. He has helped start more than 15 companies and served as founding CEO of eight. Fleming serves as a director of CONNECT, San Diego's support organization for the early-stage community, and is a past president of the Biotechnology Venture Investors Group. Before establishing Forward Ventures, He served as the chairman, president and CEO of GeneSys Therapeutics, (merged with Somatix and acquired by Cell GeneSys [NASDAQ:CEGE]). Fleming began his venture career with Ventana Growth Funds in San Diego in 1986. He earned his B.A. from Amherst College and his M.B.A. from the UCLA Graduate School of Management.
View all posts by Standish Fleming