Project FDA: Bringing the FDA into the 21st Century

On May 15, I’ll be participating in a conference, “The Digital Future of Molecular Medicine: Rethinking FDA Regulation,” being sponsored by the Manhattan Institute’s Project FDA.

I’ll be joining Andrew von Eschenbach, chairman of Project FDA and former FDA commissioner and former director of the National Cancer Institute at the National Institutes of Health; Paul Howard, a senior fellow at the Manhattan Institute and director of its Center for Medical Progress (parent of Project FDA); and Peter Huber, Manhattan Institute senior fellow and author of the forthcoming book, The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine. Also participating will be researchers, former FDA regulators, and representatives from innovative life sciences companies, patients’ groups, and the media.

I’m honored to be in such august company and to be asked to help solve this critical problem that affects every one of us.  I’ll be talking about how the digitization and rapid sharing of clinical-trial and other health-care data can be used to speed up drug discovery and development – something I’ve written a lot about in the past.

It’s no secret that the clinical trials process is an enormously expensive and time-consuming part of bringing therapies to market with FDA approval, with Phase 3 clinical trials – final testing for effectiveness on large groups of patients – particularly onerous. This terrific editorial, by Dr. von Eschenbach and Tomas J. Philipson, explains why the clinical trials process is broken and why modernizing it, using digital technologies, will not only save lives but also jump-start the US economy.

I firmly believe that we can use technology to help modernize the clinical trials process to satisfy the FDA and payors’ goals of safety and efficiency and pharmaceutical companies,’ physicians’ and patients’ needs for expedience.  

Using digital technologies, we can create new levels of information liquidity, transparency and fluidity among physicians, patients and regulators. We can create amazing advancements in bench-testing, field data collection, and data analytics that complement the amazing advancements we’ve seen in molecular medicine. With the right digital technologies, we can afford to create medicines that serve smaller patient populations, for whom there had been little or no hope in the past due to cost.

We just need to think differently and apply the technologies that are mainstream on the World Wide Web today – and to get started…TODAY.

Updated May 16, 2013:  Here’s a video of the panel that I participated in: “Precision Medicine in a Digital World: Matching Patients and Therapies.”  Other videos from the conference are available here.

This entry was posted in Health Care, Information Technology, Innovation, Life Sciences. Bookmark the permalink.

1 Response to Project FDA: Bringing the FDA into the 21st Century

  1. Health care says:

    Thanks for sharing links and updating about Project FDA

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