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It has become a cliché to say that the FDA and Congress put excessive emphasis on risk in the risk-benefit equation.
Increasingly, investors are parking their funds outside of the life science industry and beyond US borders, citing an unclear regulatory environment for many different programs, ever increasing costs of clinical trials and the resulting uncertainty that products will ever reach patients. Ironically, for all of the talk in Washington about tackling the costs of chronic diseases, the tougher regulatory environment is actually pushing companies away from investments into better therapies for diabetes, cardiovascular disease, and obesity.
Andrew C. von Eschenbach, M.D.
This plenary session focuses on how to maintain American innovation and entrepreneurship through a modernization and transformation of the FDA into an agency that focuses not only on safety, but on efficacy, innovation and its mission to protect and promote public health. It provides a perspective on how life sciences companies and patient groups can navigate the current regulatory process while collaborating on process improvements toward a regulatory pathway that is transparent and efficient, yet still rigorous and science led.
Keynote:
Andrew C. von Eschenbach, MD
Former Commissioner, FDA
President, Samaritan Health Initiatives
Steve Walker
Steve Walker
Co-Founder
The Abigail Alliance for Better Access to Developmental Drugs
