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Event Health FDA Reform, Pharmaceuticals

The Digital Future of Molecular Medicine Rethinking FDA Regulation

Wednesday May 2013

The advent of powerful new diagnostics and sophisticated computing platforms is poised to transform drug development from "trial and error" to "success by design"—matching new drugs to the molecular profiles of the patients who are most likely to respond and least likely to suffer serious side effects. But the transition to precision medicine will involve revamping decades-old clinical trial protocols that are better suited to the twentieth century than to the twenty-first.

The Manhattan Institute's Project FDA invites you to join leading scientific and technical experts, industry stakeholders, and experienced FDA regulators to discuss how we can better incorporate new technologies into the drug development process in order to accelerate biomedical innovation and improve outcomes for patients.

Under the leadership of former FDA commissioner Dr. Andrew von Eschenbach, Project FDA represents a group of leading economists, practicing physicians, and policy experts who discuss and promote reforms that will enable a more 
predictable, transparent, and efficient pathway for bringing safe and effective new products to patients.

INTRODUCTION: Dr. Andrew von Eschenbach, Chairman, Project FDA; Former Commissioner, U.S. Food and Drug Administration; Former Director, National Cancer Institute

The Digital Future of Molecular Medicine: Rethinking FDA Regulation
Discussant: Peter Huber, Senior Fellow, Manhattan Institute; Author, The Cure in the Code: How 20th Century Law Is Undermining 21st Century Medicine (Basic Books, Fall 2013)

ROUNDTABLE I: Precision Medicine in a Digital World: Matching Patients and Therapies
Moderator: Paul Howard, Director, Center for Medical Progress 
Discussants: Linda Avey, Co-Founder & CEO, Curious Inc.; Co-Founder, 23andMe; John Crowley, President & CEO, Amicus Therapeutics; Andy Palmer, Founder, Koa Lab; Co-Founder, Vertica Systems; Karen Gutekunst, Vice President, Research and  Development, Clarient

ROUNDTABLE II: Rethinking FDA Regulation in a Digital World
Moderator: Susan Winckler, President & CEO, Food & Drug Law Institute
Discussants: Newton Crenshaw, Vice President, Oncology, Eli Lilly; Vicki Seyfert Margolis, Chief Strategy & Science Officer, Precision for Medicine; Former Senior Advisor for Science Innovation & Policy, U.S. FDA; Marty Kohn, Chief Medical Scientist, Care Delivery Systems, IBM Research

KEYNOTE: How to Unleash Investment in Molecular Medicine
Speaker: Mark Levin, Partner & Co-Founder, Third Rock Ventures