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THE DIGITAL FUTURE OF MOLECULAR MEDICINE:

RETHINKING FDA REGULATION

WEDNESDAY, MAY 15, 2013 | NEW YORK CITY


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.

 

9:00AM - 9:05AM   INTRODUCTION
   

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

9:05AM - 9:50AM   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)

9:55AM - 10:50AM   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

11:00AM - 11:50AM   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

1:00PM - 2:00PM   KEYNOTE: How to Unleash Investment in Molecular Medicine
   

Speaker:
Mark Levin, Partner & Co-Founder, Third Rock Ventures

After the conference, Project FDA will continue to release new white papers and organize bipartisan discussion groups in New York and Washington D.C. to explore the impact of digital technologies on the regulation of drug development and related issues. These efforts will culminate with the November 2013 publication of Peter Huber's book The Cure in the Code: How 20th Century Law Is Undermining 21st Century Medicine (Basic Books).

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.

 

 

 

 


Andrew C. von Eschen

 
 
 

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