Drug Repurposing and Repositioning
A Workshop
June 24, 2013
The Keck Center of the National Academies, Room 100
500 Fifth Street, NW
Washington, DC 20001
Workshop Objectives:
| 8:30–8:35 A.M. | Welcoming Remarks |
Sharon F. Terry, Roundtable Co-Chair | |
President and Chief Executive Officer Genetic Alliance | |
Geoffrey Ginsburg, Roundtable Co-Chair | |
Director, Genomic Medicine, Duke Institute for Genome Sciences & Policy; Executive Director, Center for Personalized Medicine, Duke Medicine; Professor of Medicine and Pathology, Duke University Medical Center | |
| 8:35–8:40 A.M. | Charge to Workshop Speakers and Participants |
Aidan Power, Workshop Chair | |
Vice President and Head, PharmaTx Precision Medicine | |
Pfizer Inc. | |
| 8:40–10:20 A.M. | SESSION I: CURRENT LANDSCAPE Moderator:Gabriela Lavezzari Assistant Vice President, Scientific Affairs PhRMA |
8:40–8:55 A.M. | State of the Science: Academia |
Larry Sklar | |
Distinguished Professor | |
Director, Center for Molecular Discovery | |
Associate Director, Cancer Center | |
University of New Mexico School of Medicine | |
8:55–9:10 A.M. | State of the Science: Industry |
Don Frail | |
Vice President of Science | |
New Opportunities Innovative Medicines Unit | |
AstraZeneca | |
9:10–9:25 A.M. | State of the Science: FDA |
Weida Tong | |
Director, Division of Bioinformatics and Biostatistics | |
National Center for Toxicological Research | |
U.S. Food and Drug Administration | |
9:25–9:40 A.M. | State of the Science: Rare Disease |
Hal Dietz | |
Victor A. McKusick Professor of Medicine and Genetics | |
Institute of Genetic Medicine | |
Investigator, Howard Hughes Medical Institute | |
Johns Hopkins University School of Medicine | |
9:40–10:20 A.M. | Discussion with Speakers and Attendees |
| 10:20–10:35 A.M. | BREAK |
| 10:35 A.M. –12:30 P.M. | SESSION II: ENABLING TOOLS AND TECHNOLOGY |
Moderator:Geoffrey Ginsburg | |
Director, Genomic Medicine, Duke Institute for Genome Sciences & Policy; Executive Director, Center for Personalized Medicine, Duke Medicine; Professor of Medicine and Pathology, Duke University Medical Center | |
10:35–10:55 A.M. | Computational Strategies (modeling, literature-based discovery) |
Atul Butte | |
Chief and Associate Professor of Systems Medicine | |
Department of Pediatrics | |
Stanford University School of Medicine | |
10:55–11:15 A.M. | Data Mining (post-market surveillance, high-throughput screening, databases) |
Lon Cardon | |
Senior Vice President, Alternative Discovery and Development | |
GlaxoSmithKline | |
11:15–11:30 A.M. | Government-Sponsored Efforts: NCATS |
John McKew | |
Acting Director, Division of Pre-Clinical Innovation | |
National Center for Advancing Translational Sciences | |
11:30–11:45 A.M. | Government-Sponsored Efforts: NINDS |
Petra Kaufmann | |
Director, Office of Clinical Research | |
National Institute of Neurological Disorders and Stroke | |
11:45 A.M. –12:30 P.M. | Discussion with Speakers and Attendees |
| 12:30–1:20 P.M. | WORKING LUNCH |
| 1:20–2:45 P.M. | SESSION III: VALUE PROPOSITION FOR REPURPOSING |
Moderator:Allen Roses | |
Jefferson–Pilot Professor of Neurobiology and Genetics | |
Professor of Medicine (Neurology) | |
Director, Deane Drug Discovery Institute | |
Senior Scholar Fuqua School of Business, R. David Thomas Executive Training Center Duke University | |
1:20–1:35 P.M. | Business Model/Economic Incentives |
Michael Ringel | |
Partner and Managing Director | |
The Boston Consulting Group | |
1:35–1:50 P.M. | Repurposing Drugs Currently in Development |
Simeon Taylor | |
Vice President, Research and Scientific Affairs | |
Bristol-Myers Squibb | |
1:50–2:05 P.M. | Repurposing Drugs That Were Not Successful for Their First Indication |
Thomas O. Daniel | |
Executive Vice President | |
President, Global Research and Early Development | |
Celgene Corporation | |
2:05–2:45 P.M. | Discussion with Speakers and Attendees |
| 2:45–3:00 P.M. | BREAK |
| 3:00–4:25 P.M. | SESSION IV: POLICY APPROACHES AND LEGAL FRAMEWORK |
Moderator:Arti Rai | |
Elvin R. Latty Professor of Law | |
Duke University | |
3:00–3:15 P.M. | Strategies for Overcoming Barriers to Drug Repurposing: NCATS |
Christine Colvis | |
Director, Extramural Therapeutics Discovery | |
National Center for Advancing Translational Sciences | |
3:15–3:30 P.M. | Strategies for Overcoming Barriers to Drug Repurposing: MRC/AZ |
Chris Watkins | |
Director, Translational Research and Industry Medical Research Council | |
3:30–3:45 P.M. | Legal/Intellectual Property |
Arti Rai | |
Elvin R. Latty Professor of Law | |
Duke University | |
3:45–4:25 P.M. | Discussion with Speakers and Attendees |
| 4:25–5:15 P.M. | SESSION V: INCREASING THE EFFICIENCY AND SUCCESS OF REPURPOSING |
4:25–5:15 P.M. | Advancing Repurposing Efforts |
Moderator:Aidan Power, Workshop Chair | |
Vice President and Head, PharmaTx Precision Medicine | |
Pfizer Inc. | |
Respondents: | |
Ronald J. Bartek | |
President | |
Friedreich’s Ataxia Research Alliance | |
Lon Cardon | |
Senior Vice President, Alternative Discovery and Development | |
GlaxoSmithKline | |
Christine Colvis | |
Director, Extramural Therapeutics Discovery | |
National Center for Advancing Translational Sciences | |
Hal Dietz | |
Victor A. McKusick Professor of Medicine and Genetics | |
Institute of Genetic Medicine | |
Investigator, Howard Hughes Medical Institute Johns Hopkins University School of Medicine | |
Michael Pacanowski | |
Acting Associate Director for Genomics | |
Center for Drug Evaluation and Research | |
Office of Clinical Pharmacology | |
U.S. Food and Drug Administration | |
Arti Rai | |
Elvin R Latty Professor of Law | |
Duke University | |
Michael Ringel | |
Partner and Managing Director | |
The Boston Consulting Group | |
| 5:15–5:30 P.M. | SESSION VI: CONCLUSION |
| 5:15–5:30 P.M. | CONCLUDING REMARKS |
Aidan Power, Workshop Chair | |
Vice President and Head, PharmaTx Precision Medicine | |
Pfizer Inc. | |
| 5:30 P.M. | ADJOURN |