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:
- To assess the current landscape of drug repurposing activities in industry, academia, and government.
- To examine enabling tools and technology for drug repurposing.
- To evaluate the business models and economic incentives for pursuing a repurposing approach.
- To discuss how genomic and genetic research could be positioned to better enable a drug repurposing paradigm.
| 8:30–8:35 A.M. | Welcoming Remarks |
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Sharon F. Terry, Roundtable Co-Chair |
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President and Chief Executive Officer Genetic Alliance |
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Geoffrey Ginsburg, Roundtable Co-Chair |
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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 |
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| 8:35–8:40 A.M. |
Charge to Workshop Speakers and Participants |
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Aidan Power, Workshop Chair |
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Vice President and Head, PharmaTx Precision Medicine |
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Pfizer Inc. |
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| 8:40–10:20 A.M. | SESSION I: CURRENT LANDSCAPE Moderator: Gabriela Lavezzari Assistant Vice President, Scientific Affairs PhRMA |
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8:40–8:55 A.M. |
State of the Science: Academia |
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Larry Sklar |
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Distinguished Professor |
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Director, Center for Molecular Discovery |
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Associate Director, Cancer Center |
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University of New Mexico School of Medicine |
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8:55–9:10 A.M. |
State of the Science: Industry |
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Don Frail |
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Vice President of Science |
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New Opportunities Innovative Medicines Unit |
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AstraZeneca |
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9:10–9:25 A.M. |
State of the Science: FDA |
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Weida Tong |
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Director, Division of Bioinformatics and Biostatistics |
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National Center for Toxicological Research |
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U.S. Food and Drug Administration |
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9:25–9:40 A.M. |
State of the Science: Rare Disease |
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Hal Dietz |
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Victor A. McKusick Professor of Medicine and Genetics |
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Institute of Genetic Medicine |
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Investigator, Howard Hughes Medical Institute |
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Johns Hopkins University School of Medicine |
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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 |
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Moderator: Geoffrey Ginsburg |
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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 |
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10:35–10:55 A.M. |
Computational Strategies (modeling, literature-based discovery) |
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Atul Butte |
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Chief and Associate Professor of Systems Medicine |
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Department of Pediatrics |
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Stanford University School of Medicine |
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10:55–11:15 A.M. |
Data Mining (post-market surveillance, high-throughput screening, databases) |
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Lon Cardon |
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Senior Vice President, Alternative Discovery and Development |
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GlaxoSmithKline |
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11:15–11:30 A.M. |
Government-Sponsored Efforts: NCATS |
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John McKew |
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Acting Director, Division of Pre-Clinical Innovation |
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National Center for Advancing Translational Sciences |
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11:30–11:45 A.M. |
Government-Sponsored Efforts: NINDS |
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Petra Kaufmann |
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Director, Office of Clinical Research |
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National Institute of Neurological Disorders and Stroke |
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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 |
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Moderator: Allen Roses |
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Jefferson–Pilot Professor of Neurobiology and Genetics |
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Professor of Medicine (Neurology) |
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Director, Deane Drug Discovery Institute |
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Senior Scholar Fuqua School of Business, R. David Thomas Executive Training Center Duke University |
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1:20–1:35 P.M. |
Business Model/Economic Incentives |
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Michael Ringel |
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Partner and Managing Director |
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The Boston Consulting Group |
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1:35–1:50 P.M. |
Repurposing Drugs Currently in Development |
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Simeon Taylor |
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Vice President, Research and Scientific Affairs |
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Bristol-Myers Squibb |
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1:50–2:05 P.M. |
Repurposing Drugs That Were Not Successful for Their First Indication |
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Thomas O. Daniel |
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Executive Vice President |
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President, Global Research and Early Development |
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Celgene Corporation |
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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 |
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Moderator: Arti Rai |
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Elvin R. Latty Professor of Law |
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Duke University |
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3:00–3:15 P.M. |
Strategies for Overcoming Barriers to Drug Repurposing: NCATS |
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Christine Colvis |
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Director, Extramural Therapeutics Discovery |
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National Center for Advancing Translational Sciences |
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3:15–3:30 P.M. |
Strategies for Overcoming Barriers to Drug Repurposing: MRC/AZ |
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Chris Watkins |
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Director, Translational Research and Industry Medical Research Council |
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3:30–3:45 P.M. |
Legal/Intellectual Property |
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Arti Rai |
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Elvin R. Latty Professor of Law |
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Duke University |
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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 |
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4:25–5:15 P.M. |
Advancing Repurposing Efforts |
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Moderator: Aidan Power, Workshop Chair |
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Vice President and Head, PharmaTx Precision Medicine |
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Pfizer Inc. |
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Respondents: |
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Ronald J. Bartek |
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President |
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Friedreich’s Ataxia Research Alliance |
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Lon Cardon |
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Senior Vice President, Alternative Discovery and Development |
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GlaxoSmithKline |
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Christine Colvis |
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Director, Extramural Therapeutics Discovery |
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National Center for Advancing Translational Sciences |
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Hal Dietz |
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Victor A. McKusick Professor of Medicine and Genetics |
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Institute of Genetic Medicine |
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Investigator, Howard Hughes Medical Institute Johns Hopkins University School of Medicine |
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Michael Pacanowski |
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Acting Associate Director for Genomics |
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Center for Drug Evaluation and Research |
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Office of Clinical Pharmacology |
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U.S. Food and Drug Administration |
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Arti Rai |
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Elvin R Latty Professor of Law |
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Duke University |
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Michael Ringel |
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Partner and Managing Director |
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The Boston Consulting Group |
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| 5:15–5:30 P.M. |
SESSION VI: CONCLUSION |
| 5:15–5:30 P.M. |
CONCLUDING REMARKS |
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Aidan Power, Workshop Chair |
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Vice President and Head, PharmaTx Precision Medicine |
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Pfizer Inc. |
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| 5:30 P.M. |
ADJOURN |
