Personalized Medicine and Molecular Diagnostics

Legal, Regulatory and Ethical Perspectives
Arizona State University, Friday, March 2, 2007

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Program

Welcome

Gary Marchant, Executive Director of Center for the Study of Law Science & Technology, ASU
MP3 audio file
 

Session I: Future Paths for Personalized Medicine

Overview of Personalized Medicine  
George Poste, Director, The Biodesign Institute at Arizona State University
Presentation file      MP3 audio file
 
Co-Development of Drugs and Diagnostics : Case Studies 
Raymond Woosley, President and CEO, C-PATH Institute
Presentation file      MP3 audio file
 
Economic and Reimbursement Challenges for Molecular
Kathryn A. Phillips, Professor of Health Services Research and Health Economics, UCSF
Presentation file      MP3 audio file
 
Session 1 Question and Answer
MP3 audio file
 

Session II: Regulatory Issues

FDA Regulation of In Vitro Diagnostics
Elizabeth Mansfield, Ph.D., Science Policy Analyst, OIVD, CDRH, FDA
Presentation file      MP3 audio file
 
Regulatory Issues for Personalized Medicine
David W. Feigal, NDA Partners, LLP (former Director of FDA CDRH)
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Session II Question and Answer
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Lunch Speaker: Wayne A. Rosenkrans, PhD, Chairman & President of the Personalized Medicine Coalition
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Session III: Business and IP Issues

Economics of Linked Diagnostics and Drugs: Policy and Business Implications
M. J. Finley Austin, Director of US External Science Policy, Hoffmann-La Roche
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Intellectual Property and Diagnostics
Barbara A. Caulfield, Executive VP and General Counsel, Affymetrix
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Licensing and Translational Issues for Personalized Medicine
Ron G. King, Vice President, Strategic Alliances and Commercialization, TGEN
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Session III Question and Answer
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Session IV: Ethical and Liability Issues

Liability and Personalized Medicine
Gary Marchant, Executive Director of Center for the Study of Law Science & Technology, ASU & Robert Milligan, Partner, Gallagher & Kennedy
Presentation file      MP3 audio file 
 
Ethical Issues in Personalized Medicine
Mark A. Rothstein, Director of the Institute for Bioethics, Health Policy and Law, University of Louisville
Presentation file      MP3 audio file
 
Policy Issues in Personalized Medicine
Barbara J. Evans, Director of the Program in Pharmacogenomics, Ethics, and Public Policy at the Indiana University Center for Bioethics
Presentation file      MP3 audio file
 
Session IV Question and Answer
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