Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report (1999)
Chapter: Appendix B: Speakers and Panelists
Appendix B
Speakers and Panelists
Susan Alpert, M.D., Ph.D.
Director of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
Robert Califf, M.D.
Director
Duke Clinical Research Institute
Michaele C. Christian, M.D.
Associate Director, Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Michael Clayman, M.D.
Vice President
Cardiovascular Research and Clinical Investigations
Lilly Research Laboratories
Eli Lilly and Company
Susan Ellenberg, Ph.D.
Director
Division of Biostatistics and Epidemiolgy
Center for Biologics Evaluation and Research
Food and Drug Administration
Ronald Estabrook, Ph.D.
Professor of Biochemistry
University of Texas
Southwestern Medical Center
William Fairweather, Ph.D.
Associate Director
Office of Epidemiology and Biostatistics
Food and Drug Administration
Frank L. Hurley, Ph.D.
Chief Science Officer
Quintiles Transnational Corporation
Charma Konnor
Director
Bioresearch Monitoring Division
Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
Kiyoshi Kuromiya
Critical Path AIDS Project
David Lepay, M.D., Ph.D.
Director
Division of Scientific Investigations
Food and Drug Administration
Robert Levy, M.D.
Senior Vice President, Science and Technology
American Home Products
Wyeth-Ayerst Research
Murray Lumpkin M.D.
Deputy Director for Review Management
Center for Drug Evaluation and Research
Food and Drug Administration
Michael McGarvey, M.D.
Chief Medical Officer
Blue Cross and Blue Shield of New Jersey, Inc.
Roger Meyer, M.D.
Senior Consultant
Division of Biomedical and Health Sciences Research
American Association of Medical Colleges
Kristin O'Connor, M.P.H.
Director, Data Management
Boehringer Ingleheim Pharmaceuticals, Inc.
Nicholas Pelliccione, Ph.D.
Senior Director
Worldwide Regulatory Affairs
Schering Plough
Jim Phillips, Ph.D.
Senior Director for Biostatistics
Quintiles Transnational Corp.
John Schultz, Ph.D.
Vice President
General Manager
Neuroclinical Trials Center
University of Virginia
Eleanor Segal, M.D.
Senior Director
Drug Safety and Clinical Quality Assurance
Chiron Corporation
Kenneth I. Shine, M.D.
President
Institute of Medicine
Jay Siegel, M.D.
Director
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Whaijen Soo, M.D., Ph.D.
Vice President, Clinical Sciences
Roche Pharmaceuticals
Hoffmann-La Roche, Inc.
Frances Visco, J.D.
President
National Breast Cancer Coalition
William Waggoner, Ph.D., FAACT
Chairman
Essex Institutional Review Board, Inc.
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Food and Drug Administration
Stan Woollen
Deputy Director
Division of Scientific Investigations
Center for Drug Evaluation and Research
Food and Drug Administration
