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



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OCR for page 56
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

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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

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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