Appendix A
Workshop Agenda

INSTITUTE OF MEDICINE

National Academy of Sciences

ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision-Making

April 14–15, 1998

National Academy of Sciences Auditorium

2101 Constitution Avenue, N.W., Washington, D.C.

TUESDAY, APRIL 14: DAY ONE

OPENING PLENARY

8:30 a.m.

Welcome

Kenneth Shine, M.D.

President, Institute of Medicine

 

Opening Statement, Charge to Participants

Ronald Estabrook, Ph.D., Roundtable Chair

Virginia Lazenby O'Hara Professor of Biochemistry

University of Texas Southwestern Medical Center

8:45 a.m.

Overview of Issues

Janet Woodcock, M.D.

Director, Center for Drug Evaluation and Research

Food and Drug Administration



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Appendix A Workshop Agenda INSTITUTE OF MEDICINE National Academy of Sciences ROUNDTABLE ON RESEARCH AND DEVELOPMENT OF DRUGS, BIOLOGICS, AND MEDICAL DEVICES Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision-Making April 14–15, 1998 National Academy of Sciences Auditorium 2101 Constitution Avenue, N.W., Washington, D.C. TUESDAY, APRIL 14: DAY ONE OPENING PLENARY 8:30 a.m. Welcome Kenneth Shine, M.D. President, Institute of Medicine   Opening Statement, Charge to Participants Ronald Estabrook, Ph.D., Roundtable Chair Virginia Lazenby O'Hara Professor of Biochemistry University of Texas Southwestern Medical Center 8:45 a.m. Overview of Issues Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research Food and Drug Administration

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SESSION I: PRESUBMISSION 9:00 a.m. Data Collection John R. Schultz, Ph.D. Vice President and General Manager, Neuroclinical Trials Center Virginia Neurological Institute, University of Virginia 9:30 a.m. Questions and Answers 9:45 a.m. Monitoring Eleanor Segal, M.D. Senior Director for Drug Safety and Clinical Quality Assurance Chiron Corporation 10:15 a.m. Michaele Christian, M.D. Associate Director, Cancer Therapy Evaluation Program National Cancer Institute, National Institutes of Health 10:45 a.m. Questions and Answers 11:00 a.m. BREAK 11:15 a.m. Data Handling and Clean-up Kristin O'Connor, M.P.H. Director, Data Management Boehringer Ingleheim Pharmaceuticals, Inc. 11:45 a.m. Questions and Answers 12:00 p.m. LUNCH SESSION II: FDA SUBMISSION 1:30 p.m. Preparation and Content of Marketing Applications Nicholas Pelliccione, Ph.D. Senior Director, Worldwide Regulatory Affairs Schering Plough 2:00 p.m. Questions and Answers 2:15 p.m. Panel Discussion I: Presubmission and Submission Moderator: Susan Alpert, M.D., Ph.D. Center for Devices and Radiological Health Food and Drug Administration

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  Panelists: Robert Califf, M.D. Duke Clinical Research Institute   Michaele Christian, M.D. National Cancer Institute, National Institutes of Health   Susan Ellenberg, Ph.D. Center for Biologic Evaluation and Research Food and Drug Administration   Frank Hurley, Ph.D. Quintiles Transnational Corporation   Kiyoshi Kuromiya Critical Path AIDS Project   David Lepay, M.D., Ph.D. Center for Drugs Evaluation and Research Food and Drug Administration   Mike McGarvey, M.D. Blue Cross/Blue Shield of New Jersey   Kristin O'Connor, M.P.H. Boehringer Ingleheim Pharmaceuticals, Inc.   Nicholas Pelliccione, Ph.D. Schering Plough   John R. Schultz, M.D. University of Virginia   Eleanor Segal, M.D. Chiron Corporation 3:45 p.m. BREAK 4:00 p.m. Plenary Review of the Day, Discussion of Issues, and Plans for Tomorrow   Michael Clayman, M.D. Vice President, Cardiovascular Research and Clinical Investigations, Lilly Research Laboratories, Eli Lilly and Company 5:00 p.m. ADJOURN, RECEPTION

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WEDNESDAY, APRIL 15: DAY TWO SESSION III: FDA REGULATORY REVIEW 8:30 a.m. FDA Review: Paper Auditing Jay P. Siegel, M.D. Director, Office of Therapeutics Research and Review Center for Biologic Evaluation and Research Food and Drug Administration 9:00 a.m. FDA Clinical Site Review and IRB Audit David Lepay, M.D., Ph.D. Director, Division of Scientific Investigations Center for Drug Evaluation and Research Food and Drug Administration 9:30 a.m. Questions and Answers 9:45 a.m. BREAK 10:00 a.m. Sanctions Stan Woollen Deputy Director, Division of Scientific Investigations Center for Drug Evaluation and Research Food and Drug Administration 10:15 a.m. Assessment Murray Lumpkin, M.D. Deputy Director for Review Management Center for Drug Evaluation and Research Food and Drug Administration 10:45 a.m. Susan Alpert, M.D., Ph.D. Director, Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration 11:15 a.m. Questions and Answers 11:30 a.m. LUNCH 1:00 p.m. Panel Discussion II: FDA Review Moderator: Whaijen Soo, M.D. Ph.D. Vice President, Clinical Sciences Hoffmann-La Roche, Inc.

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  Panelists:   Susan Alpert, M.D., Ph.D. Center for Devices and Radiological Health Food and Drug Administration   William Fairweather, Ph.D. Office of Epidemiology and Biostatistics Food and Drug Administration   Charma Konnor Center for Devices and Radiological Health Food and Drug Administration   Robert Levy, M.D. Wyeth-Ayerst Research   Murray Lumpkin, M.D. Center for Drugs Evaluation and Research Food and Drug Administration   Roger Meyer, Ph.D. American Association of Medical Colleges   Jay Siegel, M.D. Center for Biologics Evaluation and Research Food and Drug Administration   Frances Visco, J.D. National Breast Cancer Coalition   William Waggoner, Ph.D. Essex Institution Review Board   Stan Woollen Center for Drugs Evaluation and Research Food and Drug Administration 2:30 p.m. Wrap-up Discussion Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research Food and Drug Administration   Ronald Estabrook, Ph.D. Roundtable Chair   Virginia Lazenby O'Hara Professor of Biochemistry University of Texas Southwestern Medical Center 3:30 p.m. ADJOURN