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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
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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
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