C Institute of Medicine Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials
First Committee Meeting
Monday and Tuesday, July 25-26, 1994
The Foundry Building (Room 2004)
AGENDA
MONDAY, July 25, 1994 |
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8:30 a.m. |
EXECUTIVE SESSION |
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Welcoming remarks, introductions and charge to committee |
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Joseph S. Cassells, M.D. (IOM Interim Executive Officer) |
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Morton Swartz, M.D. (Professor of Medicine, Harvard Medical School; Chief, James Jackson Firm; and Emeritus Chief, Infectious Disease Unit, Medical Services, Massachusetts General Hospital) |
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Frederick J. Manning, Ph.D. (Study Director) |
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Discussion of bias/conflict of interest issues |
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Joseph Cassells |
10:15 a.m. |
Break |
10:30 a.m. |
Findings of the FDA Office of Compliance |
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Mary L. Richardson (Acting Director, Division of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration) |
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Ross Pierce, M.D. (Medical Officer, Clinical Investigations Branch, Division of Scientific Investigations, Office of Compliance, (CDER), U.S. Food and Drug Administration) |
12:00 Noon |
Luncheon Buffet, Meeting Room 2004 |
1:00 p.m. |
Report of the FDA Task Force on Fialuridine: Hepatic and Pancreatic Toxicity |
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Roger L. Williams, M.D. (Associate Director for Science and Medical Affairs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration) |
2:00 p.m. |
Role of the Division of Anti-Vital Drug Products |
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David Feigal, M.D. (Director, Division of Anti-Viral Drug Products, Office of Drug Evaluation, CDER, U.S. Food and Drug Administration) |
3:15 p.m. |
Break |
3:30 p.m. |
Review of Studies R91-010 and PPPC |
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Jay H. Hoofnagle, M.D. (Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health) |
5:00 p.m. |
Meeting Adjourns for the Day |
TUESDAY, July 26, 1994 |
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8:00 a.m. |
Review of Studies R89-001 and R90-001 |
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Lawrence Corey, M.D. (Professor, Laboratory Medicine, Microbiology and Medicine, Virology Office, University of Washington, Seattle) |
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Douglas D. Richman, M.D. (Professor of Pathology and Medicine, University of California, San Diego) |
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Stephen E. Straus, M.D. (Chief Laboratory of Clinical Investigation, Medical Virology Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health) |
10:00 a.m. |
Review of Preclinical Studies |
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John Emmerson, Ph.D. (Distinguished Lilly Research Scholar, Toxicology Division, Eli Lilly) |
11:00 a.m. |
Eli Lilly Overview |
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Donald G. Therasse, M.D. (Director, Anti-Infective Division, Eli Lilly Research Laboratories ) |
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Allan J. Weinstein, M.D. (Vice President, Eli Lilly Research Laboratories) |
12:15 p.m. |
Lunch, Meeting Room 2004 |
1:00 p.m. |
Report to the Director, NIH, of the Director's Advisory Committee's (DAC) Subcommittee to Review FIAU Studies |
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David R. Challoner, M.D. (Vice-President for Health Affairs, University of Florida) |
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David M. Kipnis, M.D. (Distinguished University Professor of Medicine, Washington University School of Medicine) |
2:15 p.m. |
EXECUTIVE SESSION |
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Barbara Rice, NAS Office of News and Public Information |
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Discussion of Work Plan |
3:00 p.m. |
Break |
3:15 p.m. |
Continuation of Work Plan Discussion |
5:00 p.m. |
Adjourn |
INSTITUTE OF MEDICINE COMMITTEE TO REVIEW THE FIALURIDINE (FIAU/FIAC) CLINICAL TRIALS
Second Committee Meeting
Thursday and Friday, September 8-9, 1994
Cecil and Ida Green Building
Room 116
AGENDA
THURSDAY, Sept. 8, 1994 |
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8:00 a.m. |
EXECUTIVE SESSION (study outline; tape; report on patient interviews ) |
9:30 a.m. |
Presentations to the Committee |
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Judith Fallon, M.D. (Former Chair, Institutional Review Board NIAID) |
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Howard Austin, M.D. (Chair, Institutional Review Board NIDDK) |
10:30 a.m. |
David Feigel, M.D. (Director, Antiviral Drug Division CDER, FDA) |
12:00 Noon |
Lunch |
1:00 p.m. |
Continuation of presentations |
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Barbara Savarese, R.N. (Study Coordinator R-90, R-91, 6-mo. trials) |
2:00 p.m. |
Robin McKenzie, M.D. (Medical Officer, NIAID, Associate Investigator, 6 mos. trial) |
3:00 p.m. |
Yoon Park, R.N. (Clinical Nurse, Warren Grant Magnuson Clinical Center, R-90, R-91, 6-mo. studies) |
4:00 p.m. |
EXECUTIVE SESSION |
5:00 p.m. |
Meeting Adjourns for the Day |
FRIDAY, Sept. 9, 1994 |
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8:00 a.m. |
Presentations to the Committee |
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Peter Barton Hutt, LL.D. (Former General Counsel FDA) |
10:00 a.m. |
Mary Richardson (Deputy Director, Division of Scientific Investigations, Office of Compliance, CDER, FDA) |
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Ross Pierce, M.D. (Division of Scientific Investigations, Office of Compliance CDER) |
12:00 p.m. |
Lunch |
1:00 p.m. |
EXECUTIVE SESSION (study plan, writing assignments, info needs) |
INSTITUTE OF MEDICINE COMMITTEE TO REVIEW THE FIALURIDINE (FIAU/FIAC) CLINICAL TRIALS
Third Committee Meeting
Wednesday and Thursday, November 16-17, 1994
The Foundry Building
Room 2004
AGENDA
WEDNESDAY, Nov. 16, 1994 |
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8:30 a.m. |
Review of Draft Report Sections Each author in turn; see attached outline |
10:15 a.m. |
Break |
10:30 a.m. |
Resume Review of Draft Sections |
12:00 Noon |
Luncheon Buffet, Meeting Room 2004 |
1:00 p.m. |
Assemble Recommendations and Conclusions |
2:30 p.m. |
Break |
3:00 p.m. |
Revision of Report Sections On laptops in 2004 or at HSPD Offices |
5:00 p.m. |
Meeting Adjourns for the Day |
THURSDAY, Nov. 17, 1994 |
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8:00 a.m. |
Review of Revised and New Sections |
10:15 a.m. |
Break |
10:30 a.m. |
Resume Review |
12:00 p.m. |
Lunch, Meeting Room 2004 |
1:00 p.m. |
Resume Review |
3:15 p.m. |
Rewrites as necessary |
5:00 p.m. |
Adjourn |