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OCR for page 178
Review of the Fialuridine (FIAU) Clinical Trials
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
8:30 a.m.
EXECUTIVE SESSION
Welcoming remarks, introductions and charge to committee
Joseph S. Cassells, M.D.
(IOM Interim Executive Officer)
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)
Frederick J. Manning, Ph.D.
(Study Director)
Discussion of bias/conflict of interest issues
Joseph Cassells
10:15 a.m.
Break
10:30 a.m.
Findings of the FDA Office of Compliance
Mary L. Richardson
(Acting Director, Division of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration)
OCR for page 179
Review of the Fialuridine (FIAU) Clinical Trials
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
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
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
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
8:00 a.m.
Review of Studies R89-001 and R90-001
Lawrence Corey, M.D.
(Professor, Laboratory Medicine, Microbiology and Medicine, Virology Office, University of Washington, Seattle)
OCR for page 180
Review of the Fialuridine (FIAU) Clinical Trials
Douglas D. Richman, M.D.
(Professor of Pathology and Medicine, University of California, San Diego)
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
John Emmerson, Ph.D.
(Distinguished Lilly Research Scholar, Toxicology Division, Eli Lilly)
11:00 a.m.
Eli Lilly Overview
Donald G. Therasse, M.D.
(Director, Anti-Infective Division, Eli Lilly Research Laboratories )
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
David R. Challoner, M.D.
(Vice-President for Health Affairs, University of Florida)
David M. Kipnis, M.D.
(Distinguished University Professor of Medicine, Washington University School of Medicine)
2:15 p.m.
EXECUTIVE SESSION
Barbara Rice, NAS Office of News and Public Information
Discussion of Work Plan
3:00 p.m.
Break
3:15 p.m.
Continuation of Work Plan Discussion
OCR for page 181
Review of the Fialuridine (FIAU) Clinical Trials
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
8:00 a.m.
EXECUTIVE SESSION (study outline; tape; report on patient interviews )
9:30 a.m.
Presentations to the Committee
Judith Fallon, M.D.
(Former Chair, Institutional Review Board NIAID)
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
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)
OCR for page 182
Review of the Fialuridine (FIAU) Clinical Trials
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
8:00 a.m.
Presentations to the Committee
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)
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
8:30 a.m.
Review of Draft Report Sections
Each author in turn; see attached outline
OCR for page 183
Review of the Fialuridine (FIAU) Clinical Trials
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
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
Representative terms from entire chapter:
scientific investigations
