Review of the Fialuridine (FIAU) Clinical Trials (1995)
Chapter: Appendix C: Agendas from the Three Committee Meetings
CInstitute 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) |
| 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) |
| 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 |
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) |
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 |
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 |
