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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)



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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 178
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 178
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 178
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 178
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 178
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