The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Expanding Access to Investigational Therapies for HIV Infection and AIDS: March 12-13, 1990 Conference Summary
Expanding Access to Investigational Therapies March 12–13, 1990 Program
Monday, March 12
8:15
Welcome and Opening Remarks
- Harold Ginsberg, Eugene Higgins Professor of Medicine and Microbiology, College of Physicians & Surgeons, Columbia University, and Co-chair, AIDS Roundtable
8:20
Expanding Access to Investigational Therapies: The Challenges Ahead
- Samuel O. Thier, President, Institute of Medicine
8:30
A Lucid Explanation and Brief History of Food and Drug Administration Policy on Investigational Drugs for Treatment Purposes
- Peter Barton Hutt, Partner, Covington & Burling
9:00
The Promise of Treatment Investigational New Drug Regulations: Have They Done What They Were Supposed to Do?
Moderator:
J. Richard Crout, Vice President, Medical and Scientific Affairs, Boehringer Mannheim Pharmaceuticals
Panelists:
Robert Temple, Director, Office of Drug Evaluation I, Food and Drug Administration
Jay Lipner, Partner, Silverstein Langer Lipner & Newburgh
Stephen Sherwin, Vice President for Clinical Research, Genentech, Inc.
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole. Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 1
Expanding Access to Investigational Therapies for HIV Infection and AIDS: March 12-13, 1990 Conference Summary
Expanding Access to Investigational Therapies
March 12–13, 1990
Program
Monday, March 12
8:15
Welcome and Opening Remarks
- Harold Ginsberg, Eugene Higgins Professor of Medicine and Microbiology, College of Physicians & Surgeons, Columbia University, and Co-chair, AIDS Roundtable
8:20
Expanding Access to Investigational Therapies: The Challenges Ahead
- Samuel O. Thier, President, Institute of Medicine
8:30
A Lucid Explanation and Brief History of Food and Drug Administration Policy on Investigational Drugs for Treatment Purposes
- Peter Barton Hutt, Partner, Covington & Burling
9:00
The Promise of Treatment Investigational New Drug Regulations: Have They Done What They Were Supposed to Do?
Moderator:
J. Richard Crout, Vice President, Medical and Scientific Affairs, Boehringer Mannheim Pharmaceuticals
Panelists:
Robert Temple, Director, Office of Drug Evaluation I, Food and Drug Administration
Jay Lipner, Partner, Silverstein Langer Lipner & Newburgh
Stephen Sherwin, Vice President for Clinical Research, Genentech, Inc.
OCR for page 2
Expanding Access to Investigational Therapies for HIV Infection and AIDS: March 12-13, 1990 Conference Summary
Lawrence Corey, Professor of Laboratory Medicine, Microbiology, and Medicine, University of Washington
Raphael Dolin, Head, Infectious Diseases Unit, University of Rochester School of Medicine and Dentistry
10:00
Discussion
10:45
The Philosophy of Drug Regulation in the United States: Is It Changing from Beneficence to Patient Autonomy?
Moderator:
Dan Brock, Professor of Philosophy, Brown University
Panelists:
Harold Edgar, Professor of Law, Columbia University School of Law
Bernard Lo, Director, Program in Medical Ethics, University of California
Daniel Wikler, Professor, Department of Philosophy, University of Wisconsin
Carol Levine, Executive Director, Citizens Commission on AIDS
12:00
Discussion
1:45
Issues of Cost and Coverage: How Will the Changes Affect the Drug Industry, Payers, and Patients?
Moderator:
Patrick Gage, Executive Vice President, Genetics Institute, Inc.
Panelists:
Jerome Birnbaum, Executive Vice President for Research, Bristol-Myers Squibb Company
Paul De Stefano, Chief Corporate Counsel, Genentech, Inc.
David Higbee, Branch Chief, Catastrophic Medical Services, Office of Coverage Policy, Health Care Financing Administration
Susan Gleeson, Executive Director, Technology Management, Blue Cross and Blue Shield Association
Steven Peskin, Vice President and Medical Director, CIGNA Healthplan of Texas, Inc.
OCR for page 3
Expanding Access to Investigational Therapies for HIV Infection and AIDS: March 12-13, 1990 Conference Summary
Lee Mortenson, Executive Director, Association of Community Cancer Centers
3:00
Discussion
3:45
Expanding Access and Gathering and Analyzing Data: Can You Have Your Cake and Eat It Too?
Moderator:
Lincoln Moses, Professor of Statistics, Stanford University
Panelists:
Melanie Thompson, President, AIDS Research Consortium of Atlanta, Inc.
Marvin Zelen, Chair, Department of Biostatistics, Harvard School of Public Health
Floyd J. Fowler, Senior Research Fellow, Center for Survey Research, University of Massachusetts
Susan Ellenberg, Chief, Biostatistics Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases
5:00
Discussion
5:30
Adjournment
Tuesday, March 13
8:15
Reaching the Disenfranchised: What Role for Clinical Trials?
Moderator:
Gerald Friedland, Professor of Medicine, Epidemiology, and Social Medicine, Albert Einstein College of Medicine
Panelists:
Lawrence Brown, Jr., Senior Vice President for Research and Medical Affairs, Addiction Research and Treatment Corporation
Mark Smith, Associate Director, AIDS Service, Johns Hopkins University School of Medicine
Deborah Cotton, Clinical Director for AIDS, Beth Israel Hospital
OCR for page 4
Expanding Access to Investigational Therapies for HIV Infection and AIDS: March 12-13, 1990 Conference Summary
Philip Pizzo, Chief, Pediatric Branch, National Cancer Institute
9:30
Discussion
10:15
Parallel Track: An Update
—James Allen, Director, National AIDS Program Office, Public Health Service
10:30
Parallel Track: What Should It Achieve?
Moderator:
Anthony Fauci, Associate Director for AIDS Research, National Institutes of Health, and Director, National Institute of Allergy and Infectious Diseases
Panelists:
Louis Lasagna, Dean, Sackler School of Graduate Biomedical Sciences, Tufts University
James Eigo, Member, Treatment and Data Committee, AIDS Coalition to Unleash Power
Daniel Hoth, Director, Division of AIDS, National Institute of Allergy and Infectious Diseases
Ellen Cooper, Director, Division of Antiviral Drug Products, Food and Drug Administration
11:45
Discussion
12:15
Expanding Access and the Needs of the Traditional Primary Care Provider
—Harvey Makadon, Assistant Professor of Medicine, Harvard Medical School, and Executive Director, Boston AIDS Consortium
12:35
Discussion
12:50
Summation
—Sheldon Wolff, Endicott Professor and Chairman, Department of Medicine, Tufts University School of Medicine, and Co-chair, AIDS Roundtable
1:00
Adjournment
Items in cart [0]
