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.



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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 1
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 1
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 1
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