INTRODUCTION1

As the toll from the acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) disease continues to mount in the United States and around the world, accelerating the discovery and development of new, more effective drugs and vaccines is critical to the treatment and prevention of HIV infection. Simply spending more money on HIV/AIDS research, however, is not the sole answer; some scientists question whether additional funds could indeed be spent productively. They argue that a better strategy would be to enhance the effectiveness of current investments in therapeutic research and development efforts. Increasing collaborations among AIDS researchers in the public and private sectors hold considerable potential in this regard, because cross-fertilization among scientists interested in a common problem can accelerate the advancement of scientific knowledge and understanding.

HIV/AIDS therapeutic drug research and development is under way in three sectors: government (primarily through the intramural research program of the National Institutes of Health [NIH]), academia (supported in large part by NIH grants and contracts), and the pharmaceutical industry. Research collaborations between industry and academia and between NIH and academia are regarded as generally effective and productive. Indeed, numerous joint efforts have helped to provide a detailed understanding of the virus and its life cycle and to identify the first generation of antiretroviral agents that offer therapeutic value, albeit of limited duration. But, in recent years, researchers have frequently expressed dissatisfaction and skepticism about the effectiveness of current mechanisms for government and industry collaborations.

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This section is based on material presented by Patrick Gage.



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Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 INTRODUCTION1 As the toll from the acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) disease continues to mount in the United States and around the world, accelerating the discovery and development of new, more effective drugs and vaccines is critical to the treatment and prevention of HIV infection. Simply spending more money on HIV/AIDS research, however, is not the sole answer; some scientists question whether additional funds could indeed be spent productively. They argue that a better strategy would be to enhance the effectiveness of current investments in therapeutic research and development efforts. Increasing collaborations among AIDS researchers in the public and private sectors hold considerable potential in this regard, because cross-fertilization among scientists interested in a common problem can accelerate the advancement of scientific knowledge and understanding. HIV/AIDS therapeutic drug research and development is under way in three sectors: government (primarily through the intramural research program of the National Institutes of Health [NIH]), academia (supported in large part by NIH grants and contracts), and the pharmaceutical industry. Research collaborations between industry and academia and between NIH and academia are regarded as generally effective and productive. Indeed, numerous joint efforts have helped to provide a detailed understanding of the virus and its life cycle and to identify the first generation of antiretroviral agents that offer therapeutic value, albeit of limited duration. But, in recent years, researchers have frequently expressed dissatisfaction and skepticism about the effectiveness of current mechanisms for government and industry collaborations. 1   This section is based on material presented by Patrick Gage.

OCR for page 1
Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994 Increasing the importance of government and industry collaboration is the considerable investment that each sector makes in HIV/AIDS research. The federal government has spent more than $3 billion during recent years, and in fiscal year 1994 NIH will have spent approximately $1.3 billion on HIV/AIDS research. Although precise monetary estimates are not available for industry, survey data collected by the Pharmaceutical Research and Manufacturers of America (formerly Pharmaceutical Manufacturers Association) indicate that pharmaceutical and biotechnology companies are making a substantial—perhaps comparable—investment.2 In 1993, for example, 74 companies had 103 HIV/AIDS-related products in development, and already 21 medicines for HIV disease and its associated conditions have been approved by the Food and Drug Administration. Promoting a fundamental collaboration between these two major research enterprises is expected to make both programs more effective, and in turn yield faster progress in HIV drug and vaccine development. The recent blending of research goals, methods, and outcomes in public-and private-sector laboratories has been driven in large measure by advances in molecular genetics. The pharmaceutical industry today embraces a “rational drug discovery” strategy that depends inherently on state-of-the-art research and modern tools of biotechnology. In this approach, industry scientists strive to elucidate underlying disease mechanisms and then use novel targets (e.g., viral enzymes), identified through this fundamental research, for powerful drug design efforts. Basic research in government and university laboratories, while continuing to reveal new information, also increasingly yields product concepts or actual therapeutic candidates that immediately go into development, often in biotechnology companies. The separation between basic and applied research in the life sciences, including HIV/AIDS research, has thus become blurred, with important contributions in each area being made across the scientific community. The time seems right, then, for enhancing collaboration between government and industry. Yet representatives from both sectors maintain that establishing collaborative relationships is increasingly difficult and complicated and thus hampers this type of research. Workshop participants identified a number of obstacles to greater research collaboration between government and the pharmaceutical industry. These obstacles concern such issues as the disposition of patent rights to cooperatively developed inventions; the government's role in establishing or restricting the price of drugs, particularly those developed with federal support; and companies' access to data from government-sponsored clinical trials. Carefully eliminating or lowering the barriers in these and other areas, workshop participants agreed, would allow the nation to tap more fully the potential of scientific interaction. Indeed, they felt that fostering government and 2   Pharmaceutical Manufacturers Association, AIDS Medicines: Drugs and Vaccines in Development, November 1993.