William A. Haseltine, Ph.D.
Chairman of the Board & Chief Executive Officer, Human Genome Sciences, Inc.

"From Genes to Drugs: A Genomic Perspective"

Human Genome Sciences, Inc. has developed a broad, enabling technology to facilitate the early steps of drug development, i.e. isolation and characterization of the majority of human genes and many bacterial genes. The company has focused on using this technology to develop products to address unmet serious medical needs, alone, and together with a network of corporate partners.

The nature of the underlying technology and its application to drug development by Human Genome Sciences will be outlined, with a focus on products that are being prepared for clinical evaluation.

Penelope A. Fenner-Crisp, Ph.D.
Special Assistant to the Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances,U.S. Environmental Protection Agency

U.S. EPA's Research Planning Process: How Well Does It Work?*

Like FDA, EPA is a regulatory agency. Its mission is to protect public health and the environment. This mission is carried out through the implementation of a dozen separate pieces of legislation, passed at different times and managed by several different offices within the Agency. This dispersion of responsibilities makes it difficult and challenging for the Agency, led by the Office of Research and Development, to develop a coherent and resourceful short- and long-term research strategy that will serve the needs of the regulatory programs and prepare for future trends in the status of the environment. The current process by which research planning is carried out in EPA will be described. The pros and cons of such a process will be discussed, both from the perspective of the program office scientist and the laboratory re searcher. Ways in which the process could be improved will be offered-from the personal perspective of the presenter.

*Views expressed are those of the presenter, and do not necessarily represent Agency policy.

Bernard A. Schwetz, D.V.M., Ph.D.
Interim Chief Scientist, Office of Science, Food and Drug Administration

A Culture of Science: The Researcher - Reviewer Interface at FDA

On March 13, 1997, the Science Board Subcommittee on FDA Research recommended that the Chief Scientist of FDA "support the agency's mission by fostering the cooperative participation of research personnel with review staff in regulatory decision-making, and by integrating the agency's regulatory/review and scientific research staff and functions to the maximum extent possible."

The 1997 FDA Forum on Regulatory Sciences serves as a basis for implementing this recommendation by focusing on the importance of an active interface between research and review scientists at FDA. The forum provides a venue for FDA researchers and reviewers to improve existing, and where necessary, establish new collaborative and/or consultative relationships. The benefits of an effective researcher-reviewer interface will be discussed, including improved processes for research prioritization, identification and resolution of information gaps, and development of an overall "culture of science" at FDA in which research and review scientists are encouraged to collaborate and consult with one another.

Last updated on 11/28/97 by frf