FDA science: from concept to consumer: the science behind the regulatory decisions made by the Food and Drug Administration often gets lost in media reports touting the "approval"—or "rejection"—of a food ingredient, drug, medical device, or other product that comes under the scrutiny of the nation's premier consumer protection agency

However, science is the foundation of all the FDA's wide-ranging regulatory decisions. It's physicians and patient representatives comparing notes on the clinical trials of a new drug; it's physicians, pharmacists, and other medical professionals poring over applications for new products; it's an inspector testing the safety of imported foods on docks nationwide.

Science at FDA also means solitary scientists doing long hours of original research in biotechnology, genomics, proteomics, and other areas on the cutting edge.

"Imagine, for example, that we might be able to personalize medicine if we know someone's genome," says Thomas A. Cebula, Ph.D., a lead scientist for molecular biology and chairman of the 10th Annual FDA Science Forum. Understanding gene structure, he says, is one scientific area that has the potential to revolutionize certain aspects of medicine. Other promising areas in dude using collections of either DNA or protein targets (microarrays) to develop tests that identify strains of bacteria, or using imaging techniques to determine how a drug works in the human body.

FDA science will be on display on May 18 and 19, 2004, during the science forum at the Washington, D.C., Convention Center. Touted as a training ground, a marketplace for the exchange of ideas, and a place where collaborations can he created, this year's forum features a free-to-the-public, 90-minute session with FDA scientists. Called "Communicating FDA Science to the Public," the session will be chaired by Acting FDA Commissioner Dr. Lester M. Crawford and is the only forum event that does not require a registration fee.

"If someone wants a broad view of the agency's activities," says Jan Johannessen, Ph.D., a senior science advisor in the FDA's Office of Science, "this is an opportunity to get that information in non-technical language." This new session, Johannessen says, is the result of an outpouring of responses to last year's event from patient and consumer groups.

The theme for this year's forum focuses on the important public health issue of incorporating new technologies into the process of identifying safe and effective products to improve public health. Through sessions with some of the agency's top scientists in fields as diverse as chemistry, microbiology, and nutritional science, Cebula says that attendees will get an up-close look at technologies that some day are likely to have a dramatic impact on the public health.

FDA scientists--many of whom assess risks and benefits, ensure that products meet certain standards, and investigate biological effects of widely used chemicals--will address some of the challenges that scientific advances pose on these important responsibilities.

For example, there are new challenges to develop vaccines and other measures to defend against counterterrorism, to combat obesity--the nation's secondleading cause of preventable death and to address the problem of antimicrobial resistance. In addition scientists are facing challenges in several new fields of science, including the study of gene structure (genomics) the study of proteins in living cells (proteomics), and other technologies fast making their marks on the FDAs scientific roadmap.

This year's forum offers a mix of presentations scientific posters shared both by FDA employees and non-FDA scientists, exhibitions, and breakout sessions all of which will allow consumers and scientists to exchange ideas and insights.

An exhibition hall will provide an opportunity for consumers to interact with the FDA's top scientists and learn how the agency's leading scientific efforts support its mission. Participants will discover ways to participate in future scientific initiatives that can identify emerging public health issues, as well as improve the safety, effectiveness, and quality of regulated products.

FDA scientists who have excelled through their scientific accomplishments will be honored at the forum's scientific achievement awards ceremony.

Registration Information for Free Session

To register for the free session of the FDA Science Forum designed for people without a science background, visit: www.cfsan.fda.gov/~frf/forum04/pubsci.html

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