The Burrill Report


Academic biomedical researchers should take a greater role in drug discovery and development to help transform clinical research in the United States, says a senior U.S. Food and Drug Administration official.

The drug development enterprise in the United States is “floundering” in its efforts to translate innovative science and bring to market therapies based on that science, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

“The academic medical center needs to help reengineer the clinical research enterprise. Currently, clinical research is very expensive, driving much of it overseas. You’re losing clinical research in the United States,” Woodcock said during a California Institute for Quantitative Biosciences seminar at the University of California, San Francisco April 26.

Clinical trials tend to be extremely expensive, unpleasant for most participants, inefficient, not totally reliable, and unavailable to the vast majority of patients, she said. “The vast majority of clinical research is done by industry, and I think that’s probably wrong,” said Woodcock. A better model, she argues, would come from academia and industry building on each other’s strengths.

While the pharmaceutical industry has built expertise in clinical rigor, medicinal chemistry, lead optimization, and late-phase development, among other areas, academic researchers can bring to the table talent in molecular biology, in-depth understanding of disease, animal and in vitro testing capabilities, and relationships with relevant patients, said Woodcock.

By working more closely with industry, academic researchers could fill an urgent need for new drug safety evaluation tools and help create hubs for clinical trial networks that incorporate sophisticated and standardized scientific tools, she said.

Current drug development often ends in late-stage clinical failure because of factors such as unexpected drug toxicity and failure to outperform existing therapies, she said, comparing the process to physics without engineering. “We build an airplane and see if it can fly,” she said. The application of new scientific knowledge in the clinical testing process, built with a central role for academic scientists, could provide a huge opportunity for improvement, she said.

At least some innovative partnerships already exist, Woodcock said. One, in which UCSF is already participating, provides a very good prototype for future of clinical trials: the I-Spy 2, a biomarker-based and adaptive trial investigating multiple breast cancer drugs. She also highlighted work done by the Foundation for the National Institutes of Health to help support scientific work on new endpoints for use in clinical trial design.

Slides from Woodcock’s talk, “Today’s biomedical innovation: lost in translation?” are available online.

April 28, 2012
http://www.burrillreport.com/article-fda%e2%80%99s_woodcock_argues_for_clinical_research_makeover.html