FDA Critical Path Initiative addresses differences between women's and men's health outcomes

Dec 20 2007

Advanced medical technology and analysis methods now being promoted through the Food and Drug Administration's Critical Path Initiative to facilitate the development of drugs, biologics and devices can help address differences between women and men in the detection and treatment of disease, according to a paper published in the Winter 2007 issue of Drug Discovery Today: Technologies.

“Biological sex differences affect most disease areas,” said Sherry Marts, Ph.D., vice president of scientific affairs at the Society for Women's Health Research and an author of the paper. “And the scientific community increasingly recognizes the importance of appropriately studying women and including them in all phases of research so that we can develop the right tools for treating them.

“However, the cost of thoroughly studying subpopulations can drive up research costs and lengthen the time it takes to develop new treatments. The good news is that cutting edge research and evaluation tools such as biomarkers, pharmacogenetics and bioinformatics can improve and accelerate medical research and help address the tough questions about population differences we now have.”

The paper, authored by Marts and Ameeta Parekh, Ph.D., Wendy Sanhai, Ph.D., and Kathleen Uhl, of the FDA, outlines promising technologies that speed the development of new treatments.

Biomarkers can help identify which research subjects are most likely to respond to a treatment, allowing scientists to focus their work in the most promising areas. Pharmacogenomics focuses on genetic differences among patients and eventually may allow researchers to tailor treatments to individual patient characteristics. Bioinformatics is the application of information technology to life sciences databases to better collect and analyze research data on large scales, a historical challenge because research takes place at so many different institutions and information collected is not always standardized.

The paper concludes by noting that the further development and utilization of these technologies and methods “holds immense promise” for understanding the biological underpinnings of differences between women and men in areas such as heart disease and cancer and for advancing personalized medical care.

“Greater knowledge and understanding of sex differences at the time of evaluation and marketing approval decisions will enable sponsors and the FDA to usher in the era of individualized medicine more efficiently, and will ultimately benefit all patients and consumers,” Marts said.

The paper's focus was guided by a November 2006 thought leaders' workshop and subsequent report by the Society for Women's Health Research that discussed how the FDA's Critical Path Initiative can advance the study of sex differences in health.

http://www.womenshealthresearch.org/