PKD Foundation, FDA Team Up

As part of its Critical Path Initiative, the Food and Drug Administration wil work with the PKD Foundation to hold a workshop that will bring together the scientific and pharmaceutical communities to focus on therapeutic developments for PKD.

The workshop, tentatively planned for March 2007, is an exciting opportunity for the PKD Foundation and PKD families everywhere; the Critical Path Initiative is a new method of mobilizing support for drug development for a disease.

The Critical Path Institute was established in 2004 as part of the FDA’s effort to improve the safety and efficacy of drugs reaching the public, while at the same time reducing the time and cost of drug development. It facilitates interactions between the FDA, scientists, physicians, pharmaceutical companies and the private sector (like the PKD Foundation) to develop partnerships that will lead to safer, faster drug approval.

A few months ago, Dr. Ron Perrone of the Tufts-New England Medical Center and the new Chair of the Foundation’s Scientific Advisory Committee, contacted Shirley Murphy, M.D., Office of Critical Paths at the FDA, to discuss identifying PKD as a promising target for this approach.

After deliberation at the FDA, a teleconference was held involving Dr. Murphy, Dr. Perrone, Wendy Buckman from the Commissioner’s Office and Dan Larson, Mark Stone and Lorrie Rome of the PKD Foundation. During this discussion, plans for the joint workshop began.

Remember to check the PKD Foundation website, www.pkdcure.org, for regular updates!