Ready, Set, START – 7 Programs Selected for FDA’s START Rare Disease Pilot Program

June 13, 2024By Sarah Wicks & Charles D. Snow & James E. Valentine & Frank J. Sasinowski

Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the inaugural class of the FDA’s “Support for clinical Trials Advancing Rare disease Treatment” (START) pilot program. The START pilot program was announced last September as a way to offer selected participants developing potentially life-saving and life-changing rare disease therapies enhanced communications with FDA review staff and a mechanism for addressing clinical development issues, similar to the “Operation Warp Speed” communication model for vaccines in development during the COVID-19 pandemic.

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot. Following an evaluation of the pilot and feedback from the initial pilot participants, FDA may consider a second iteration of the START program.

HPM is proud to aid 5 of the 7 selected participants for the START pilot program.