I recently participated in an FDA-sponsored satellite symposium related to Focused Ultrasound-mediated Targeted Drug Delivery (FUS-TDD). The symposium was the afternoon following the close of the 2010 Accelerating Anticancer Agent Development and Validation Workshop, a 3-day post-graduate workshop for clinical and translational investigators interested in designing effective strategies to develop new anticancer agents.
Familiar faces included two members of the FUS-TDD Core Stakeholder group, Prof. Andreas Melzer of Dundee University and Nathan McDannold, Ph.D. of Brigham and Women’s Hospital, as well as Yoav Medan, D.Sc., M.B.A. of InSightec. In addition, Richard Frank, M.D., PhD. from GE Healthcare presented an excellent overview of the optimal approach to collaboration with academics, the NIH, FDA and Industry that could assure proper evaluation of drug delivery agents in order to gain commercial success.
The Symposium offered an important opportunity to present the concept of Image guided Mediated Targeted Drug Delivery, of which FUS-TDD is a key example, to the FDA for potential inclusion in the full workshop in the future. This may have been the initial step in engaging in dialogue involving the FDA, academics, and the national labs about the optimal process for evaluation of nanoparticle and drug delivery agents. I believe that our work at the Foundation will positively contribute to developing this dialogue and consequently support the FUS-TDD community in its path to successful clinical applications.