BioSpace x DIA: Advanced Therapy Product Regulatory Confusion

Regulators suggest developers engage in discussions early, however those conversations cannot take place unless developers are sure of the asset's category. Existing confusion surrounding advanced therapy products may become more challenging as both science and technology evolve. With both developers and regulators, two risk adverse entities, addressing this evolution and continually updated regulations, advanced therapy product development continues to be a collaborative process. This is the second episode in our preparation for the roundtable discussion: ⁠Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products⁠ taking place at the ⁠DIA 2024 Global Annual Meeting⁠. James Wabby, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie is chairing the discussion between Rob Schulz, President and Chief operating officer of Suttons Creek, William Daunch, Chief Technology Officer, Focal Medical, Inc, Andrea Gray, Biomedical Engineer Advisor, CBER, FDA, and Michael Lehmicke, Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine. Lori Ellis will be covering DIA Global Annual meeting 2024, June 16-20 in San Diego. Host  ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠⁠BioSpace⁠⁠   Guests ⁠James Wabby⁠, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, ⁠AbbVie, United States⁠ ⁠Rob Schulz⁠, President and COO, ⁠Suttons Creek, Inc., United States