Regulatory confusion surrounding advanced therapy products

Regulators suggest that developers engage in discussions early, but these conversations cannot take place if developers are unsure of the asset’s category.

Existing confusion around advanced therapy products may become more challenging as science and technology evolve.

With both developers and regulators, two risk-adverse entities, dealing with this evolution and constantly updated regulations, the development of advanced therapy products continues to be a collaborative process.

This is the second episode of our preparations 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 of Regulatory, Emerging Technologies and Combination Products, AbbVie, chaired the discussion with Rob Schulz, President and Chief Operating Officer of Suttons Creek, William Daunch, Chief Technology Officer of Focal Medical, Inc, Andrea Gray, Engineer Biomedical Advisor, CBER, FDA and Michael Lehmicke, Senior Vice President for Science and Industry, Alliance for Regenerative Medicine.

Lori Ellis will cover the DIA Global 2024 Annual Meeting, June 16-20 in San Diego.

Host

⁠⁠⁠Lori Ellis Lori Ellis⁠⁠⁠, Head of Analysis, ⁠⁠⁠Biospace⁠⁠⁠

Guests

⁠⁠James Wabby, Global Head of Regulatory, Emerging Technologies and Combination Products, ⁠⁠AbbVie, United States⁠⁠

Rob Schulz, president and chief operating officer,Suttons Creek, Inc., United States

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