BioSpace x DIA: Robust Integrated Regulatory Strategies

How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology? Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement.

Strategic vision and education are paramount as the science and technology converge. While each country has the same focus, which is the right drug product at the right time, they have different cultures, regulatory processes, and reimbursement. Understanding the differences are essential for regulatory professionals.

At the end of the session, Tamei Elliot, associate director, scientific programs (Americas) DIA and I discuss some of the emerging themes at the DIA Global Annual Meetingv2024.

This discussion is part three of a precursor of the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 2024 Global 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

Tamei Elliott, Associate Director, Scientific Programs (Americas), DIA


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