PODCAST: Accelerated Approval Study and Implications for Rare Disease Patients

This podcast discusses the results of Vital Transformation’s latest research study outlining the impact of proposed changes to the Accelerated Approval pathway, and what this would mean for patients with rare conditions.

The study quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market, and the vital role played by small innovative biotech firms in that process. As well, with the use of the U.S. Government’s ‘march-in rights’ for NIH funded research being discussed as an option to influence pricing and patient access, this podcast also touches on the relative role that private and public R&D serves in the creation of needed new therapies via groundbreaking intellectual property. The podcast features contributions by Nick Shipley, the Executive Vice President of BIO; John Murphy, BIO’s Chief Policy Officer & Deputy Counsel; and Joseph Hammang Ph.D., Vital Transformation’s U.S. Business Director.