Calculating the Value and Impact of Accelerated Approvals

11:00 AM - 12:00 PM (PDT), Wednesday, June 15, 2022

Vital Transformation will present new research supported by a BIO led consortium which quantifies the impact of the Accelerated Approval pathway in bringing new therapies for unmet needs to market. This session will discuss the potential primary and secondary impacts of regulatory changes to Accelerated Approvals which have been implemented by CMS, and are currently under review by FDA and state level Medicaid programs.

With the use of the US Government’s ‘march-in rights’ for NIH funded research being discussed as an option to influence pricing and patient access, this session will also provide new evidence as to the relative role that private and public R&D serves in the creation of needed new therapies via groundbreaking intellectual property.

This session is made possible with the support of BIO, Rare Disease Company Coalition (RDCC), Global CEO Initiative on Alzheimer's Disease (CEOi), Sarepta, Travere, Gilead, Alexion, Bristol Myers Squibb, Novartis, The Global Innovation Policy Center (GIPC), and Pfizer.

Vice President of Public Policy & Government Affairs
Autoimmune Association
Global Alzheimer's Platform Foundation
Executive Director, Government Affairs & Policy
Sarepta Therapeutics, Inc.
Vital Transformation