As the global voice of the cell and gene therapy sector, the Alliance for Regenerative Medicine (ARM) commends Reps. DeGette and Upton for the release of ‘Cures 2.0’ legislation that will expedite the development of transformative medicines that address the root causes of disease. The bill will benefit patients by increasing the use of real-world evidence, incorporating patient experience data into regulatory reviews, and establishing guidance for CMC standards in expedited pathways. Together, these and other provisions of the bill will help our regulatory system keep pace with the groundbreaking advances of 21st Century science.
The 21st Century Cures Act of 2016, which established the Regenerative Medicine Advanced Therapy (RMAT) expedited pathway, has already delivered for patients in need. Three of the four regenerative medicines approved by the FDA this year received the RMAT designation, the first-ever approvals under the pathway. ARM is proud to again partner with Reps. DeGette and Upton on the next iteration of ‘Cures’ legislation to deliver on the promise of cell and gene therapy for an even greater number of patients.