Media Contact:
Stephen Majors
Head of Global Communications
smajors@alliancerm.org
BRUSSELS
Without changes recognizing the unique characteristics of ATMPs, the EU’s new Joint Clinical Assessment will fail to deliver the next generation of transformative therapies to rare disease patients, according to the Alliance for Regenerative Medicine, EveryLife Foundation for Rare Diseases, and Rare Diseases International.
Brussels, BE
The legislative revision is an opportunity for EU policymakers to help address the EU’s stagnation in ATMP clinical trials, company formation, and investment in comparison to the US and China. While the 26 April Commission proposal in some ways improves upon an earlier version, it still falls significantly short of building a sustainable future for the ATMP sector and providing access for EU patients.
Washington, DC
Advancing value-based payment arrangements for cell and gene therapy has been a long-standing priority for ARM, and we view this as a step in the right direction to promoting access to cell and gene therapies for the Medicaid patients that need them.
Washington, DC
As the global voice of the cell and gene therapy sector, ARM believes courts lack the technical expertise to second-guess the FDA’s scientific and medical judgment.
