Alliance for Regenerative Medicine Promotes Michael Lehmicke to Senior Vice President, Science & Industry Affairs
July 19, 2023
The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization representing the engineered cell therapy and genetic medicines sector, announced the promotion of Michael Lehmicke to Senior Vice President, Science & Industry Affairs, effective immediately.
Proposed joint clinical assessment methodology would have rejected nearly 90% of the ATMPs currently authorized in the EU
June 20, 2023
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.
ARM Releases Statement on European Commission's Proposal to Revise EU Pharmaceuticals Legislation
April 27, 2023
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.
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.