The Alliance for Regenerative Medicine (ARM) is the preeminent international organization focused specifically on the issues facing regenerative medicine and advanced therapies. We are advocates for progress in gene therapy, cell therapy, and tissue engineering.
Working with our members and policymakers, we foster investment, research & development, and successful commercialization of safe, effective, and transformational therapies for patients around the world.
2020 Priorities:
2020 Priorities:
2020 Priorities:
ARM is the leading voice in the regenerative medicine sector educating stakeholders on policy issues affecting the development of and patient access to regenerative medicines. For a full list of ARM’s presentations and publications, click here.
Produced by the Marwood Institute and funded by ARM, this report uses a “Transformative Therapy Value Model,” and demonstrates that durable cell or gene therapies for multiple myeloma, sickle cell disease, and hemophilia A could provide cumulative cost-savings of $33B over the next ten years.
New cell and gene therapies are changing the face of medicine – and raising questions on how to pay for durable and potentially curative new treatments. Watch this webinar playback to gain insights from experts in the developer, payor, and policy spheres.
ARM CEO Janet Lambert presented at ASGCT’s 2020 Virtual Conference on value demonstration for cell & gene therapy. The presentation cites findings from ARM’s library of original policy analyses.
ARM commends the Energy and Commerce Health Subcommittee for holding a hearing to discuss “Legislative Proposals to Support Patients with Rare Diseases”. We believe cell and gene therapies are critical in targeting the root causes of these diseases rather than treating symptoms and have the potential to transform the lives of afflicted patients.
The Alliance for Regenerative Medicine (ARM) thanks Representatives McCaul, Eshoo, Bilirakis, Barragan, Trahan and Burgess for introducing H.R.7384: Creating Hope Reauthorization Act of 2024 which provides a timely and clean reauthorization of the Food and Drug Administration’s (FDA) Rare Pediatric Disease Priority Review Voucher (PRV) program.
The Alliance for Regenerative Medicine (“ARM”) appreciates the opportunity to respond to the solicitation by the National Institute of Standards and Technology (“NIST”) for comments on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, which reviews the factors that an agency may consider when deciding whether to exercise march-in rights (the “Draft Framework”), about which we have serious concerns.
ARM recommends that Office of Inspector General adopt new safe harbors to permit certain arrangements that seek to overcome significant barriers to access for patients seeking cell and gene therapies.
ARM recently submitted a response to the House Committee on Education and the Workforce’s Request for Information on health plans operating under the Employee Retirement Income Security Act as they seek opportunities to build upon and strengthen the foundation of employer-sponsored health care.
The Alliance for Regenerative Medicine (ARM) urges CMS to take ARM Letter to CMCS Credentialing 030824 1steps now to facilitate credentialing by Medicaid providers across state lines.
Letter
ARM thanks Senator Cassidy for taking the lead on ensuring Americans have access to innovative and life-changing gene therapies and the opportunity to offer input on behalf of our diverse membership in response to his recent request for information.