ARM's Impact


The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options.

Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 360+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups.


The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options.

Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 360+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups.

Our Focus

Enable market access and value-based reimbursement policies

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  • Remove and mitigate barriers to federal and state adoption of value-based agreements for regenerative medicines and advanced therapies
  • Work with the Centers for Medicare and Medicaid Services (CMS) in the United States to ensure the appropriate reimbursement of innovative therapies
  • Work with national and pan-European authorities to promote better and faster access to advanced therapy medicinal products (ATMPs) in Europe

Advocate for clear, predictable, and efficient regulatory and review pathways

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  • Drive effective chemistry, manufacturing, and controls (CMC) guidance refinement
  • Maintain an appropriate regulatory framework for somatic genome editing
  • Limit the growth and use of Hospital Exemption in Europe and other regulatory carve outs that threaten patient safety
  • Streamline clinical trial requirements for regenerative medicines and advanced therapies, particularly those related to requirements for genetically modified organisms in Europe

Reduce technical & regulatory barriers to the manufacture and scale up of innovative therapies

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  • Create and promote industry consensus on best practices for the manufacture of gene and cell therapies
  • Lead US Food and Drug Administration (FDA) engagement on key sector issues, including CMC guidance gaps, the use of induced pluripotent stem cells (iPSCs), and virus testing
  • Represent the industry and patient view in the global gene editing dialogue

Curate original data and analyses to inform patients, industry, members of the media, & other key stakeholders

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  • Curate ARM’s unique dataset on the clinical and financial landscape for regenerative medicine and advanced therapy developers
  • Present regenerative medicine and advanced therapy trends and metrics at the annual State of the Industry and other sector conferences throughout the year
  • Serve as the leading source of sector information for members of the media

Facilitate sustainable access to capital and engagement with investors

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  • Engage and educate the investment community through ARM events and presentations
  • Track public and private financings for regenerative medicine and advanced therapy developers

ARM Analysis & Insights

As the voice of the sector, ARM takes the lead on 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.

Recently Submitted Comments, Letters, Statements