Mission & Role

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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.

ARM Works To:

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

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  • Assess all FDA, EMA, and related guidance relevant to cell and gene therapy, including guidance related to manufacturing, CMC, and related issues.
  • Support policies to address industrialization and manufacturing hurdles faced by developers, reducing barriers to scale up
  • Promote international convergence of key regulation and guidance to promote global product development by identifying specific areas of regulatory inconsistency among jurisdictions and developing proposals for adoption by regulatory agencies

Enable market access and value-based reimbursement policies

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  • Educate stakeholders, including public and private insurers, on the long-term value presented by regenerative medicine products
  • Work with CMS and other insurers to foster the development and adoption of value-based innovative payment models
  • Secure favorable access to and reimbursement for regenerative medicine products

Conduct key stakeholder outreach, communication, and education

  • Enhance and broaden positive visibility of the regenerative medicines sector
  • Curate and produce timely quarterly and annual data reports to highlight sector trends and metrics

Facilitate sustainable access to capital and identify sources of potential public funding

  • Engage and educate the investment community about funding the development of these transformational products