Enable market access and value-based reimbursement policies

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

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

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

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

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

Alliance for Regenerative Medicine (ARM) Videos

ARM`s 2022 Cell & Gene State of the Industry Briefing - Video