Alliance for Regenerative Medicine Launches Reimbursement and Market Access-Focused White Paper Series, First Paper Published in In Vivo

– November 15, 2016

WASHINGTON, D.C., November 15, 2016 – The Alliance for Regenerative Medicine (ARM) today announced the launch of its three-part white paper series focused on the value and adoption of future gene and cell therapies.  The first paper, “Curative Regenerative Medicines: Preparing Health Care Systems for the Coming Wave” is available online today in In Vivo, a publication focusing on the global medical and healthcare industry.

The white paper series is part of a broader initiative of ARM’s Reimbursement Committee, intended to explore current and future opportunities and challenges related to valuation, pricing, reimbursement and financing that could face the anticipated wave of cell and gene therapies and other regenerative medicine products. These therapies have the unique potential to offer transformative and durable clinical responses after a single administration across a wide range of currently unmet medical needs.

“Our intention with this initiative and with these white papers is to provide all stakeholders – including patients, physicians, policy makers, researchers, payers, regulators, journalists and the general public – with an in-depth exploration of the many potential benefits and challenges these therapies represent, and to help prepare our healthcare system to accommodate and accelerate their impact via alternative payment models,” said Michael Werner, executive director of ARM. “This white paper series serves as both an educational resource and as a foundation for future policy recommendations to ensure these therapies can benefit the patients that need them.”

Authored by ARM Reimbursement Committee Co-Chairs Faraz Ali of REGENXBIO; Ted Slocomb of Audentes Therapeutics; and Michael Werner of ARM, the first paper in the series provides an overall assessment of the sector landscape, detailing the potential clinical impact, quality of life improvement, healthcare system cost effect and societal benefits these gene, cell and tissue engineered therapies represent. The paper also covers the various challenges the sector must overcome, as well as highlights several alternative payment and finance models that have been proposed by others to address existing and potential barriers to the adoption of these transformative therapies. A diverse collection of member organizations involved in the ARM Reimbursement Committee, including biopharmaceutical innovators large and small, contributed to this first paper.

The next white paper in the series will provide a deeper assessment and prioritization of the potential reimbursement and financing models for these products from multiple stakeholder perspectives; in addition, the paper will explore the legal, statutory and regulatory hurdles to their implementation. The final white paper will outline ARM’s specific policy recommendations to implement market-access enabling reimbursement and financing models for these products. As part of this broader initiative, ARM also plans to organize multi-stakeholder engagement forums to explore the issues, to envision solutions and to help co-author future papers.

For more information about ARM and its activities, please visit

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 250 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit