ARM Press Release

ALLIANCE FOR REGENERATIVE MEDICINE REPORTS SIGNIFICANT PROGRESS ON POLICY AND MEMBERSHIP OBJECTIVES– ARM to Meet with FDA Commissioner Margaret A. Hamburg, M.D.

Washington, DC —The Alliance for Regenerative Medicine (ARM), the political voice for regenerative medicine, today reported significant progress toward its policy and membership objectives since its formation in September 2009. ARM’s achievements include an upcoming meeting with U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M.D., as well as a doubling of its membership to include 50 members.

Specifically, ARM’s accomplishments include:

• A planned meeting with U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M.D., for the purpose of discussing regulatory issues facing the regenerative medicine industry.
• A doubling and diversification of its membership over the first six months. ARM now represents 50 organizations with an interest in regenerative medicine, including biotechnology, pharmaceutical, and service companies; research institutes; patient advocacy groups; investors; and foundations (see member list below).
• Establishing a dialog with NIH about grant funding and translational research in regenerative medicine.
• A presentation to The Multi-Agency Tissue Engineering Science (MATES) Interagency Working Group (IWG), a platform for exchange of tissue engineering information organized under the Subcommittee on Biotechnology of the National Science and Technology Council (NSTC) and including 13 different federal agencies.
• Substantial progress on drafting legislation that: defines the regenerative medicine industry and major obstacles to its development; as well as providing solutions to challenges that currently impede research and commercialization in the field. The Alliance has also begun to secure congressional support for the legislation.
• Participation in a primary research project, sponsored by the California Institute for Regenerative Medicine (CIRM), to define regulatory, policy and business issues impacting regenerative medicine.
• Compiling industry economic impact data as well as identifying information gaps that need to be addressed.

“We have made enormous progress in establishing ARM’s visibility with legislators and regulators, and are working to supply them with pivotal information and education that they can use as a basis for decision making,” said Michael Werner, ARM’s Co-Founder and Executive Director and a Partner at Holland & Knight. “We are delighted with the reception ARM has received thus far, and it confirms our belief that the time is right for a unified endeavor to support regenerative medicine,” Mr. Werner added.

“ARM is fortunate to have the participation of many of the most experienced, dedicated industry leaders and researchers in the regenerative medicine community among our members,” said Morrie Ruffin, Co-Founder and Managing Director of ARM and Managing Director of Adjuvant Global Advisor. “We are pleased to welcome our new members, and invite every stakeholder to the table to participate with ARM in shaping the future of regenerative medicine, a field which has the potential to transform human health.”

“ARM has rapidly established itself as an influential force for regenerative medicine, and on behalf of the membership we are thankful that our industry now has strong representation,” said John Walker, Chairman of ARM and Chief Executive Officer of iPerian.

ARM’s agenda encompasses funding, policy, regulation, reimbursement, communication and education around issues pertaining to regenerative medicine, including access to life-saving stem-cell therapies. ARM carries out its mission through its Executive, Government Relations & Policy, Regulatory & Reimbursement and Communication & Education committees.