COMMUNICATIONS
PRESS RELEASE
March 30, 2009
ALLIANCE FOR REGENERATIVE MEDICINE REPORTS SIGNIFICANT PROGRESS ON POLICY AND MEMBERSHIP OBJECTIVES-- ARM to Meet with FDA Commissioner Margaret A. Hamburg, M.D.
Dedicated to advancing scientific research in regenerative medicine
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.
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PRESS RELEASE
January 25, 2009
ALLIANCE FOR REGENERATIVE MEDICINE MEETS WITH FEDERAL MULTI-AGENCY TISSUE ENGINEERING SCIENCE INTERAGENCY WORKING GROUP (MATES IWG)
Dedicated to advancing scientific research in regenerative medicine
Washington, DC —The Alliance for Regenerative Medicine (ARM), the political voice for regenerative medicine, recently met with the federal Multi-Agency Tissue Engineering Science Interagency Working Group (MATES IWG) to present its agenda. ARM is actively seeking to build bridges with federal agencies and congress to promote policies that address the unique challenges and opportunities in regenerative medicine. ARM’s comprehensive agenda encompasses funding, policy, regulation, reimbursement, communication and education.
“As a forum for exchange between fourteen different federal agencies with an interest in tissue engineering, it’s essential that MATES be familiar with our objectives,” said ARM chairman John Walker, Chief Executive Officer of iPerian. “This meeting gave us the opportunity to introduce ARM, express support for the work being done in tissue engineering by MATES IWG agencies, and begin to explore common ground.
“In the coming year, ARM will continue to represent the voice of regenerative medicine, with a focus on growing membership, introducing legislation, increasing our sphere of influence, and promoting understanding and awareness of regenerative medicine among policy makers and the public,” said Mr. Walker.
“The evidence shows that regenerative medicine has the potential to dramatically improve human health, reduce the burden of chronic disease, and contribute to economic growth, but advocacy and public education are needed if we’re going to realize these benefits,” said ARM Executive Committee member Steven Nichtberger, MD, President and Chief Executive Officer of Tengion, who participated in the MATES IWG meeting. “This was an important first step toward coalescing unified support around the cause of regenerative medicine.”
Formed in late 2009, ARM represents a diverse membership that includes academic research institutes, biotechnology companies, patient groups, pharmaceutical companies and service providers. ARM carries out its mission through four committees: Executive, Government Relations & Policy, Regulatory & Reimbursement, as well as Communication & Education.
The Multi-Agency Tissue Engineering Science (MATES) Interagency Working Group (IWG), organized under the auspices of the Subcommittee on Biotechnology of the National Science and Technology Council (NSTC), was established in 2000. The principal purpose of the MATES IWG is to provide a platform across which member agencies can interact and exchange information on tissue engineering efficiently and effectively. It is the means by which Federal agencies involved in tissue engineering stay informed of each other's activities and coordinate their efforts in a timely and efficient manner. MATES is chaired by Dr. Christine Kelley from the National Institute of Biomedical Imaging and Bioengineering at the NIH; participating agencies include: The US Department of Agriculture (USDA), the National Institute of Standards and Technology (NIST), Defense Advanced Research Projects Agency (DARPA), Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Aeronautics and Space Administration (NASA), Naval Research Laboratory (NSF), Department of Commerce, Department of Defense (DoD), Centers for Medicare & Medicaid Services (CMS), Food and Drug Administration (FDA), Department of Energy (DOE), National Science Foundation (NSF), Department of Veterans Affairs (VA).
The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit www.alliancerm.org.
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PRESS RELEASE
October 5, 2009
Alliance for Regenerative Medicine Names Executive Committee
Dedicated to advancing scientific research in regenerative medicine
Washington, DC — The charter members of the Alliance for Regenerative Medicine (Alliance) approved bylaws, and elected officers and an executive committee at its first official meeting on September 22nd. The mission of the Alliance is to promote regulatory, research, and reimbursement policies that will foster innovation in regenerative medicine and lead to transformative clinical outcomes for patients.
The new officers of the Alliance are:
Chair – John Walker: Chief Executive Officer, iPierian
Vice Chair – Anthony Atala, MD: W.H. Boyce Professor, Director of the Institute for Regenerative Med. and chair of the Dept. of Urology at Wake Forest University
Secretary – Leona Brenner-Gati, MD: Vice President of Science and Technology, Johnson & Johnson’s Corporate Office of Science and Technology
Treasurer – Dean Tozer: Senior Vice President, Advanced BioHealing
The Alliance’s first executive committee includes:
- Dr. Anthony Atala: Director, Wake Forest Institute for Regenerative Medicine
- Dr. Leona Brenner-Gati: Vice President, Corp. Office of Science and Tech., J&J
- Ray Cypess: President and CEO, ATCC
- Doug Doerfler: President and CEO, MaxCyte
- Ed Field: President & COO, Aldagen
- Gary Kurtzman: Vice President, Life Sciences, Safeguard Scientifics
- Alan Lewis: President, Juvenile Diabetes Research Foundation
- Martin McGlynn: President and CEO, Stem Cells Inc.
- John McNeish: Executive Director, Regenerative Medicine, Pfizer
- Dr. George Muschler: Vice Chair, Orthopedic and Rheumatologic Inst., Cleveland Clinic
- Dr. Steven Nichtberger: President and CEO, Tengion
- Jon Obermeyer: Executive Director, Regenerative Medicine Foundation
- Dr. Tom Okarma: President and CEO, Geron
- Dr. Beth Seidenberg: Partner, Kleiner, Perkins, Caufield, and Byers
- Bernard Siegel: Executive Director, Genetics Policy Institute
- Dean Tozer: Senior Vice President, Advanced BioHealing
- John Walker: President and CEO, iPierian
- Scott Wolchko: Chief Financial Officer, Fate Therapeutics
“I am delighted and honored to serve as the first chairman of the Alliance for Regenerative Medicine. The regenerative medicine community needs a strong and focused political voice and I am confident that this group of leading companies, research institutions, and non-profits that has come together will do just that,” stated John Walker, CEO and president of iPierian and the newly elected Chair of the Alliance. “With the accelerating pace of development in regenerative medicine and new therapeutic advancements being introduced into the clinic at an ever increasing rate, it has never been more important that the companies and researchers involved in this field work together,” added Dr. Anthony Atala, vice chair of the Alliance and the W.H. Boyce Professor, Director of the Institute for Regenerative Medicine and chair of the Department of Urology at Wake Forest University.
The charter members of the Alliance include: foundations and non-profits such as the Foundation for Regenerative Medicine, the Genetics Policy Institute, the Juvenile Diabetes Research Foundation, the Association of Clinical Research Organizations, and the New York Stem Cell Foundation; research institutions such as the Cleveland Clinic and the Wake Forest Institute for Regenerative Medicine; leading regenerative medicine life sciences companies Advanced BioHealing, Aldagen, ATTC The Global Bioresource Center, Geron, Fate Therapeutics, iPierian, Johnson & Johnson, Life Technologies, MaxCyte, Organovo, Pfizer Inc, Stem Cells Inc., Tengion and Transgeneron Therapeutics; and investor organizations Kleiner, Perkins, Caufield and Byers, Proteus Ventures, Safeguard Scientific and Toucan Capital.
“One of our first orders of business will be to establish a dialogue with the FDA and to work with Congress, and other parts of the Administration overseeing this field to help ensure safe and timely access to these new therapies,” explained Dr. Leona Brenner-Gati, a newly elected officer of the Alliance and Vice President of Science and Technology at Johnson and Johnson.
In addition to its advocacy mission, the Alliance will serve as a source of information about regenerative medicine for policy makers, the media and the general public. For more information about the Alliance, please visit the Alliance website at www.alliancerm.org or send an email to info@alliancerm.org. For specific questions please contact Michael Werner at mwerner@alliancerm.org (202.419.2515) or Morrie Ruffin at mruffin@alliancerm.org (301.328.1048).
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PRESS RELEASE
July 1, 2009
Alliance for Regenerative Medicine Launches
Dedicated to advancing scientific research in regenerative medicine
Washington, DC — A coalition of universities, life sciences companies, health care investors, and patient advocates with the common goal of advancing cell-based therapies united today to launch the Alliance for Regenerative Medicine (Alliance).
Headquartered in Washington, DC, the Alliance is dedicated to promoting regulatory, research, and reimbursement policies that will foster innovation in regenerative medicine. Additionally, the Alliance will serve as a source of information about regenerative medicine for policy makers, the media, and the general public.
Initial charter members of the Alliance include: university-based organizations such as the Wake Forest Institute for Regenerative Medicine and Georgia Tech University; the Genetics Policy Institute; leading regenerative medicine life sciences companies Geron, Johnson & Johnson, Aldagen, iZumi, Fate Therapeutics and Maxcyte; and investor organizations Kleiner, Perkins, Caufield and Byers and Proteus Ventures. Alliance organizers will announce the final list of charter members later this month.
“We are delighted to be a founder of this extremely important effort,” said Dr. Anthony Atala, Director of the Wake Forest Institute for Regenerative Medicine and founder of the Regenerative Medicine Foundation. “The Regenerative Medicine Community needs to speak with one voice and we are eager to join our corporate colleagues in helping lawmakers understand the immense clinical value of these important technologies.”
“Regenerative medicine holds enormous promise," said Thomas Okarma, President and CEO of Geron Corporation. “It is critical to educate policy makers about this technology in order to gain the Federal support necessary to turn that potential into cost-effective treatments for patients.”
Regenerative Medicine is defined by the National Institutes of Health as the process of creating living, functional tissues to repair or replace tissue or organ function lost due to disease, damage, congenital defects or age. This process may include: regenerating damaged tissues by stimulating previously irreparable organs to heal themselves, using stem cells to grow cells, tissues and organs to repair damaged or destroyed cells and tissue the body cannot heal by itself; and helping to address the problem of the shortage of organs available for donation compared to the number of patients that require life-saving organ transplantation.
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