Press release from ARM Foundation for Cell & Gene Medicine

CONTACT: Mariesa Kemble
+1 (608) 850-4745
kemblem@mac.com

Experts in regenerative medicine bring exceptional leadership to ARM Foundation to help increase understanding and acceptance of cell and gene medicine.

Washington, D.C., August 14, 2018 – The ARM Foundation for Cell & Gene Medicine (ARM Foundation), an independent 501(c)(3) non-profit organization, today announced five appointments to its Board of Directors: Amy DuRoss of Vineti; Brett Kopelan of debra of America; David Nagler, formerly of Audentes; Frank Sasinowski, M.S., M.P.H., J.D. of Hyman, Phelps and McNamara and Claudia Zylberberg of Akron Biotech.

The appointees will work with ARM Foundation Board Members and its leadership team to deliver on the organization’s mission of providing education and research that will accelerate patient access to safe, efficacious and potentially curative cell and gene therapies, tissue-engineered products and organ regeneration.

“We are honored that these experienced leaders in the cell and gene medicine community will lend their expertise to the important work of the ARM Foundation,” said Stewart Parker, chair of the ARM Foundation Board of Directors. “Each of them brings a unique perspective, deep commitment and enthusiasm to engage, inform, and empower the public and other stakeholders on key scientific, clinical, and regulatory issues that affect the advancement
and acceptance of cell and gene medicines as viable and transformative treatment options.”

The newly appointed Board members will also serve on steering committees that will guide the ARM Foundation’s initial projects including a gene medicine education program; an in-depth impact analysis of cell and gene therapies and other regenerative medicines on national and international healthcare economies; and research to identify and prioritize the infrastructure, logistics, and healthcare system requirements for wide-scale adoption of transformative medicines.

About the ARM Foundation for Cell and Gene Medicine (ARM Foundation)
The ARM Foundation for Cell and Gene Medicine is an independent, 501(c)(3) non-profit organization dedicated to providing education and research that will accelerate patient access to safe, efficacious and potentially curative therapies. Its programs engage, educate and empower patients, caregivers, industry leaders and other stakeholders to help advance the science and benefits of gene therapy, gene editing, cell therapy, tissue-engineering and organ regeneration. By increasing understanding and acceptance of these transformative technologies, the Foundation hopes to involve more people in the clinical trial process and therefore help expedite the development of life-saving therapies. To learn more, visit http://www.thearmfoundation.org.

BOCA RATON, FL — The regenerative medicine industry experienced tremendous growth in 2017. With the FDA’s new policy framework in place, as well as the approval of two cell therapies and endorsement of another, the industry is primed to continue its rapid climb into 2018 and beyond. Akron’s progress to date, and plans moving forward, are a testament to that. Here are some highlights from the past year:

In June 2017, Akron CEO Claudia Zylberberg co-chaired a meeting with the National Academies of Sciences, Engineering, and Medicine and the Regenerative Medicine Forum focused on cell therapy manufacturing. Participants discussed the main challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. Leading up to the workshop, Dr. Zylberberg co-authored a paper titled “Manufacturing Cell Therapies: The Paradigm Shift in Health Care of This Century.”

This year, we released four publications and received two grants, highlighting our commitment to discovery and innovation. Through our research and development department and our strong relationships with academic partners, we strive to solve challenging problems. Some of our key academic partners include Stanford University and the Worcester Polytechnic Institute. Furthermore, Akron served as a marketing case study for EMBA students at the Wharton School, University of Pennsylvania.

Akron was delighted to join two of the new, federally-funded Manufacturing Innovation Institutes: the Advanced Regenerative Manufacturing Institute (ARMI) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). These organizations are dedicated to accelerating innovation in manufacturing within the regenerative medicine industry. Akron is also coordinating efforts to create a Florida Institute for Regenerative Medicine, in collaboration with key research, clinical, and industrial partners in the state. In addition, Akron is leading efforts to drive industry growth and consolidation through the development of industry standards as a co-founder of the Standards Coordinating Body (SCB) and a leader on various ISO standards under development.

Akron was represented at numerous conferences, including Phacilitate’s Cell & Gene Therapy World, the International Society of Cell Therapy (ISCT) annual meeting, the Alliance of Regenerative Medicine Meeting on the Mesa, the BioFlorida Annual Meeting, the American Association of Blood Banks (AABB) annual meeting, the Organ Preservation Alliance Organ Banking Summit, the Tissue Engineering and Regenerative Medicine International Society (TERMIS) meeting, the International Society for Stem Cell Research (ISSCR) meeting, and the American Society of Cell & Gene Therapy (ASGCT) meeting.

We launched two new products (M26 and IL-2 liquid syringe) and invested in a significant expansion of our existing facilities. At our Boca Raton headquarters, we doubled our office space and tripled our laboratory and cleanroom footprint. With this increase in installed capacity, we are poised to remain a leading driver of growth in the burgeoning regenerative medicine industry.

With the boom in the cell and gene therapy industries, we significantly expanded our clientele as a supplier of key cGMP ancillary materials, a purveyor of technical services, and as a contractor for products and services ranging from custom media to sterile-fill/finish to scaffold electrospinning. Our ancillary materials and reagents have been utilized in FDA-approved cell therapies, marking Akron’s ability to provide high-quality materials and services from the benchtop to clinical trials to market.

Thank you to our collaborators, partners, and clients for a productive year. Together, we have set a solid foundation for growth – and we look forward to working with you in 2018 and beyond.

ABOUT AKRON
Akron is an innovative company dedicated to the development, manufacture, and marketing of ancillary materials and novel products/tools under cGMP compliance for tissue, cell and gene therapies, serving the regenerative medicine industry from bench to bedside.

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