WASHINGTON, DC – January 30, 2017 – The Alliance for Regenerative Medicine (ARM) today announced it will host a free webinar titled “Understanding the 21st Century Cures Act for Cell & Gene Therapies.” During this one-hour live event, Michael Werner, Executive Director for ARM will be joined by Director Wilson W. Bryan, M.D., and Deputy Director Rachael F. Anatol, Ph.D., of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT), as well as Anne-Virginie Eggimann, Vice President of Regulatory Science for bluebird bio, to provide an overview of several provisions within the 21st Century Cures Act.
The legislation, which was signed into law on December 13, 2016, introduced, for the first time in the U.S., a specific Regenerative Medicine/Advanced Therapy (RMAT) product designation, as well as regenerative medicine-specific language intended to optimize the FDA’s approval pathways for regenerative medicine products, without reducing the agency’s high approval standards for product safety and efficacy.
This webinar will highlight the RMAT-specific provisions and how they affect companies in the Cell and Gene Therapies sector, including discussion of the FDA’s recent statement on how it intends to implement the new RMAT designation.
A live Q&A will follow.
The event will be held on Thursday, February 2, 2017 from 1:00 to 2:00 p.m. Eastern. Space is limited to the first 500 registrants.
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 http://www.alliancerm.org.