The Alliance for Regenerative Medicine (ARM) today announced it will co-host a webinar titled “RMAT Designation – Impact on the Regenerative Medicine Sector & How it Compares to Other Accelerated Approval Programs.” During this one-hour live event, Michael Werner, Co-founder and Senior Policy Counsel for ARM will be joined by Tim Miller, President & Chief Scientific Officer of Abeona Therapeutics; Gil Van Bokkelen, CEO of Athersys; and Alvin Shih, CEO of Enzyvant Therapeutics to discuss the Regenerative Medicine/Advanced Therapy (RMAT) designation and its significance. Each company will detail its experience in obtaining the designation and its impact on their product development program. The discussion will be moderated by Amanda Micklus, Principal Analyst of Pharma Intelligence at Informa. Patricia Reilly, VP of Pharma Intelligence, will introduce the topic with a primer on the RMAT designation.
The RMAT designation was created as a part of the 21st Century Cures Act, passed in December 2016. The RMAT product designation, which was launched in November 2017, provides an expedited pathway to approval for regenerative medicine products that have preliminary clinical evidence indicating that the therapy addresses an unmet medical need. Since its introduction, the FDA has granted 19 RMAT designations, 14 of which focus on rare diseases.
This webinar will compare the RMAT designation to other accelerated approval designations, discuss the benefits of an RMAT designation, and include companies’ perspectives on obtaining the designation.
A live Q&A will follow.
The event will be held on Wednesday, June 13, 2018 from 11:00 a.m. to 12:00 p.m. ET. Participant capacity is limited to the first 500 registrants.
To RSVP, please visit: http://pharma.intelligence.informa.com/verticalph-web-arm-2018-prs-lp. If you have any questions, please contact Lyndsey Scull at lscull@alliancerm.org.
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 290 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.
