Media Contact:
Stephen Majors
Senior Director, Public Affairs
smajors@alliancerm.org
Washington, DC
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) today released Project A-Gene, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into a manufacturing case study of a viral vector commonly used in gene therapies.
WASHINGTON, DC
ARM commends Reps. Upton and DeGette for their continued leadership in driving scientific innovation and patient access. The Cures 2.0 discussion draft released today would help accelerate the development and delivery of life-changing cell and gene therapies. Harnessing real-world evidence, providing educational programming and training for caregivers, and requiring the FDA to provide more clarity around CMC standards for breakthrough and RMAT-designated therapies would help bring the future of medicine to patients in need.
Washington, DC
Created to address the underrepresentation of Black employees in the regenerative medicine workforce, the Alliance for Regenerative Medicine (ARM) launched the GROW RegenMed Internship Program this month with 17 interns in its inaugural class. GROW interns, who are undergraduate and graduate students, are working in paid positions at ARM and 13 of its member organizations this summer in a variety of roles, from the lab to regulatory affairs and public policy.
BRUSSELS, BELGIUM
Legislation approved by the German Parliament on 11 June would accelerate patient access to transformative cell and gene therapies by addressing a bureaucratic barrier that delayed their availability in hospitals.
The reduction of the “NUB gap” – advocated for by the Alliance for Regenerative Medicine (ARM), its member organizations, and the Association for German University Hospitals (VUD) – would enable NUB inquiries to occur twice a year for Advanced Therapy Medicinal Products (ATMPs) instead of just once. Inquiries could also be made before market authorization of a therapy.
