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This webinar features FDA representatives Tejashri Purohit-Sheth and Ilan Irony from the Office of Tissues and Advanced Therapies, CBER, as they discuss the effect of COVID-19 on cell and gene therapy clinical trials. Discussion topics include assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
This webinar features speakers Mary Beth Bosco, Nicole Elliott, and Joel Roberson, Partners at Holland & Knight LLP, to discuss the emergency loan program for small businesses established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This fiscal stimulus program went live April 3, 2020 and loans will only be available until funds are exhausted, so the government is advising borrowers to apply as soon as possible.
As more regenerative medicine products approach clinical testing and commercialization, seize this opportunity to hear detailed insights and industry best practices from preeminent sector experts. Gain a deeper understanding of the many manufacturing and industrialization hurdles unique to bringing durable and even curative therapies to patients in need.
This webinar is intended to provide members of the press in Europe with an overview of the ATMP landscape in Europe, including major financings, the clinical pipeline, and the potential for these therapies to significantly improve the standard of care for many patients suffering from devastating diseases and disorders. The webinar also provides a brief introduction to ARM and ARM’s role in improving the landscape for ATMPs in Europe and globally.
Gain a deeper understanding of the implications of the Regenerative Medicine Advanced Therapies (RMAT) designation and the significance of its support and advancement by the FDA in this webinar recording. Held in partnership with the Alliance for Regenerative Medicine (ARM), ARM, Informa Pharma Intelligence, and representative from Abeona, Athersys, and Enzyvant discuss the RMAT designation and its implications on the sector.
Michael Werner, Co-Founder and Senior Policy Counsel for ARM, and Robert Falb, Director of U.S. Policy and Advocacy, participated in BIO’s webinar on NTAP and advanced therapies on May 9. ARM believes that it is critical that the NTAP program be modernized to facilitate patient access to new and life-saving treatments.
CAR-T cell therapy is now approved in the U.S. The first product, Novartis’ Kymriah, is approved to treat pediatric and young adult patients with B-cell acute lymphoblastic lymphoma, and products for other oncological indications are hot on its heels. Join Informa Pharma Intelligence and ARM for an interactive webinar to explore what this historic approval means for the patient community, as well as how this sector will approach the scientific, clinical, policy and business issues surrounding CAR-T approvals.
CMS: Charges for CAR T-cell therapies
Letter
March 2020