Immerse yourself in CGT policy discussions at the Policy Summit, Sept. 18-19!
Learn more about sessions and presentations at the 26th Annual Meeting
Saturday, May 20 2023 8:00 AM – 12:00 PM PT
The Accelerating Medicines Partnership Program - Bespoke Gene Therapy Consortium (BGTC), managed by the Foundation for the National Institutes of Health (FNIH), is a public-private partnership consisting of multiple NIH ICs, the FDA, and numerous bio/pharma companies and patient advocacy organizations. The goal of the BGTC is to accelerate the development of gene therapies to treat genetic diseases of no commercial interest by developing: (1) a mechanistic understanding of AAV biology and factors that influence AAV gene expression and vector production; and (2) a gene therapy playbook, which will be a public resource that leverages best-practices templates, master regulatory files, and aligned manufacturing and testing processes. This playbook approach will be stress-tested through multiple clinical trial test cases, providing insights which will streamline the regulatory process for future gene therapy development for genetic diseases of no commercial interest. This workshop at ASGCT will serve as BGTC's first annual meeting, during which we will update on our progress so far, including AAV biology, the clinical program, and playbook development, engage the community on next steps, and provide member and patient perspectives on overcoming the challenges faced in the gene therapy field.
10:00 AM – 10:45 AM - Room 403 AB
Amritha Jaishankar, PhD. IQVIA, MA
Carmen Sivakumaren. IQVIA, NC
Jenny Fam. IQVIA, NC
10:44 AM – 11:45 AM - Room 403 AB
Michael Lehmicke, MS. Alliance for Regenerative Medicine, DC
10:45 AM – 11:45 AM - Room 403 AB
Sadik Kassim, PhD. Danaher Genomic Medicines, Boston, MA
Debra Miller. CureDuchenne, CA
Peter Marks. Food & Drug Administration, Silver Spring, MD
PJ Brooks, PhD. Division of Rare Diseases Research Innovation, NCA, MD
8:00 AM – 12:00 PM - Room 403 AB
Courtney Silverthorn, PhD. Foundation for the National Institutes of Health (FNIH), North Bethesda, ...
8:01 AM – 8:30 AM - Room 403 AB
Courtney Silverthorn. Foundation for the National Institutes of Health (FNIH), North Bethesda, MD
8:30 AM – 8:55 AM - Room 403 AB
Junghae Suh, PhD. Biogen, TX
8:55 AM – 9:20 AM - Room 403 AB
Edward Neilan, MD, PhD. National Organization for Rare Disorders (NORD), Quincy, MA
9:20 AM – 9:40 AM - Room 403 AB
Shyam Patel, PhD. CIRM, CA
Abla Creasey, PhD. California Institute for Regenerative Medicine, South San Francisco, CA
© 2000-2023 All rights reserved. American Society of Gene & Cell Therapy.
Kentico CMS Development by Reason One | Powered by Kentico