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Replies to post #421911 on NorthWest Biotherapeutics Inc (NWBO)
Lecture
Approval pathways for innovative gene & cell therapies.
TIME:
4:25 PM - 4:40 PM
DATE:
Monday 29th of November
Speaker
Adnan Jaigirdar
@ FDA
Lecture
Innovative concepts for clinical trials: Synthetic Control Arms.
TIME:
3:55 PM - 4:10 PM
DATE:
Tuesday 30th of November
Speaker
Emily Bratton
@ IQVIA
https://cddf.org/events/upcoming-events/cddf-multi-stakeholder-workshop-november-2021-2/cddf-multi-stakeholder-workshop-on-gene-and-cell-therapies-in-oncology-programme/
Adnan Jaigirdar
COMPANY:
FDA
Adnan Jaigirdar is an oncologist in the Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). More recently, he also served as the Acting Associate Director for Cell and Gene Therapy in the Oncology Center of Excellence (OCE), FDA. As an FDA regulator, he conducts key assessments of novel innovative therapies and clinical issues that surround the development and approval of new drugs and biologics in oncology.
He received his M.D. at the University of Cincinnati, during which time he trained in cancer immunology focusing on tumor vaccines, at the National Cancer Institute (NCI). He received his general surgery training at the University of California, San Francisco (UCSF), where he was also a post-doctoral research fellow at the UCSF Department of Surgery, Transplant Division, studying mechanisms of immune tolerance. During his surgical oncology clinical fellowship training, he also conducted cellular and immunotherapy research at the Surgery Branch, NCI.
Prior to joining the FDA, Dr. Jaigirdar was a practicing surgical oncologist in the U.S. Navy at the Walter Reed National Military Medical Center, Fort Belvoir, and a clinical assistant professor of surgery at Uniformed Services University of the Health Science (USUHS). He joined the FDA in 2016 and focuses on the review of investigational biologic and combination advanced therapies involving cell and gene therapy in solid tumors.
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