FDA Clinical Trial Guidance During COVID-19

april 2020

10apr10:00 am11:00 amFDA Clinical Trial Guidance During COVID-19CELL GENE WEBINAR SERIES HOSTED BY ALLIANCE FOR REGENERATIVE MEDICINE

Event Details

Join ARM and FDA representatives Tejashri Purohit-Sheth and Ilan Irony from the Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, to discuss the effect of COVID-19 (coronavirus) on cell and gene therapy clinical trials. Discussion topics will 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. After the presentation, the audience will have the opportunity to ask questions.

Register here.

Speakers:

    • Tejashri Purohit-Sheth, Clinical Deputy Division Director of the Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, FDADr. Tejashri Purohit-Sheth provides supervisory oversight for the clinical and pharmacology/toxicology review of submissions to OTAT. She previously served as the Clinical Deputy Director in DAGRID/ODE/CDRH/FDA as well as Acting Division Director and Branch Chief in Office of Scientific Investigation overseeing Bio research Monitoring in CDER/FDA and as a Medical Officer in the Division of Pulmonary and Allergy Products (CDER/FDA). She completed an Internal Medicine Residency at Naval Medical Center Portsmouth followed by a fellowship in Allergy/Immunology at Walter Reed Army Medical Center. Following fellowship, she took over as Service Chief of the Allergy/Immunology clinic at National Naval Medical Center in Bethesda, MD. Following her end of obligated service as an active duty Naval Officer, she transferred her commission to the U.S. Public Health Service and began her FDA career.
    • Ilan Irony, Deputy Director of the Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, FDADr. Irony is an internist and endocrinologist who joined the FDA Center for Biologics Evaluation and Research (CBER) in September 2000 as a clinical reviewer, after six years in group medical practice in the D.C. area and postdoctoral training at the University of California, San Francisco (UCSF) and NIH. He transferred to the Division of Metabolism and Endocrinology Products in the FDA Center for Drug Evaluation and Research in 2005 and became a Clinical Team Leader in 2009. Since December 2011, he has been at CBER as the Chief of the General Medicine Branch, which is part of the Division of Clinical Evaluation and Pharmacology/Toxicology in the Office of Tissues and Advanced Therapies, and, more recently, as Deputy Division Director. Dr. Irony wrote or contributed to FDA draft and final guidances, actively participates in scientific and regulatory working groups within and outside the FDA, and interacts with a variety of stakeholders, in addition to regulated industry. He oversees the clinical and the pharmacology/toxicology aspects of regulatory applications for cellular, gene, and plasma derived products.

Time

(Friday) 10:00 am - 11:00 am EST

X