Organization of Regulatory and Clinical Associates
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Webinar - Precision Medicine and FDA’s New, Innovative Drug Approval Mechanism
Please remember to renew your membership before registering for this meeting,
2017-2018 ORCA memberships expired on July 31, 2018.
The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
TOPIC: Precision Medicine and Genomics to the Rescue: FDA’s First Approval of a Tissue- and Site-Agnostic Indication
TOPIC DESCRIPTION:
An excerpt from the Federal Food, Drug, and Cosmetic Act states that the term “drug” means “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Notably the definition does not specify that a drug is approved to treat a specific organ or tissue type. Indeed, although drug labels have historically always specified “drug X is approved for the treatment of disease Y,” in the case of various types of cancer, it has been determined that tumors originating in different organs, while causing different “diseases” and affecting different tissues, often have very similar molecular etiologies. Recognizing this phenomenon, in the advent of precision medicine, in May 2017, the FDA granted accelerated approval to pembrolizumab as its first tissue/site-agnostic indication.
Dr. Jonlin’s presentation will describe the history of this approval; the biochemical mechanisms of the therapy itself; alternative clinical trial designs that allow data collection to make development of this type of approval possible; and changes at the FDA that address precision medicine approaches, particularly in the field of oncology.
SPEAKER: Erica Jonlin, PhD
SPEAKER BIOGRAPHY: Dr. Erica Jonlin is the regulatory manager for clinical research activities conducted at the University of Washington Institute for Stem Cell and Regenerative Medicine. Her responsibilities include human subjects protection, clinical protocol design, and coordinating and managing the regulatory submission and review processes for clinical research involving products developed from pluripotent stem cells. Dr. Jonlin is also the IRB consultant for the UW Dept. of Pathology, specializing in biospecimens research. She regularly lectures on Good Clinical Practice guidelines, and for thirteen years taught for UW’s Certificate in Clinical Trials program.
Early in her career, Dr. Jonlin served as a human subjects review administrator for one of UW’s Institutional Review Boards. Dr. Jonlin was the recipient of an AAAS Science and Diplomacy Fellowship in Washington, D.C., after earning her Ph.D. in Biochemistry at the University of California, Los Angeles.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification
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