Speaker:
Lynn Rose, Ph.D.
Chief, Scientific Administration
Benaroya Research Institute
Chris Weir
IRB Operations Manager
Fred Hutch Cancer Research Center
Topic: Pre-submission meetings and FDA inspections – preparing for the FDA - Perspectives from a local IRB
Session Time: 9.00am
Session Objectives:
• Discuss the role of FDA in overseeing clinical research, including the regulations relevant to clinical research of investigational drugs or medical devices.
• Outline process for preparing for initial meetings with the FDA.
Speaker Bio:
Lynn Rose, PhD is the Chief of Scientific Administration at Benaroya Research Institute and an Affiliate Associate Professor in the Department of Pharmacy, UW School of Pharmacy. She is a member of the faculty for the School of Pharmacy Biomedical Regulatory Affairs program and for the Institute of Translational Health Sciences (ITHS), also at the University of Washington. Dr. Rose is an experienced translational researcher. Prior to returning to academic positions, she gained extensive experience in biomedical research and product development in corporate settings. She is skilled at critical review of biomedical product concepts and development of regulatory strategies. At Benaroya Research Institute she has oversight responsibility for the Clinical Research Program and Research Protections Department, which manages the IRB and other compliance committees. Dr. Rose’s primary clinical experience is in areas of infectious disease, cystic fibrosis, autoimmune disease, thrombosis and hemostasis. Her drug development experience has included management of manufacturing, preclinical, and clinical programs for the companies she has worked for. As a member of the ITHS Drug and Device Advisory Committee and the BRI Business Development Committee, she consults with academic innovators to facilitate the development of potential medical products.
Chris Weir, CIP is currently the IRB Operations Manager for the Fred Hutch Cancer Research Center. Previously, he spent almost 15 years with Benaroya Research Institute supporting all aspects of the research protections mission; specifically, the three BRI Compliance Committees (IRB, IACUC, IBC).
Prior to his BRI experience, he spent a few years at Quorum Review IRB, supporting researchers and sponsors in approving multi-center FDA regulated trials nationwide. A graduate of the UW in Speech Communication, spent several years previously living and working in Japan and Taiwan as a teacher. Active member of the Virginia Mason Bioethics Committee since 2017.
Speaker Contact Details:
Lynn Rose
(206) 287-1085
Chris Weir
206-661-1960