Webinar 5: Interdisciplinary Safety Evaluation for Learning and Decision-Making: Education for Executives 16 November 15:00 – 16:45 (GMT) 10:00 –11:45 (EST) |
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Abstract: Interdisciplinary Safety Evaluation for Learning and Decisionmaking: Education for Executives Jacqueline Corrigan-Curay (FDA), Sheila Mahoney (LifeSciHub), Greg Ball (ASAPprocess), and Barbara Hendrickson (University of Chicago)
This webinar is the 5th of 5 webinars related to interdisciplinary safety evaluation, with an overall goal to improve the content and implementation of safety analysis for medical research, leading to better data interpretations, better decision-making, and increased efficiency in the clinical drug development and review processes. |
Presenter | Bio |
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Greg Ball, ASAP Process ConsultingGreg Ball served in the Navy and taught High School maths and physics before earning his master’s in statistics from Purdue and his PhD in Biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). With Mary Nilsson, Greg co-leads the PHUSE Safety Analytics Working Group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement. | |
Jacqueline Corrigan-Curay, FDAJacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in the FDA’s Center for Drug Evaluation and Research (CDER), where she provides executive leadership on strategic initiatives that advance CDER’s mission to deliver safe, effective and high-quality medications to the American public. Prior to taking on this role, Dr. Corrigan-Curay was the director of CDER’s Office of Medical Policy leading the development, coordination and implementation of medical policy programmes and strategic initiatives, including on real-world evidence, use of technology in drug development and prescription drug promotion. Before joining the FDA, she served as senior medical officer with the Immediate Office of the Director, National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH). She also served as Director of the Office of Biotechnology Activities (OBA), Office of Science Policy at NIH. Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. | |
Dr Barbara Hendrickson, University of ChicagoDr Barbara Hendrickson is on faculty at the University of Chicago and a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is a physician with subspecialty training in paediatrics and infectious diseases and has 19 years of pharmaceutical industry experience. In addition to involvement in multiple new product and supplementary indication submissions, she has led several company safety initiatives. One initiative was a pilot project for ongoing blinded clinical trials, which implemented a process using pre-designated assessment entities to support IND safety reporting decisions based on aggregate safety data. In addition, Dr Hendrickson co-leads the DIA-ASA Aggregate Safety Assessment Planning (ASAP) Working Group, which has published suggested best practices for the ASAP process. | |
Sheila Mahoney-Jewels, MBA |
In Partnership With | |||
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