TITLE: Multi-regional Clinical Development and Safety/Benefit-Risk evaluation
INSTRUCTOR: Bruce Binkowitz, Aloka Chakravarty, Arcutis Biotherapeutics Inc, Gang Li, Eisai Inc, Jim Buchanan, Covilance LLC, and Judy Li, BMS
MODERATOR: Ivan S. F. Chan and William Wang
Even though these two books focus on different perspectives of drug development, in this two-day short course we will connect them by the same clinical development case studies. In particular, we plan to use a cardiovascular drug development program to illustrate the concepts. A workshop style discussion will also be arranged on Day 2 on these case studies.
Outline of the Short Course:
⦁ Case Studies in Therapeutic Areas such as CV and Oncology
Dr. Bruce Binkowitz is the Vice President of Biometrics at Arcutis Biotherapeutics Inc. Bruce has more than 30 years of pharmaceutical industry experience across many therapeutic areas as well as from early phase through phase IV clinical trials. He has experience in study design, conduct, analysis, and interpretation of results for clinical trials, as well as many interactions with health authorities worldwide. Dr. Binkowitz is active in the Statistical Community. Bruce is currently in his second term as co-leader of the cross-industry Multi-Regional Clinical Trial Consistency Expert Group. Dr. Binkowitz was elected a fellow of the American Statistical Association in 2015, and was awarded the 2022 Distinguished Alumni Award by the Rutgers School of Public Health.
Dr. Gang Li is Senior Director, Real World Evidence (RWE) and Medical Value, the Neurology Business Group of Eisai Inc. He received his PhD in Mathematical Statistics from the State University of New York at Binghamton. He co-authored over 60 publications on statistical methodologies, and research on psychiatry, obesity, and diabetes. He served as the Executive Director of the International Statistical Association (2017–2019). Dr. Li is a Fellow of the American Statistical Association.
Dr. James Buchanan, president of Covilance LLC, has 30+ years of drug safety experience in the pharmaceutical industry. He is a co-lead of the ASA Biopharmaceutical Safety Working Group and the Interactive Safety Graphics taskforce that is developing novel, open-source, interactive graphical tools to evaluate drug safety issues.
Dr. Judy X. Li is currently Senior Director, Biostatistics Lead for San Diego site Bristol Myers Squibb. She also has extensive experience working at the US Food and Drug Administration as a master statistical reviewer and supervisory mathematical statistician. She is the founding co-chair of the ASA Biopharmaceutical Safety Working Group.