Bio: Bret Musser is currently the Head of the Biostatistics department at Regeneron Pharmaceuticals, where he leads a group covering early clinical development, late clinical development, and commercialization support. Bret joined Regeneron after having worked at Merck Research Laboratories, where he drove the application of statistical principles across clinical development and pharmacometrics. His experience spans from preclinical studies through large outcomes trials. Dr. Musser has led groups dedicated to the development and application of advanced mathematical models in drug discovery and development. Dr. Musser’s current research interests focus on the application of statistical models in clinical trial analysis and in the development of novel biomarkers based on wearable sensor technologies, and he is passionate about developing the next generation of statisticians.

Bio: For the past 27 years, Gene A. Pennello has been a review and research statistician at the US Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). At FDA, Gene’s official area of expertise is design and analysis of studies concerning diagnostic devices, with particular emphasis on drug-diagnostic co-development and evaluation of imaging systems. In 2020, Gene joined the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), whose research includes addressing emerging challenges in regulatory assessment of artificial-intelligence(AI)-enabled medical devices. Gene is a fellow of the American Statistical Association (ASA).

Bio: Dr. Zhenming Shun received his Ph.D. in Statistics from the University of Chicago and an M.S. in Mathematics from Peking University. He has more than 30 years of experience in the pharmaceutical industry, serving as both a statistical expert and corporate leader. Dr. Shun has extensive expertise in oncology and cardiovascular drug development and has contributed to numerous successful global NDA/BLA regulatory approvals. In addition to his technical accomplishments, he has provided strong leadership in business decision-making, strategic planning, organizational development, mentoring of junior statisticians, and in advancing scientific rigor and statistical innovation across the drug development industry. His statistical research interests include statistical methodologies in clinical trial design and mixed-effects models. He has published in leading statistical journals such as JRSS B, JASA, Statistics in Medicine, Journal of Biopharmaceutical Statistics, and Statistics in Biopharmaceutical Research, as well as in top clinical journals including NEJM and JAMA Oncology. In recognition of his contributions, Dr. Shun was elected Fellow of the American Statistical Association in 2025.

Bio: L.J. Wei is a professor of Biostatistics at Harvard University. Before joining Harvard, he was a professor at the University of Wisconsin, University of Michigan, and George Washington University. His main research interest is in clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods which are utilized often in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. He is a fellow of American Statistical Associating and Institute of Mathematical Statistics. In 2014, to honor his mentorship, Harvard School of Public Health established a Wei-family scholarship to support students studying biostatistics. His recent research area is concentrated on translational statistics, personalized medicine under the risk-benefit paradigm via biomarkers and revitalizing clinical trial methodology. He has more than 280 publications and serves numerous editorial and scientific advisory boards including data monitoring for governments and industry. He has extensive working experience in regulatory science for developing and evaluating new drugs/devices.