Title: 4 ‘T’ for success – Theory, Tool, Think, and Talk

Thursday, Aug 14th, 2025

Speaker: J. Jack Lee, Professor

University of Texas MD Anderson Cancer Center

J. Jack Lee, Ph.D., M.S., D.D.S. is Professor of Biostatistics and Kenedy Foundation Chair in Cancer Research at the University of Texas MD Anderson Cancer Center. His areas of expertise include design and analysis of cancer clinical trials, Bayesian adaptive designs, statistical computation/graphics, drug combination studies, biomarkers identification and validation, and statistical methods for precision medicine. In over 30 years at MD Anderson, Dr. Lee has been working with many multidisciplinary research teams and providing biostatistical support to clinical, translational, and basic science studies. He is an elected Fellow of American Statistical Association, Society for Clinical Trials, and American Association for the Advancement of Science. He has published extensively in statistical and medical journals. He co-authored two books entitled: “Bayesian Adaptive Methods for Clinical Trials” and “Model-Assisted Bayesian Designs for Dose Finding and Optimization: Methods and Applications.” Dr. Lee received his D.D.S. from National Taiwan University in 1982 and M.S. and Ph.D. in Biostatistics from University of California, Los Angeles in 1984 and 1989, respectively.

Abstract

TBD

Thursday, Aug 14th, 2025

Speaker: Lixin Gao

President of Biopier

Lixin Gao is the Founder and President of BioPier Inc. Following its acquisition by Veramed in 2024, he continues to lead BioPier, LLC as President, overseeing U.S. operations within Veramed’s global biometrics organization. Known in the biopharma industry for his hands-on leadership and focus on quality, timeliness, and operational efficiency, Lixin began his career in 1996 as a statistical programmer at Parexel. He founded BioPier in 2006 and has since built it into a trusted partner for top pharmaceutical companies, widely recognized for its expertise in fast-track study analysis and regulatory submission support. Under his leadership, BioPier has played a pivotal role in the approval of 15 innovative drugs, positively impacting countless lives through transformative treatments. Lixin earned an MS in Applied Statistics from WPI, complemented by a background in Theoretical Physics and programming. A dedicated endurance athlete, he has completed over 20 marathons and multiple 70.3 Ironman races.

Abstract

TBD

Statistical Thinking in Regulatory Contexts.

Thursday, Aug 14th, 2025

Speaker: Dr. Kumaresh Dhara

statistician, FDA

Dr. Kumaresh Dhara is a mathematical statistician at Vaccine Evaluation Branch at the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Prior to joining FDA, Dr. Dhara earned his doctoral degree from Florida State University and conducted his postdoctoral research at University of Florida. His research interests include different phases of vaccine trials.

Abstract

TBD

Title: TBD

Thursday, Aug 14th, 2025

Speaker: Dr. Bryan McComb

biostatistician, Pfizer

Dr. Bryan McComb (he/him) is a biostatistician at Pfizer, where he leads the design, analysis, and strategic planning of late-phase clinical trials in hemophilia. His work is focused on advancing clinical development in rare bleeding disorders, with a focus on generating robust evidence in small and underserved populations

In parallel with his industry work, Dr. McComb is an active educator and course developer in biostatistics and clinical trial design. He teaches within the UC San Diego Extended Studies program, supporting the training of current and future clinical research professionals.

Dr. McComb’s professional interests span innovative trial design, rare disease methodology, and interdisciplinary collaboration. He is a member of the ASA-Dah Shu Master Protocol Working Group, where he contributes to thought leadership in complex trial design and methodologies. He holds a B.S. in Mathematics from Muhlenberg College and a Ph.D. in Biostatistics from New York University.

Abstract

TBD