In May of 2017, the Boston Chapter organized a one-day workshop on the "Design and Monitoring of Adaptive Clinical Trials". The workshop was given by Cyrus Mehta and his team at Cytel Inc. and held at Takeda Pharmaceuticals in Cambridge. The workshop gave an overview of recent developments and best practices in clinical trials and included hands-on training for East, the industry standard clinical trial design software tool. The program was of great value to the many participants, as was the opportunity to network with industry colleagues. A decision was made to continue holding similar events on an annual basis in the Boston area. Building on the success of the 2017 event, the Boston Chapter held its second annual pharmaceutical symposium in Cambridge on Friday April 27, 2018. This was a full-day event hosted by Takeda Pharmaceuticals. Below is the event information.

Second Annual Boston Pharmaceutical Symposium on Friday, May 4

The Boston Chapter of ASA will hold its second annual pharmaceutical symposium in Cambridge on Friday, May 4, 2018. This will be a full-day event hosted by Takeda Pharmaceuticals. Details of the program are provided below:

Date and Time: Friday, May 4, 2018, 9 a.m. to 5 p.m.

Location: Takeda Pharmaceuticals, 35 Landsdowne Street, Cambridge

Program Highlights:

Using prediction to conduct adaptive clinical studies

Dr. L.J. Wei is a professor of Biostatistics at Harvard University. Before joining Harvard, he was a professor at University of Wisconsin, University of Michigan, and George Washington University. His main research interest is in the clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods which are utilized in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. In January 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 the personalized medicine under the risk-benefit paradigm via biomarkers and revitalizing clinical trial methodology. Dr. Wei has been closely working with pharmaceutical industry and the regulatory agencies for developing and evaluating new drugs/devices.

Recent Innovation and Development in Joint Models for Longitudinal and Survival Data

Dr. Minghui Chen is currently Professor and Head of the Department of Statistics at the University of Connecticut (UConn). He was elected to Fellow of International Society for Bayesian Analysis in 2016, Fellow of the Institute of Mathematical Statistics in 2007, and Fellow of American Statistical Association in 2005. He has published over 375 statistics and biostatistics methodological and medical research papers in mainstream statistics, biostatistics, and medical journals. He has also published five books including two advanced graduate-level books on Bayesian survival analysis and Monte Carlo methods in Bayesian computation. He served as Program Chair and Publication Officer of SBSS of the American Statistical Association and the ASA Committee on Nomination for 2016-2017 to nominate candidates for ASA President/Vice President. Currently, he serves as an Associate Editor of ASA journals JASA and JCGS and an Editor of Bayesian Analysis and Statistics and Its Interface.

Conjoint Analysis: An Illustrative Primer and Case Study in Rheumatoid Arthritis

Dr. Joseph C. Cappelleri is an executive director of biostatistics in the Statistical Research and Data Science Center at Pfizer Inc. He earned his M.S. in statistics from the City University of New York, Ph.D. in psychometrics from Cornell University, and M.P.H. in epidemiology from Harvard University. As an adjunct professor, Dr. Cappelleri has served on the faculties of Brown University, University of Connecticut, and Tufts Medical Center. He has co-authored over 800 conference presentations and 400 publications on clinical and methodological topics, including on regression-discontinuity designs, meta-analyses, and health measurement scales. Dr. Cappelleri is lead author of the monograph Patient-Reported Outcomes: Measurement, Implementation and Interpretation. He is a Fellow of the American Statistical Association.

Optimal Seamless Phase 2/3 Oncology Trial Designs and Its Implementation

Dr. Guohui Liu is a director at Takeda pharmaceuticals, which he joined after graduation from University of Maryland, Baltimore county in 2006. Currently he is stat lead for a late stage oncology compound development, including study design, regulatory interaction, global submission and payer analyses. Also, he supervises work on a few early stage compounds.

Dr. Zhaoyang Teng is a senior statistician at Takeda Pharmaceutical, with extensive experience in all phases of oncology drug development. Dr. Teng’s research interests include adaptive design, seamless phase 2/3 study design, biomarker driven study design and multi-regional clinical trials. He has published multiple statistics journal articles, and chapters in statistics books.

Design and analysis of pragmatic trials for patient-centered causal inference

Dr. Eleanor Murray, ScD, is a research fellow in the Department of Epidemiology focusing on causal inference methods after her graduation from the Harvard T.H. Chan School of Public Health in 2016 development under the mentorship of Dr. Miguel Hernan and Dr. James Robins. Her research focuses on methods to improve medical decision making, including the design and analysis of pragmatic randomized trials, and the development of agent-based models for causal inference.

A case study of a Bayesian adaptive dose-finding Phase 2 trial design using Go/No-Go criteria and adaptive randomization

Yeting Du is a Biostatistician in the Strategic Consulting Group at Cytel. He completed his MS in Statistics at McGill University in 2012, and his PhD in Biostatistics at Harvard University in 2017. His expertise includes analysis of longitudinal data and correlated data, feature selection, finite mixture models, and statistical methods for genetic association analysis. He has published theoretical and methodological papers in journals including The American Statistician, Metrika, and The Canadian Journal of Statistics. Since Joining Cytel in July 2017, he has worked with clients to create and simulate complex adaptive designs, conducted data analysis for several confirmatory trials, and performed validation of software packages.

New tools for clinical trial design: East and beyond

Charles Liu, PhD, is a Senior Product Manager at Cytel. Before joining Cytel in 2012, he was a postdoctoral fellow at Boston University. His current research interests include: Enrollment & events prediction, Go/No-Go decision making, and Program & Portfolio optimization.