Opening Remarks

Speaker: Margaret (Meg) Gamalo, Pfizer Global Product Development.

Margaret (Meg) Gamalo, PhD is currently VP, Statistics Head for Inflammation and Immunology in Pfizer Global Product Development. She combines expertise in biostatistics, regulatory science and adult and pediatric clinical development in multiple disease areas. Prior to joining Pfizer, she was Research Advisor, Global Statistical Sciences at Eli Lilly and Company and Mathematical Statistician at the Food and Drug Administration. Meg led the Pediatric Innovation Task Force at the Biotechnology Innovation Organization and a member of the European Forum for Good Clinical Practice – Children’s Medicine Working Party that provided guidance on inclusion of adolescents in adult research. She co-leads the scientific workgroups on Statistics in Pediatric Drug Development and the Statistical Perspective on AI/ML in Pharmaceutical Development within the Biopharmaceutical Section of the ASA. Meg is a Fellow of the American Statistical Association.

Speaker: Andrew Moiseff, University of Connecticut

Andrew Moiseff is Professor of Physiology & Neurobiology and the Associate Dean for Research and Graduate Affairs for the College of Liberal Arts and Sciences (CLAS). His research interests are to apply electrophysiological and behavior methods to reveal how the nervous system extracts biologically useful information from signals in a natural environment. Currently he is investigating how fireflies use their flashes to communicate in a natural, noisy environment. As Associate Dean he supports the CLAS research faculty though college initiatives and as liaison to the Office of the Vice President for Research.

Title: Envisioning the Future of Healthcare - Opportunities and Challenges.

Speaker: Amrit Ray, MD, MBA, Life Sciences Board Director

Amrit Ray, MD, MBA is passionate about solving the toughest medical challenges to bring extraordinary impact to the lives of patients and families around the world. He has over 25 years of healthcare experience ranging from physician providing patient care to Fortune 100 corporate executive, public and private company board director, and private equity advisor. He is a dedicated advocate for patients and committed to building winning, diverse teams that use scientific insights to advance R&D pipelines and drive access to medicines.
Amrit is an independent board director and advisor to multiple public and private life sciences companies. Previously, he was Global President, Head of R&D, and Executive Leadership Team member at Pfizer Upjohn. He has held multiple C-suite roles at major companies, including as the Chief Medical Officer at Janssen (Johnson & Johnson), and as the Chief Patient Officer at Biohaven (acquired by Pfizer, 2022). As a physician researcher, he has applied deep functional experience across R&D, medical affairs and RWE to advance pipelines, registration, launch, access and high patient impact for several transformational medicines in Neuroscience, Oncology, Immunology, Cardio-metabolism and other areas. As a business executive, he has played instrumental roles in multiple, successful corporate M&A transactions, and has experience as a Senior Advisor to Bain Capital private equity.
He began his career as a hospital doctor providing patient care in Britain’s National Health Service. He is a Visiting Professor of Practice in the Faculty of Medical Sciences, Newcastle University, UK.

Title: Opportunities for accelerating drug development with statistical innovation

Speaker: Ivan S. F. Chan, Bristol Myers Squibb

Dr. Ivan S.F. Chan has more than 25 years of experience in the pharmaceutical industry. He is VP and Head of Hematology Biostatistics, Global Biometrics & Data Sciences at Bristol Myers Squibb. In this role he leads the global statistical support for hematology development. Prior to joining BMS, Ivan was VP and Head of Statistical Sciences at AbbVie, and he previously worked at Merck Research Laboratories where he led the global statistical support for vaccines. Ivan received his Ph.D. in Biostatistics from the University of Minnesota. He is an elected Fellow of the American Statistical Association (ASA) and an elected Fellow of the Society for Clinical Trials (SCT). Ivan was the 2021 recipient of the Deming Lecturer Award from ASA for his outstanding contributions to vaccine development. He currently serves as Co-Chair of Deming Conference on Applied Statistics and Executive Director of the International Society for Biopharmaceutical Statistics. Ivan has previously served as the President of the International Chinese Statistical Association and the Program Chair of the ASA Biopharmaceutical Section. He has 90+ publications in statistical and clinical journals.

Title: Pitfalls of association analysis via a regression model.

Speaker: LJ Wei, Harvard T.H. Chan School of Public Health

L.J. Wei's research is in the area of developing statistical methods for the design and analysis of clinical trials. In 1977-78 he introduced the "urn design" for two-arm sequential clinical studies. This design has been utilized in several large-scaled multi-center trials, for example, the Diabetes Control and Complications Trial sponsored by the NIH and the Matching patients to Alcoholism Treatments sponsored by NIAAA. In 1979, he proposed a response adaptive design, a randomized version of Marvin Zelen's play the winner rule, was used in the ECMO trial, a well-known study which evaluated extracorporeal membrane oxygenation for treating newborns with persistent pulmonary hypertension. Currently several trials sponsored by private industry are using this particular design to relax the ethical problem arising in using the conventional 50-50 randomization treatment allocation rule clinical studies. To monitor trials sequentially for economic and ethical reasons, in 1982 Wei and his colleagues presented a rather flexible monitoring scheme, which has become a classical reference for the literature in interim analysis for clinical trials. Dr. Wei has developed numerous methods for analyzing data with multiple outcome or repeated measurements obtained from study subjects. In particular, his "multivariate Cox procedures" to handle multiple event times have become quite popular. He and his colleagues are also responsible for developing alternative models to the Cox proportional hazards model for analyzing survival observations. A very important issue in statistical inference is to check whether the model used to fit the data is appropriate or not. Currently, Wei and his colleagues are developing graphical and numerical methods for checking the adequacy of the Cox proportional hazards model, other semi-parametric survival models, parametric models, and random effects models for repeated measurements. The new procedures are much less subjective than the conventional eye-ball methods based on ordinary residuals plots. Since the cost of computing has been drastically reduced, some analytically intractable statistical problems can be handled numerically. Presently, Wei and his colleagues are working on various resampling methods for quantile regression, rank regression, and regression models for censored data. Dr. Wei is also a senior statistician at the Statistical and Data Analysis Center. He works closely with the medical investigators in Pediatrics AIDS clinical trials for evaluating new treatments for HIV patients.