Speakers represent academia, industry and government agencies.
Robert Beckman Georgetown University
Ming-Hui Chen University of Connecticut
Balarama Gundapaneni Pfizer
Rima Izem Children's National Hospital
Qing Liu Quantitative and Regulatory Medical Science, LLC
Peng Sun Biogen
Feng Tai Agios Pharmaceuticals
Lee-Jen Wei Harvard University
Jingjing Ye CDER, FDA
Robert Beckman, M.D., an oncology clinical researcher and mathematical biologist, has played significant leadership roles in developing new oncology clinical research groups at 4 pharmaceutical companies and in 5 cross-company collaborations, and brought 23 new oncology therapies into man, and 2 to market. He has co-invented novel clinical study designs and development strategies, and leads a 200-person international group in this field. Dr. Beckman’s theoretical studies of cancer evolution predicted broad features of tumor evolution before experimental results were available, and have more recently led to a new approach to cancer precision medicine, dynamic precision medicine, which holds promise for significant improvement in patient outcomes. His versatile publication record ranges from computational chemistry to clinical oncology, emphasizing quantitative approaches. He is currently Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center and Scientific Advisor to the Senior Vice President for Research, Georgetown University.
Dr. Ming-Hui 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, Fellow of American Statistical Association in 2005. He has published over 395 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 has supervised or been supervising 28 PhD students. He served as President of the International Chinese Statistical Association (ICSA) in 2013, Program Chair and Publication Officer of SBSS of the American Statistical Association (ASA) and the ASA Committee on Nomination for 2016-2017 to nominate candidates for ASA President/Vice President. Currently, he serves as President of the New England Statistical Society (nestat.org), Chair of Eastern Asia Chapter of ISBA in 2018 (https://isba-eastasia.github.io/), Co Editor-in-Chief of Statistics and Its Interface, and an Associate Editor of JASA, JCGS, and LIDA.
Balarama Gundapaneni has been a statistician in the Rare Disease Unit at Pfizer since 2018. He received his Master’s in Statistics from University of South Carolina, Columbia in 2004. He has been working in the rare disease area for the past 8 years, primarily in TTR mediated polyneuropathy and cardiomyopathy. He is a member of the DIA Small Populations Working Group that is looking for solutions to methodological challenges in clinical trials in small populations. Balarama currently lives in St Louis and enjoys reading, travelling, and cooking in spare time.
Rima Izem is an Associate Professor of Pediatrics at Children’s National Research Institute and the George Washington University, since December 2018. At Children’s National, she supports different aspects of clinical research as they relate to study design and statistical analyses of clinical and epidemiological studies in the pediatric population. Her research interests include study design in rare diseases and causal inference and signal detection in large electronic healthcare databases. Prior to joining Children’s National, she was a senior statistician at the Food and Drug Administration with expertise in design and analysis of studies supporting safety or effectiveness of medical products. Her experience in drug review spans pre-market and post-market development across a wide range of therapeutic areas: cardiovascular, anti-infective, ophthalmic, reproductive health, analgesia and addiction and antiviral.
Ziliang Li is an Associate Director in the Biostatistics department at Vertex, focusing on (early) clinical development strategy of various rare diseases. Previously, Ziliang worked in the late development statistics in Merck leading/supporting late phase development (regulatory filings/FDA Advisory Committee meetings, Phase 2/3 execution) for several respiratory compounds.
Qing Liu, Ph.D. and ASA Fellow, is the Founder of Quantitative & Regulatory Medical Science, LLC. Qing’s mission is to bring innovative methods and technologies to clinical trials by leveraging his rich clinical trial experience, extensive research and publications in innovative design and statistical methods, and IT expertise in cloud based parallel- and super-computing.
Qing is a statistical expert who gained rich experience in broad disease areas in oncology, neurology, psychiatry, pain, cardiovascular, anti-infective, anti-virus, immunology and metabolic diseases from employment in academic institution, regulatory agency (FDA) and the bio-pharmaceutical industry. Qing’s clinical research experience includes more than 30 due- diligence projects in new drug licensing & acquisitions, numerous successful dispute resolutions with the FDA, successful implementation of various regulatory acceptable innovative trial designs and strategic clinical development planning. Qing has substantially contributed to clinical trial design, protocol review, monitoring, analysis, study report and regulatory submission.
Qing provided expert consulting for small and startup companies in efficient clinical development of innovative therapies with emphasis on medical devices, immuno-oncology, breakthrough designation drugs, rare disease therapies, and individualized medicine. Qing’s recent work at Amicus focuses on innovative trial designs and statistical analyses for rare disease drug developments. This includes randomized delayed start design with an integrated analysis of efficacy as well as a randomized controlled trial with internal comparative real world evidence.
Qing has extensive publications in statistical research for innovative clinical trial designs and in medical research through broad collaborative research with statisticians in academics, the National Institute of Health (NIH), and top tier pharmaceutical companies. Qing has the foresight to develop an evidential paradigm for statistical inference in response to recent ASA’s formal statements on p-values.
Qing was named a Fellow of the ASA in 2013. Qing was a Sr. Research Fellow of Janssen R&D, J&J; Head of Biostatistics at Cephalon, Inc.; Senior Statistician at RWJ PRI of J&J; Mathematical Statistician at the FDA/CDER/DB1. Qing started his career as a Faculty at St. Jude Children's Research Hospital.
After receiving his Ph.D. degree in statistics in 2006 from the University of Iowa, Peng worked in clinical pharmacology statistics group at Merck for four years before joining GSK. At GSK, Peng was the lead statistician for the global submission of a combination treatment for metastatic melanoma that received accelerated approval from the FDA. Peng currently works at Biogen as the later stage statistical lead in the neuromuscular area.
Dr. Feng Tai graduated and obtained PhD degree in Biostatistics from University of Minnesota. He worked for Novartis Oncology for more than 9 years, led the successful submission and approval of CAR-T therapy for DLBCL indication. He is currently working at Agios Pharmaceuticals, focusing on drug development for solid tumors.
Chenkun Wang is a Principal Statistician in the Biostatistics department at Vertex with four-year experience in the rare disease of Cystic Fibrosis. Chenkun is also a group member of the DIA adaptive design working group on historical borrowing.
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. 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, the personalize medicine under the risk-benefit paradigm via biomarkers and revitalizing clinical trial methodology. He has more than 200 publications and served on numerous editorial and scientific advisory boards. L. J. Wei has extensive working experience in regulatory science for developing and evaluating new drugs/devices.
Dr. Jingjing Ye is a team leader in division of biometric V (DBV) in office of biostatistics (OB), CDER, FDA. Her team in DBV is responsible for statistical review of investigational drugs, therapeutic biologics, and biosimilar products in DHP (Division of Hematology Products) in OHOP (Office of Hematology and Oncology Products) and OCE (oncology center of excellence). She received her PhD in statistics from University of California, Davis. She has more than 13 years working experience in pharmaceutical industry and FDA. She is statistics representative in OCE (oncology center of excellence) PeRC (Pediatric Review Committee) subcommittee, overseeing all pediatric plans, assessments and studies submitted to OCE. She has been FDA representative on various scientific working groups with industry, regulatory agency and academia.