Speaker

Biography

Dr. Heng Li

Dr. Heng Li is a Lead Mathematical Statistician in the Division of Biostatistics, CDRH/FDA. He is instrumental in the establishment and evaluation of policies and procedures to maintain a unified and consistent program for biostatistical aspects of the regulation of medical device. He leads a team of statisticians in technical reviews and research. He has made substantial contributions in advancing regulatory statistics, especially propensity score-based methods, including developing and implementing novel propensity score-based approaches for leveraging real-world evidence to support regulatory decision-making.

Dr. Lilly Yue

Dr. Lilly Yue is a Deputy Director, Division of Biostatistics in the FDA's Center for Devices and Radiological Health, where she oversees statistical reviews of therapeutic and diagnostic medical devices. She has played a key leadership role in advancing regulatory statistics, including efforts on adapting and advancing propensity score methodology for premarket observational studies and on developing and implementing the novel propensity score-integrated approaches for leveraging real-world evidence to support regulatory decision-making. Dr. Yue is an Editor-in-Chief of Pharmaceutical Statistics and served as an Associate Editor (and a Guest Editor) for Journal of Biopharmaceutical Statistics and Pharmaceutical Statistics. She is a Fellow of the American Statistical Association.

Dr. Jason (Jixian) Wang

Jason (Jixian) Wang is a statistician in Statistical Methodology Group in Bristol Myers Squibb based in Switzerland. He has more than 20 years’ experience in the pharmaceutical industry, has worked in several therapeutic areas such as cardiovascular, oncology, hematology, and cell therapies, and in difference phases including clinical development, in which he did multiple regulatory submissions, as well as pre-clinical statistics, clinical pharmacology, and post-marketing drug safety and HTA. He was an academic researcher in biostatistics and epidemiology before joining the industry. He has a wide range of research interests including casual inference, innovative trial designs, dose optimization, machine learning, and PK/PD and health economics modeling and simulation. He published more than 60 papers, one book and two book chapters. He is a member of the RWD SIG in PSI/EFSPI.

Chair

Biography

Amy Mulick

Amy is Head of the Evidence and Value Generation group at Veramed, which generates clinical evidence for pharmaceutical products and medical devices using data collected partially or wholly outside the context of randomised controlled trials. Previously she was based at the London School of Hygiene and Tropical Medicine using the Clinical Practice Research Datalink (CPRD) to research disease epidemiology, and developing a novel cause of death estimation method to cope with sparse data inputs. She has expertise in Bayesian methods for evidence synthesis as well as causal and predictive statistical modelling.