Shanti Gomatam is a senior Mathematical Statistician in FDA/CDER. She currently works for the division that assesses quantitative safety. She has over 29 years of experience in academic and regulatory environments, of which almost 20 years have been with the FDA. Her experience at the FDA covers both CDER and CDRH, efficacy, safety, therapeutics and diagnostics. She received her Ph.D. from Florida State University. Her statistical interests span a range of topics, she has been focusing on the estimand framework recently.

Alexei C. Ionan is a Senior Mathematical Statistician in the Division of Biometrics IX of the Office of Biostatistics, supporting application review in the Office of Oncologic Diseases at the FDA. He has been evaluating, developing, and applying statistical methods in oncology since 2003. He leads multiple groups at the FDA. His research interests include Bayesian methods, estimands, decision theory, causal inference, predictive biomarkers, early detection of cancer, and optimal design.

John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and a past Editor of the journal Pharmaceutical Statistics.

Clinical team leader in the Division of Pulmonology, Allergy, and Critical Care within the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. Received M.D. at the University of Maryland and completed internal medicine residency and fellowship in Allergy and Clinical Immunology at The Johns Hopkins School of Medicine. Assistant Professor at The Johns Hopkins School of Medicine and a practicing allergist.

After many years as an industry statistician, Susan joined FDA in 2018 and is now a Senior Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. Susan’s interests in estimands, safety and benefit-risk assessment, and graphics have a common thread and focus: addressing the question of scientific interest, to make clear and precise decisions aligned with the clinical goals of the program by using structured thinking and framing during drug development and reporting, for the benefit of public health.