Featured Speakers
Plenary Session 1
Evolving Roles of Statisticians in the AI/ML Era
Thursday, September 25, 8:00 a.m. – 9:45 a.m.
FDA Speaker:
Mark Levenson
US Food and Drug Administration
Bio
Mark Levenson is the deputy office director of the Office of Biostatistics in the US Food and Drug Administration Center for Drug Evaluation. He has led many major pre-market and post-market statistical reviews, leading to approvals of novel drugs and important safety warnings. He contributes to statistical policy and guidance development in regulatory and real-world evidence. He is a member of the CDER Medical Policy and Program Review Council, the FDA Real-World Evidence Committee, the CBER-CDER Rare Disease Policy and Portfolio Council, and the Office of Biostatistics Statistical Policy Council. Levenson earned a PhD in statistics from The University of Chicago and a BA in mathematics from Cornell University. He graduated from the Bronx High School of Science and is an elected Fellow of the American Statistical Association.
Industry Speaker:
Margaret Gamalo
Vice President, Statistics Head of Inflammation, Immunology, and Specialty Care
Pfizer
Academic Speaker:
Xiao-Li Meng
Whipple V. N. Jones Professor of Statistics
Harvard University
Plenary Session 2
Part 1: Statistical Innovation in the AI/ML Era
10:00 – 10:45 a.m.
Mark Levenson
US Food and Drug Administration
Bio
Mark Levenson is the deputy office director of the Office of Biostatistics in the US Food and Drug Administration Center for Drug Evaluation. He has led many major pre-market and post-market statistical reviews, leading to approvals of novel drugs and important safety warnings. He contributes to statistical policy and guidance development in regulatory and real-world evidence. He is a member of the CDER Medical Policy and Program Review Council, the FDA Real-World Evidence Committee, the CBER-CDER Rare Disease Policy and Portfolio Council, and the Office of Biostatistics Statistical Policy Council. Levenson earned a PhD in statistics from The University of Chicago and a BA in mathematics from Cornell University. He graduated from the Bronx High School of Science and is an elected Fellow of the American Statistical Association.
John Scott
US Food and Drug Administration
Bio
John Scott is director of the Division of Biostatistics in the FDA’s Center for Biologics Evaluation and Research. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas such as Bayesian and adaptive clinical trial design and analysis, vaccine and drug safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA efforts in complex and innovative trial design and has been heavily involved in a number of the FDA’s statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2020 Guidance on Interacting with the FDA on Complex Innovative Trial Design, the ICH E9(R1) expert working group on estimands and sensitivity analyses, and the ICH E20 expert working group on adaptive designs. Scott holds a PhD in biostatistics from the University of Pittsburgh, an AM in mathematics from Washington University in St. Louis, and a BA in liberal arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and a former editor of Pharmaceutical Statistics.
Gregory Alexander
US Food and Drug Administration
Florian Lasch
Biostatistics Specialist
European Medicines Agency, Netherlands
Bio
Florian Lasch is a biostatistician with a degree in mathematics and a PhD from Hannover Medical School. He works as a biostatistics specialist at the European Medicines Agency, providing scientific support throughout all stages of marketing authorization assessments, and leads the EMA Estimands Implementation Group.
Devan Mehrotra
Merck
Bio
Devan V. Mehrotra is vice president of biostatistics at Merck Research Laboratories, the research and development division of Merck & Co. Over the past 34 years, he has made significant contributions toward the research, development, and regulatory approval of medical drugs and vaccines across a broad spectrum of therapeutic areas. He was awarded an MRL Presidential Fellowship in 2012. Mehrotra is also an adjunct professor of biostatistics at the University of Pennsylvania and an elected Fellow of the American Statistical Association. He has served as a subject matter expert for the Bill and Melinda Gates Foundation (for HIV vaccine development), the National Academy of Sciences (for missing data issues in clinical trials), the Coalition for Epidemic Preparedness Innovations (for COVID-19 vaccine development), and the International Council on Harmonization (for ICH E9/R1 [estimands and sensitivity analysis in clinical trials]). He currently leads an organization of ~90 statisticians supporting R&D projects in drug discovery, preclinical, early-phase clinical development, biomarkers and diagnostics, pharmacogenomics, and manufacturing.
Li Wang
AbbVie
Bio
Li Wang is senior director and head of the statistical innovation group at AbbVie. He is leading design advisory, which provides strategic and quantitative consulting to all development teams in all therapeutic areas to facilitate innovative thinking and innovative design evaluation. Li leads clinical trial innovation capability at AbbVie to drive machine learning and advanced analytics research and application in development and is co-leading the ASA Biopharmaceutical Section Scientific Working Group for statistical perspectives on AI/ML in pharmaceutical product development. Li also has extensive success in filing and approvals, leading to three blockbuster drugs—Eliquis, Rinvoq, and Onglyza—improving the lives of millions of patients every day.
Part 2: Collaboration Across Quantitative Disciplines in the AI/ML Era
10:45 a.m. – 11:30 a.m.
Stella Grosser
US Food and Drug Administration
Bio
Stella Grosser is director of the Division of Biometrics 8 in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research. This division provides statistical support to the Office of Generic Drugs and collaborates in research and guidance development. She has been at the FDA for 25 years, beginning as a statistical reviewer for new drug products and serving as a team leader before assuming her current position. Grosser earned her PhD in biostatistics from the University of California at Los Angeles and spent several years there afterward as an assistant professor in the school of public health.
Mat Soukup
US Food and Drug Administration
Bio
Mat Soukup has more than two decades of experience in pharmaceutical regulation and drug safety evaluation. He earned his PhD in biostatistics from the University of Virginia in 2004 and is currently the director of the Division of Biometrics VII at the US Food and Drug Administration. In his tenure at FDA, he has contributed to drug safety methodology and regulation, benefit-risk assessment, and the development of standardized statistical practices and processes for regulatory review.
Somnath Sarker
Sanofi
Bio
Somnath Sarkar is the global head of evidence generation and decision science at Sanofi, where he leads the EGDS functions: real-world evidence; modeling and simulation; and global biostatistics. A senior leader in pharmaceutical research and development, he has broad executive experience across the pharmaceutical and health technology industries, driving innovation at the intersection of science, data, and strategy. Passionate about integrated evidence generation, he generates actionable insights through real-world data, modeling and simulation, and biostatistics to enable informed decisions and accelerate the delivery of impactful therapies.
Sara Hughes
GSK
Bio
Sara Hughes is senior vice president and head of biostatistics and pipeline project management at GSK. Her biostatistics group of more than 800 staff globally provides statistics, programming, and data science resources across research and development activities in GSK’s medicines and vaccines portfolio and is a strategic partner, providing industry-leading quantitative expertise in study and experimental design, statistical analysis and decision-making across research, development, commercialization, and manufacturing. The Pipeline Project Management group of more than 100 staff globally anticipates and orchestrates the unique combination of people and plans needed to optimize delivery of the pipeline, optimizing the critical path of project plans to ensure efficient execution. Sara herself sits on GSK’s Clinical Development Leadership Team and the senior R&D technical and investment governance boards, where she champions the use of quantitative decision-making approaches. Externally, Sara is a past president of PSI and ex-council member of the Royal Statistical Society. She has published about 30 papers in peer-reviewed journals.
Haoda Fu
Amgen
Bio
Haoda Fu is head of exploratory biostatistics at Amgen and a Fellow of the American Statistical Association and Institute of Mathematical Statistics. He is also an adjunct professor in the biostatistics department at The University of North Carolina at Chapel Hill and Indiana University School of Medicine. Fu earned his PhD in statistics from the University of Wisconsin - Madison in 2007 and then joined Eli Lilly. He has more than 100 publications in areas such as Bayesian adaptive design, survival analysis, recurrent event modeling, personalized medicine, indirect and mixed treatment comparison, joint modeling, Bayesian decision-making, and rare events analysis in journals such as Journal of the American Statistical Association, Journal of the Royal Statistical Society, Series B, Biometrika, Biometrics, ACM, IEEE, Journal of the American Medical Association, and Annals of Internal Medicine. In recent years, his research has focused on machine learning and artificial intelligence.
Shein-chung Chow
Duke University
Bio
A professor in the department of biostatistics and bioinformatics at the Duke University School of Medicine, Chow is also an adjunct professor at the University of Toronto. He was a special government employee appointed by the US Food and Drug Administration as an Oncologic Drug Advisory Committee voting member and statistical adviser to the FDA from 2015–2017 and 2019–2022. From 2017–2019, Chow was on leave from the FDA as an associate director in the Office of Biostatistics, Center for Drug Evaluation and Research. He was also the editor in chief of the Journal of Biopharmaceutical Statistics (1992–2020) and the Biostatistics Book Series at Chapman and Hall/CRC Press (1992–2024). He is an elected Fellow of the American Statistical Association and an elected member of the International Statistical Institute. Chow is the author or co-author of more than 350 methodology papers and 33 books, including Design and Analysis of Bioavailability and Bioequivalence Studies, Adaptive Design Methods in Clinical Research, Design and Analysis of Clinical Trials, Advanced Statistics in Regulatory Critical Clinical Initiatives, and, most recently, Innovative Methods for Rare Disease Drug Development.
