Featured Speakers
The Intersection of Statistics, Data Science, and AI in Drug Development
Thursday, September 26, 8:00 a.m. – 9:45 a.m.
Patrizia Cavazzoni
FDA Keynote Speaker
Bio
Patrizia Cavazzoni is the director of the Center for Drug Evaluation and Research at the US Food and Drug Administration. She earned her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. During her training, she was an investigator in clinical trials of novel antipsychotic and antidepressant medications and became a research collaborator within the International Group for the Study of Lithium Treated Patients. She subsequently received a full-time appointment to the faculty of medicine at the University of Ottawa and joined the mood disorders program at the Royal Ottawa Hospital. After her tenure in academic medicine, Cavazzoni worked in the pharmaceutical industry for several years and held senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas until she joined the FDA.
Cavazzoni was certified by the American Board of Neurology and Psychiatry in 1997 and 2008 and was a fellow of the Canadian Royal College of Physicians and Surgeons from 1997 until 2023. She is a fellow of the Canadian College of Neuropsychopharmacology and a recipient of the American College of Psychiatrists’ Laughlin Fellowship.
Cavazzoni was certified by the American Board of Neurology and Psychiatry in 1997 and 2008 and was a fellow of the Canadian Royal College of Physicians and Surgeons from 1997 until 2023. She is a fellow of the Canadian College of Neuropsychopharmacology and a recipient of the American College of Psychiatrists’ Laughlin Fellowship.
Sylva Collins
Plenary Panelist
Bio
Sylva Collins is the director of the Office of Biostatistics at the Center for Drug Evaluation and Research at the US Food and Drug Administration. She provides leadership to a staff of more than 250 statisticians responsible for review of regulatory submissions and conducting research to advance statistical science. She promotes innovative, science-based, quantitative decision-making throughout the drug development life cycle. Prior to joining the FDA, Collins had a long career in the pharmaceutical industry leading global operations in statistics, data management, and statistical programming.
Ask the Regulators
Thursday, September 26, 10:00 a.m. – 11:45 a.m.
Andrew Thomson
Panelist
Bio
Andrew Thomson is a statistician in the task force dedicated to data, analytics, and methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development and therapeutic areas. He is also the main scientific secretariat for the European Medicines Agency Methodology Working Party. Prior to joining the European Medicines Agency, he was head of epidemiology at the MHRA (the UK licensing authority), where his regulatory career started as a statistical assessor 17 years ago.
In terms of international collaboration, Thomson is the regulatory chair for ICH E6 Annex 2, which covers trials with decentralized and pragmatic elements, as well as those using real-world evidence. He was also the lead of the statistics subgroup and regulatory chair of ICH E11A on pediatric extrapolation.
In terms of international collaboration, Thomson is the regulatory chair for ICH E6 Annex 2, which covers trials with decentralized and pragmatic elements, as well as those using real-world evidence. He was also the lead of the statistics subgroup and regulatory chair of ICH E11A on pediatric extrapolation.
Emmanuel Zuber
Panelist
Bio
Emmanuel Zuber has been working as a statistician in global drug development for more than 26 years at several large pharmaceutical companies, including 20 years at Novartis. He has held key leadership positions in oncology, hematology, neuroscience, and ophthalmology, driving the global developments, filings, and approvals for more than a dozen treatments, including cytotoxic chemotherapies, targeted therapies, cell therapies, biologics, and radio-ligand therapies.
Driven by his passion for innovative, evidence-based, and efficient drug development paths, Zuber has been actively involved in promoting open dialog between drug developers and regulators. He has served as an organizing and scientific committee member of the European Federation of Statisticians in the Pharmaceutical Industry Regulatory Statistics Workshop since its inception in 2016.
Driven by his passion for innovative, evidence-based, and efficient drug development paths, Zuber has been actively involved in promoting open dialog between drug developers and regulators. He has served as an organizing and scientific committee member of the European Federation of Statisticians in the Pharmaceutical Industry Regulatory Statistics Workshop since its inception in 2016.
Gregory Levin
Panelist
Bio
Gregory Levin is the associate director for statistical science and policy in the Office of Biostatistics at the US Food and Drug Administration Center for Drug Evaluation and Research. He has experience supporting drug review across a wide range of therapeutic areas and has represented the Center for Drug Evaluation and Research on several policy and guidance working groups, including efforts related to adaptive design, master protocols, safety, benefit-risk, and the evaluation of effectiveness.
John Scott
Panelist
Bio
John Scott is director of the Division of Biostatistics in the US Food and Drug Administration Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and cellular, tissue, and gene therapies. Prior to joining the FDA in 2008, Scott 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 about Bayesian and adaptive clinical trial design and analysis, vaccine and drug safety, data and text mining, and benefit-risk assessment. He is the Center for Biologics Evaluation and Research lead for 21st Century Cures and has been heavily involved in several of the FDA’s statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, 2020 Guidance on Interacting with the FDA on Complex Innovative Trial Design, ICH E9(R1) expert working group on estimands and sensitivity analyses, and ICH E20 expert working group on adaptive designs. Scott is a fellow of the American Statistical Association and a past editor of the journal Pharmaceutical Statistics.
Lei Nie
Panelist
Bio
Lei Nie is the division director of the Division of Biometrics IV in the Office of Biostatistics of the US Food and Drug Administration Center for Drug Evaluation and Research. He is interested in developing and promoting innovative statistical methods in drug development.
Mark Levenson
Panelist
Bio
Mark Levenson is the director of the Division of Biometrics VII in the Center for Drug Evaluation and Research of the US Food and Drug Administration. He has been the primary or secondary reviewer on many major pre-market and post-market drug safety problems and contributes to statistical policy and guidance development in drug safety, real-world data, and regulatory evidence. He is a member of the Center for Drug Evaluation and Research Medical Policy Program Review Committee and FDA Real-World Evidence Committee. He is also an elected fellow of the American Statistical Association.
Margaret Gamalo
Panelist
Bio
Margaret (Meg) Gamalo is vice president and 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 a research adviser of global statistical sciences at Eli Lilly and Company and mathematical statistician at the US Food and Drug Administration. She led the Pediatric Innovation Task Force at the Biotechnology Innovation Organization and served as 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. Gamalo co-leads the scientific working groups on statistics in pediatric drug development and the statistical perspective on AI/ML in pharmaceutical development within the Biopharmaceutical Section of the ASA. She is also a fellow of the American Statistical Association.
Nicole Gormley
Panelist
Bio
Nicole Gormley is the division director for the Division of Hematologic Malignancies II at the US Food and Drug Administration and serves as the associate director for oncology endpoint development in the Oncology Center of Excellence, where she provides direction, coordination, and oversight for scientific and policy efforts related to early endpoint development in oncology.
Gormley previously served as a clinical reviewer and Multiple Myeloma Clinical Team lead. While in these roles, she actively engaged with the multiple myeloma community on the development of novel endpoints—including minimal residual disease—and methods to address racial disparities. Gormley completed fellowship training in hematology and critical care at the National Institutes of Health and served as the deputy clinical director at the National Heart, Lung, and Blood Institute prior to joining the FDA.
Yuan Ji
Panelist
Bio
Yuan Ji is a professor of biostatistics at The University of Chicago. His research focuses on innovative Bayesian statistical methods for translational cancer research and he is the author of more than 200 publications in peer-reviewed journals. He is also the inventor of many innovative Bayesian adaptive designs such as the mTPI and i3+3, which have been widely applied in dose-finding clinical trials worldwide. His work on cancer genomics was reported by many media outlets in 2015. He received the Mitchell Prize in 2015 by the International Society for Bayesian Analysis and is an elected fellow of the American Statistical Association.
Yue Shentu
Panelist
Bio
Yue Shentu is an executive director at Merck Research Laboratories and a section head of late-development statistics in oncology, overseeing thoracic and head and neck, as well the TROP2 and HER3 ADC asset development. He holds a PhD in statistics from Rutgers University. His research interests include adaptive design and subgroup identification and estimation in clinical trials.
