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.
Simon Davies
Moderator
Bio
Simon Davies leads statistical and quantitative sciences and the ShinrAI Center for Artificial Intelligence and Machine Learning functions as part of the Takeda Data Sciences Institute in R&D. He has extensive cross-functional drug development experience across a variety of leadership roles with large-cap biopharmaceutical companies. Davies’ focus at Takeda is on leading an organization that is strategically and tactically entrenched in better health and a brighter future through innovative statistical and data sciences. He leads his organization to enable bringing transformative therapies to patients by harnessing the power of data through innovative trial design and drug development strategies, advanced statistical and data science methods, and modeling built on a best-in-class data and programming engine driven by automation. Through this ecosystem, Davies continues to focus on opportunities for automation, machine learning, and artificial intelligence that make Takeda faster and better at making quantitatively-driven decisions to achieve its ambitions for patients.
Paul Schuette
Plenary Panelist
Bio
Paul Schuette is the deputy division director for the US Food and Drug Administration’s Office of Biostatistics Division of Analytics and Informatics. He joined the FDA in 2008, after working in academia and as a government contractor. Schuette supervises a team of statistical analysts who support the statistical and scientific programming needs of the Office of Biostatistics. Additionally, he is a Center for Drug Evaluation and Research representative on the FDA’s Scientific Computing Board and serves as an Office of Biostatistics representative on multiple FDA artificial intelligence/machine learning working groups. Schuette earned his MA and PhD from the University of Wisconsin-Madison and his BS in mathematics from Kansas State University.
Rajanikanth Madabushi
Plenary Panelist
Bio
Rajanikanth (Raj) Madabushi has more than 15 years of regulatory experience as a pharmacometrics reviewer and clinical pharmacology team lead in the Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration Center for Drug Evaluation and Research. He serves as the associate director of guidance and scientific policy in the Office of Clinical Pharmacology and director of the Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence. Madabushi plays an instrumental role in the FDA’s Prescription Drug User Fee Act Model-Informed Drug Development initiatives and is the Center for Drug Evaluation and Research’s point of contact for the Model-Informed Drug Development Paired Meeting Program. He has also spearheaded several guidance and policy development initiatives, including the global harmonization of expectations for drug interaction studies as the rapporteur for the ICH M12 Expert Working Group.
Nevine Zariffa
Plenary Panelist
Bio
Névine Zariffa is a highly accomplished thought leader in the biostatistics and data science fields with extensive experience across all phases of drug development. She had a 25-year career taking on senior roles at GlaxoSmithKline and AstraZeneca, where she also led the enterprise data and analytics initiative. She has been a key contributor to development strategies for more than 200 drug projects across oncology, cardiovascular, metabolic, respiratory, inflammation, and renal diseases. Zariffa has also been a reviewer for The Lancet and has more than 30 peer-reviewed publications to her name. She is currently a strategic consultant to several organizations, including scientific data consortia such as ctDNA, and advised the FDA Office of the Commissioner on the application of real-world evidence to COVID-19. She serves on the scientific advisory boards of ANOVA, ZS Associates, Beaconcure, and Intelligencia (chair) and was a board member of CDISC for six years. Zariffa recently published her first novel, Sisters Pieced Together.
Kannan Natarajan
Plenary Panelist
Bio
Kannan Natarajan is the global head of biometrics and data management and chief statistical officer within global product development at Pfizer. He is a member of the global product development leadership team and the deputy chair of the clinical development board, a governance body that provides strategic, scientific advice and oversight of clinical development strategy of medicines across all therapeutic categories. Natarajan has been in the pharmaceutical industry for more than 30 years, working across various therapeutic areas. Prior to joining Pfizer, he was senior vice president and global head of oncology biometrics and data management at Novartis Pharmaceuticals. There, he was part of the oncology development leadership team, managing the oncology development portfolio and contributing to the global development strategy and approvals of several major drugs. He has authored and coauthored many articles and presented in several forums. Natarajan holds a master’s in statistics from the Indian Statistical Institute, Kolkata, and a PhD in statistics from the University of Florida, Gainesville.
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.
