Session 1: Causal inference in randomized studies 

November 22, 2025 | 8:30 a.m. to 1:00 p.m. 

Keynote:

Appropriate implementation of the estimands framework in clinical trials 

Greg Levin, PhD, Associate Director for Statistical Science and Policy, Office of Biostatistics, Food and Drug Administration

BREAK

Speakers:

  • Exploring causal inference methods for clinical trials
  • Florian Lasch, PhD, Biostatistics Specialist, European Medicines Agency
  • Unveiling estimands: potential, pitfalls, perspective
  • Mouna Akacha, PhD, Group Head of Statistical Methodology, Novartis
  • Assessing spillover effects among staff in implementation interventions
    • Alisa J. Stephens Shield, PhD, Associate Professor of Biostatistics in Biostatistics and Epidemiology, Hospital of the University of Pennsylvania

Break

Panel Discussion:

  • Moderator: Janet Wittes, PhD, Consultant
  • Panelists:
    • Greg Levin, PhD, Associate Director for Statistical Science and Policy, Office of Biostatistics, Food and Drug Administration
    • Dan Scharfstein, ScD, Chief of the Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine
    • Kelley Branch, MD, PhD, Professor of Medicine and Associate Director Clinical Trials Service Unit, University of Washington
    • Qing Liu, PhD, Director, Design and Innovation, Amgen

Session Chair:

Andrea Rotnitzky, PhD, Professor of Biostatistics, Department of Biostatistics, University of Washington School of Public Health

Session 2: Causal inference in observational studies

November 23, 2025 | 8:30 a.m. to 1:00 p.m. 

Keynote:

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Maria Glymour

Evidence triangulation in dementia research

Maria Glymour, SD, Chair and Professor, Department of Epidemiology, Boston University

Break

Speakers:

  • Assessing vaccine effectiveness in observational studies via nested trial emulation
    • Michael Hudgens, PhD, Professor and Chair, Department of Biostatistics, University of North Carolina Chapel Hill
  • Prediction under the interventions of stopping or continuing treatments for chronic kidney disease using electronic health records data
    • Ruth Keogh, PhD, Professor of Biostatistics and Epidemiology, Medical Statistics Department; Co-Director, Centre for Data and Statistics Science for Health, London School of Hygiene and Tropical Medicine
    • Leah Pirondini, PhD, Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine
  • Strategies for enhancing transparency and interpretability of findings from clinical studies

Break

Panel Discussion:

  • Moderator: Steven R. Cole, PhD, Cary C. Boshamer Distinguished Professor, Department of Epidemiology, University of North Carolina Chapel Hill)
  • Panelists:
    • Maria Glymour, SD, Chair and Professor, Department of Epidemiology, Boston University
    • James M. Robins, PhD, Mitchell L. and Robin LaFoley Dong Professor of Epidemiology, Harvard T.H. Chan School of Public Health
    • Jay Kaufman, PhD, Professor, Department of Epidemiology, Biostatistics and Occupational Health, McGill University

Session Chair:

Andrea Rotnitzky, PhD, Professor of Biostatistics, University of Washington School of Public Health

Session 3: Data fusion in causal inference 

November 24, 2025 | 8:30 a.m. to 1:00 p.m. 

Keynote:

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Tianxi Cai

Unlocking the potential of EHR data for real-world evidence: opportunities and challenges

Tianxi Cai, ScD, Professor of Biomedical Informatics, Harvard Medical School; John Rock Professor of Population and Translational Data Sciences, Harvard T.H. Chan School of Public Health

Break

Speakers:

  • Causal approaches for hybrid randomized clinical trials with longitudinal outcomes
    • Jiawen Zhu, PhD, Senior Principal Statistical Scientist, Genentech
      • Integrating diverse evidence sources in clinical research: causal inference at the intersection of trials and real-world evidence
    • Shu Yang, PhD, Professor of Statistics, North Carolina State University
  • Trial augmentation using external data and foundation models
    • Issa Dahabreh, PhD, Associate Professor of Epidemiology, Harvard T.H. Chan School of Public Health

Break

Panel Discussion

  • Moderator:Dan Scharfstein, ScD, Chief of the Division of Biostatistics, Department of Population Health Sciences, University of Utah School of Medicine
  • Panelists:
    • Tianxi Cai, ScD, Professor of Biomedical Informatics, Harvard Medical School; John Rock Professor of Population and Translational Data Sciences, Harvard T.H. Chan School of Public Health
    • Hana Lee, PhD, Senior Staff Fellow, Food and Drug Administration
    • Antonio Remiro Azócar, PhD, Statistical Innovation Leader, Novo Nordisk

Session Chair:

Alex Luedtke, PhD, Faculty, Department of Health Care Policy, Harvard Medical School

Session 4: Causal inference: past, present and future 

November 25, 2025 | 8:30 a.m. to 1:00 p.m. 

Keynote:

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Eric Tchetgen Tchetgen

Fortified Proximal Causal Inference with many imperfect negative controls

Eric Tchetgen Tchetgen, PhD, Professor of Biostatistics, Biostatistics and Epidemiology; Professor of Statistics and Data Science; The Wharton School, University of Pennsylvania

Break

Speakers:

  • Inferential replicability for online decision-making algorithms
    • Susan A. Murphy, PhD, Mallinckrodt Professor of Statistics and of Computer Science; Associate Faculty, Kempner Institute; Harvard University
  • Outcomes trials in diabetes and obesity – casual inference needed?
    • Henrik Ravn, PhD, Senior Statistical Director, Novo Nordisk
  • Causal AI for clinical care: deep causal behavioral policy learning
    • Maya Petersen, PhD, Professor, Epidemiology and Biostatistics, University of California Berkeley

Break

Panel Discussion

  • Moderator:  Andrea Rotnitzky, PhD, Professor of Biostatistics, University of Washington School of Public Health
  • Panelists:
    • Eric Tchetgen Tchetgen, PhD, Professor of Biostatistics, Biostatistics and Epidemiology; Professor of Statistics and Data Science; The Wharton School, University of Pennsylvania
    • Mark van der Laan, PhD, Professor, Biostatistics and Statistics, University of California, Berkeley
    • Elizabeth A. Stuart, PhD, AM, Chair and Professor, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health

Session Chair:

Alex Luedtke, PhD, Faculty, Department of Health Care Policy, Harvard Medical School