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Monday, June 17 • 2:15pm - 3:15pm
#142: Causal Inference Methodology in Drug Development

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Component Type: Session
Level: Intermediate

This session will explore special topics in causal inference. Presenters will describe trial design and analysis issues in drug development, related to both randomized trials and real-world data (RWD), that may benefit from statistical methodology to allow for better and more accurate generation of evidence with respect to drug treatment effects.

Learning Objectives

Describe various statistical approaches to handle complex design and analysis issues in drug development. Explain use case examples for illustration for causal inference methods.

Chair

Pallavi Mishra-Kalyani, PhD, MS

Speaker

Causal Inference in Clinical Drug Development: Industry Update
Antara Majumdar, PhD

Methodological Challenges and Potential Solutions When Conducting External Control Studies Intended for Causal Inference
Shia Kent

Regulatory Considerations and Case Studies of Externally Controlled Trials
Pallavi Mishra-Kalyani, PhD, MS


Speakers
avatar for Pallavi Mishra-Kalyani

Pallavi Mishra-Kalyani

Deputy Division Director, DBV, OB, CDER, FDA, United States
Pallavi Mishra-Kalyani, Ph.D. is the Deputy Director of the Division of Biometrics V, Office of Biostatistics in the Center for Drug Evaluation and Research (CDER). Since joining the Food and Drug Administration (FDA) in 2015, Dr. Mishra-Kalyani has contributed to the efforts to address... Read More →
SK

Shia Kent

Epidemiologist, Pharmacovigilance Epi and Causal Inference Team, Amgen, United States
avatar for Antara Majumdar

Antara Majumdar

Director, Oncology Statistics, GlaxoSmithKline, United States
Antara is the Director of Statistics at AcornAI by Medidata. Antara is part of a team responsible for implementation of external controls in clinical drug development. Prior to this, Antara worked for Bristol-Myers Squibb for over a decade. Antara has deep and broad experience in... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session