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Jun 11, 2024 1:00 PM - Jun 11, 2024 4:00 PM

Protocol Development Best Practices using Estimand Thinking

This is a virtual pre-meeting Short Course in conjunction with the DIA Global Annual Meeting.


Munish  Mehra, PhD, MS, MSc

Munish Mehra, PhD, MS, MSc

Managing Director, Principal Biostatistician, Tigermed, United States

Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across multiple therapeutic areas. He has represented sponsors at FDA Type B pre-IND, end of phase II and pre-NDA as well as Type C meetings as an expert biostatistician. Dr. Mehra is currently Chair of the DIA Statistics and Data Sc. Community and has chaired sessions at several DIA Annual Meetings. He holds a PhD in biostatistics and a MS in computer science from the Univ. of KY, as well as a MS in mathematics from the Indian Institute of Technology.

Rekha  Jhamnani, MD, MSc

Rekha Jhamnani, MD, MSc

Medical Officer, DNPDI, OND, CDER, FDA, United States

Rekha Jhamnani is a medical officer in the Division of Nonprescription Drugs at the FDA. She completed medical school at the George Washington University School of Medicine and internal medicine residency at Georgetown University Hospital. She then completed a fellowship in Allergy Immunology at the National Institutes of Health.

Elena  Polverejan, PhD

Elena Polverejan, PhD

Scientific Director, Statistical Modeling and Methodology, Statistics and Decisi, Johnson & Johnson, United States

Elena is a Scientific Director in the Statistical Modeling & Methodology group of Johnson & Johnson. Her work has a focus on estimands, missing data methodology and their implementation in clinical trials. Elena is the lead of the J&J Estimands and Missing Data Working Group and the co-chair of the Estimand and Missing Data Working Group of the International Society for CNS Clinical Trials and Methodology. Elena joined Johnson & Johnson in 2004 and before that she worked at Pfizer for several years. She has been involved across the years in several therapeutic areas including Immunology, Cardiovascular and Metabolic, Pain and CNS.

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