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Wednesday, June 19 • 4:30pm - 5:30pm
#377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-676-L04-P; CME 1.00; RN 1.00

This session will include short presentations delivered by speakers from three Regulatory Agencies sharing perspectives based on their own experience with the ICH E9(R1) estimand framework implementation. The session participants will have the opportunity to engage with the speakers in a 25-minute open discussion, fueled by a few survey questions.

Learning Objectives

Highlight how scientific questions of interest from different stakeholders require different strategies for the intercurrent event of new anti-cancer medication; discuss implications for the trial design and decision-making; emphasize the importance of the specific mechanism bringing about the hypothetical scenario, when determining whether the use of a hypothetical strategy is reasonable. Illustrate how in some settings the use of a hypothetical scenario may not be appropriate.

Chair

Marian Mitroiu, PhD

Speaker

EMA Update
Francesco Pignatti, MD

FDA Update
Cesar Daniel Torres, PhD, MS

MEB Update
Laura Rodwell, PhD


Speakers
avatar for Marian Mitroiu

Marian Mitroiu

Associate Director Biostatistics, Biogen, Switzerland
Marian is from Romania. In 2015-2016 he did a traineeship at EMA in London at the Biostatistics and Methodology Office. In 2017, he started his doctoral studies at Julius Center, UMC Utrecht and Utrecht University. He worked in parallel at CBG-MEB, being part of the Methodology Working... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Laura Rodwell

Laura Rodwell

Statistical Assessor, Dutch Medicines Evaluation Board, Netherlands
Laura has been working in research and biostatistics in one way or another for the past 20 years. After starting her career in crime research she became more interested in medical research and clinical trials. She completed her Master of Biostatistics in 2010 and a PhD in Biostatistics... Read More →
avatar for Cesar Torres

Cesar Torres

Senior Mathematical Statistician, OB, OTS, CDER, FDA, United States
Cesar received his B.S. in Probability & Statistics at the University of California, San Diego, before completing his graduate studies at the University of Washington’s Department of Biostatistics. He now works at the FDA’s Center for Drug Evaluation and Research as a reviewer... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session