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Wednesday, June 17 • 8:00am - 9:00am
#306 L: Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-589-L04-P; CME 1.00; IACET 1.00; RN 1.00

Describe ongoing pilot efforts by statistical and clinical reviewers at FDA to create ‘default’ estimands for different therapeutic areas. Clinical and statistical teams’ experience on estimands in pulmonary-allergy and other areas will be discussed.

Learning Objectives

Discuss the Agency’s pilot experiences and opinions on estimands in a few clinical settings from the regulatory perspective; Demonstrate the value to statisticians and clinicians for clearly understanding medical questions by defining appropriate estimands.

Chair

Yongman Kim, PhD

Speaker

Estimands and ICH E9 (R1): Adoption and Challenges - 3 Years Later
Munish Mehra, PhD, MS, MSc

Estimands Approach Taken in Analgesia and Thoughts for the Future
David M. Petullo, MSc

Why Clinicians are Interested in Estimands: How it Helps Their Reviews and What They Wish to Achieve
Rekha Jhamnani, MD

Estimands Approach Taken in Pulmonology-Allergy-Critical Care Statistics at CDER FDA
Susan Duke, MSc



Speakers
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
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... Read More →
avatar for Susan Mayo

Susan Mayo

Mathematical Statistician, OB, DB3, OTS, CDER, FDA, United States
Susanis is a Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. She became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG, which lead to subsequent interests... Read More →
DP

David Petullo

Mathematical Statistician, OB, OTS, CDER, FDA
David has worked in the pharmaceutical industry for over 20 years with experience at Walter Reed, Human Genome Sciences, Eli Lilly, and FDA. He is currently working as team leader supporting Gastroenterology but worked for over 10 years supporting the Division of Analgesia, Anesthesia... Read More →
avatar for Yongman Kim

Yongman Kim

Lead Mathematical Statistician, OB, OTS, CDER, FDA
Yongman Kim is currently leading an FDA statistical team supporting pulmonary-allergy product review division for about 3 years after reviewing analgesia and rheumatology products about 14 years. Prior to joining FDA, he worked for several drug companies 7 and half years in areas... Read More →
RJ

Rekha Jhamnani

Medical Officer, DPARP, OND, CDER, FDA
Rekha Jhamnani is a medical officer in the Division of Pulmonary Allergy and Critical Care 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... Read More →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session