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Wednesday, June 22 • 9:15am - 10:15am
#311: Ahead of Analyses: Planning, Designing, and Pre-Specifying Observational Studies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-604-L04-P ; CME 1.00; RN 1.00

This session features regulator, pharmaceutical industry, and real-world data provider speakers discussing key considerations for designing observational studies that may be considered for regulatory decision-making

Learning Objectives

Describe the steps involved in the design of an observational study intended to support a regulatory submission; Discuss key real-world data (RWD) source and study development considerations for both the sponsor and the real-world data/evidence (RWD/E) provider


Jillian Mae Rockland, MPH


Case Study
Matthew Rioth, MD, MSc

Case Study
David James Nimke, DrPH, MPH

Case Study
Robert Kalesnik-Orszulak, PharmD

avatar for Robert Kalesnik-Orszulak

Robert Kalesnik-Orszulak

Director, Regulatory Innovation Lead for RWE and Data Science, Bristol Myers Squibb, United States
Rob Kalesnik-Orszulak is the Regulatory Innovation Lead for Real World Evidence (RWE) and Data Science at Bristol Myers Squibb (BMS). In this role, he is responsible for establishing the regulatory department's expertise, capabilities, and strategy around RWE from a regulatory perspective... Read More →
avatar for David Nimke

David Nimke

Senior Director, Real World Evidence- US Advanced Informatics and Analytics, Astellas, United States
David is the Real World Evidence – US and Digital Information Products Lead at Astellas Advanced Informatics and Analytics. His team of observational researchers and analysts conduct research using secondary use databases. Prior to this role, he worked in pharmacoepidemiology and... Read More →
avatar for Matthew Rioth

Matthew Rioth

Senior Medical Director, Syapse, United States
Dr. Rioth is a medical oncologist and biomedical informaticist at Syapse. As a clinical researcher he has participated in over 100 clinical trials spanning the full spectrum of clinical development. In his role at Syapse he works to use real world data to accelerate cancer resear... Read More →
avatar for Jillian Rockland

Jillian Rockland

Director, Regulatory Strategy, Flatiron Health, United States
Jillian Rockland leads Flatiron Health’s Regulatory Strategy team, which supports Flatiron Health’s life science partners in using RWD/E for regulatory decision-making. Previously, she oversaw Flatiron RWE product and operations, managing the scoping, creation and delivery of... Read More →

Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum