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Sheraton Philadelphia Downtown Hotel

Oct 24, 2024 7:30 AM - Oct 25, 2024 4:10 PM

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 3: RWD Innovations in Late Phase and Postmarket Settings: A Review of Use Cases

Session Chair(s)

Camille  Jackson

Camille Jackson

Director, Regulatory Policy; Legal and Regulatory

Flatiron Health , United States

Real world data can help answer a number of research questions across the drug development lifecycle using innovative study designs and technology. This session will explore recent use cases involving innovations in applying real world data in late phase and postmarket settings. A panel of experts from industry and RWD organizations will share learnings from utilizing registry-based randomized controlled trials (R-RCTs) to improve drug development efficiency, implementing clinical trial linkage to RWD to gain deeper insights to a drug’s benefits and risks, and exploring new ways for studying the medication safety during pregnancy through innovations in post-approval pregnancy safety studies (PA-PSS).

Learning Objective :
  • Describe the current landscape using recent use cases of RWD innovations in the late phase and postmarket settings
  • Describe the best practices for trial linkage and strategies to overcome some of the common challenges in implementation
  • Incorporate regulatory considerations into the design of registry-based RCTs and PA-PSS

Speaker(s)

Mehdi  Najafzadeh, PhD, MA, MS

Implementing Clinical Trial Linkage to Real-World Data (RWD)

Mehdi Najafzadeh, PhD, MA, MS

Medidata Solutions, United States

Senior Director

Jingyu (Julia)  Luan, PhD

Utilize Registry-based RCT to Improve Drug Development Efficiency: DAPA-MI as a Case Study

Jingyu (Julia) Luan, PhD

AstraZeneca, United States

Executive Regulatory Science Director, BioPharmaceuticals R&D

Krista Marie Schroeder, MHS, PhD

Post-Approval Pregnancy Safety Study (PA-PSS) Innovations: New Ways for Studying the Safety of Medications During Pregnancy

Krista Marie Schroeder, MHS, PhD

Eli Lilly and Company, United States

Director, Global Patient Safety, Pharmacoepidemiology

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