LIVE WEBINAR
Tuesday, November 17th | 11am ET
Duration: 1 hour
Can't make the live date? Register and we'll send you a link to the recording. ​

Regulatory pathways in oncology are evolving rapidly, but for emerging pharma and biotech, generating credible comparative evidence is only getting harder. External control arms (ECAs) built on real-world data sourced directly from EHR systems offer a path forward–providing the clinical depth, timeliness, and rigor needed to hold up under regulatory scrutiny where historical benchmarks and traditional data sources may fall short.

In this webinar you’ll learn: 

• Regulatory considerations when evaluating external control arms today, and what it takes to count as credible evidence in a submission
• How ECAs can inform go/no-go decisions, refine trial design and strengthen single-arm results before you file 
• How RWD has been used in ECAs that contributed to a regulatory approval, and what sets them apart

SPEAKERS

Edgar Simard, PhD, MPH
Executive Director, Head of Epidemiology & RWD Strategy
Revolution Medicines
 

James Roose
Director, Research Services
Flatiron Health
 

Marie Bradley, PhD, MPharm, MSc
​Division Director of Real-World Evidence Analytics Office of Innovation and Clinical Trial Modernization
Office of Medical Policy, Center for Drug Evaluation and Research, FDA
 

Donna Rivera, PharmD, MSc, FISPE
Executive Vice President, Clinical Evidence Modernization
Canal Row Advisors
 

Christian Hampp, PhD, FISPE
Senior Director, Pharmacoepidemiology
Regeneron Pharmaceuticals, Inc.
 

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Jessica Davies, MPH
Scientific Director, Clinical Development & Multimodal Solutions
Flatiron Health