

Pancreatic cancer drug development may be entering a new phase. As emerging targeted therapies raise the possibility of a fundamentally different standard of care, sponsors could increasingly confront a familiar but more urgent challenge in oncology: how to generate robust, credible comparative evidence when traditional randomization is no longer feasible, ethical, or aligned with evolving patient and clinical expectations.
This webinar will examine the growing role of external controls in pancreatic cancer trial design. Our experts will discuss how sponsors can use high-quality patient-level data from historical clinical trials to support hybrid and single-arm studies, contextualize treatment effects, and prepare for regulatory conversations in a fast-moving treatment landscape.
Join us for this session to explore:
We’ll also share exclusive perspectives from Medidata’s recent participation in the pancreatic cancer external control arm validation work with Friends of Cancer Research, presented publicly in April 2026. You’ll learn what makes pancreatic cancer a timely use case for external controls, what evidence standards matter most, and how sponsors can begin planning now for trials designed around the realities of tomorrow’s standard of care.

Ruthanna “Ruthie” Davi is Senior Vice President, Clinical Data and Regulatory Innovation Solutions at Medidata, and has a background in pharmaceutical clinical trials with more than 20 years working at the FDA, most recently as a Deputy Division Director in the Office of Biostatistics in CDER. At Medidata Ruthie is part of a team using data science to create analytical tools to improve the efficiency and rigor of clinical trials. Ruthie’s recent work is focused on creation and analysis of synthetic or external controls, and she has numerous publications on this topic. Ruthie holds a Ph.D. in Biostatistics from George Washington University.

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). For over 25 years, Friends has created unique scientific partnerships, accelerated policy change, and supported groundbreaking research to deliver new therapies to patients quickly and safely. As a key thought leader on issues related to the U.S. Food and Drug Administration, healthcare, and regulatory policy, he is regularly published in prestigious medical journals and policy publications and has contributed his expertise to the legislative process on multiple occasions. Recent Friends initiatives include the establishment of the Breakthrough Therapies designation, innovative research consortia to enhance biomarker development, and the launch of a unique cross-sector partnership to accelerate clinical trial conduct and rapidly assess if a patient’s treatment is working. Jeff received his Ph.D. in cell and molecular biology from Georgetown University and holds a Bachelor of Science in Biology from Bowling Green State University.