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Monday, June 28 • 2:30pm - 3:30pm
#130 SL: Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

RECIST-based response is an established endpoint in clinical trials, but how do you assess response in routine patient care? This session presents efforts to develop a real-world response endpoint and its utility in clinical development.

Learning Objectives

Describe the utility of measuring treatment response in clinical trials and challenges of accessing it in routine clinical care; Discuss methods, data elements, and rigor needed to evaluate this endpoint and future implications for clinical development.

Chair

Michael W. Lu, PharmD

Speaker

Real-World Response: Harnessing Electronic Health Records to Develop Robust Clinical Endpoints in Solid Tumors
Ariel Bourla, MD, PhD

Application of Real-World Response in Prospective Studies
Michael W. Lu, PharmD

Exploring Real-World Response and Progression Free Survival in the AACR GENIE Biopharma Collaborative
Gregory Riely, MD, PhD



Speakers
avatar for Michael Lu

Michael Lu

Platform Strategy Leader, RWD, Personalized Healthcare Oncology, Genentech, A Member of the Roche Group, United States
Michael Lu serves as a Real World Data Platform Strategy Leader at Genentech. He oversees development efforts in Prospective Evidence Generation and real world endpoints. Leveraging his clinical development experience across Phase I-IV studies with global filing experience, he is... Read More →
AB

Ariel Bourla

Medical Director, Flatiron Health, United States
Ariel Bourla serves as Medical Director at Flatiron Health. She oversees the development of new real-world endpoints and the incorporation of clinical images into the endpoint portfolio. She is also responsible for working with Flatiron’s partners to design prospective real-world... Read More →
GR

Gregory Riely

Vice Chair, Clinical Research, Department of Medicine, Memorial Sloan Kettering Cancer Center, United States
Dr. Gregory Riely is a medical oncologist in the Department of Medicine at Memorial Sloan-Kettering Cancer Center. His primary research focus is in clinical research of patients with non-small cell lung cancer. He completed fellowship training in Medical Oncology at Memorial Sloan-Kettering... Read More →


Monday June 28, 2021 2:30pm - 3:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   03: Data-Data Standards, Session