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#560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-590-L04-P; CME 1.00; RN 1.00

Novel endpoints, biomarkers, and digital tools offer transformative potential but face regulatory acceptance challenges. Explore current landscape, successful case studies, and strategies for enhanced regulatory engagement through collaboration.

Learning Objectives

Discuss the current FDA regulatory framework for novel endpoints, biomarkers, and digital tools; Identify key challenges and gaps in regulatory acceptance and validation; Examine strategies for enhancing regulatory engagement and scientific alignment; Apply lessons from case studies and partnerships to future development programs.

Chair

Pujita Vaidya, MPH

Speaker

Industry Perspective
M. Khair ElZarrad, PHD, MPH

Duke Margolis Perspective
Valerie J. Parker, MSC

Industry Perspective
Lauren Tobe, JD


Speakers
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Vice President, Regulatory Policy, BridgeBio, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Valerie Parker

Valerie Parker

Assistant Research Director, Duke-Margolis Institute For Health Policy, United States
Valerie J. Parker is an Assistant Research Director at the Duke-Margolis Institute for Health Policy. Valerie manages one of the institute’s cooperative agreements with the US FDA as well as oversees a core workstream of the institute’s Real-World Evidence Collaborative, where... Read More →
avatar for Lauren Tobe

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →
avatar for Pujita Vaidya

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States
Pujita Vaidya has 13+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

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