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#222: Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
Tuesday June 17, 2025 10:30am - 11:30am EDT
204ABC
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-569-L04-P; CME 1.00; RN 1.00

This session examines innovative regulatory strategies and validation approaches for developing diagnostics for rare biomarkers, focusing on oncology and how to optimize the use of alternative data sources and regulatory flexibilities to enhance test

Learning Objectives

Identify regulatory flexibilities and strategies to support the development of diagnostics for rare biomarkers in oncology; Recognize approaches for leveraging alternative data sources to validate diagnostics, including real-world data, alternative samples, and in silico methods.

Chair

Hillary Andrews, PhD

Speaker

Establishing a National Clinical Laboratory Network of Validated Assays
Chris Karlovich, PhD

Regulatory Considerations and Strategies for Rare Biomarker Validation
Dun Liang, PhD

Discuss challenges and best practices for CDx validation
Elaine Katrivanos

Provide global regulatory expectations, challenges, and approaches
Chris Bray


Speakers
avatar for Hillary Andrews

Hillary Andrews

Director, Regulatory and Research Partnerships, Friends of Cancer Research, United States
Hillary Andrews serves as the Director, Regulatory and Research Partnerships at Friends of Cancer Research (Friends) where she supports the development and implementation of the organization’s research and policy agenda. She uses her scientific and advocacy background to develop... Read More →
avatar for Chris Bray

Chris Bray

Head of Global Regulatory Affairs Precision Medicine & Companion Diagnostics, Merck Serono Ltd., United Kingdom
Chris has worked within the biotechnology and pharma industry for over 25 years, including over 20 years in the IVD and personalized healthcare space. He has a successful track record in CDx and drug (co-) development, collaborating with global teams to deliver on precision medicine... Read More →
avatar for Chris Karlovich

Chris Karlovich

Director, Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, United States
Chris Karlovich Ph.D. is Director of the Molecular Characterization (MoCha) Laboratory at the Frederick National Laboratory (FNL). Since joining FNL in 2017, he has made key contributions to several important NCI precision medicine initiatives. Among these was NCI-MATCH, the largest... Read More →
avatar for Elaine Katrivanos

Elaine Katrivanos

Vice President Regulatory Affairs, Tempus AI, United States
Elaine Katrivanos is Vice President, Regulatory Affairs at Tempus Labs, Inc. and, in this role, is responsible for leading the Regulatory Affairs department. Prior to joining Tempus, Elaine was a global regulatory lead in pharmaceutical drug development at AstraZeneca. Before that... Read More →
avatar for Dun Liang

Dun Liang

Director, Global Regulatory Affairs, Diagnostics, Eli Lilly & Co., United States
Dun is a diagnostics and regulatory expert uniquely positioned at the intersection of pharma, diagnostics, and regulation. At Eli Lilly, he provides critical guidance, interpretation, risk assessments, and troubleshooting on precision medicine strategy globally. He coordinates and... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

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