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Tuesday, June 17
 

10:30am EDT

Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Advanced

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, Leidos Biomedical 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 →
EK

Elaine Katrivanos

Senior Director Regulatory Affairs, Tempus AI, United States
DL

Dun Liang

Director, Global Regulatory Affairs, Diagnostics, Eli Lilly & Co., United States
Dun is a diagnostics and regulatory expert with unique experience across pharma, diagnostics, and government. At Eli Lilly, He provides critical strategic and tactical guidance, interpretation, and assessments on diagnostic regulations globally. He coordinates, plans, and executes... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD 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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    00: Plenary
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    01: ClinSafety-PV
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    02: ClinTrials-Ops
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    08: RD-Quality-Compliance
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    11: Statistics-Data Science
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    14: DIAmond
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    15: Content-Hubs
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    16: Community-Rounds
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    17: Posters
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    18: InnovationTheaters
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    20: Short-Courses
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  • Level
    Advanced
    Basic
    Intermediate
  • Keyword
    Advanced Analytics
    Artificial Intelligence (AI)
    Bioethics
    Biomarkers
    Cell and Gene Therapy
    Clinical Trial Design
    Diagnostics
    Digital Technology
    Global Perspectives
    Non-CE
    Patient Experience
    Payers
    Pediatrics
    Rare Disease
    Real-World Data (RWD) / Real-World Evidence (RWE)
    Regulator Perspectives
    Regulatory Collaboration
    Regulatory Convergence and Harmonization
    Regulatory Reliance
    Student Programming
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EH
TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming