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  4. Identification of Concepts and Terminology for Multi-Component Biomarkers Workshop - 03/23/2020
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Workshop | Mixed

Event Title
Identification of Concepts and Terminology for Multi-Component Biomarkers Workshop
March 23, 2020

March 23, 2020
Event Location
FDA, White Oak Campus, The Great Room
Building 31

10903 New Hampshire Avenue
Silver Spring, MD 20903
United States


A foundational discussion on the concepts, hierarchy, and terminology used in the multi-component biomarker domain

About this Event

The format for this meeting will include case examples to showcase conceptual terminology needs, followed by panel and public discussions of the needs demonstrated in the case examples. There will be a final session that synthesizes the identified concepts and discussion of hierarchies and related conceptual areas to conclude the meeting.

A draft agenda is included below:


Emerging Conceptual Language for Multi-Component Biomarkers and their Application in Decision-making
Dr. Robert Califf, M.D., Duke University

Session 1

  • BEST: A resource for effective communication
    C. Leptak, CDER, OND
  • Biomarkers and drug development: A Regulatory Perspective
    C. Leptak, CDER, OND

Session 2: Imaging Biomarkers

  • Pharmacodynamic response biomarker measuring Crohn’s Disease activity as a co­primary endpoint
    John Michael Sauer, Program Officer of the Biomarkers Program, Critical Path Institute
  • Prognostic biomarker for the enrichment/identification of subjects with knee osteoarthritis
    Stephanie Cush, Ph.D., Lead, Inflammation and Immunology Steering Committee, FNIH Biomarkers Consortium
  • Moderator & Panel/Public discussion and comment

Session 3: Fluid Biomarkers 1

  • Prognostic and predictive biomarkers for detection of early/acute HIV-1 infection
    Indira Hewlett (alt Dr. Devadas), CBER
  • Predictive biomarker Homologous recombination deficiency (HRD) in ovarian cancer
    Sarah Dorff, Ph.D., Biologist, OTS/OCP, CDER
  • Moderator & Panel/Public discussion and comment

Session 4: Fluid Biomarkers 2

  • Safety biomarker (Nephrocheck immunoassay) identifying potential for post-cardiac or respiratory event related renal injury
    Irene Tebbs, CDRH (Point of Contact Kellie Kelm)
  • Biomarkers to identify exposure to harmful or potentially harmful constituents in tobacco smoke
    Stephen Hecht, Ph.D., Wallin Professor of Cancer Prevention/ American Cancer Society Professor/American Chemical Society Fellow/Masonic Cancer Center/University of Minnesota
  • Moderator & Panel/Public discussion and comment

Session 5: Common Themes and Concepts

  • Common Themes Panel discussion: Set questions
  • Close-out of Public/Panel discussion

Webcast Information

The webcast is accessible through the following link. LOGIN as a GUEST with your FULL NAME via the Event Login URL at 7:30 AM EST on 3/23/20: CERSI Conferences

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