Workshop
Event Title
FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers
March 23 - 24, 2022
- Date:
- March 23 - 24, 2022
- Day1:
- - ET
- Day2:
- - ET
Attend
Agenda:
The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group will convene a virtual workshop on March 23-24, 2022, 1-3 PM (ET) with title “Identification of Concepts and Terminology for Multi-Component Biomarkers”. The workshop is intended to develop multi-component biomarker concepts and terminology, to identify areas of conceptual language development through presentation of use cases, and discuss gaps in terminology for concepts and approaches related to multi-component biomarkers. You can find more information on the goals and objectives of the symposium here.
The symposium will be accessible to the public via live webcast. Please register online to receive an email with the instructions on how to join this event. Additionally, there are pre-recorded talks that will be available to the public three weeks prior to the live event, and participants are highly encouraged to view the presentations before attending the live discussions.
Pre-recorded introduction to multi-component biomarkers and biomarker terminology
10 minutes |
Introduction by the FDA Biomarker Working Group Co-chairs
Multi-component biomarkers - Set the stage for the other sessions (where we are, where we are going) Daniel Krainak (FDA/ CDRH) and Abena Agyeman (FDA/CDER)
|
45 minutes |
Keynote lecture (TBD) |
10 minutes |
BEST: A Resource for Effective Communication Lisa McShane, PhD, Chief, Biometric Research Program, National Cancer Institute, NIH
|
20 minutes |
Biomarkers and Drug Development: A Regulatory Perspective Jeffrey Siegel, MD, PhD (FDA/ CDER)
|
30 minutes |
Multi-markers in Test Evaluation Patrick Bossuyt, PhD, Professor of Clinical Epidemiology, Biomarker and Test Evaluation Research Program, University of Amsterdam
|
Pre-recorded talks of biomarker in clinical setting
|
|
20 minutes |
Prognostic & Predictive Biomarkers for Detection of Early/Acute HIV-1 Infection Krishnakumar Devadas, PhD, Staff Scientist, Laboratory of Molecular Virology (FDA/ CBER)
|
20 minutes |
Predictive Biomarker Homologous Recombination Deficiency (HRD) in Ovarian Cancer Francisca Reyes Turcu, PhD, Senior Scientific Reviewer (FDA/ CDRH)
|
20 minutes |
iBox Scoring System: A composite surrogate for long-term graft loss after kidney transplantation Amanda Klein, PharmD CDCES, Interim Executive Director, Transplant Therapeutics Consortium (C-Path)
|
20 minutes |
Prognostic Biomarker for the Enrichment/Identification of Subjects with Knee Osteoarthritis Steve Hoffmann, Associate Vice president for Research and Partnership, FNIH Biomarker Consortium
|
20 minutes |
Biomarker Test to Identify Risk of Moderate or Severe Acute Kidney Injury (AKI) in Intensive Care Patients Following Acute Cardiovascular or Respiratory Compromise Irene Tebbs, PhD, Scientific Reviewer (FDA/ CDRH)
|
20 minutes |
Biomarkers to Identify Exposure to Harmful or Potentially Harmful Constituents in Tobacco Smoke Stephen Hecht, PhD, Wallin Land Grant Professor of Cancer Prevention, University of Minnesota
|
Live Virtual Discussion
(4 hours total: 2 hours on Day 1; 2 hours on Day 2)
Day 1 |
March 23rd, 2022 |
15 minutes |
Introduction Day 1 – Setting the Stage/ Highlights of the Background Talks BWG co-chairs Daniel Krainak (FDA/ CDRH) and Abena Agyeman (FDA/CDER)
|
5 minutes |
Summary of Prognostic & Predictive Biomarkers for Detection of Early/Acute HIV-1 Infection Krishnakumar Devadas, PhD, Staff Scientist, Laboratory of Molecular Virology (FDA/ CBER)
|
5 minutes |
Summary of Predictive Biomarker Homologous Recombination Deficiency (HRD) in Ovarian Cancer Francisca Reyes Turcu, PhD, Senior Scientific Reviewer, (FDA/ CDRH)
|
30 minutes |
Panel Discussion 1 – Fluid Biomarkers 1 and Comments
Moderator: Abbas Bandukwala (FDA/ CDER) Panelists: Robert Schuck (FDA/ CDER), Krishnakumar Devadas (FDA/ CBER), Indira Hewlett (FDA/ CBER); Francisca Reyes Turcu, PhD (FDA/ CDRH)
|
5 minutes |
Summary of Biomarker Test to Identify Risk of Moderate or Severe Acute Kidney Injury (AKI) in Intensive Care Patients Following Acute Cardiovascular or Respiratory Compromise Irene Tebbs, PhD, Scientific Reviewer (FDA/ CDRH)
|
5 minutes |
Summary of Biomarkers to Identify Exposure to Harmful or Potentially Harmful Constituents in Tobacco Smoke Stephen Hecht, PhD, Wallin Land Grant Professor of Cancer Prevention, University of Minnesota
|
30 minutes |
Panel Discussion 2 – Fluid Biomarkers 2 and Comments
Moderator: Theresa Thekkudan (FDA/CTP) Panelists: Irene Tebbs (FDA/ CDRH), Stephen Hecht (Univ. of Minnesota), Cindy Chang (FDA/ CTP), Kellie Kelm (FDA/ CDRH)
|
15 minutes |
Wrap up Day 1 |
Day 2 |
March 24th, 2022 |
5 minutes |
Introduction Day 2 – brief summary of Day 1, reminder of goals for workshop BWG co-chairs Daniel Krainak (FDA/ CDRH) and Abena Agyeman (FDA/CDER)
|
5 minutes |
Summary of iBox Scoring System: A composite surrogate for long-term graft loss after kidney transplantation Amanda Klein, PharmD CDCES, Interim Executive Director, Transplant Therapeutics Consortium (C-Path)
|
5 minutes |
Summary of Prognostic Biomarker for the Enrichment/Identification of Subjects with Knee Osteoarthritis Steve Hoffmann, Associate Vice president for Research and Partnership, FNIH Biomarker Consortium
|
30 minutes |
Panel Discussion 3 and Comments
Moderator: Abena Agyeman (FDA/ CDER) Panelists: Jeffrey Siegel (FDA/ CDER), Steve Hoffmann (FNIH), Nicholas King (C-Path), Klaus Romero (C-Path), Daniel Krainak (FDA/ CDRH), Soma Ghosh (FDA/ CDRH)
|
5 minutes |
Summary Panel Discussion 1 - Fluid Biomarkers 1 Abbas Bandukwala (FDA/ CDER)
|
5 minutes |
Summary Panel Discussion 2 - Fluid Biomarkers 2 Theresa Thekkudan (FDA/ CTP)
|
5 minutes |
Summary Panel Discussion 3 – Imaging Biomarkers Abena Agyeman (FDA/ CDER)
|
45 minutes |
Common Themes and Concepts Panel Discussion and Comments
Moderator: Sue-Jane Wang (FDA/ CDER) Panelists: Patrick Bossuyt (Univ. of Amsterdam), Steve Hoffmann (FNIH), Samir Lababidi (FDA/ OC), Phillip Turfle (FDA/ CVM); Lisa McShane (NCI/NIH)
|
15 minutes
|
Workshop Wrap-up & Next Steps Jeffrey Siegel (FDA/ CDER) |
Event Materials
Title | File Type/Size |
---|---|
MultiComponentBiomarkerWorkshop 1-Pager Description Clean 1.14.2022 | pdf (77.34 KB) |
Agenda Composite Biomarker Workshop Final | pdf (42.09 KB) |