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  4. FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers - 03/23/2022
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Workshop | Virtual

Event Title
FDA Public Meeting: Identification of Concepts and Terminology for Multi-Component Biomarkers
March 23 - 24, 2022

Date:
March 23 - 24, 2022
Day1:
Wed, Mar 23
Day2:
Thu, Mar 24

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

 

Multi-Component Biomarkers: Promise, Practice and Perspective on Terminology

John Wagner, MD, PhD. Chief Medical Officer at Koneksa Health

 

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 (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 Assess Likelihood of Progression to Cirrhosis or Clinical Outcomes in Patients with Advanced Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

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
1:00 – 1:15

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
1:15 – 1:20

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
1:20 – 1:25

Summary of Predictive Biomarker Homologous Recombination Deficiency (HRD) in Ovarian Cancer

Francisca Reyes Turcu, PhD, Senior Scientific Reviewer, (FDA/ CDRH)

 

30 minutes
1:25 – 1:55

Panel Discussion 1 – Fluid Biomarkers 1 and Comments

 

Moderator: Abbas Bandukwala (FDA/ CDER)

Panelists: Robert Schuck (FDA/ CDER), Krishnakumar Devadas (FDA/ CBER), Francisca Reyes Turcu, PhD (FDA/ CDRH), Nicholas King (C-Path)

 

5 minutes
2:00 – 2:05

Biomarker Test to Assess Likelihood of Progression to Cirrhosis or Clinical Outcomes in Patients with Advanced Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

Irene Tebbs, PhD, Scientific Reviewer (FDA/ CDRH)

 

5 minutes
2:05 – 2:10

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
2:10 – 2:40

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
2:40 – 2:55

Wrap up Day 1
 

 

 

Day 2

March 24th, 2022

5 minutes
1:00 – 1:05

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
1:05 – 1:10

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
1:10 – 1:15

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
1:15 – 1:45

Panel Discussion 3 and Comments

 

Moderator: Abena Agyeman (FDA/ CDER)

Panelists: Jeffrey Siegel (FDA/ CDER), Steve Hoffmann (FNIH), Klaus Romero (C-Path), Daniel Krainak (FDA/ CDRH), Soma Ghosh (FDA/ CDRH), Amanda Klein (C-Path)

 

5 minutes
1:45 – 1:50

Summary Panel Discussion 1 - Fluid Biomarkers 1

Abbas Bandukwala (FDA/ CDER)

 

5 minutes
1:50 – 1:55

Summary Panel Discussion 2 - Fluid Biomarkers 2

Theresa Thekkudan (FDA/ CTP)

 

5 minutes
1:55 – 2:00

Summary Panel Discussion 3 – Imaging Biomarkers

Abena Agyeman (FDA/ CDER)

 

45 minutes
2:00 – 2:45

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), John Wagner (Koneksa Health)

 

15 minutes
2:45 – 3:00

 

Workshop Wrap-up & Next Steps

Jeffrey Siegel (FDA/ CDER)

 

Meeting Recordings

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