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TB Public Workshop Agenda, June 7-8, 2010

Advancing the Development of Diagnostic Tests 
and Biomarkers for Tuberculosis

 

Monday June 7, 2010

 

8:00 a.m.

Registration

 

8:30 a.m.

Welcome: Workshop Objectives and Structure

FDA perspective: Leonard Sacks

CDC perspective: Ken Castro

NIH/NIAID perspective: Christine Sizemore

 

 

Background, Current Research, and Barriers

Moderator: Christine Sizemore, NIH

9:00 a.m.

The Current Status of TB Diagnostics

Phyllis Della-Latta, Columbia University

 

9:30 a.m.

Clinical and Research Priorities for TB Diagnostics

Richard Chaisson, Johns Hopkins University

10:00 a.m.

Break

 

10:15 a.m.

Current Research and Development in TB Diagnostics and Biomarkers: Microbiological/Molecular/Immunological/’nomic’ 
Approaches

John Belisle, Colorado State University

 

10:45 a.m.

New Platforms to be Considered for TB Diagnostics

Maria Giovanni, NIH/NIAID

  

11:15 a.m.

Panel Discussion

  • What technologies and biological specimens appear most
    promising for answering critical questions?
  • What are the challenges to advancing TB diagnostics and
    biomarkers?
  • What are the gaps/needs that must be addressed?

Moderator: Christine Sizemore

Panel:

  • John Belisle, University of Colorado
  • Richard Chaisson, Johns Hopkins University
  • Phyllis Della-Latta, Columbia University
  • Maria Giovanni, NIH/NIAID

 

12:00 p.m.

Lunch

 

Regulatory Perspective

Moderator: Bonnie Plikaytis, CDC

1:00 p.m.

FDA Perspective

Sally Hojvat, FDA

 

1:20 p.m.

European Perspective

Mair Powell, Medicines and Healthcare Products 
Regulatory Agency

 

1:40 p.m.

Discussion and Questions

 

Resources for Developing New TB Diagnostics

Moderator: Bonnie Plikaytis, CDC

2:00 p.m.

NIH/NIAID Funding Opportunities 

Barbara Mulach, NIH/NIAID

 

2:15 p.m.

Integration of Clinical Trials with Diagnostics

Jan Gheuens, Bill & Melinda Gates Foundation

 

2:30 p.m.

RFP Point of Care Diagnostics for Global Health

Boris Nikolic, Bill & Melinda Gates Foundation

 

2:45 p.m.

Break

 

 

3:00 p.m.

 

 

 

Clinical Diagnostics Research Consortium (CDRC)

Susan Dorman, Johns Hopkins University

Jerry Ellner, Boston University

3:25 p.m.

AIDS Clinical Trials Group (ACTG)

Annie Luetkemeyer, University of California, San Francisco

 

Development of a TB Repository

 

3:45 p.m.

 

Experience from the WHO/TDR RB Repository

Martine Guillerm, WHO/TDR

4:05 p.m.

WHO/TDR's Perspective on TB Diagnostics

Francis Moussy, WHO/TDR

 

Other Repository Models

 

4:25 p.m.

Perspective of the Aspergillus Technology Consortium (AsTeC)
Dennis Dixon NIH/NIAID

 

4:45 p.m.

Discussion and Questions

 

5:15 p.m.

Adjourn

 

Tuesday, June 8, 2010

 

8:00 a.m.

Welcome and Summary of Day 1
Bonnie Plikaytis CDC/NCHHSTP

 

Key Note Presentations

 

8:15 a.m.

The Gates Foundation Perspective and Initiatives 
in Developing TB Diagnostics

Peter Small, Gates Foundation

 

8:45 a.m.

The FIND Perspective on Implementing and Initiatives for 
TB Diagnostics

Mark Perkins, Foundation for Innovative Diagnostics

 

Industry Perspective on the Development of TB Diagnostics and Biomarkers

Moderator: Susan Dorman, Johns Hopkins University

 

 

9:15 a.m.

Diagnostic Development

Gen-Probe, Incorporated: Vivian Jonas

9:30 a.m.

Cepheid: David Persing

 

9:45 a.m.

Pharmaceutical Development

Tibotec: David McNeeley

 

10:00 a.m.

 

Break
10:20 a.m.

Development of a TB Clinical Trial Repository

Melvin Spigelman, Global Alliance for Tuberculosis

 

10:45 a.m.

Roundtable Discussion:

  • The role of FDA, CDC, and NIH in addressing unmet needs
    in advancing the development, evaluation, and implementation
    of TB diagnostics
  • The advantages and limitations of a 'frozen trial initiative' as
    part of an international TB repository and how sample repositories
    could improve the pipeline for the development and validation of
    high-quality diagnostic tests. What are the advantages and
    limitations of a ‘frozen trial initiative’ as part of an international
    TB repository and to what extent will an open repository of
    samples increase the pipeline of improved, high-quality
    diagnostic tests?
  • What can we learn from clinical trials about diagnostic needs?
  • How can a specimen/isolate repository address regulatory, industry,
    and public health needs?

Moderator: Susan Dorman, Johns Hopkins University

Panel:

    • Philip LoBue, CDC  
    • David McNeeley, Tibotec
    • Eileen Navarro, FDA
    • Mark Perkins, Foundation for Innovative Diagnostics
    • Christine Sizemore, NIH/NIAID
    • Peter Small, Bill and Melinda Gates Foundation
    • Melvin Spigelman, Global Alliance for Tuberculosis
12:00 p.m.

Introduction to Afternoon Session

Steven Gitterman, FDA

12:05 p.m.

Lunch

 

1:00 p.m.

Strategy Development

  • Developing a Collaboration on a Frozen Trial Initiative (Rationale, 
    Scope, Establishment, Governance, Logistics, Partners, Funding)

Co-moderators:

Leonard Sacks, FDA

Michael Iademarco, (OS)

 

Panel

    • Dennis Dixon, NIH
    • Kenneth Castro
    • Jerry Ellner, Boston University
    • Jan Gheuens, Bill & Melinda Gates Foundation
    • Martine Guillerm, WHO
    • Sally Hojvat, FDA
    • Vivian Jonas, GenProve, Incorporated
    • Annie Luetkemeyer, University of California, San Francisco
    • David McNeeley, Tibotec
    • Francis Moussy, WHO
    • Eileen Navarro, FDA
    • Mark Perkins, Foundation for Innovative Diagnostics
    • David Persing, Cepheid
    • Mair Powell, MHRA
    • Peter Small, Bill & Melinda Gates Foundation
    • Melvin Spigelman, Global Alliance for Tuberculosis
    • Jim Vaught, NCI
    • Carolyn Wilson, FDA
    • Kenneth Castro, CDC
    • William MacKenzie, CDC
    • Richard Hafner, NIH
    • Susan Swindells, ACTG

4:00 p.m.

Adjourn