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

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

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

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

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

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

8:00 a.m.

Welcome and Summary of Day 1
Bonnie Plikaytis CDC/NCHHSTP

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

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.

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

Introduction to Afternoon Session

Steven Gitterman, FDA

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