Next Generation TB Diagnostics An Update from BMGF. Lee Pyne-Mercier
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1 Next Generation TB Diagnostics An Update from BMGF Lee Pyne-Mercier November 2012
2 Presentation Outline Foundation Strategic Context Next Generation TB Diagnostics Program TB Diagnostics Forum November 13, Bill & Melinda Gates Foundation 2
3 Presentation Outline Foundation Strategic Context Next Generation TB Diagnostics Program TB Diagnostics Forum November 13, Bill & Melinda Gates Foundation 3
4 TB Strategy : Goal and vision of success Impact goal Accelerate the reduction of global TB incidence Vaccines 1 vaccine candidate in phase 3 Drugs 1 TB drug regimen in phase 3 Diagnostics Country-level Innovation in TB Control Global Access and Market Dynamics 1 new TB biomarker identified 2 new molecular diagnostics endorsed by WHO STAG Increase national TB budgets Accelerated uptake of innovative TB control New products with frugal engineering Reduced costs of FDC and second-line drugs Accelerated uptake of innovation in target countries and globally Advocacy Funding secured for one TB vaccine and one TB drug phase 3 clinical trial November 13, Bill & Melinda Gates Foundation 4
5 Presentation Outline Foundation Strategic Context Next Generation TB Diagnostics Program TB Diagnostics Forum November 13, Bill & Melinda Gates Foundation 5
6 Significant Progress To Date in TB Diagnostics; Challenges Remain November 13, Bill & Melinda Gates Foundation 6
7 November 13, Bill & Melinda Gates Foundation 7
8 Fast-follower NAATs are rapidly entering the market Loopamp by Eiken, Japan TrueLab by Molbio, India GeneDrive by Epistem, UK NATeasy by Ustar, China
9
10 Simple and Affordable Molecular Testing for Tuberculosis To support the creation of a validated, lowcost, nucleic-acid assay for clinical TB detection on platforms capable of operation in rudimentary laboratories in low-resource settings. It is our intention for these assays to be to created and validated for use within months November 13, Bill & Melinda Gates Foundation 10
11 Target Product Profile Key Characteristics Characteristic Optimal Minimal Cost of consumables < $4 < $8 Cost of instrument < $5,000 < $10,000 Time to market < 24 mos < 36 mos Specificity > 99% > 97% Sensitivity > 98% smear-positive and 80% smear-negative patients 95% of smear-positive and 65% smear-negative patients Sample Prep & processing Integrated Minimal, < 5 steps Time to result < 1 hour < 2 hours Sample type Sputum Sputum Drug resistance screening Detection of Rif, FQ, and INH resistance testing via a separate cartridge with additional consumable cost (Reflex Testing) Training <.5 day < 1 day Rifampin drug resistance testing via a separate cartridge with additional consumable cost (Reflex Testing) Full TPP Available: November 13, Bill & Melinda Gates Foundation 11
12 Presentation Outline Foundation Strategic Context Next Generation TB Diagnostics Program TB Diagnostics Forum November 13, Bill & Melinda Gates Foundation 12
13 Problem Statement Progress is accelerating on drug regimens (REMox, PaMZ) Desire to save new drugs from resistance Historic underinvestment in TB R&D has led to significant unknowns, specifically related to DST for key regimen components Lack of coordination between researchers, drug developers, and the public health community that will be needed to achieve a common goal November 13, Bill & Melinda Gates Foundation 13
14 Background and Purpose TB Diagnostics Forum established in 2012 in collaboration with NIH Overall purpose is to facilitate: Communication and discussion of research priorities, research gap areas, and new relevant data Coordination of research and research funding Collaboration on select projects The Diagnostics Forum has identified rapid drug susceptibility testing as an initial topic of focus.
15 Proposed Structure TB Diagnostics Research Forum Coordinating Committee NIH, CDC, BMGF, WHO, EDCTP Forum Coordinator Enabling Science Workgroup Chair: David Sherman (Seattle Biomed) Modeling Workgroup Chair: David Dowdy (JHU) Surveillance Workgroup Chair: Bonnie Plikaytis (CDC) Assay Development Workgroup Chair: Mark Perkins (FIND) Program Management Support November 13, Bill & Melinda Gates Foundation 15
16 Coordinated timeline BMGF Activities Drug Development Bedaquiline Delaminid REMox PaMZ Next Generation TB Diagnostics Next Generation Diagnostic Development Next Generation Diagnostic Development Enabling Science for Rapid DST (e.g. PZA) TB Diagnostics Forum Enhanced Drug Resistance Surveillance Rapid DST Development/Adaptation TB Biomarker Program Phase 1 Modeling to Support Rapid DST Project Field Validation of Leads November 13, Bill & Melinda Gates Foundation 16
17 Grand Challenge: Biomarkers for the Diagnosis of TB $7.7M invested in 10 projects, 24 month grants Program Goal: support innovative research to facilitate development of a low-cost, simple-touse tool that can quickly and accurately diagnose TB in developing countries Investigators are evaluating both host and pathogen markers in highly characterized clinical samples through partnership with FIND Concurrent development of TPPs for POC diagnostics to inform decisions grandchallenges.org/biomarkers November 13, Bill & Melinda Gates Foundation 17
18 Thank You 2012 Bill & Melinda Gates Foundation. All Rights Reserved. Bill & Melinda Gates Foundation is a registered trademark in the United States and other countries.
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