POC Diagnostics Initiative, Grand Challenges Exploration, TB RFP
Gene WaltherDeputy Director - Diagnostics
Shanghai, China
26 September, 2012
Agenda
Point of Care Initiative
Grand Challenges Exploration
Tuberculosis Request for Proposal
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Point-of-Care Diagnostics Initiative
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What is Point-of-Care (POC)?
Point-of-Care Testing:
Testing that is performed near or at the site of patient care with the result leading to possible change in the course of care of the patient. Testing that is performed outside a central laboratory environment, generally nearer to, or at the site of the patient. Also referred to as “near-patient” testing, or “point-of-need testing.
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Defining the Target Use Setting
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CONFIDENTIAL
Level 1Health centers and health posts
Level 2District Labs and
Hospitals
Level 3Regional/Provincial
Reference Labs
Level 4National
Reference Labs/Hospitals
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Access to a New Diagnostic Depends on the Level of Infrastructure Available
Advanced/Moderate
• Hospitals andurban clinics
• Electricity,clean water,well-equippedlaboratories,trained clinicians
Minimal
• Health clinics (Africa),rural clinics (Asia,Latin America)
• No reliable electricityor clean water, no laboratory, minimalexpertise
None
• Village or community
• No electricity,clean water, physical infrastructure, ortrained staff
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POC Dx Initiative Goals
Develop an open point of care instrument platform capable of delivering optimum performance
Establish interoperability standards to encourage menu expansion by competing companies/sources
Reduce barriers to entry into the GH markets by eliminating the need for expensive instrument development
Achieve a harmonized regulatory environment
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Global Health Challenges Delivery
• Poorly defined Target Product Profiles• Limited product menu• Understanding of what tests are needed Technical
• Interoperability• Technology requirements Regulatory
• Inefficient regulatory systems Business
• Poor ROI’s• FTO requires significant royalty stacking• Lack of efficient distribution channels in developing world• Unclear funding structure
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Grand Challenges Exploration
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Grand Challenges Exploration
Goal: Break down the barriers in global health so innovation can come from
anyone anywhere
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Grand Challenges | Explorations
Why is this program different?
Low Burden of Entry• Two page proposals: define idea and aims• No preliminary data required• “Blind” review• Accelerated review
Champion Based Review• Each proposal independently reviewed 4-6 times
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Grand Challenges | Explorations Innovation Anyone Anywhere
Profile of our winners:Academic
Not-for-profits
Industry (over 20 companies)
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Grand Challenges | Explorations Topics
Limit Drug Resistance Protect Against Infectious Disease Cure HIV Infection Latency in Tuberculosis Vaccines Eradication of Malaria Low-Cost Diagnostics Induce Mucosal Immunity Contraception Cell Phone-Based Applications Improve the Health of Mothers and Newborns
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Tuberculosis Request For Proposals Objective: creation of a validated, low-cost, nucleic-acid assay
for clinical TB detection on platforms capable of operation in Level 1 laboratories
It is our intention for these assays to be to created and validated for use within 24-36 months
Some examples of projects that would be considered within the scope of this Program:• Improvement of an existing assay for tuberculosis• Development of a tuberculosis assay on an existing platform• Development of sputum processing methods or automation to
complement a platform or assay• Clinical trials for tuberculosis assays
Projects that would be considered outside the scope of this Program:• Development of a new molecular platform
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Tuberculosis Request For Proposals
Final Request for Letters of Intent (LOI) released
• Wednesday, September 26, 2012
Letters of Intent (LOI) due
• Friday, December 14, 2012
Invitations for Full Proposals sent• February, 2013
Full proposals due
• April, 2013
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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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