poc diagnostics initiative, grand challenges exploration

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

October 26, 2012 © 2012 Bill & Melinda Gates Foundation | 2

Point-of-Care Diagnostics Initiative

September 25, 2012 © 2012 Bill & Melinda Gates Foundation | 3

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.


Defining the Target Use Setting


CONFIDENTIAL

Level 1Health centers and health posts

Level 2District Labs and

Hospitals

Level 3Regional/Provincial

Reference Labs

Level 4National

Reference Labs/Hospitals


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

6

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


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



Goal: Break down the barriers in global health so innovation can come from

anyone anywhere


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


Grand Challenges | Explorations Innovation Anyone Anywhere

Profile of our winners:Academic

Not-for-profits

Industry (over 20 companies)


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


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


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


poc diagnostics initiative, grand challenges exploration

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