Progress and retooling needs as Progress and retooling needs as perceived by developersperceived by developers

Retooling Task Force work planning meeting

15-16 January 2008

Dr Giorgio RoscignoCEO – FIND

Health Health PostPost

ReferralReferralHospitalHospital

MicroscopyMicroscopyCenterCenter

20122007 2009 2010Level

AntibodyDetection

AntigenDetection

Eiken NAAT

Zeiss LED

MGIT MTB/DST

Capilia

Biotec DST

Projects 20112008

Hain DST

Quantiferon

Cepheid NAAT

Evaluation

Access

AccessSTAG

Demonstration AccessSTAG

Demonstration AccessSTAG

Feasibility &Development

Evaluation Demo AccessSTAG

EvaluationFeasibility Develop Demonstration AccessSTAG

EvaluationFeasibility &Development Demonstration AccessSTAG

EvaluationFeasibility & Development Demonstration AccessSTAG

EvaluationFeasibility & Development Demonstration AccessSTAG

I

A

ASTAG Impact

IImpact

IImpact

IImpact

A

A

ImpactDemonstration Access ASTAG

IImpactA

IImpact

IImpact

A

A

FIND has a rich set of products in the pipeline intended for the different levels of the health system which are developed and evaluated following a well-defined process from feasibility onwards…

FIND’s perspective:

Project phases & milestones

PHASES

Milestones

Output

FIND

FeasibilityContract

phase Development

phaseEvaluation

phaseDemonstration

phaseGlobal Policy

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Registration

Customer support documentMarketing

plan

FeasibilityContract

phase Development

phaseEvaluation

phaseDemonstration

phaseGlobal Policy

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Impact

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Customer support document

FINDPARTNERSPARTNERS

Marketing plan

Partnership Strategy

But achieving impact requires engagement with the retooling process, once new tools are adopted into global policy

Laboratory preparedness for introduction of new technologies requires addressing:

• Infrastructure and equipment

• Staffing and training• Biosafety aspects• Development of SOPs• QA systems

At the appropriate level of the health care system

(Hardware)

(Software)

Adoption into globalPolicy

Global Impact

Collecting evidence for scaling up

• Uptake in pilot countries• Accreditation /franchising• Laboratory Support• Measuring Impact

Development, Evaluation, Demonstrationphases

WHO

Link to PEPFAR, Global Fund, other initiatives

Scaling up and continued adoption

FIND’s approach:

• Facilitate introduction of new technologies in selected countries

• Concentrate on “software”, and collaborate with partners who can provide “hardware”

• Document experience and knowledge for widescale replication elsewhere

And is based on:– Product requirements– Local needs and capacity– Level of healthcare system where product will be used– Collaboration with Ministries of Health based on a signed MOU– Adapted to the national context

Emerging Economies Low-income/Asia Low-income/Africa

China, India, S. Africa, Russia, Brazil Indonesia, Bangladesh, Pakistan, Philippines, Afghanistan, Cambodia, Myanmar, Vietnam, etc.

DR Congo, Ethiopia, Kenya, Mozambique, Nigeria, Uganda, Tanzania, etc.

• Better funding available, mostly from national budget

• Human resource capacity stronger• Private for-profit sector role often

considerable

• More dependent on international donors for funding

• Moderate human resource capacity• Current lab services weak to moderate• Private for-profit role significant

• Very dependent on international donors• Generally weak human resource

capacity• Current lab services weak• Private for-profit role present, but

variable

• Large NTLP with established reference lab (#8/22 HBC)

• PEPFAR and other partners present with support for HIV/AIDS and TB programs

• NTLP identified continued gap on “software” side

NTLP has requested support from FIND to:•Provide long term, technical assistance over many months

•Support integration of new diagnostic technologies into NTLP at reference (automated liquid culture) and regional levels (manual liquid culture)

FIND approach to retooling: Example 1: Ethiopia

• No TB reference laboratory existed

• Focus was on referral level

Please refer to WHO presentation

FIND approach to retooling: Example 2: Lesotho

• Large NTLP (#14/22 HBC)

• Multiple partners present with resources for infrastructure, equipment procurement

• NTLP turned to FIND for support with “software”

In collaboration with other partners, FIND is:•Supporting national referral laboratory for preparation for introduction of liquid culture, including: planning for upgrading infrastructure to meet bio-safety requirements (see next)

•Reinforcing quality assurance systems

FIND approach to retooling: Example 3: Tanzania

– Excellent in case finding with a quality assured microscopy services offered in more than 12000 microscopy centres under the NTP

– But fewer competent NRLs

FIND input:

MOU signed with the Health Ministry Government of India and State Government of Rajasthan

FIND/INDIA office started in New Delhi on 1st Oct,2007

Step 1 - Introduce novel technology at all 3 GLC identified DOTS plus sites in Delhi , Ahmadabad and Nagpur & establish a training site in Jaipur, Rajasthan

Appoint Microbiologists at the above sites and a study coordinator

FIND approach to retooling: Example 4: India

FIND’s perspective on retooling: Conclusion

Adoption into globalPolicy

Collecting evidence for scaling up

Global Impact

• Uptake in pilot countries• Accreditation /franchising• Laboratory Support• Measuring Impact

Development, Evaluation, Demonstrationphases

WHO

Link to PEPFAR, Global Fund, other initiatives

Scaling up and continued adoption

FIND

Partners

FIND

Partners

Retooling to prepare laboratories for the introduction of new diagnostic technologies cannot be done alone…but in partnership