1. Progress and retooling needs as perceived by developers Retooling Task Force work planning meeting 15-16 January 2008 Dr Giorgio Roscigno CEO – FIND

2. 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:

3. Project phases & milestones PHASES Milestones Output FIND Feasibility Contra ct phase Develo pment phase Evalu ation phase Demonst ration phase Glob al Polic y 2365471 Customer Requirements Specifications 8 Natio nal Practi ce Imp act Customer support document WHO guidelines Effectiveness Efficacy Product in box Effectiveness & Access Registration Customer support document Marketing plan Feasibility Contra ct phase Develo pment phase Evalu ation phase Demonst ration phase Glob al Polic y 2365471 Customer Requirements Specifications 8 Natio nal Practi ce Imp act Customer support document WHO guidelines Effectiveness Efficacy Product in box Effectiveness & Access Registration Customer support document FIND PARTNERS Marketing plan Partnership Strategy

4. 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 global Policy Global Impact Collecting evidence for scaling up Uptake in pilot countries Accreditation /franchising Laboratory Support Measuring Impact Development, Evaluation, Demonstration phases WHO Link to PEPFAR, Global Fund, other initiatives Scaling up and continued adoption

5. 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 EconomiesLow-income/AsiaLow-income/Africa China, India, S. Africa, Russia, BrazilIndonesia, 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

6. 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

7. No TB reference laboratory existed Focus was on referral level Please refer to WHO presentation FIND approach to retooling: Example 2: Lesotho

8. 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

9. –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 1 st 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

10. FIND’s perspective on retooling: Conclusion Retooling to prepare laboratories for the introduction of new diagnostic technologies cannot be done alone…but in partnership