1. TASK FORCE ON RETOOLING STOP TB PARTNERSHIP Cape Town November 2007

2. Background   1.6 million people died in 2005   Challenges: MDR-TB & XDR-TB; TB/HIV  MEDICINES  More than 40 years old  Treatment course: 6–9 months  Generate drug resistance  DIAGNOSTICS  More than a century old and  Insensitive (HIV coinfection)  No indication of drug susceptibility  VACCINES  More than 85 years old  Marginal protection for infants and very young  MEDICINES  More than 40 years old  Treatment course: 6–9 months  Generate drug resistance  DIAGNOSTICS  More than a century old and  Insensitive (HIV coinfection)  No indication of drug susceptibility  VACCINES  More than 85 years old  Marginal protection for infants and very young

3. The Global Plan to Stop TB 2006-2015 NEW TOOLS ARE ON THE WAY: PIPELINES DRUGS 7 Clinical stage, Phase I and II 3 Preclinical stage 3 Discovery stage DIAGNOSTICS 6 at Reference lab 5 at Peripheral lab 2 at Health post VACCINES 2 viral vectored vaccines 2 modified recombinant BCG 3 protein subunit vaccines 1 bacteria-vectored vaccines

4. Rationale Lesson learned from previous experience with other communicable diseases show significant delays between the availability of new tools and use at country levels Challenge to the TB community Coordinated action by the Stop TB community at global and national levels for timely adoption and introduction of new tools as they become available The Board ’ s response The Coordinating Board, Abuja, April 2006, established the Task Force on Retooling Lessons learned

5. What is Retooling? “Retooling” is defined as.. The process of preparing for Adoption and Introduction of New Diagnostics, Drugs and Vaccines in TB control

6. Plan for adoption and introduction of new tools Plan for adoption and introduction of new tools Create framework for policy-makers and practitioners to accelerate introduction of new tools Create framework for policy-makers and practitioners to accelerate introduction of new tools Clarify processes to move from trials to policy and implementation Clarify processes to move from trials to policy and implementation Engage stakeholders from high TB burden countries Engage stakeholders from high TB burden countries Learn from other disease communities Learn from other disease communities Fast-track effective new tools into WHO and national policies Fast-track effective new tools into WHO and national policies Link all working groups around the theme of retooling Link all working groups around the theme of retooling Plan for adoption and introduction of new tools Plan for adoption and introduction of new tools Create framework for policy-makers and practitioners to accelerate introduction of new tools Create framework for policy-makers and practitioners to accelerate introduction of new tools Clarify processes to move from trials to policy and implementation Clarify processes to move from trials to policy and implementation Engage stakeholders from high TB burden countries Engage stakeholders from high TB burden countries Learn from other disease communities Learn from other disease communities Fast-track effective new tools into WHO and national policies Fast-track effective new tools into WHO and national policies Link all working groups around the theme of retooling Link all working groups around the theme of retooling Goals

7. “New technologies for TB control: a Framework on their Adoption, Introduction and Implementation” Objectives of the guide  Provide a common framework to discuss the adoption of new tools for TB control;  Identify some key issues that need to be addressed to accelerate the adoption and implementation; and  Provide guidance on what actions are needed for adoption, access and proper use of tools by the community as they become available.  Provide a common framework to discuss the adoption of new tools for TB control;  Identify some key issues that need to be addressed to accelerate the adoption and implementation; and  Provide guidance on what actions are needed for adoption, access and proper use of tools by the community as they become available. Publications

8. Structure of the document CHALLENGES   Systemic and programmatic readiness for change.   Adoption and development of new policy   Introduction and implementation of new tools TECHNICAL and OPERATIONAL   Annexes 1 to 4 Provides an overview of selected new medicines, diagnostics and vaccines in the pipeline; Lists key actions for the adoption and implementation of each technology category; Provides illustrative generic timeline for adoption, introduction and implementation; Lists key readings that provide more detailed discussions of the issues and road maps Provides an overview of selected new medicines, diagnostics and vaccines in the pipeline; Lists key actions for the adoption and implementation of each technology category; Provides illustrative generic timeline for adoption, introduction and implementation; Lists key readings that provide more detailed discussions of the issues and road maps

9. Overview of selected new medicines, diagnostics and vaccines in the TB pipeline First publication in November 2006 More tools since the launch of the Global Plan to Stop TB Annual Update by the Drugs, Diagnostics and Vaccines Working Groups of the Stop TB Partnership Annex 1 What is in the TB Pipeline?

10. Liquid Media for Culture and Drug Susceptibility Testing (LMC-DST) Generic checklist for TB Diagnostics developed by Retooling Task Force was customized and adapted specifically for LMC-DST Generic checklist for TB Diagnostics developed by Retooling Task Force was customized and adapted specifically for LMC-DST Based on expert opinion, further refinement was made Based on expert opinion, further refinement was made Checklist was sent to 27 NTP managers with copies to WHO regional representatives soliciting their feedback and comments Checklist was sent to 27 NTP managers with copies to WHO regional representatives soliciting their feedback and comments Refined checklist will be finalized and widely disseminated Refined checklist will be finalized and widely disseminated Similar checklists for each upcoming new technology will be developed as they become available Similar checklists for each upcoming new technology will be developed as they become available Annex 2 Checklist of Key Actions for Diagnostics

11. Annex 3: Timeline for Adoption and Implementation (illustrative)

12. Why, who, when and how to engage stakeholders? illustrative lists of global, regional, and country level stakeholders; selected examples of stakeholder engagement for: – – adoption and introduction of fixed dose combination in the Philippines and South Africa; – – adoption of Artemisinin-based combination therapy in Nepal, and; – – engaging the community for home based management of fever in Rwanda. simple tools for preparing a stakeholder analysis and a stakeholders engagement plan Engaging Stakeholders for Retooling TB Control New Publication Available beginning 2008

13. Pilot project Philippines Field testing framework and stakeholder engagement plan Field testing framework and stakeholder engagement plan Utilized existing technical working group Utilized existing technical working group –Private sector, NGOs, donors, DoH, lab services Useful process to engage partners and plan jointly Useful process to engage partners and plan jointly Lessons learned Lessons learned Engaging Stakeholders for Retooling TB Control

14. Advocacy Package: Executive summary, FAQs, Overview on Retooling, Postcard Arabic, Chinese, English, French, Spanish & Russian WHO Weekly Epidemiological Record Recent Publications

15. For further information Website: www.stoptb.org/retoolingwww.stoptb.org/retooling Email: stoptbretooling@who.int

16. Learn More ! Retooling Task Force Forum Friday, November 9 8:30 am – Noon Roof Terrace Room