TASK FORCE ON RETOOLINGTASK FORCE ON RETOOLING

STOP TB PARTNERSHIP

Cape Town November 2007

BackgroundBackground

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

The Global Plan to The Global Plan to Stop TB 2006-2015Stop TB 2006-2015

NEW TOOLS ARE ON THE WAY: PIPELINESNEW 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

RationaleRationale

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 communityChallenge 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

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

What is Retooling?What is Retooling?

““Retooling” is defined as.. Retooling” is defined as.. ““Retooling” is defined as.. Retooling” is defined as..

The process of preparing for The process of preparing for Adoption and Introduction of Adoption and Introduction of New Diagnostics, Drugs and New Diagnostics, Drugs and

Vaccines in TB controlVaccines in TB control

The process of preparing for The process of preparing for Adoption and Introduction of Adoption and Introduction of New Diagnostics, Drugs and New Diagnostics, Drugs and

Vaccines in TB controlVaccines in TB control

Plan for adoption and introduction of new toolsPlan for adoption and introduction of new tools Create framework for policy-makers and Create framework for policy-makers and

practitioners to accelerate introduction of new toolspractitioners to accelerate introduction of new tools Clarify processes to move from trials to policy and Clarify processes to move from trials to policy and

implementationimplementation Engage stakeholders from high TB burden countriesEngage stakeholders from high TB burden countries Learn from other disease communities Learn from other disease communities Fast-track effective new tools into WHO and Fast-track effective new tools into WHO and

national policiesnational policies Link all working groups around the theme of Link all working groups around the theme of

retoolingretooling

Plan for adoption and introduction of new toolsPlan for adoption and introduction of new tools Create framework for policy-makers and Create framework for policy-makers and

practitioners to accelerate introduction of new toolspractitioners to accelerate introduction of new tools Clarify processes to move from trials to policy and Clarify processes to move from trials to policy and

implementationimplementation Engage stakeholders from high TB burden countriesEngage stakeholders from high TB burden countries Learn from other disease communities Learn from other disease communities Fast-track effective new tools into WHO and Fast-track effective new tools into WHO and

national policiesnational policies Link all working groups around the theme of Link all working groups around the theme of

retoolingretooling

GoalsGoals

“New technologies for TB control: a Framework on their Adoption, Introduction and Implementation”

Objectives of the guideObjectives of the guideObjectives of the guideObjectives of the guide

Provide a common framework to discuss the Provide a common framework to discuss the adoption of new tools for TB control;adoption of new tools for TB control;

Identify some key issues that need to be addressed Identify some key issues that need to be addressed to accelerate the adoption and implementation; and to accelerate the adoption and implementation; and

Provide guidance on what actions are needed for Provide guidance on what actions are needed for adoption, access and proper use of tools by the adoption, access and proper use of tools by the community as they become available.community as they become available.

Provide a common framework to discuss the Provide a common framework to discuss the adoption of new tools for TB control;adoption of new tools for TB control;

Identify some key issues that need to be addressed Identify some key issues that need to be addressed to accelerate the adoption and implementation; and to accelerate the adoption and implementation; and

Provide guidance on what actions are needed for Provide guidance on what actions are needed for adoption, access and proper use of tools by the adoption, access and proper use of tools by the community as they become available.community as they become available.

Publications

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

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?

Liquid Media for Culture and Drug Susceptibility Testing Liquid Media for Culture and Drug Susceptibility Testing (LMC-DST)(LMC-DST)

Generic checklist for TB Diagnostics developed by Generic checklist for TB Diagnostics developed by Retooling Task Force was customized and adapted Retooling Task Force was customized and adapted specifically for LMC-DSTspecifically for LMC-DST

Based on expert opinion, further refinement was Based on expert opinion, further refinement was mademade

Checklist was sent to 27 NTP managers with copies Checklist was sent to 27 NTP managers with copies to WHO regional representatives soliciting their to WHO regional representatives soliciting their feedback and commentsfeedback and comments

Refined checklist will be finalized and widely Refined checklist will be finalized and widely disseminateddisseminated

Similar checklists for each upcoming new technology Similar checklists for each upcoming new technology will be developed as they become availablewill be developed as they become available

Annex 2Annex 2

Checklist of Key Actions for DiagnosticsChecklist of Key Actions for Diagnostics

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

National Implementation

ADOPTION

INTRODUCTION

AND

IMPLEMENTATION

Pre-launch Year 1 Year 2 Year 3

Global Policy

Manufacturing Arrangements

National Policy Development

Planning & Budgeting

Regulatory

Guidelines, Training, and

ACSM

Procurement and Distribution

Quality Assurance

Pharmaco-vigilance

Monitoring and Evaluation

Regulatory operational guides, tools, SOPs, product specific documents

Health systems review, options & cost benefit analysis

Decision making & policy recommend-ations

Establish taskforce

Product registration & licensing

Develop/revise guidelinesDevelop training plan & training materials

Establish monitoring plan

7 8 9 10 11 12

WHO prequalification

Develop supervisory plan

1 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6 7 8 9 10 11 121 2 3 4 5 6

Ongoing ACSM training to support new product use

Implement ACSM strategy

Develop and implement quantification, procurement and distribution plan

Conduct post-marketing surveillance Ongoing ADR monitoring

Establish/Strengthen existing system for pharmacovigilance

Monitor scale up and adjust procurement and distribution plans

Develop local and national QA as neededInfrastructure systems strengthening as needed to meet criteria for start up

Engagement in global policymakingOperations research

PricingGlobal ForecastsSupply Agreements

Implement nationwide training

Phase-in (roll out new TB technologies)

Monitor efficacy and use of product

Global support for implementation

Global and country indicators

Update WHO Guidelines, EML, EMDL, Model Formulary, etc.

Ongoing Global ForecastsGDF list, access to international procurement service agencies

Develop phase-in planIdentify financial resourcesOutline budget for implementation

Monitor product pipelineStakeholder discussion, compile evidence, build consensus, establish policy, develop guidelines, and recommendations

Engagement of NTP and NRL managers

Train core trainers

Establish ACSM strategy and materials

Time-limited

Continuous

Phase out old products as applicable

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 PublicationAvailable beginning 2008

Pilot project PhilippinesPilot project Philippines

Field testing framework and stakeholder Field testing framework and stakeholder engagement planengagement plan

Utilized existing technical working groupUtilized existing technical working group– Private sector, NGOs, donors, DoH, lab servicesPrivate sector, NGOs, donors, DoH, lab services

Useful process to engage partners and plan jointly Useful process to engage partners and plan jointly Lessons learnedLessons learned

Engaging Stakeholders for Retooling TB Control

• Advocacy Package: Executive summary, FAQs, Overview on Retooling, Postcard

Arabic, Chinese, English, French, Spanish & Russian

• WHO Weekly Epidemiological Record

Recent Publications

For further informationFor further information

Website: www.stoptb.org/retoolingEmail: stoptbretooling@who.int

Learn Learn MoreMore!!

Retooling Task Force ForumRetooling Task Force Forum

Friday, November 9Friday, November 9

8:30 am – Noon8:30 am – Noon

Roof Terrace RoomRoof Terrace Room