Transcript Task Force on Retooling []

TASK FORCE ON RETOOLING
STOP TB PARTNERSHIP
Cape Town
November 2007
Background
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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
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
Rationale
Lessons learned
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
What is Retooling?
“Retooling” is defined as..
The process of preparing for
Adoption and Introduction of
New Diagnostics, Drugs and
Vaccines in TB control
Goals
Plan for adoption and 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
 Engage stakeholders from high TB burden countries
 Learn from other disease communities
 Fast-track effective new tools into WHO and national
policies
 Link all working groups around the theme of retooling
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Publications
“New technologies for TB control: a
Framework on their Adoption,
Introduction and Implementation”
Objectives of the guide
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Provide a common framework to discuss the adoption of
new tools for TB control;
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Identify some key issues that need to be addressed to
accelerate the adoption and implementation; and
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Provide guidance on what actions are needed for adoption,
access and proper use of tools by the community as they
become available.
Structure of the
document
CHALLENGES
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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
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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
Annex 1
What is in the TB Pipeline?
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 2
Checklist of Key Actions for Diagnostics
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
 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
 Refined checklist will be finalized and widely disseminated
 Similar checklists for each upcoming new technology will be
developed as they become available
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Annex 3:
Timeline for Adoption and
Implementation (illustrative)
Pre-launch
Year 1
1
Global Policy
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Stakeholder discussion, compile evidence,
build consensus, establish policy, develop
guidelines, and recommendations
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7
Year 2
8
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Year 3
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Monitor product pipeline
Time-limited
Engagement of NTP and NRL managers
Manufacturing
Arrangements
National Policy
Development
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2
Global support for
implementation
National
Implementation
Planning &
Budgeting
Regulatory
Guidelines,
Training, and
ACSM
Continuous
Pricing
Global Forecasts
Supply Agreements
Engagement in global policymaking
Operations research
Health
systems
review,
options &
cost benefit
analysis
Decision
making &
policy
recommendations
Update WHO Guidelines, EML,
EMDL, Model Formulary, etc.
Regulatory operational guides, tools,
SOPs, product specific documents
GDF list, access to international
procurement service agencies
WHO prequalification
Establish taskforce
Ongoing Global Forecasts
Global and country indicators
Develop phase-in plan
Identify financial resources
Outline budget for implementation
Product registration & licensing
Develop/revise guidelines
Develop training plan & training materials
Train core trainers
Implement nationwide training
Establish ACSM strategy and
materials
Procurement
and Distribution
Quality
Assurance
Pharmacovigilance
Develop and implement
quantification, procurement and
distribution plan
Phase-in (roll out new TB technologies)
Phase out old products as applicable
Develop local and national QA as needed
Infrastructure systems strengthening as needed to meet criteria for start up
Establish/Strengthen existing system for pharmacovigilance
Establish monitoring plan
Monitoring and
Evaluation
Ongoing ACSM training to support new
product use
Implement ACSM strategy
Develop supervisory plan
Conduct post-marketing surveillance
Ongoing ADR monitoring
Monitor scale up and adjust procurement and
distribution plans
Monitor efficacy and use of product
New Publication
Available beginning 2008
Engaging Stakeholders for Retooling TB Control
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Why, who, when and how to engage stakeholders?
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illustrative lists of global, regional, and country level
stakeholders;
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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.
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simple tools for preparing a stakeholder analysis and
a stakeholders engagement plan
Engaging Stakeholders for
Retooling TB Control
Pilot project Philippines
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Field testing framework and stakeholder engagement
plan
Utilized existing technical working group
– Private sector, NGOs, donors, DoH, lab services
Useful process to engage partners and plan jointly
Lessons learned
Recent Publications
• Advocacy Package:
Executive summary, FAQs, Overview on Retooling, Postcard
Arabic, Chinese, English, French, Spanish & Russian
• WHO Weekly Epidemiological Record
For further information
Website: www.stoptb.org/retooling
Email: [email protected]
Learn More!
Retooling Task Force Forum
Friday, November 9
8:30 am – Noon
Roof Terrace Room