WHO Expert Working Group WHO Expert Working Group on R&D Financingon R&D Financing

Stop TB New Tools Working GroupsStop TB New Tools Working Groups

Marcos EspinalMarcos EspinalExecutive SecretaryExecutive Secretary

Stop TB PartnershipStop TB Partnership

What: What: A global social movement to Stop A global social movement to Stop TBTB– Need for multisectoral approach Need for multisectoral approach – New opportunities to work in partnershipNew opportunities to work in partnership

Vision: Vision: A TB-free worldA TB-free world Mission:Mission:

– Ensure that every TB patient has access to effective Ensure that every TB patient has access to effective diagnosis, treatment and curediagnosis, treatment and cure

– Stop transmission of TBStop transmission of TB

– Reduce the inequitable social and economic toll of TBReduce the inequitable social and economic toll of TB

– Develop and implement new preventive, diagnostic Develop and implement new preventive, diagnostic and therapeutic tools and strategies to stop TBand therapeutic tools and strategies to stop TB

Targets for global TB controlMILLENNIUM DEVELOPMENT GOALS"to have halted and begun to reverse

incidence.."

Implementation (DOTS) Target year

Case detection 70% 2005Treatment success 85% 2004/5

ImpactPrevalence 50% of ≈ 300/100K 2015Deaths 50% of ≈ 30/100K (<1m) 2015Incidence <1 per million 2050

Principles and Principles and Values of Stop TBValues of Stop TB

1.1. UrgencyUrgency

2.2. EquityEquity

3.3. Shared responsibilityShared responsibility

4.4. InclusivenessInclusiveness

5.5. ConsensusConsensus

6.6. SustainabilitySustainability

7.7. Dynamism Dynamism

Governance and Governance and StructureStructure

New TB Drugs

TB/HIV MDR-TBNew TB

DiagnosticsDOTS

expansion

W O R K I N G G R O U P SW O R K I N G G R O U P S

New TBVaccines

Global Partners Forum

Global TB Drug Facility Coordinating BoardPartnership Secretariat

WHO TechnicalAdvisory Group

Advocacy NetworkAdvocacy NetworkAdvocacy NetworkAdvocacy Network

Partnership towards Partnership towards Stop TB TargetsStop TB Targets

Partners Forum

Coordinating Board

Secretariat/GDF

Goals & Targets

DOTS Expansion

WG

TB/HIVWG

DOTS-PlusMDRTB WG

New Drugs WG

TB DiagnosticsWG

New VaccinesWG

Communication/Advocacy WG

The Global Plan to Stop TB

The Global PlanThe Global Plan

1. 10-year perspective on the road to 20502. Response to country needs for long-term planning3. Outlines financial requirements for sustainability4. A pathway towards the Partnership's targets for 2015 and

goal for 20505. A Plan with credibility will serve a key advocacy role6. Treatment of 50 million people with TB, 3 million TB/HIV

co-infected patients on ARV, and ~ 1 million with MDR7. Saving of 14 million lives from 2006-2015

8. The first new TB drug introduced by 20109. The "point of care" diagnostics introduced by 201010.Develop a new vaccine by 2015

Research & Development WGsResearch & Development WGs

By 2006 By 2010 By 2015

vaccines 3 vaccines

in phase I trials

9 candidates

in phase II trials; at least 2 vaccines in "proof of concept" trials; beginning phase III trials

4 phase III trials carried out;

one safe, effective vaccine available

drugs 27 new compounds

in the pipeline

1-2 new drugs registered;

treatment shortened to 3-4 months

7 new drugs;

treatment shortened to 1-2 months

diagnostics rapid culture for case detection and DST in demonstration phase

point of care, rapid culture, improved microscopy, phage detection, simplified

NAAT

predictive test for LTBI

Global Plan: $ 56 bn cost by type of investment

DiagnosticUS$ 0.5 bn

DrugsUS$ 4.8 bnVaccines

US$ 3.6 bn

ACSM US$ 2.9 bn DOTS

Expansion US$ 32 bn

DOTS Plus US$ 5.8 bn

TB/HIV US$ 6.8 bn

Funding gap: $ 31 bn

Total costs for implementation Total costs for implementation and new tools, 2006-2015and new tools, 2006-2015

1212

Global Plan: The Next Decade of TB R&D

Research $206.0 M

Clinical Trials Demonstration $211.0 M

Clinical Trials Evaluation $80.0 M

Clinical Trials Support $12.0 M

Working Group Operations $6.0 M

Regulatory Approval $1.0 M

Discovery$1.4 B

BCG Programmes$1.5 B

Development$31.0 M

Vaccine Production$217.0 M

WG Operations$69.0 M

Clinical Trials $457.0 M

Infrastructure$69.0 M

Lead Optimization $2.2 B

Clinical Trials $2.4 B

Basic Research $57.0 M

Preclinical $126.0 M

Regulatory Approval $6.0 M

Working Group Operations $2.0 M

Diagnostics Diagnostics $0.52B$0.52B

Vaccines Vaccines $3.6 B$3.6 B

Drugs Drugs $4.8B $4.8B

BMGF has committed more than 900 million US$ to the Global Plan needs on R&D

Mission & Mission & Objectives of Stop Objectives of Stop TB Vaccine WGTB Vaccine WG

I. Mission To ensure the availability of a safe, effective and reasonably priced

new TB vaccine by 2015

II. Objectives Coordinate international activities that strengthen and accelerate the

development and introduction of improved TB vaccines

Promote a concerted approach to development and introduction of improved TB vaccines by encouraging interactions among groups involved in scientific research, clinical/epidemiological investigations, industrial development, regulatory and public health programs

Develop and implement a strategic action plan for the Initiative for Vaccine Research program at WHO to provide a framework for the development, clinical study and introduction of improved TB vaccines

Interact with Partners to identify significant impediments to commercial development of improved TB vaccines and establish mechanisms for cooperation and collaborations that lead to accelerated vaccine development

2003 2004

Governance and Governance and working working environmentenvironment Chair: Michel Greco, Parterurop, France Secretariat: Uli Fruth, Initiative for Vaccine Research, WHO Core Group: Various Stakeholders Sub-groups:

Innovative approaches to new TB vaccines Harmonization of laboratory assays for TB vaccine development Clinical research issues Advocacy for TB vaccine Economics and product profiles

WG meets once a year, sets its own agenda and workplan Partners in the WG maintain their own independence and plans Funded in part by the Stop TB Partnership Secretariat (50% of

its operational budget) and partners Liaison Officer in the Partnership Secretariat

2003 2004

preclinical clinical trials manufacture

promote global access

promote global access

Role of the Working Group on New Vaccines

Gates (Aeras)EU (TB-VAC, EDCTP)

NIH, Wellcome . .

Developing new TB vaccines

Target

Actual

Targets Actual

By 2006 5 vaccines in phase I trials

8 vaccines candidates have entered clinical trials, and some have moved beyond Phase I.

By 20109 candidates in phase II trials; at least 2 vaccines in "proof of concept" trials; beginning phase III trials

Two vaccines candidates have entered Phase II clinical trials.

By 2015

4 phase III trials carried out. One safe, effective, licensed vaccine available

NA

Recommendation 7: The Partnership should continue to use Working Groups as a major vehicle contributing to TB control and research, systematize the processes for their establishment and performance review, and provide them support from the Secretariat

Independent Evaluation of the Stop TB Partnership. Final Report. 21 April 2008. Mckinsey & Company.

2003 2004