Transcript WHO Expert Working Group on R&D Financing Stop TB New Tools Working Groups Marcos Espinal Executive Secretary.

WHO Expert Working Group
on R&D Financing
Stop TB New Tools Working Groups
Marcos Espinal
Executive Secretary
Stop TB Partnership

What: A global social movement to Stop TB
– Need for multisectoral approach
– New opportunities to work in partnership
Vision: A TB-free world
 Mission:

– Ensure that every TB patient has access to effective
diagnosis, treatment and cure
– Stop transmission of TB
– Reduce the inequitable social and economic toll of TB
– Develop and implement new preventive, diagnostic and
therapeutic tools and strategies to stop TB
Targets for global TB control
MILLENNIUM DEVELOPMENT GOALS
"to have halted and begun to reverse
incidence.."
Implementation (DOTS)
Case detection
70%
Treatment success 85%
Target year
2005
2004/5
Impact
Prevalence 50% of ≈ 300/100K
2015
Deaths
50% of ≈ 30/100K (<1m) 2015
Incidence <1 per million
2050
Principles and Values
of Stop TB
1.
2.
3.
4.
5.
6.
7.
Urgency
Equity
Shared responsibility
Inclusiveness
Consensus
Sustainability
Dynamism
Governance and Structure
Global Partners Forum
Global TB Drug Facility
Coordinating Board
Partnership Secretariat
W O R K I N G
DOTS
expansion
TB/HIV
MDR-TB
WHO Technical
Advisory Group
G R O U P S
New TB
New TB
Vaccines Diagnostics
Advocacy Network
New TB
Drugs
Partnership towards
Stop TB Targets
TB/HIV
WG
DOTS
Expansion
WG
DOTS-Plus
MDRTB WG
Goals &
Targets
Secretariat/GDF
TB Diagnostics
WG
New Vaccines
WG
Coordinating Board
New Drugs WG
Partners Forum
Communication/
Advocacy WG
The Global Plan to Stop TB
The Global Plan
10-year perspective on the road to 2050
Response to country needs for long-term planning
Outlines financial requirements for sustainability
A pathway towards the Partnership's targets for 2015 and goal for
2050
5. A Plan with credibility will serve a key advocacy role
6. Treatment of 50 million people with TB, 3 million TB/HIV coinfected patients on ARV, and ~ 1 million with MDR
7. Saving of 14 million lives from 2006-2015
1.
2.
3.
4.
8. The first new TB drug introduced by 2010
9. The "point of care" diagnostics introduced
10. Develop a new vaccine by 2015
by 2010
Research & Development WGs
vaccines
drugs
diagnostics
By 2006
By 2010
By 2015
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
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
rapid culture for case point of care, rapid
detection and DST in culture, improved
demonstration phase microscopy, phage
detection, simplified
NAAT
predictive test for
LTBI
Global Plan: $ 56 bn
cost by type of investment
Vaccines
US$ 3.6 bn
Drugs
US$ 4.8 bn
ACSM
US$ 2.9 bn
TB/HIV
US$ 6.8 bn
DOTS Plus
US$ 5.8 bn
Diagnostic
US$ 0.5 bn
DOTS
Expansion
US$ 32 bn
Funding gap: $ 31 bn
Total costs for implementation
and new tools, 2006-2015
Global Plan: The Next Decade of TB R&D
Working Group
Operations $6.0 M
Clinical Trials
Support $12.0 M
Preclinical
$126.0 M
Diagnostics
$0.52B
Regulatory Approval
$6.0 M
Basic Research
$57.0 M
Working Group
Operations $2.0 M
Regulatory Approval
$1.0 M
Clinical Trials
Evaluation $80.0 M
Clinical Trials Demonstration
$211.0 M
Lead Optimization
$2.2 B
Clinical Trials
$2.4 B
Drugs
$4.8B
Infrastructure
$69.0 M
WG Operations
$69.0 M
Research $206.0 M
Clinical Trials
$457.0 M
BCG Programmes
$1.5 B
Vaccine Production
$217.0 M
Development
$31.0 M
Vaccines
$3.6 B
Discovery
$1.4 B
12
BMGF has committed more than
900 million US$ to the Global
Plan needs on R&D
Mission & Objectives
of Stop TB 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

2003 to identify significant impediments
2004
Interact with Partners
to commercial
development of improved TB vaccines and establish mechanisms for cooperation
and collaborations that lead to accelerated vaccine development
Governance and
working environment




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
2003
 Liaison Officer in the Partnership Secretariat
2004
Role of the Working
Group on New Vaccines
promote global access
preclinical
clinical trials manufacture
Gates (Aeras)
EU (TB-VAC, EDCTP)
NIH, Wellcome . .
promote global access
Developing new TB vaccines
Targ
et
Targets
Actual
Actual
By 2006
5 vaccines in phase I trials
8 vaccines candidates have entered clinical trials,
and some have moved beyond Phase I.
By 2010
9 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