The Research and Development Goals of the Global Plan to Stop TB Marcos Espinal Executive Secretary

Our vision is a TB-free world: The first children born this millennium will see TB eliminated in their lifetime. Stop TB is a global movement to accelerate social and political action to stop the unnecessary spread of TB around the world. THE STOP TB PARTNERSHIP Targets By 2015: the global burden of TB disease (deaths and prevalence) will be reduced by 50% relative to 1990 levels. By 2050: The global incidence of TB disease will be less than 1 per million population.

EXPECTED RESULTS OF THE GLOBAL PLAN - Achieve the Millennium Development Goal to have halted and begun to reverse the incidence of TB by Save an additional 14 million lives - Treat 50 million people for TB - Expand access to high-quality TB diagnosis and treatment for all - Put 3 million TB patients coinfected with HIV on ARVs - Treat 800,000 people for MDR-TB - Produce the first new anti-TB drug in 40 years by Develop a new vaccine by Provide rapid and inexpensive diagnostic tests at the point of care

Major planned achievements New Tools Working Groups - by 2006: Introduction of the 1st new diagnostic for culture and sensitivity testing - by 2010: New rapid diagnostic at clinic level - by 2010: New drugs will be launched - by 2015: New regimen of novel chemical entities (treatment shortened) - by 2015: New generation of vaccines

New TB Vaccines Working Group strategic vision Aim: bring together the wide range of international groups with an interest in TB vaccine development, acting as a "broker" to promote synergy and to accelerate identification and introduction of the most effective vaccination strategy. 1.Coordinate international activities that strengthen and accelerate the development and introduction of improved TB vaccines 2.Promote a concerted approach to development and introduction of improved TB vaccines by encouraging useful interactions among different groups 3.Prioritize actions needed and areas of new resources, including epidemiological studies, cost- effectiveness studies, formation of public/private partnerships for vaccine production, programs to address issues of regulatory streamlining and technology transfer that will advance the sustained access of improved TB vaccines to endemic countries 4.Formulate with other Stop TB partners and Working Groups the integration of vaccine, immunotherapy and drug treatment programs to eliminate TB

New TB Vaccines Working Group Main achievements as of December KEEP THE VACCINES PIPELINE FILLED Priming, pre-exposure : 10 candidates (Phase I in 2008, 2009 or later) Boosting, pre-exposure: 17 candidates (Phase I in 2008, 2009 or later) Post exposure, immunotherapy: 12 candidates (Phase I in 2008, 2009 or later) –MAINTAIN AND IMPROVE BCG VACCINES Development of a plan for vaccine production capacity and scale-up (AERAS) –CAPACITY AT NEW TB VACCINES TRIAL SITES Phase III trial sites has been expanded beyond South-Africa to Ethiopia, India and Uganda (AERAS, EU Country Clinical Trials Platform & EU TBVAC initiatives)

New TB Diagnostics Working Group Strategic vision Aim: a group of Partners working to introduce cost-effective and appropriate new diagnostic tools that will contribute towards control of global TB epidemic and improve quality of patient care. The ideal toolbox will contain a portfolio of diagnostic technologies that will perform well in different categories of patients to 1.Improve TB case detection 2.Rapidly identify drug resistant TB 3.Reliable identify latent infection and determine risk of progression

Targets for introduction of tests, leading to sustainable adoption, 2006–2015

New TB Diagnostics Working Group Main achievements as of December EXPANDED DIAGNOSTICS PIPELINE WHO STAG recommendation on liquid culture and DST in 2007 (Ref lab level) Expert Committee to review evidence on the use of molecular test for rapid screening of patients at risk of multi-drug resistant TB in 2008 (STAG) 10 products at reference lab level (incl liquid culture and speciation test) 7 products at peripheral level (incl LED) 2 products at point of care –DEVELOPMENT OF SCIENTIFIC BLUEPRINT Development of a roadmap, for best practices guidelines for diagnostic test development, evaluation and implementation

Main challenges Insufficient basic research (TBRM) Insufficient funding for TB R&D –Global funding for TB tools: $413 million –Funding Gap: $6 billion over the next 10 years –Investment in TB research was 19 times less than HIV* Inadequate clinical trial platform No clear regulatory framework for diagnostics and TB drugs Political awareness Sustained political commitment *Tuberculosis R&D: a critical analysis of funding trends (Treatment Action Group Report