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 What: A global social movement to Stop TB –Need for multisectoral approach –New opportunities to work in partnership Vision: A TB-free world Vision: A TB-free world Mission: 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) Target year Case detection 70% 2005 Treatment success 85% 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. Urgency 2. Equity 3. Shared responsibility 4. Inclusiveness 5. Consensus 6. Sustainability 7. Dynamism

Governance and Structure New TB Drugs TB/HIVMDR-TB New TB Diagnostics DOTS expansion W O R K I N G G R O U P S New TB Vaccines Global Partners Forum Global TB Drug Facility Coordinating Board Partnership Secretariat WHO Technical Advisory Group Advocacy Network

Partnership towards Stop TB Targets Partners Forum Coordinating Board Secretariat/GDF Goals & Targets DOTS Expansion WG TB/HIV WG DOTS-Plus MDRTB WG New Drugs WG TB Diagnostics WG New Vaccines WG Communication/ Advocacy WG

The Global Plan to Stop TB

The Global Plan year perspective on the road to 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 A Plan with credibility will serve a key advocacy role Treatment of 50 million people with TB, 3 million TB/HIV co- infected patients on ARV, and ~ 1 million with MDR Saving of 14 million lives from The first new TB drug introduced by The "point of care" diagnostics introduced by Develop a new vaccine by 2015

Research & Development WGs By 2006By 2010By 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

Funding gap: $ 31 bn

Total costs for implementation and new tools,

12 Global Plan: The Next Decade of TB R&D Diagnostics $0.52B Vaccines $3.6 B Drugs $4.8B

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 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

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   Liaison Officer in the Partnership Secretariat

preclinical clinical trials manufacture promote global access Role of the Working Group on New Vaccines Gates (Aeras) EU (TB-VAC, EDCTP) NIH, Wellcome..

Developing new TB vaccines Targ et Actual TargetsActual By vaccines in phase I trials 8 vaccines candidates have entered clinical trials, and some have moved beyond Phase I. By 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 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 Mckinsey & Company