1. R&D for TB: Updates & Opportunities for the Private Sector Christian Lienhardt Senior Scientific Advisor, Stop TB Partnership WHO, Geneva GBC Conference on TB, TB/HIV co-infection & Global Fund Partnership - Johannesburg, October 11- 13, 2010

2. Contents Context/Scene-Setting Brief “pipeline update” Role of PDPs in R&D Advocacy for TB R&D: what can the private sector do?

3. Estimated number of cases Estimated number of deaths 1.9 million (range 1.6–2.3 million) 9.4 million (range 8.9–9.9 million) 440,000 (0.39-0.51 million) All forms of TB Multidrug-resistant TB (MDR-TB) HIV-associated TB 1.4 million (15%) (1.3–1.6 million) 520,000 (0.45–0.62 million) The global burden of TB in 2008 150,000 (0.05–0.27 million)

4. Estimated TB Incidence rates, 2008 Africa 31% West Pacific 20% SE Asia 34% Europe 5% East Mediterranean 7% Americas 3%

5. TB Control Global Targets 2015: 50% reduction in TB prevalence and deaths relative to 1990 levels 2050 : elimination (<1 case per million population) 2015: Goal 6: Combat HIV/AIDS, malaria and other diseases Target 8: to have halted by 2015 and begun to reverse the incidence… Indicator 23: incidence, prevalence and deaths associated with TB Indicator 24: proportion of TB cases detected and cured under DOTS

6. The Global Plan 2006-2015 defines direction and costs A new strategy requires a new plan… 11 billion US$ to develop new tools The Global Plan 2011-2015 strengthens the fight 9.8 billion US$ to develop new tools

7. 7 Sputum smear microscopy Discovered 1882 DIAGNOSTIC 1st-line TB drugs Discovered 1943-1970 TREATMENT VACCINE BCG Developed 1920s Today's tools for TB control are old tools – a struggle to cut deaths by half by 2015 and eliminate TB by 2050

8. Traditional area of core TB control not enough Need to focus on research Innovative action needed in 4 spheres "Moving beyond the TB box"

9. Needs for diagnostics in tiered health system

10. TB Drug Pipeline WGND, July 2010 Gatifloxacin Moxifloxacin TMC-207 OPC-67683 PA-824 Rifapentine Linezolid LL3858 AZD5847 SQ-109 Oxazolidinone CPZEN-45 SQ641 SQ609 DC-159a Benzothiozinones Preclinical DevelopmentDiscoveryClinical Development Nitroimidazoles Mycobacterial Gyrase Inhibitors Riminophenazines Diarylquinoline TL1 Inhibitor MTopo InhA Inhibitor Tryptanthrins LeuRS Inhibitor Protein Kinase Inhibitors Actinomycete Metabolites Fungal Metabolites DNA metabolism Novel compound evaluations Phenotypic screens

11. TB Vaccine Pipeline VPM 1002 rBCG30* AdAg85A Hybrid-I+CAF01 Hyvac 4/ AERAS-404 RUTI M smegmatis* Hybrid-I+IC31 M72 MVA85A/ AERAS-485 AERAS-402/ Crucell Ad35 M vaccae* Preclinical Phase IIPhase IIIPhase IIbPhase I *indicates candidates that have been in clinical trials in the past, but are not currently being tested in clinical trials Source: Tuberculosis Vaccine Candidates – 2009; Stop TB Partnership Working Group on New TB Vaccines Working Group on New vaccines - July 2010 AERAS-rBCG Mtb [∆lysA ∆panCD ∆secA2] MTBVAC01 [∆phoP, ∆fad D26] HBHA Hybrid 56 HG85 A/B Prime Boost Post-infection Immunotherapy Preclinical vaccine candidates are not yet in clinical trials, but have been manufactured under Good Manufacturing Practice (GMP) for clinical use and have undergone some preclinical testing that meets regulatory standards.

12. Advocacy for TB R&D: what can the private sector do? direct investment in R&D patronage/sponsoring university research support innovative starts-ups (venture capital funding) Advocate for tax breaks for R&D offer incentives "champions" for promotion of innovation in R&D promote debates and discussions (roundtables)

13. Conclusion – the TB Research Movement TB Research Movement promotes the need for harmonized and complementary funding of TB research to target revolutionary discoveries that will foster better care and control for the elimination of TB. Development of a consensus-driven Roadmap for International Research to eliminate TB www.stoptb.org/researchmovement/

14. Thank you for your attention !