R&D for TB: Updates & Opportunities for the Private Sector Christian Lienhardt Senior Scientific Advisor, Stop TB Partnership WHO, Geneva GBC Conference.

R&D for TB: Updates & Opportunities for the Private Sector

Christian LienhardtSenior Scientific Advisor,Stop TB PartnershipWHO, Geneva

GBC Conference on TB, TB/HIV co-infection &

Global Fund Partnership-

Johannesburg, October 11-13, 2010

Contents

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

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)

Estimated TB Incidence rates, 2008

Africa 31%

West Pacific 20%

SE Asia 34%

Europe 5%

East Mediterranean 7%

Americas 3%

TB Control Global Targets

2015: 50% reduction in TB prevalence and deaths relative to 1990 levels2050: 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

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

Sputum smear microscopyDiscovered 1882

DIAGNOSTIC

1st-line TB drugs Discovered 1943-1970

TREATMENTVACCINE

BCGDeveloped 1920s

Today's tools for TB control are old tools – a struggle to cut deaths by half by 2015 and eliminate TB by 2050

TB care and control

Development

Research

Health systemsAnd policies

Traditionalarea of core TB control

not enough

Traditionalarea of core TB control

not enough

Need to focus on research

Need to focus on research

Innovative action needed in 4 spheres

"Moving beyond the TB box"

Needs for diagnostics in tiered health system

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 DevelopmentDiscovery Clinical Development

•Nitroimidazoles•Mycobacterial Gyrase Inhibitors•Riminophenazines•Diarylquinoline•TL1 Inhibitor•MTopo

•InhA Inhibitor•Tryptanthrins•LeuRS Inhibitor•Protein Kinase Inhibitors•ActinomyceteMetabolites•Fungal Metabolites•DNA metabolism•Novel compound evaluations

•Phenotypic screens

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 II Phase 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.

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)

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/

Thank you for

your attention !