Christo van Niekerk, M.D. Senior Director, Clinical Development Pretoria, South Africa Innovating TB Treatment: Opportunities for Private Sector Engagement

 Develop new, better treatments for TB that are:  faster-acting and less complex  effective against MDR/XDR-TB  compatible with anti-retrovirals for TB/HIV coinfection  Ensure that new regimens are affordable, adopted for use, and made widely available  Coordinate and act as catalyst for global TB drug development activities TB Alliance Mission

TB Alliance Vision FDCs 2 – 4 months 6 – 24 months 10 days Success will require novel multi-drug combinations

Critical Path to New TB Drug Regimens (CPTR)  Accelerates the development of new regimens by testing promising new drugs together, rather than by sequential testing of individual drugs  Overcomes intellectual property barriers to private sector collaboration  Collaboration maximizes synergy, reduces cost, increases efficiency  Engages regulatory authorities to develop new pathways and guidances for combination testing and approval

CPTR Participants

Engaging Communities Community engagement creates greater awareness about TB symptoms, screening and treatment and ultimately gets more patients to health clinics Research literacy programs improve understanding of the research process Programmes are for trial communities, designed by trial communities Empowerment  Education Sustainable Change

Challenges and Lessons Learned Monitoring and Evaluation: Changes in TB-related knowledge and attitudes towards TB drug research, following implementation of CE strategies, Research Literacy: Lack of knowledge and understanding in communities about research and clinical trials, Cross-Site Engagement: CE is new for many TB drug research sites. Information sharing helps improve success of programs. Providing opportunities for CABs to share experiences and lessons learned is a critical for their development and capacity building

South Africa: Center of Excellence in TB Trials South Africa can play a central role in transforming TB therapy –South Africa has the only two functioning sites required for the highly specialized TB trials (EBA trials) in the world –Quality academic institutions to produce strong clinical researchers –South Africa has the technical expertise, and the infrastructure needed to conduct registration-standard trials Strengthening clinical trial capacity has enormous benefits –Recognition for world-class clinical research will attract future partnership opportunities –Staff training leading to a more employment opportunities

How Can the Private Sector Engage? TB treatment is on the verge of great advancement; the first entirely novel TB regimen is set to enter human trials by Quarter 3 of 2010  However, the greatest risk to success is the lack of financial resources Pooled private sector resources could allow smaller investments and minimize the burden on any one company Clinical operations in Southern Africa need support; investment opportunities span from clinical staff and lab capacity building, to early- and late-stage demonstration trials for introduction of new TB drugs, to community engagement and access projects Non-cash support can play an important role in defraying TB Alliance costs i.e. Mobile laboratories, Office space and utilities, Airline miles, Laptops and software,Health economics expertise The private sector can make a difference in delivering a better cure for TB