Christo van Niekerk, M.D.Senior Director, Clinical Development

Pretoria, South Africa

Innovating TB Treatment:Innovating TB Treatment:Opportunities for Private Sector Opportunities for Private Sector

Engagement 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 VisionFDCs

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 EducationSustainable Change

Challenges and Lessons LearnedMonitoring 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