TB DIAGNOSTICS R&D: Not Just Technology Peter Mehlape, General Manager GBC Southern Africa Conference 11th October 2010, Johannesburg BD Experience with Implementation & Support

About BD (Becton, Dickinson and Co.) Medical Technology Company  $7.5B  Offices in 52 countries  29,000 employees Four Areas of Focus  Reducing the spread of infection  Advancing global health  Enhancing therapy  Improving disease management Africa Presence  120 Employees  Offices in Johannesburg, Nairobi and Accra  Distribution, service and support network

Progress in TB Diagnostics for the Developing World 2010 Future ?

Product Development Technology Development Implementation Service and Support Biomarkers Specimen collection Rapid turnaround Sensitivity and specificity Validation studies Cost efficient Clinical trials New Diagnostics: A Common Perception Dx ACCESS

BD Product Development Process ImplementationQualificationDevelopmentDefinitionConcept Customer Voices Business Voices Customer Requirements Operational Requirements Product Requirements Process Requirements Product Specifications Process Specification Verification Units Validation Units Process Validation Manufacturing Engineering Prototypes Pilot Manufacturing Support Pricing Regulatory Laboratory Strengthening Advocacy and Policy Service/Repairs Training Set Up

TB Diagnostics R&D: Design Challenges Need for improved laboratory capacity Roads, electricity, cold chain Regulatory hurdles Lack of trained personnel

Patients who need to be treated are not reached Specimens from non-responding patients need to be referred Stakeholders have had difficulty routing specimens to the NTRL Verification of microscopy results and the response to blinded re- checking of smears is incomplete Used GPS technology to map patient sample collection sites Created reference network and ability to gather data Trained on proper TB specimen collection and transport More than 1000 patient samples referred and more than 900 sites mapped BD Example: Uganda Specimen Referral Program

Private Sector Core Competencies –Public/private and private/private collaboration Technology development Advocacy –Project management Working with local MoH –Training and education Leverage employee skill-set Strengthen healthcare capacity Implementation and Support Dx ACCESS

Conclusions Effective R&D considers implementation/service up front –Anything can work in a laboratory or work in the field once – replicability and sustainability is essential Incentives should not only be for technology/product development –Look for incentives on implementation and service as well Leverage core competencies of the private sector –Multi-faceted problems require collaborative approach

Thank You