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TB DIAGNOSTICS R&D: Not Just Technology

TB DIAGNOSTICS R&D: Not Just Technology. BD Experience with Implementation & Support. Peter Mehlape, General Manager GBC Southern Africa Conference 11th October 2010, Johannesburg. About BD (Becton, Dickinson and Co.). Medical Technology Company $7.5B Offices in 52 countries

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TB DIAGNOSTICS R&D: Not Just Technology

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

  2. 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

  3. Progress in TB Diagnostics for the Developing World 1882 2000 2010 ? Future

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

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

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

  7. 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

  8. 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

  9. 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

  10. Thank You

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