TB DIAGNOSTICS R&D: Not Just Technology

Peter Mehlape, General Manager

GBC Southern Africa Conference11th 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

1882 2000

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