Transcript find scope of activities

FIND and Operational Research
in HIV-Associated Tuberculosis
Rick O’Brien
Foundation for Innovative New
Diagnostics, Geneva
1
Background and History
• FIND was established in 2003 with a grant from
the Bill and Melinda Gates Foundation
• FIND is based in Geneva as a Swiss tax-exempt
foundation
• FIND is the only public / private partnership
wholly dedicated to improved diagnostic
technologies for infectious disease endemic in
developing countries
• FIND’s initial focus is on tuberculosis
2
FIND’s mission
FIND’s mission is to accelerate the
development, evaluation, and appropriate
use of high-quality yet affordable
diagnostic tools for infectious diseases in
developing countries.
3
FIND SCOPE OF ACTIVITIES
Upstream
FIND’s focus
Downstream
Market access
and distribution
Discovery
and research
-
Proof of
principle
Development
Evaluation
Facilitate,
co-fund,
co-develop
Regulatoryquality
lab & field
trials
Product
in box
Demonstration
Efficacy
Data
Large-scale
projects
measuring Effectiveness
Data
feasibility and
impact on
disease control
programs
4
Industry approach
Demonstration
Research
Development
Facilitate, cofund and codevelop
Liaison with
funders,
pharmaceutical
and biotechnology
companies,
research
institutes Proof of principle
and
academia
Evaluation
Regulatory
quality lab and
field trials
Product in box
Large scale
projects to measure
feasibility and
impact on disease
control programs
Efficacy data
Access
Liaise with
funders, NGO’s,
health ministries
and agencies,
e.g., GDF and
GFATM
FIND
ACTIVITY
Effectiveness data
FIND focus
Create network of public and private partnerships
to create effective tests and demonstrate their
effectiveness
5
segmentation - diagnostic question vs. health system level
diagnostic
question
health
system level
1. Detection
2. Resolution
• Who shall be treated?
• Is patient responding
• Change treatment for failure? • Are programs effective?
• Is the strain resistant?
Health Center
(Clinic)
• Are there new strains?
• QC procedures &
policies
• strain typing
Central lab
District lab
3. Surveillance
• fill detection gap
• resolve unclear cases
• resistance testing
• Yes–No answer
• medical monitoring
RESOLUTION
faster than
culture !
• easy & robust lab
procedures
• support for multiple
health problems
• universal platforms
• dedicated POC
devices
• minimal skill
requirements
DETECTION
more sensitive
than smear !
6
FIND product timeline
Development
Feasibility
2005
Evaluation
2006
Demonstration
2007
Access
2008
2009
Health center
Breath test
Feasibility
Adapted AFB
Demonstration
Ag detection
Serology
Feasibility
Feasibility
Development
Development
Evaluation
Evaluation
Automated AFB
Feasibility
Development
Evaluation
Simple NAAT
Feasibility
Development
Evaluation
Access
Development
Evaluation
District lab
TK
Devel
Fastplaque
Development
Robust NAAT
Fea Development
MGIT
Demonstration
Evaluation Demonstration
Evaluation
Demonstration
Demonstration
Evaluation
Access
Central lab
Current NAAT
Access
Access
FIND-BD MGIT Demonstration
Projects
• Formal agreement with BD Dec 04
– FIND to undertake CF and DST demo projects
– BD to supply MGIT equipment/reagents at
“affordable” price to public sector in HBCs
• FIND objectives
– Demonstrate feasibility and impact of MGIT
– Provide data for WHO recommendations
8
FIND-BD MGIT TB/HIV CaseFinding Demonstration Projects
• FIND-CREATE MOU Dec 04
– MGIT culture in support of studies in Zambia,
South Africa, and Brazil
• Under discussion
– GAP/PATH/Tanzania NTLP
– WHO/CDC/RIT-JICA/FHI/Cambodia MOH
– AMPATH (Eldoret, Kenya)
9