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Partnering to tackle NeglectedTropical Diseases2013 IEEE Global Humanitarian Technology Conference
Tala de los SantosDiagnostics GroupLeader
21 October 2013
NEGLECTED TROPICAL DISEASES
Photo credit: Olivier Asselin
The most important diseases you’ve never heard of
NEGLECTED TROPICAL DISEASES
Dengue
Leprosy
Yaws
Rabies
Trachoma
HAT
ChagasDiseaseSTHBuruliUlcer
OnchocerciasisLeishmaniasisSchistosomiasis
http://www.who.int/neglected_diseases/diseases/en/Photo credits: WHO/TDR, APOC
http://www.who.int/neglected_diseases/diseases/en/Photo credits: WHO/TDR
Disability
Poverty
Disease
Blindness Disfigurement Malnutrition Extreme disability
Social stigmatization Decrease in economic productivity
1 billion people worldwide currentlysuffer from at least one NTD.
An additional 2 billion people are atrisk.
THE LONDON DECLARATION
By 2020:• Eradicate guinea worm• Eliminate lymphatic
filariasis, leprosy,sleeping sickness, andblinding trachoma
• Control schistosomiasis,STH, Chagas disease,visceral leishmaniasis,and onchocerciasis
6
COMMUNITYBASEDINTERVENTIONS
COMMUNITYBASEDINTERVENTIONS
COMMUNITYBASEDINTERVENTIONS
DEVICESDEVICESDEVICES DIAGNOSTICSDIAGNOSTICSDIAGNOSTICS DRUGSDRUGSDRUGS VACCINESVACCINESVACCINES
OUR 5 PLATFORMS7
PATH drives transformative innovation
Full spectrum of technology development and introduction
Slide 8
Scale up/Apply
Introduce/Optimize
Approve/Recommend
Develop/Validate
Research/Design
Task at hand
9
How can we meet the LondonDeclaration goals for 2020?ChallengeChallenge
Build the right coalition fordevelopment and deployment of new
technology.OpportunityOpportunity
Photo credit: www.thequists.com
Page 10
2
3
4
1
Identify endemiccommunities
Develop
Deliver
Achieve publichealth success
Rx
Reducinginterventionfrequency
Monitoring impact
Picture credit: End7 Campaign
Page 11
2
3
4
1
Identify endemiccommunities
Develop
Deliver
Achieve publichealth success
Rx
Reducinginterventionfrequency
Monitoring impact
Picture credit: End7 Campaign
Page 12
2
3
4
1
Identify endemiccommunities
Develop
Deliver
Achieve publichealth success
Rx
Reducinginterventionfrequency
Monitoring impact
Picture credit: End7 Campaign
Page 13
2
3
4
1
Identify endemiccommunities
Develop
Deliver
Achieve publichealth success
Rx
Reducinginterventionfrequency
Monitoring impact
Picture credit: End7 Campaign
CASE STUDY: ONCHOCERCIASIS
Photo credit: John M. Hunter
Nangodi, Northern Ghana1966
Photos courtesy of Tom Nutman, NIAID, NIH
WHO/TDR/Crump
WHO/TDRPage 16
“The river eats your eyes” WHO/TDR/Stammers
WHO/TDR/OCP
1978: Could ivermectin work againstonchocerciasis?
11/1/2013Page 17
Dr. William Campbell
?
1987: Mectizan® will be made available for aslong as needed.
11/1/2013Page 18
Dr. Roy Vagelos
19
37 million infected37 million infected
300,000blind
300,000blind
Second leadinginfectious cause of
blindness
Second leadinginfectious cause of
blindness
180 million atrisk
180 million atrisk
Photo credits (left to right): T. de los Santos, BMGF, Voice of America, Helen Keller International
1987 1993 1995
APOCAfricaAPOCAfrica
OEPAAmericas
OEPAAmericas
MectizanDonationProgram
MectizanDonationProgram
MectizanDonationProgram
Photo credit: Sightsavers, www.mectizan.orgPage 20
140 milliontablets annually
Over 2 billion tablets donated
July 2013: Colombia declares elimination of onchocerciasis
11/1/2013Page 21
22
Endemic communities Drugs
Delivery Partners
(NGO’s)
MectizanDonation Program
DiagnosticsDonors
Challenges of controlling the disease in Africa
Geographic coverage
Human and fly migration
Vector efficiency
Co endemicity with Loaloa infections
Political unrest and postconflict areas
Marching towardelimination
11/1/2013Page 24
When is it safe to stopmass drug
administration?
How to monitor forpossible re emergence
of infection?
Features of the Ov16 Rapid test
• Easy to use and field friendly
• Rapid results (20 minutes)
• Uses finger stick as sample (5 – 30 uL).
• Long read window / end point stability (>4 weeks)
• Robust and stable
• >1 year at 45 C
• >3 weeks at cycling temperatures
• Does not need to be timed with treatment
• Can easily be integrated with other NTD surveillance
efforts
25
What is the Ov16 rapid test?
• It is a serology based rapid test• Detects human IgG4 antibodies to the Onchocerca
volvulus antigen Ov16
Assay Principle:
Human IgG4
GST Ov16
Reporter AbAnti human IgG4
• Detects exposure to infection (antibody)• Does not detect parasites (antigen)
26
Activities and outputs at Concept Phase
• Identification andengagement of keystakeholders
• User needs assessment• Market research• User and Market
Requirements Document• Target Product Profile
• Identification andengagement of keystakeholders
• User needs assessment• Market research• User and Market
Requirements Document• Target Product Profile
Slide 27 CONFIDENTIAL
Scale up/Apply
Introduce/Optimize
Approve/Recommend
Develop/Validate
Research/Design
CONCEPTNeeds ID andAssessments
PLANNINGDiscovery and
Feasibility
R&DDevelopment and
Prototyping
FIELD STUDIESPilot and
Evaluation
INTRODUCTIONIntroduction and
Deployment
SUSTAINIntegration andSustainability
Case Study: River Blindness Project
Activities and outputs at R&D Phase
• Development of workingprototypes
• SOPs• Failure Mode and Effects Analysis• Commercialization Strategy• Partner search
• Development of workingprototypes
• SOPs• Failure Mode and Effects Analysis• Commercialization Strategy• Partner search
Slide 28 CONFIDENTIAL
Scale up/Apply
Introduce/Optimize
Approve/Recommend
Develop/Validate
Research/Design
CONCEPTNeeds ID andAssessments
PLANNINGDiscovery and
Feasibility
R&DDevelopment and
Prototyping
FIELD STUDIESPilot and
Evaluation
INTRODUCTIONIntroduction and
Deployment
SUSTAINIntegration andSustainability
Case Study: River Blindness Project
Prototype Evolution
• Investigated severalform factors
29
1. Closed assembly
2. Open assembly
3. Removed filter
BC: Behind conjugate
OC: On conjugate
NC: on Nitrocellulose
Direction of flow
T C
Activities and outputs at Field Studies Phase
• Evaluation of beta prototypes• Initiation of technology transfer• Production of small scale validation lots• Validated assay performance and SOPs• Executed commercialization agreement
• Evaluation of beta prototypes• Initiation of technology transfer• Production of small scale validation lots• Validated assay performance and SOPs• Executed commercialization agreement
Slide 30 CONFIDENTIAL
Scale up/Apply
Introduce/Optimize
Approve/Recommend
Develop/Validate
Research/Design
CONCEPTNeeds ID andAssessments
PLANNINGDiscovery and
Feasibility
R&DDevelopment and
Prototyping
FIELD STUDIESPilot and
Evaluation
INTRODUCTIONIntroduction and
Deployment
SUSTAINIntegration andSustainability
Case Study: River Blindness Project
PATH Ov16 Prototypes:Field Evaluation in Togo
Current Status
• All field baseddata collectioncompleted
• Completingreference testingin Togo laboratory
• Will begin analysisand integration ofdata in November2013
11/1/2013Page 32
11/1/2013Page 33
prototypes
Field evaluations
Technology transfer
Commercial launch
Operations research
Policy development
Product uptake
Slide 34
OnchocerciasisLymphaticFilariasis
Polio
Yellow Fever
Chagas
Multiplex STDpanel
Infant HIV
TB EQA
TB MODS
Malaria G6PD
NA extractionkit
GestationalDiabetes
Diabetesscreening
InfluenzaNeglected
Tropical Disease
HIV/STD
Malaria
Noncommunicable
TB
Portfolio Key
Clin
ical
Man
agem
ent
Surv
eilla
nce
Enab
ling
tech
nolo
gies
Other
Diagnostics Group Product Portfolio
Slide 34 CONFIDENTIAL
Scale up/Apply
Introduce/Optimize
Approve/Recommend
Develop/Validate
Research/Design
CONCEPTNeeds ID andAssessments
PLANNINGDiscovery and
Feasibility
R&DDevelopment and
Prototyping
FIELD STUDIESPilot and
Evaluation
INTRODUCTIONIntroduction and
Deployment
SUSTAINIntegration andSustainability
DiarrhealDiseases
Onchocerciasis teamTala de los Santos – Project lead
ScientistsGonzalo DomingoAllison GoldenRoger Peck
TechniciansLindsay YokobeEric StevensNicole LaRue
Field AssociatesMelissa ValdezDunia Faulx
CommercializationRalph SchneidemanJeff Wellhausen
AdministrationDan PhillipsAmanda Vilbrandt
Past team members:Ken HawkinsKathy TietjeBecky Barney
CollaboratorsAPOCOEPATask Force for Global HealthNational Institutes of HealthTogo Ministry of HealthTubingen UniversityUniversity of S. FloridaCenters for Disease ControlWashington UniversityStandard DiagnosticsErasmus University
Thank you!
Health within reach for everyone
PATH/Gabe Bienczycki36
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