partnering to tackle neglected tropical diseases · filariasis polio yellow fever chagas multiplex...

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



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

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/TDR

“The river eats your eyes” WHO/TDR/Stammers

WHO/TDR/OCP

1978: Could ivermectin work againstonchocerciasis?

11/1/2013

Dr. William Campbell

?

1987: Mectizan® will be made available for aslong as needed.

11/1/2013

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



Photo credit: Sightsavers, www.mectizan.org

140 milliontablets annually

Over 2 billion tablets donated

July 2013: Colombia declares elimination of onchocerciasis

11/1/2013

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

11/1/2013

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


Scale up/Apply

Introduce/Optimize

Approve/Recommend

Develop/Validate

Research/Design



Feasibility

R&DDevelopment and

Prototyping


Evaluation


Deployment



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


Scale up/Apply

Introduce/Optimize

Approve/Recommend

Develop/Validate

Research/Design



Feasibility

R&DDevelopment and

Prototyping


Evaluation


Deployment



PATH Ov16 Prototypes:Field Evaluation in Togo

Current Status

• All field baseddata collectioncompleted

• Completingreference testingin Togo laboratory

• Will begin analysisand integration ofdata in November2013

11/1/2013

11/1/2013

prototypes

Field evaluations

Technology transfer

Commercial launch

Operations research

Policy development

Product uptake

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


Scale up/Apply

Introduce/Optimize

Approve/Recommend

Develop/Validate

Research/Design



Feasibility

R&DDevelopment and

Prototyping


Evaluation


Deployment


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

partnering to tackle neglected tropical diseases · filariasis polio yellow fever chagas multiplex...

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