Partnering to tackle Neglected Tropical Diseases

Transcription

1 Partnering to tackle Neglected Tropical Diseases 2013 IEEE Global Humanitarian Technology Conference Tala de los Santos Diagnostics Group Leader 21 October 2013

2 NEGLECTED TROPICAL DISEASES The most important diseases you ve never heard of Photo credit: Olivier Asselin

3 NEGLECTED TROPICAL DISEASES Dengue Leprosy Yaws Rabies Trachoma HAT ChagasDisease STH BuruliUlcer Onchocerciasis Leishmaniasis Schistosomiasis Photo credits: WHO/TDR, APOC

4 Blindness Disfigurement Malnutrition Extreme disability Poverty Disability Disease Social stigmatization Decrease in economic productivity Photo credits: WHO/TDR

5 1 billion people worldwide currently suffer from at least one NTD. An additional 2 billion people are at risk.

6 THE LONDON DECLARATION By 2020: Eradicate guinea worm Eliminate lymphatic filariasis, leprosy, sleeping sickness, and blinding trachoma Control schistosomiasis, STH, Chagas disease, visceral leishmaniasis, and onchocerciasis 6

7 PATH drives transformative innovation COMMUNITY BASED INTERVENTIONS DEVICES DIAGNOSTICS DRUGS VACCINES 7 OUR 5 PLATFORMS

8 Full spectrum of technology development and introduction Research/ Design Develop/ Validate Approve/ Recommend Introduce/ Optimize Scale up/ Apply Slide 8

9 Task at hand Challenge How can we meet the London Declaration goals for 2020? Build the right coalition for development and deployment of new technology. Opportunity Photo credit: 9

10 Identify endemic communities Rx 1 2 Develop Deliver 3 Reducing intervention frequency Monitoring impact 4 Achieve public health success Page 10 Picture credit: End7 Campaign

11 Identify endemic communities Rx 1 2 Develop Deliver 3 Reducing intervention frequency Monitoring impact 4 Achieve public health success Page 11 Picture credit: End7 Campaign

12 Identify endemic communities Rx 1 2 Develop Deliver 3 Reducing intervention frequency Monitoring impact 4 Achieve public health success Page 12 Picture credit: End7 Campaign

13 Identify endemic communities Rx 1 2 Develop Deliver 3 Reducing intervention frequency Monitoring impact 4 Achieve public health success Page 13 Picture credit: End7 Campaign

14 CASE STUDY: ONCHOCERCIASIS

15 Nangodi, Northern Ghana 1966 Photo credit: John M. Hunter

16 The river eats your eyes WHO/TDR/Stammers Photos courtesy of Tom Nutman, NIAID, NIH WHO/TDR/OCP WHO/TDR/Crump Page 16 WHO/TDR

17 1978: Could ivermectin work against onchocerciasis?? Dr. William Campbell Page 17 11/1/2013

18 1987: Mectizan will be made available for as long as needed. Dr. Roy Vagelos Page 18 11/1/2013

19 37 million infected 300,000 blind Second leading infectious cause of blindness 180 million at risk Mectizan Donation Program OEPA Americas APOC Africa Photo credits (left to right): T. de los Santos, BMGF, Voice of America, Helen Keller International 19

20 Mectizan Donation Program Over 2 billion tablets donated 140 million tablets annually Page 20 Photo credit: Sightsavers,

21 July 2013: Colombia declares elimination of onchocerciasis Page 21 11/1/2013

22 Endemic communities Drugs Delivery Partners (NGO s) Donors Diagnostics Mectizan Donation Program 22

23 Challenges of controlling the disease in Africa Geographic coverage Human and fly migration Vector efficiency Co endemicity with Loa loa infections Political unrest and post conflict areas

24 Marching toward elimination When is it safe to stop mass drug administration? How to monitor for possible re emergence of infection? Page 24 11/1/2013

25 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

26 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: Reporter Ab Anti human IgG4 Human IgG4 GST Ov16 Detects exposure to infection (antibody) Does not detect parasites (antigen) 26

27 Activities and outputs at Concept Phase Case Study: River Blindness Project Research/ Design Develop/ Validate Approve/ Recommend Introduce/ Optimize Scale up/ Apply CONCEPT Needs ID and Assessments PLANNING Discovery and Feasibility R&D Development and Prototyping FIELD STUDIES Pilot and Evaluation INTRODUCTION Introduction and Deployment SUSTAIN Integration and Sustainability Identification and engagement of key stakeholders User needs assessment Market research User and Market Requirements Document Target Product Profile Slide 27 CONFIDENTIAL

28 Activities and outputs at R&D Phase Case Study: River Blindness Project Research/ Design Develop/ Validate Approve/ Recommend Introduce/ Optimize Scale up/ Apply CONCEPT Needs ID and Assessments PLANNING Discovery and Feasibility R&D Development and Prototyping FIELD STUDIES Pilot and Evaluation INTRODUCTION Introduction and Deployment SUSTAIN Integration and Sustainability Development of working prototypes SOPs Failure Mode and Effects Analysis Commercialization Strategy Partner search Slide 28 CONFIDENTIAL

29 Prototype Evolution Investigated several form factors Direction of flow T C BC: Behind conjugate NC: on Nitrocellulose OC: On conjugate 1. Closed assembly 3. Removed filter 2. Open assembly 29

30 Activities and outputs at Field Studies Phase Case Study: River Blindness Project Research/ Design Develop/ Validate Approve/ Recommend Introduce/ Optimize Scale up/ Apply CONCEPT Needs ID and Assessments PLANNING Discovery and Feasibility R&D Development and Prototyping FIELD STUDIES Pilot and Evaluation INTRODUCTION Introduction and Deployment SUSTAIN Integration and Sustainability 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

31 PATH Ov16 Prototypes: Field Evaluation in Togo

32 Current Status All field based data collection completed Completing reference testing in Togo laboratory Will begin analysis and integration of data in November 2013 Page 32 11/1/2013

33 prototypes Field evaluations Technology transfer Commercial launch Operations research Policy development Product uptake Page 33 11/1/2013

34 Slide 34 Onchocerciasis Lymphatic Filariasis Polio Yellow Fever Chagas Multiplex STD panel Infant HIV TB EQA TB MODS Malaria G6PD NA extraction kit Gestational Diabetes Diabetes screening Influenza Neglected Tropical Disease HIV/STD Malaria Non communicable TB Portfolio Key Clinical Management Surveillance Enabling technologies Other Diagnostics Group Product Portfolio Slide 34 CONFIDENTIAL Scale up/ Apply Introduce/ Optimize Approve/ Recommend Develop/ Validate Research/ Design CONCEPT Needs ID and Assessments PLANNING Discovery and Feasibility R&D Development and Prototyping FIELD STUDIES Pilot and Evaluation INTRODUCTION Introduction and Deployment SUSTAIN Integration and Sustainability Diarrheal Diseases

35 Onchocerciasis team Tala de los Santos Project lead Scientists Gonzalo Domingo Allison Golden Roger Peck Technicians Lindsay Yokobe Eric Stevens Nicole LaRue Field Associates Melissa Valdez Dunia Faulx Commercialization Ralph Schneideman Jeff Wellhausen Administration Dan Phillips Amanda Vilbrandt Collaborators APOC OEPA Task Force for Global Health National Institutes of Health Togo Ministry of Health Tubingen University University of S. Florida Centers for Disease Control Washington University Standard Diagnostics Erasmus University Past team members: Ken Hawkins Kathy Tietje Becky Barney

36 Health within reach for everyone Thank you! PATH/Gabe Bienczycki 36