moving global health technologies to impact: examples from mnh, hiv, and ebola usaid mini-university...
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Moving Global Health Technologies to Impact: Examples from MNH, HIV, and Ebola
USAID Mini-University
Brinnon Garrett Mandel, MPH, MBA
Tigistu Adamu, MD, MPH
Deepti Tanuku, MA, MBA
March 2, 2015
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JHPIEGO- AFFILIATE OF JOHNS HOPKINS UNIVERSITY
Founded in 1973Working in over 35 countries,
2000 people globallyJhpiego Innovations:
Programmatic and service delivery innovations
Small portfolio of technologies we are developing
Collaborating and partnering to advance technologies developed by others
To understand the pathway to impact for global health technology innovations- emerging or existing
To learn the value of critical success factors through select case studies
LEARNING OBJECTIVES
Brinnon Mandel, MPH, MBA Director of Innovations Program, Jhpiego
Tigistu Adamu, MD, MPH, Associate Medical Director, Jhpiego
Deepti Tanuku, MA, MPH Program Director, Accelovate Program
(USAID)
PANEL INTRODUCTIONS
DevicesDrugsDiagnosticsVaccinesConsumer ProductsmHealth or eHealth SolutionsTraining Solutions
WHAT ARE GLOBAL HEALTH TECHNOLOGIES?
Ten Years Ago
Past Five Years
Some Barriers to Entry Have
Lowered
Open Innovation
platforms and funding
opportunities that draw wider
and more diverse
participation
Developments in science and
technology
Broader interest in global health with new actors
Others Have Not
Messiness of Sustainability and Scale-Up
Sustained financing
through the pathway
Complexity of regulatory and
research requirements
Market dynamics:
viable commercial
product aligned with global health need
Development
Understand the market, develop solutions, test and evaluate,
plan for “launch”
WHAT IS THE PATHWAY FROM AN IDEA TO IMPACT
Assessment
Define and characterize the
problem and identify solution
requirements
Introduction
Program integration,
supply chain, manufacturing
and distribution, approvals
Scale
Institutionalize, sustained investment,
maintenance
Common Challenges and Success FactorsClear definition of the right solution for that problemUnderstanding the market factors that influence development, adoption, and scaleHaving the right research and stakeholders to introduce productIdentifying regulatory and registration requirements at global and national levelsFinding right partners along and throughout the pathway
Development
CASE STUDIES
Assessment
Introduction
Scale
Why Problem Definition Matters: Developing an
Improved PPE Suit
Why Program Implementation and Introduction Matters:
PrePex Device
Why Markets Matter: Scaled use of life-saving MNH
Commodities
Why Partnerships Matter: MamaU, ePartogram
Brinnon Mandel
WHY PROBLEM DEFINITION AND
SOLUTION REQUIREMENTS DO
MATTER: DEVELOPING AN IMPROVED
PPE FOR EBOLACase Study #1
Assessment Development
THE “PROBLEM”
Challenges to current personal protective equipment (PPE) used by healthcare workers treating Ebola: 1. Most of the exposures occurred at the time of PPE removal2. Many HCWs were not following the appropriate guidelines for
using PPE3. The high temperatures and humidity in Liberia, Guinea and
Sierra Leone are such that it is difficult for any HCW to be in the PPE for more than 60-90 minutes.
DIVERSITY OF PERSPECTIVES IN DEFINING PROBLEM AND SOLUTION
REQUIREMENTS
JHU-CBID, Jhpiego, and Clinvue hosted 3 day event with JHU Schools, the Applied Physics Laboratory, the Maryland Institute College of Art, private sector partners, as well as a seamstress, midwife, architect, and robotics expert
65 participants produced extremely promising and innovative concepts (100) that were refi ned and December 2014 USAID Announced that JHU-CBID and Jhpiego were one of several recipients
Responding to USAID Fighting Ebola Grand Challenge, October 2014
Tigistu Adamu
WHY RESEARCH AND PROGRAM
INTEGRATION MATTER: PREPEX FOR VMMC
Case Study #2
Development Introduction
SEEK TO IDENTIFY DEVICES THAT:
• Make adult male circumcision procedure safer, easier and quicker than current methods;
• Facilitate more rapid healing and/or entail less risk of HIV transmission in the immediate post-operative period;
• May be used safely by health-care providers with a shorter period of training (mid-level providers);
• Are more cost-effective for male circumcision scale-up than standard surgical methods.Courtesy: WHO
Scale-up of voluntary medical male circumcision program and coverage in 14 priority countries:
growth scenarios, 2008−2016.
Sgaier SK, Reed JB, Thomas A, Njeuhmeli E (2014) Achieving the HIV Prevention Impact of Voluntary Medical Male Circumcision: Lessons and Challenges for Managing Programs. PLoS Med 11(5): e1001641. doi:10.1371/journal.pmed.1001641http://127.0.0.1:8081/ploscollections/article?id=info:doi/10.1371/journal.pmed.1001641
BACKGROUND
Initial devices consultation, 2009 Technical Advisory Group formed Dec
2010met July 2011 and January 2012
Formal prequalification programme established, September 2011
STUDY TYPES AND REQUIREMENTS
Initial safety and effi cacy clinical studies involving skilled surgeons in the country of origin or manufacture and the country of intended use
Comparative clinical studies involving skilled surgeons in the country of intended use
Acceptability studies in the country of intended final use
Field studies involving trained clinical personnel in a low-resource setting, reflecting anticipated conditions of intended use
Minimum for WHO global consideration: at least 2
comparative and 2 field studies in 2 diff erent settings
/countries
PREPEX STUDIES REVIEWED
Study (type) Location Clients Type of providers
Safety Study Rwanda 50 healthy HIV-negative men
Physicians and nurses
Randomized Comparison with Surgery
Rwanda 144 PrePex, 73 surgery Physicians and nurses
Pilot Study Rwanda 49 healthy HIV-negative men age 21–54 years
Nurses
Field Study Rwanda 666 generally healthy men [5 HIV-positive]
Lower cadre nurses
Safety Study Zimbabwe 53 HIV-negative men Physicians and nurse assistants
RandomizedComparison with Surgery
Zimbabwe 240 HIV-negative men As above
Field Study Zimbabwe 641 HIV-negative men Nurses with physician back-up support
Field Study Uganda (IHK) 634 healthy men Surgeons, medical officers, clinical officers and nurses
Field Study Uganda (Rakai)
187 HIV-negative men Not stated
THE WHO PQ PROGRAMME : PROCESS
Manufacturer submits application
Accepted
Rejected Application is screened
Manufacturer signs Letter of Agreement and submits
product dossier
Manufacturing Site Inspection
Meets WHO requirements
Product is prequalified
Post-market surveillance
Figure 1: Overview of the prequalification of Male Circumcision Devices process
Does not meet WHO
requirements
Does not meet WHO
requirements
Meets WHO requirements
Dossier Review Including Clinical Evidence
Deepti Tanuku
WHY MARKETS REALLY DO MATTER :
SCALED USE OF MNHH COMMODITIES
Case Study #3
Introduction Scale
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IF YOU WANT TO GO FROM INTRODUCTION TO SCALED USE, MARKETS MATTER
Assessment
Development Introduction Scaled Use
Problem Identification and
Priority Setting
Applied research to fill implementation knowledge gaps
Catalytic activity to facilitate adoption of
product
Country-level program/ policy rollout/ diffusion
into sustained use
Fig 1: Accelerating the Path to Introduction and Use
1
From identifying a problem to
developing an appropriate
solution
2 3
From developing a solution to
planning for its introduction into the “real world”
From planned product introduction to its full integration
into policies and programs
Source: USAID-Accelovate Program, 2014
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IF YOU WANT TO GO FROM INTRODUCTION TO SCALED USE, MARKETS MATTER
Assessment
Development Introduction Scaled Use
Problem Identification and
Priority Setting
Applied research to fill implementation knowledge gaps
Catalytic activity to facilitate adoption of
product
Country-level program/ policy rollout/ diffusion
into sustained use
Fig 1: Accelerating the Path to Introduction and Use
1
From identifying a problem to
developing an appropriate
solution
2 3
From developing a solution to
planning for its introduction into the “real world”
From planned product introduction to its full integration
into policies and programs
Source: USAID-Accelovate Program, 2014
MARKET BARRIERS ARE COMPLICATING SCALED USE OF MgSO4
31http://reprolineplus.org/misoprostol-case
FAILURE TO ADDRESS MARKET REALITIES DERAILS INNOVATIONS
* Top 3 MgSO4 Presentations Considered
Most Practical
5g in 10 mL (52%)4g in 20 mL (28%)
10g in 25 mL (16%)
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FURTHER INVESTMENT IN MH MARKETS WILL HELP SCALED USE OF MgSO4
http://reprolineplus.org/RH-assessments
34
FURTHER INVESTMENT IN MH MARKETS WILL HELP SCALED USE OF MgSO4
http://reprolineplus.org/RH-assessments
Brinnon Mandel
WHY PARTNERSHIPS MATTER :
MAMA U AND EPARTOGRAMCase Study #4
Introduction
ScaleDevelopme
ntAssessme
nt
Jhpiego partnered with Laerdal Global Health to develop Mama-U, an anatomical model for PPIUD insertion training
We knew of challenges with the current model, but didn’t have the capacity to improve it
Working closely and with numerous iterations of the design
Product was ready and being evaluated within 1-year
MAMA-U: A PPIUCD TRAINING SOLUTION
EPARTOGRAM
Jhpiego’s ePartogram is a tool that will be used by health care providers in LMIC to manage labor and guide decision-making by helping to detect complications during labor and delivery, which will reduce neonatal and maternal mortality and morbidity.
Developed early concepts with
Sought design and user interface with
Working with ICT4D and Platform Partner
Developing path to scale strategy with support from
PARTNERS ON EPARTOGRAM
Product Development Partnerships (PDPs) International AIDS Vaccine Initiative Aeras Global TB Vaccine Foundation Drugs for Neglected Diseases Initiative Foundation for Innovative Diagnostics Global Alliance for TB Drug Development International Partnership for Microbicides Medicines for Malaria Venture MISSING: for maternal and newborn health
Chlorhexadine Working Group, led by PATH as an international collaboration of organizations to advance
use of 7.1% chlorhexadine digluconate for umbilical cord care Diversity of partners addressed all critical elements in
pathway: product, programs, research, advocacy, manufacturing, regulatory, etc
OTHER PARTNERSHIP EXAMPLES: ALL SIZES AND SHAPES
Implementing Community
Clinical Experts
Regulatory Bodies
Users
Commercial Partners
“Choosers” (payors)
LESSON #2: IT IS REALLY NOT LINEAR!
Clinical and Technical
Performance
Programmatic
Effectiveness
Market viability
Strong Need
Definition to Inform
Solution
All along the pathway these four major areas have to be considered, re-evaluated, and show proof of concept
Saving Lives at Birth: A Grand Challenge for Development
Round 5 Announced a few weeks ago
Community of Innovators from past 4 years
Great resources and lessons- focus on scalability and addressing bottlenecks
www.savinglivesatbirth.net
Center for Accelerating Innovation and Impact- Warm off the Press
SOME EXCITING RESOURCES AND OPPORTUNITIES