Andrea Stewart WWARN Oxford University APPMG January 20 2015

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Worldwide Antimalarial
Resistance Network (WWARN)
Centre for Tropical Medicine & Global Health
University of Oxford
APPMG meeting
January 20th, 2015
Summary of presentation
•
Background to drug resistance
•
The Worldwide Antimalarial Resistance Network (WWARN)
•
Key project examples
•
•
Capacity building in endemic countries
•
External quality assurance
•
Drug Quality
What next with resistance?
Risk factors driving drug resistance
Adherence
Pregnant Women & Infants
Poor Quality
Drug interactions
Comorbidities
Malnutrition
Bio-availalibility
Revisiting history
2010
1970
2020
• Response to the first waves of resistance
o Slow and inadequate risk assessment
o High economic cost
o Millions of deaths
Adapted from Carter & Mendis, 2002
Drug development pipeline:
• Existing drugs
o Affordable and available
o Adaptation with new evidence
• New drugs
• Pipeline is long and complex
• Feed learning from existing medicines
Discovery
Clinical phases
Registration
• Change of National
policy
• Scaling production
• Suppliers
• Training
Flegg et al. American Journal of Tropical Medicine & Hygiene 2013
Access
“The spirit of collaboration is permeating
every institution and all of our lives…
Learning to collaborate enables you to be
more effective, problem solve, innovate and
develop your knowledge throughout your life…”
Don Tapscott
WWARN: Collaboration 230 partners
Phnom Penh
100,000 clinical trial (patient) results
Two thirds of all ACT clinical data published since 2000
Data pooled and analysed to identify failure risks
Policy - Data – Funding – Change?
WWARN strategy
Innovate
Address
heterogeneity
Collate/Collect
Building bio-informatics and technical framework
• Secure process to share and store data
• Data curation
o Check data quality
• Data standardisation
• Data analysis
• Data visualisation
o Maps
o Reports
WWARN Data Centre
An innovative model
• WWARN Data Centre
o Develop a scientific and ethical rationale
o Provide long term data storage
• Translating science into public health action
o Enhance the value of existing data
o Ensure efficacy of existing and new drugs
• Providing accurate and useful intelligence
o Share evidence to guide policy: control and elimination strategies
Optimising treatment for
artemisinin resistant strains
• “TRAC” experimental regimen
• 3 days artesunate + 3 days ACTs
• Cure rate at Day42 in Cambodia
- 97.7% [95%CI 90.9 to 99.4]
E Ashley, NJ White et al. New England Journal of
Tropical Medicine July 2014
Maintain the useful life of existing, valuable ACTs
– the power of pooled data
• Is AS+AQ (30% of ACT in Africa)
a failing combination?
• Is dosing of lumefantrine (AL)
in infants or pregnant women
inadequate ?
• Can we validate molecular
markers for current ACT
partner drugs?
Data visualisation
• Global access to information
• Interactive format
• Interrogate data from anywhere
Targeted, pro-active surveillance
• Guiding surveillance: hotspots
• Concentrate effort and
investment: high risk areas
• Proof of concept with drug
cobinations e.g.
o seasonal malaria
chemoprevention
o Malaria in Pregnancy (MiPC)
It’s not just about gathering the data….
Quality of trial
data?
Retrospective
v
prospective?
Drug Quality?
WWARN Toolkit: quality management
External Quality Assurance Programme
Antimalarial quality
Intentional fraudulent
production
Result from negligent
factory error
Falsified
Substandard
Degraded
Leave factory good quality
but degrade due to heat,
humidity
Drug Quality e.g. Africa
1.4 Million Coartem® seized
Angola, Cameroon, DRC, Benin
and Nigeria
Preventing the global spread of
ACT (ART) resistance: what next?
o Improve quality and leverage value of existing data
o Preserve efficacy of current antimalarials
o Optimise treatment
o Detect and manage resistance spread/emergence
o Adaptive regimen in target areas
o Smart surveillance (timely, accurate)
o Feed learning into development of new drugs
Risk
Factors
Regime
n
Target
Thank you
Visit: wwarn.org
Follow: @WWARN
Andrea Stewart, Head of Advocacy & Communications
APPMG meeting. January 20th, 2015
Cost of inaction?
Scenario model: 30% ACTs fail and treatment for
severe cases of malaria is reverted to quinine
Lubell et al. Malaria Journal 2014
1970
• Each year increase of > than 116,000 deaths
• Excess of $32 million in healthcare costs
• >$385 million productivity losses due to extended patient illness
www.wwarn.org/aqsurveyor
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