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Wilfred Mbacham, MS, DS, MPH, ScD,
Associate Professor of Public Health BiotechnologyUniversity of Yaounde I, Cameroon
Representative for Research & Academia,RBM Partnership Board
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Quo va dis Afrika?
Malaria is sill a disease of poverty
Africa is called to the R&D debate table
Illustrative Efforts: Is Big Pharma to the rescue?
Perspectives on the WHO Global Report on ID:
Role of Big Pharma and Africas involvement
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3
Africa Worlds Poorest Nations
have the Highest Burden of Disease
GNP
Malaria Index Jefrey Sachs
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With the Poverty of Nations
Limited resources are directed to other emotional
needs Limited resources are misguided towards politcal
strategies
Limited resources do not favour proper budgetting
Rational thinking is so week, we seek foralternatives
Health gains are not directly palpable
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Africa s Health in Peril
Its disenfranchisement dictated by war, famine,natural disasters
Mobilisation of funds are too slow, too late andtoo little
Improvements are needed on its imperfect tools,insufficient knowledge or unused knowledge
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Africas Health Needs
Stronger health systems and infrastructures
Change habits amid competing health and socialpriorities
A more biological-based perception of disease andhealth
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The Twin Trouble - Co-Morbidity
Respiratory Tract Infections
Upper and Lower
Bacterial Infections
Congenital Diseases
With a fall in infectious disease - Longer life better wealth -rise in chronic disease. But habits could resolve this - Diabetes,Cancers, Cardiovacular Disease, Obesity are confounding thepicture
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Developing an African Agenda:
Lodging in Pasteurs Quadrant
Letting experience and observations generate thequestions and drive the science;
The research products are use-inspired and also offundamental nature.
Require evidence that is difficult to capture with existing indicators
The need to collect the right data
The need to capture complexity in current practices The need to a uire bene icial technolo ies
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Understanding the Environmental &
Social Drivers of Infectious Disease Burden
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Understand the community:
Perception is Everything in Africa
Men, women and
children Vulnerablegroups: pregnant
women/ under fives/
elderly/ chronically ill/
(mentally) handicaped
Modern Medicine Perception
Parasites,
bacteria,
viruses,
In combination
with
Environment,
alcohol,
tobacco,drugs,
others
Poverty ignorance
Patients
Hospital/Health
Services
Traditional
Healers
Traditional perception
Magic influences,
Evil eye
Role of Ancestors
Smits, 2002
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Amid these Pressures -
Massive Deployment: New Questions
Post-Marketting - Surveillance for Safety and Efficacy
Street Response to the lower costs of Drugs Counterfeitsand labels
The Human Factor Behaviors of Care givers and ofMothers Home Based Mgt of Fevers
Performance of the POC diagnostics - RDTs
NO QUICK FIX
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AFRICA IS CALLED TO
THE R&D DEBATE TABLE
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Africa still has to
Properly Develop Her Research Sector
Infrastructural Investments Better funding programs/ Multidiscipinary teams
Good Governance Decentralisation and delegation of responsibilities
Monitoring and Evaluation
Information Systems and Data Management, Disease registries - infection/non-communicable
Operational research and health systems
Confounding variables
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Scientific Challenges Vaccine R & D
1. Increased antigen diversity and genetic variability
2. Lack of correlates of protection
3. Lack of animal models4. Lack of comparators (endpoint,
assays, trial design)
5. Lack of blood stage challengemodel
6. Use of knowledge so far gained
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Africa still needs to understand the
Framework for Monitoring Milestones
in Drug Discovery
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Algiers Declaration
Research for Health, June 2008
1. An Enabling Environment
2. Knowledge Management
3. Research Fundamentaland Operational
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Emerging RCS Themes from PRD College
EnablingEnvironment
Research& Operations
KnowledgeManagement
Access
Targetting
Quality
Interventions -Drugs, vaccines,Vector control
Point of care,Appropriate Rxn
KAP
Trials,Cochrane Review,
Policy
Special groups,Discentralised
Services
Purchase supplyIssues,
Health Systems
Chochrane Review,Policy
Infra-structural
development
Anti-Counterfeit,Health Best
Practices
Cochrane Review,QA/QC,
Tradi-Practitioners
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10 Compelling Reasons for
Research on Infections of Poverty
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10 Compelling Reasons for
Research on Infections of Poverty
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10 Compelling Reasons for
Research on Infections of Poverty
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10 Compelling Reasons for Research
on Infections of Poverty
Africas naive reliance on science for decisionsneeds to improve for better Knowledge Translation
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5 High Level Options for Action
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Illustrative Efforts:Is Big Pharma to the Rescue?
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Lone initiative set the pace
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A Coalition Inititiave of Drug
Companies
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The London Declaration
Eradication of 10 neglected tropical diseases by 2020 affecting 1.4billionworlds poorest countries
Bill Gates, WHO and thirteen 13 pharmaceutical companies $785 million
Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Gilead,GlaxoSmithKline, Johnson & Johnson, Merck, MSD, Novartis,Pfizer, Sanofi have agreed to share their experimental
compound libraries. They have also pledged to provide 14 billiontreatments over the next decade.
blinding trachoma, leprosy, chagas disease, sleeping sickness,leishmaniasis, guinea worm, lymphatic filariasis, river blindness,schistosomiasis and yaws
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Corporate Social Responsibility
MMV Model Exclusivity: to develop a drug for malaria and bring it to
market.
Royalty-free: to help keep costs to a minimum andensure that the drug will be sold at the lowest pricepossible in these countries.
Transferable: requires IP rights that can be transferredto other partners especially manufacturing partners -if necessary.
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Corporate Social Responsibility
SANOFI Model, With DNDi - No Profit No Loss: Drugs (ASAQ) are
manufactured and sold at industrial cost of manufacture
African Continental Presence: To boost Africascapacity to perform in GMPs
Train Care Givers: to ensure proper use of limited drugoptions
Assistance of NMCP with Pharmaco vigilance
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Corporate Social Responsibility
Training Model
Novartis Institute for Tropical Diseases
GSK Training Program in Vaccinology
Sanofis training courses in Madagascar and
Tanzania
Sanofis Annual Meeting of National MalariaControl Program Managers - APALP
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Growing Drug Discovery Networks
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High Attrition Rate of Leads
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R&D Funding for NTDs
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Perspectives of the WHO Global
Report on Infectious Diseases
Role of Big Pharma &
Africas Involvement
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Global Report on ID Recommendations
Innovative Approaches to R&D Open knowledge innovation:
Equitable licensing and patent pools.
Funding for R&D All countries to devote 0.01% of GDP ongovt-funded R&D
product development in LMICs.
20-50% of funds for health R&D should be pooledmechanism.
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Global Report on ID Recommendations
Strengthening R&D capacity and technologytransfer
Address the capacity needs of academic and public researchorganizations in developing countries.
Utilize direct grants to companies in developing countries.
Coordination Establish a Global Health R&D Observatory and relevant
advisory mechanisms under the auspices of WHO.
Formal negotiations on an international convention on
global health R&D should be initiated.
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African Involvment
Product Development PartnershipsSteps African Partner Involvement
IdeaGeneration
Africans can fuel the company's
R&D through its a policy of Open
Innovation and new technologies
Idea
Screening
Africans can perform market
analysis with end users in mind
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African Involvment
Product Development PartnershipsSteps African Partner Involvement
BusinessAnalysis
African feedback, estimate sales volume
based upon size of market and estimate
profitability and breakeven point
Market Testing Product Acceptability through prototype
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African Involvment in
Product Development PartnershipsSteps African Partner Involvement
Technical
Implementation
Africans can make the necessaryadjustments to ensure product is ready
for launch. Caregiver behavior
Commercial-
ization:
Fill the distribution pipeline with
product. Perform critical path analysis
along the PSM route
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Open Access Innovation Platform
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African Network for Drugs and
Diagnostics Innovation
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MultiIateral Initiative on Malaria
13 Years Latter
$20M MIM/TDR
Trained more than
220 Africans at graduate level
Strengthened research capability in more than 33African Institutions in 17 Countries
Resulting in over 120 scientific publications
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MIM Research Capacity Built
in more than 17 countries
Epidemiology
Antimalaria Drug Resistance
Pathogensis and Immunology
Health Systems and Social SciencesNatural Products
Entomology and Insecticide resistance
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Where Africa Needs to Reposition
1. Common/unified approach to R&D
2. Common resource allocation platform
3. Adopt the give-it-humanity strategy for new leads
4. Adopt a performance mentality by mastery of thesteps in drug discovery
5. Invest in research infrastructure to be attractive forthe outsourcing of innovative technologies fromthe north
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I thank you for your attention
&
thank the EFPIA and the host of
this meeting Dr. B Newton Dunn,MEP, for the invitation.
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