Wilfred Mbacham, MS, DS, MPH, ScD,

Associate Professor of Public Health Biotechnology University of Yaounde I, Cameroon Representative for Research & Academia, RBM Partnership Board

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

Africa Worlds Poorest Nations have the Highest Burden of Disease

GNP

Malaria Index

3 Jefrey Sachs

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 for alternatives

Health gains are not directly palpable

Africa s Health in Peril

Its disenfranchisement dictated by war, famine,

natural disasters
Mobilisation of funds are too slow, too late and

too little
Improvements are needed on its imperfect tools,

insufficient knowledge or unused knowledge

Africas Health Needs

Stronger health systems and infrastructures

Change habits amid competing health and social

priorities
A more biological-based perception of disease and

health

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 the picture

Developing an African Agenda: Lodging in Pasteurs Quadrant

Letting experience and observations generate the questions and drive the science;
The research products are use-inspired and also of fundamental 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 aquire beneficial technologies

Understanding the Environmental & Social Drivers of Infectious Disease Burden

Understand the community: Perception is Everything in Africa

Modern Medicine Perception Poverty ignorance Traditional perception Magic influences, Evil eye Role of Ancestors
Men, women and children Vulnerable groups: pregnant women/ under fives/ elderly/ chronically ill/ (mentally) handicaped

Parasites, bacteria, viruses,

In combination with
Environment, alcohol, tobacco, drugs, others
Hospital/Health Services Smits, 2002

Patients
Traditional Healers

Amid these Pressures Massive Deployment: New Questions

Post-Marketting - Surveillance for Safety and Efficacy Street Response to the lower costs of Drugs Counterfeits

and labels The Human Factor Behaviors of Care givers and of Mothers Home Based Mgt of Fevers Performance of the POC diagnostics - RDTs
NO QUICK FIX

AFRICA IS CALLED TO THE R&D DEBATE TABLE

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

Scientific Challenges Vaccine R & D

Increased antigen diversity and genetic variability Lack of correlates of protection Lack of animal models Lack of comparators (endpoint, assays, trial design) 5. Lack of blood stage challenge model 6. Use of knowledge so far gained
1. 2. 3. 4.

Africa still needs to understand the Framework for Monitoring Milestones in Drug Discovery

Algiers Declaration Research for Health, June 2008

1. An Enabling Environment
2. Knowledge Management 3. Research Fundamental

and Operational

Emerging RCS Themes from PRD College

Enabling Environment Interventions Drugs, vaccines, Vector control Special groups, Discentralised Services Infra-structural development

Research & Operations Point of care, Appropriate Rxn KAP Purchase supply Issues, Health Systems Anti-Counterfeit, Health Best Practices

Knowledge Management Trials, Cochrane Review, Policy

Access

Targetting

Chochrane Review, Policy Cochrane Review, QA/QC, Tradi-Practitioners

Quality

10 Compelling Reasons for Research on Infections of Poverty

10 Compelling Reasons for Research on Infections of Poverty

10 Compelling Reasons for Research on Infections of Poverty

10 Compelling Reasons for Research on Infections of Poverty

Africas naive reliance on science for decisions needs to improve for better Knowledge Translation

5 High Level Options for Action

Illustrative Efforts: Is Big Pharma to the Rescue?

Lone initiative set the pace

A Coalition Inititiave of Drug Companies

The London Declaration

Eradication of 10 neglected tropical diseases by 2020 affecting 1.4

billion worlds 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 billion treatments over the next decade.

blinding trachoma, leprosy, chagas disease, sleeping sickness,

leishmaniasis, guinea worm, lymphatic filariasis, river blindness, schistosomiasis and yaws

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 and

ensure that the drug will be sold at the lowest price possible in these countries.
Transferable: requires IP rights that can be transferred

to other partners especially manufacturing partners if necessary.

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 Africas

capacity to perform in GMPs

Train Care Givers: to ensure proper use of limited drug

options
Assistance of NMCP with Pharmaco vigilance

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 Malaria

Control Program Managers - APALP

Growing Drug Discovery Networks

High Attrition Rate of Leads

R&D Funding for NTDs

Perspectives of the WHO Global Report on Infectious Diseases

Role of Big Pharma & Africas Involvement

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 on govt-funded R&D

product development in LMICs. 20-50% of funds for health R&D should be pooled mechanism.

Global Report on ID Recommendations

Strengthening R&D capacity and technology transfer
Address the capacity needs of academic and public research

organizations 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.

African Involvment Product Development Partnerships

Steps Idea Generation African Partner Involvement

Africans can fuel the company's R&D through its a policy of Open Innovation and new technologies
Africans can perform market analysis with end users in mind

Idea Screening

African Involvment Product Development Partnerships

Steps Business Analysis African Partner Involvement

African feedback, estimate sales volume based upon size of market and estimate profitability and breakeven point

Market Testing Product Acceptability through prototype

African Involvment in Product Development Partnerships

Steps African Partner Involvement Africans can make the necessary Technical adjustments to ensure product is ready Implementation for launch. Caregiver behavior Fill the distribution pipeline with product. Perform critical path analysis along the PSM route

Commercialization:

Open Access Innovation Platform

African Network for Drugs and Diagnostics Innovation

MultiIateral Initiative on Malaria 13 Years Latter

$20M MIM/TDR Trained more than

220 Africans at graduate level

Strengthened research capability in more than 33

African Institutions in 17 Countries

Resulting in over 120 scientific publications

MIM Research Capacity Built in more than 17 countries

Epidemiology Antimalaria Drug Resistance Pathogensis and Immunology Health Systems and Social Sciences Natural Products Entomology and Insecticide resistance

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 the steps in drug discovery

5. Invest in research infrastructure to be attractive for

the outsourcing of innovative technologies from the north

Pharma to Re-Orient Efforts

1. Re-Orient investments to target the grassroots

2. Assist Africa build its Research Sector

3. Tap on the brain power of the new generation of Africans genome engineers

4. Invest more in NTDs and fill up the gap on PRDs

5. Rebuild new molecules from old ones through synthesis

I thank you for your attention & thank the EFPIA and the host of this meeting Dr. B Newton Dunn, MEP, for the invitation.