General Perpestives R&D Contributions From Pharma Final

7/31/2019 General Perpestives R&D Contributions From Pharma Final

1/45

Wilfred Mbacham, MS, DS, MPH, ScD,

Associate Professor of Public Health BiotechnologyUniversity of Yaounde I, Cameroon

Representative for Research & Academia,RBM Partnership Board


2/45

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


3/45

3

Africa Worlds Poorest Nations

have the Highest Burden of Disease

GNP

Malaria Index Jefrey Sachs


4/45

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


5/45

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


6/45

Africas Health Needs

Stronger health systems and infrastructures

Change habits amid competing health and socialpriorities

A more biological-based perception of disease andhealth


7/45

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


8/45

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


9/45

Understanding the Environmental &

Social Drivers of Infectious Disease Burden


10/45

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


11/45

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


12/45

AFRICA IS CALLED TO

THE R&D DEBATE TABLE


13/45

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


14/45

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


15/45

Africa still needs to understand the

Framework for Monitoring Milestones

in Drug Discovery


16/45

Algiers Declaration

Research for Health, June 2008

1. An Enabling Environment

2. Knowledge Management

3. Research Fundamentaland Operational


17/45

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


18/45

10 Compelling Reasons for

Research on Infections of Poverty


19/45




20/45




21/45

10 Compelling Reasons for Research

on Infections of Poverty

Africas naive reliance on science for decisionsneeds to improve for better Knowledge Translation


22/45

5 High Level Options for Action


23/45

Illustrative Efforts:Is Big Pharma to the Rescue?


24/45

Lone initiative set the pace


25/45

A Coalition Inititiave of Drug

Companies


26/45

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


27/45

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.


28/45


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


29/45


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


30/45

Growing Drug Discovery Networks


31/45

High Attrition Rate of Leads


32/45

R&D Funding for NTDs


33/45

Perspectives of the WHO Global

Report on Infectious Diseases

Role of Big Pharma &

Africas Involvement


34/45

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.


35/45

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.


36/45

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


37/45

African Involvment


BusinessAnalysis

African feedback, estimate sales volume

based upon size of market and estimate

profitability and breakeven point

Market Testing Product Acceptability through prototype


38/45

African Involvment in


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


39/45

Open Access Innovation Platform


40/45

African Network for Drugs and

Diagnostics Innovation


41/45

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


42/45

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


43/45

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


44/45


45/45

I thank you for your attention

&

thank the EFPIA and the host of

this meeting Dr. B Newton Dunn,MEP, for the invitation.

Documents

General Perpestives R&D Contributions From Pharma Final