Oxford Conference on Innovation and Technology Transfer for Global Health

Bridging the Gap in Global Health Innovation – From Needs to Access

University of Oxford9-13 September 2007

Oxford Conference on Innovation and Technology Transfer for Global Health

Bridging the Gap in Global Health Innovation – From Needs to Access

University of Oxford9-13 September 2007

Robert L. Mallett

Senior Vice President

Pfizer Inc

Worldwide Public Affairs & Policy

A Comprehensive Approach to Malaria Management – Targeted and Needs DrivenA Comprehensive Approach to Malaria Management – Targeted and Needs Driven

Private/Public Research Private/Public Research Collaboration (TDR) Collaboration (TDR)

Private/Public Research Private/Public Research Collaboration (TDR) Collaboration (TDR)

Public Health Public Health Interventions (Africa)Interventions (Africa)

Public Health Public Health Interventions (Africa)Interventions (Africa)

Cross Disciplinary People Cross Disciplinary People Resources and Expertise Resources and Expertise (Global Health Fellows) (Global Health Fellows)

Cross Disciplinary People Cross Disciplinary People Resources and Expertise Resources and Expertise (Global Health Fellows) (Global Health Fellows)

Targeted Development Targeted Development (Zithromax / Chloroquine (Zithromax / Chloroquine

FDC)FDC)

Targeted Development Targeted Development (Zithromax / Chloroquine (Zithromax / Chloroquine

FDC)FDC)

Training and Capacity Training and Capacity Building (IDI)Building (IDI)

Training and Capacity Training and Capacity Building (IDI)Building (IDI)

Quality Manufacturing / Quality Manufacturing / Secure Distribution Secure Distribution Process – SenegalProcess – Senegal

Quality Manufacturing / Quality Manufacturing / Secure Distribution Secure Distribution Process – SenegalProcess – Senegal

Pfizer / WHO – Tropical DiseaseResearch PartnershipPfizer / WHO – Tropical DiseaseResearch Partnership

Expertise Tropical parasitology Desired target product profiles

Screening Capability Whole organism in vitro and lab

animal in vivo screens New mechanistic targets for high

throughput screens

Funding for FTE Support Chemists to follow up hits and

lead optimisation Biologist for HTS development

and implementation Genomic work aimed at new

target identification

Compounds Access to over 3 million compounds Libraries of interesting drugs

> Antiparasitic classes> Known drugs and mechanistic actives

Medicinal Chemistry and Biology Expertise Selecting the best compounds for

follow up – AH parasitology + HH Directing lead optimisation, e.g.,

input on likely toxicity, pharmacokinetics, etc.

Support for HTS development Genomics and target

selection expertise Training and supervision for

post-Docs

What WHO-TDR BringsWhat WHO-TDR BringsWhat WHO-TDR BringsWhat WHO-TDR Brings What Pfizer BringsWhat Pfizer BringsWhat Pfizer BringsWhat Pfizer Brings

Medicines in the Pipeline: Zithromax/Chloroquine: Targeting Preventive Therapy in AfricaMedicines in the Pipeline: Zithromax/Chloroquine: Targeting Preventive Therapy in Africa

Phase 2 ConclusionsPhase 2 ConclusionsPhase 2 ConclusionsPhase 2 Conclusions

Regional efficacy differences observed Excellent response in Africa Dose-response seen in India

and Colombia Combination well tolerated

KenyaKenyaKenyaKenya

IndiaIndiaIndiaIndia

SurinameSurinameSurinameSuriname

ColombiaColombiaColombiaColombia

ZambiaZambiaZambiaZambia UgandaUgandaUgandaUganda IndonesiaIndonesiaIndonesiaIndonesia

Burkina FasoBurkina FasoBurkina FasoBurkina FasoMaliMaliMaliMali GhanaGhanaGhanaGhana

Confirmatory Adult Treatment TrialConfirmatory Adult Treatment Trialin Africain Africa

Confirmatory Adult Treatment TrialConfirmatory Adult Treatment Trialin Africain Africa Pediatric Treatment Trial in AfricaPediatric Treatment Trial in AfricaPediatric Treatment Trial in AfricaPediatric Treatment Trial in Africa

Submit for Submit for Regulatory Regulatory

ReviewReview

Submit for Submit for Regulatory Regulatory

ReviewReview

Submit for Submit for Regulatory Regulatory

ReviewReview

Submit for Submit for Regulatory Regulatory

ReviewReview

* With External Consultation

Clinical Trial: Intermittent Preventive Therapy Clinical Trial: Intermittent Preventive Therapy in Pregnancy (IPTp)in Pregnancy (IPTp)

Clinical Trial: Intermittent Preventive Therapy Clinical Trial: Intermittent Preventive Therapy in Pregnancy (IPTp)in Pregnancy (IPTp)

Clinical Trial: Intermittent Preventive Therapy Clinical Trial: Intermittent Preventive Therapy in Infants and Children (IPTi/c)in Infants and Children (IPTi/c)

Clinical Trial: Intermittent Preventive Therapy Clinical Trial: Intermittent Preventive Therapy in Infants and Children (IPTi/c)in Infants and Children (IPTi/c)

*

* *+ +

Manufacturing & Distribution Program Manufacturing & Distribution Program

Pfizer Facility, 100% owned by Pfizer

Location: Dakar, Senegal in the Free Tax Area (ZFID)

Exclusively dedicated to Anti-Malarial products

Ensures secure distribution chain/All products distributed to Private Wholesalers and the Public Sector (through tenders) in 19 countries

Now being upgraded and awaiting WHO PQS inspection

GMP certified by Senegal authorities

Infectious Disease InstituteInfectious Disease Institute

Joint Uganda Malaria Training Program (JUMP)

An AAF/IDI and ExxonMobil Malaria Initiative

JUMP was established as a partnership between the Infectious Diseases Institute (IDI) and the Uganda Malaria Surveillance Project (UMSP). UMSP is a collaboration between academic institutions and the Ministry of Health in Uganda with the aim to create a scalable training model for Uganda and other countries.

JUMP takes an innovative approach to training healthcare professionals in improved malaria prevention, diagnosis and treatment, by working directly with entire treatment teams at the health facility level and by building the skill sets of all clinic professionals, from medical officers to data entry clerks.

Ghana: Malaria is the LeadingGhana: Malaria is the LeadingCause of DeathCause of Death

Ghana: Malaria is the LeadingGhana: Malaria is the LeadingCause of DeathCause of Death

Senegal: Malaria is the Largest Senegal: Malaria is the Largest Contributor to MortalityContributor to Mortality

and Morbidityand Morbidity

Senegal: Malaria is the Largest Senegal: Malaria is the Largest Contributor to MortalityContributor to Mortality

and Morbidityand Morbidity

Kenya: #1 Killer Among Children, Kenya: #1 Killer Among Children, Concentrated in the Coast andConcentrated in the Coast and

in the Westin the West

Kenya: #1 Killer Among Children, Kenya: #1 Killer Among Children, Concentrated in the Coast andConcentrated in the Coast and

in the Westin the West

Accounts for 35% of patient visits 20% of cases reported are severe Wide epidemiological diversity

across environments (Northern Sahel, North Coast, Senegal river valley, Southern Sudan-Sahel)

Deaths have been previously documented at 8,000 per year, though current estimates dropped to 3,000 per year

Senegal has led West Africa intrials of IPT in children for seasonal malaria

20 million people at risk of malaria 30% of outpatient visits and 19%

of hospital admissions attributed to malaria

#1 killer among children Highly variable risk of malaria

across diverse environments: Endemic Highland Arid Low-risk

Malaria accounts for 44.5% of all out patient illness

100% of the population is atendemic risk

Malaria incidence is 170/1,000 population, the highest among the three assessed countries

Deaths under 5: at 33%, the highest among the three assessed countries

ACTs were introduced in Ghana in 2006, and the rollout is lagging behind GFATM targets

Transmission is seasonal in most of the country, and lasts throughout the year in the south eastern part ofthe country

Summary of Malaria Epidemiology inGhana, Senegal and KenyaSummary of Malaria Epidemiology inGhana, Senegal and Kenya

Public Health Interventions –Pfizer’s “Mobilize Against Malaria” InitiativePublic Health Interventions –Pfizer’s “Mobilize Against Malaria” Initiative

GhanaGhana KenyaKenya SenegalSenegal

Interventions

1. Training of Chemical Sellers in anti-malarial prescribing treatment, referral for severe malaria and compliance

2. Patient Education promoting treatment seeking behavior and compliance

1. Teacher Training program to improve treatment seeking behavior for malaria and compliance with anti-malarial regimens

2. Shopkeeper Training on malaria prescribing treatment, referral and compliance

1. Media Campaign promoting treatment seeking behavior, appropriate use of Artemisinin Combination Therapy and compliance with anti-malarial regimens

Partners

Pharmacy Council Ghana Social Marketing

Foundation

African Medical and Research Foundation

Healthstore Foundation ExxonMobil

Management Sciences for Health Academy for Educational

Development Christian Children’s Fund

KeyObjectives

Increase treatment seeking behavior

Increase compliance with anti-malarial regimens targeting provision and patient behavior

Increase treatment seeking behavior and correct diagnosis for fever among students

Increase compliance with anti-malarial regimens

Increase treatment seeking behavior

Increase compliance withanti-malarial regimens

Select Indicators

Increase prescription of Artemisinin Combination Therapy through Chemical Sellers

Increase in knowledge ofanti-malarial treatment

Increase knowledge of anti-malarial treatment

Number of students reached by teachers trained in the program

Increase knowledge ofanti-malarial treatment

Number of people reachedby campaign

Metrics to Determine Progress and Success Metrics to Determine Progress and Success

Principal Evaluation Partner: London School of Hygiene and Tropical Diseases

Reduction in the rate of malaria morbidity and mortality by improving malaria symptom recognition, treatment and referral

% increase of children who took anti-malarial drugs

% increase in number of caretakers seeking treatment for feverish child

% increase of informal outlet providers who supply adequate treatment

% increase of informal outlet providers who provide correct diagnosis, malaria treatment compliance information and referrals (in case of severe malaria)

# of patients adhering to treatment

Infrastructure Strengthening Sustainable programs Strengthening a substrate relevant for other disease interventions Positive reinforcement from patients in Kenya, Senegal and Ghana

Familiar Challenges ofHealthcare in the Developing WorldFamiliar Challenges ofHealthcare in the Developing World

Lack of government commitment for effectivehealthcare delivery

Lack of healthcare capacity and healthcare worker training

Lack of financial sustainability of healthcare systems

Weak medical and regulatory systems

Lack of technical capacity for clinical trials

Concerns re. placebo-controlled clinical trials inepidemic situations

Public distrust of the clinical trials process

Private sector still not viewed as a natural partner

Practical Realities of Private Sector Health Interventions in Developing CountriesPractical Realities of Private Sector Health Interventions in Developing Countries

Difficult to Identify Clusters of Trained Investigators for Clinical Trials

Getting Physicians to Encourage Patient Participation

Patient Consent Issues/Maintaining Patient Participation

Quality Records Retention and Management

Understanding the Need for Double Blind Placebo Based Studies

Assuring the Integrity of the Supply Chain for Medicines

Weak Point of Sale Quality Regulation

Limited Regional Program Evaluation Capacity

Continuing Distrust of the Role of the Private Sector in Healthcare Delivery Across the Continuum

Balancing Shareholder Fiduciary Responsibilities with Social Obligations