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Oxford Conference on Innovation and Technology Transfer for Global Health Bridging the Gap in Global Health Innovation – From Needs to Access University.

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Presentation on theme: "Oxford Conference on Innovation and Technology Transfer for Global Health Bridging the Gap in Global Health Innovation – From Needs to Access University."— Presentation transcript:

1 Oxford Conference on Innovation and Technology Transfer for Global Health Bridging the Gap in Global Health Innovation – From Needs to Access University of Oxford 9-13 September 2007 Robert L. Mallett Senior Vice President Pfizer Inc Worldwide Public Affairs & Policy

2 A Comprehensive Approach to Malaria Management – Targeted and Needs Driven Private/Public Research Collaboration (TDR) Public Health Interventions (Africa) Cross Disciplinary People Resources and Expertise (Global Health Fellows) Targeted Development (Zithromax / Chloroquine FDC) Training and Capacity Building (IDI) Quality Manufacturing / Secure Distribution Process – Senegal

3 Pfizer / WHO – Tropical Disease Research 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 Brings What Pfizer Brings

4 Medicines in the Pipeline: Zithromax/Chloroquine: Targeting Preventive Therapy in Africa Phase 2 Conclusions Regional efficacy differences observed  Excellent response in Africa  Dose-response seen in India and Colombia  Combination well tolerated KenyaKenya IndiaIndia SurinameSuriname ColombiaColombia ZambiaZambiaUgandaUgandaIndonesiaIndonesia Burkina Faso MaliMaliGhanaGhana Confirmatory Adult Treatment Trial in Africa Pediatric Treatment Trial in Africa Submit for Regulatory Review * With External Consultation Clinical Trial: Intermittent Preventive Therapy in Pregnancy (IPTp) Clinical Trial: Intermittent Preventive Therapy in Infants and Children (IPTi/c) * ** + +

5 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

6 Infectious 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.

7 Ghana: Malaria is the Leading Cause of Death Senegal: Malaria is the Largest Contributor to Mortality and Morbidity Kenya: #1 Killer Among Children, Concentrated in the Coast and in 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 in trials 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 at endemic 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 of the country Summary of Malaria Epidemiology in Ghana, Senegal and Kenya

8 Public Health Interventions – Pfizer’s “Mobilize Against Malaria” Initiative GhanaKenyaSenegal 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 Key Objectives 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 with anti-malarial regimens Select Indicators Increase prescription of Artemisinin Combination Therapy through Chemical Sellers Increase in knowledge of anti-malarial treatment Increase knowledge of anti- malarial treatment Number of students reached by teachers trained in the program Increase knowledge of anti-malarial treatment Number of people reached by campaign

9 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

10 Familiar Challenges of Healthcare in the Developing World Lack of government commitment for effective healthcare 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 in epidemic situations  Public distrust of the clinical trials process Private sector still not viewed as a natural partner

11 Practical 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


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