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Bridging the Gap in Global Health Innovation - from Needs to Access The South Bridging the Gap in Global Health Innovation - from Needs to Access The South African Malaria Initiative A Case Study E Jane Morris http: //www. acgt. co. za/sami

Scale of the malaria problem • 107 endemic countries with 3. 2 billion people Scale of the malaria problem • 107 endemic countries with 3. 2 billion people at risk (40% of world’s population) • At least 1 million people die in Africa each year from malaria • Over 200 million clinical malaria cases in Africa each year • Over 4 million people in SA live in malaria areas (10% of the population) • Almost 80 million cases each year in the Southern Africa malaria control area • Climate change will increase population at risk in Southern Africa fourfold by 2020 2

Global distribution of malaria risk Source: World Malaria Report 2005 3 Global distribution of malaria risk Source: World Malaria Report 2005 3

Current situation Research Development Disease, patients, clinical trial sites, market Production Testing 4 Current situation Research Development Disease, patients, clinical trial sites, market Production Testing 4

Building for the future: Research Development Disease, patients, clinical trial sites, market Production Testing Building for the future: Research Development Disease, patients, clinical trial sites, market Production Testing 5

The South African Malaria Initiative • A network of researchers from 16 institutions in The South African Malaria Initiative • A network of researchers from 16 institutions in South Africa • Seed funding provided by SA Department of Science and Technology • Focusing on development of drugs, diagnostics, and molecular epidemiology • Supported by core expertise groups • Capacity building and training a key component 6

The discovery pipeline in SAMI Capacity building IP Networking Tar gets Leads Products Biomarkers The discovery pipeline in SAMI Capacity building IP Networking Tar gets Leads Products Biomarkers ics st Diagno Supporting Core Expertise Functional Structural Medicinal Genomics Informatics Chemistry Genetic manipulation of parasites Functional Anti-malarial Expression assays of malaria proteins 7

From Knowledge to Innovation in SAMI Discovery Being developed in SAMI Lab testing/ validation From Knowledge to Innovation in SAMI Discovery Being developed in SAMI Lab testing/ validation Establishment of HTS platform under consideration ADMETox, Early stage trials Pre-clinical platform under discussion Clinical development, regulatory approval Clinical trials possible, lack regulatory capacity Production & marketing Capacity for production of generics. Facility for diagnostics 8 being established

From Knowledge to Innovation in SAMI Discovery Lab testing/ validation Early stage trials Clinical From Knowledge to Innovation in SAMI Discovery Lab testing/ validation Early stage trials Clinical development, regulatory approval Production & marketing Need for international collaboration Need for funding Need for business partnerships 9

Early successes • Drug delivery system able to reverse chloroquine resistance • Provisional patent Early successes • Drug delivery system able to reverse chloroquine resistance • Provisional patent covering anti-malarial activity of a drug registered for other uses • Novel RDT ready for field screening by mid-2008 • Novel in vitro HTS assay validated • Drug target accepted for in silico virtual screening (WISDOM) 10

Our strengths • Excellent base of cutting edge research and facilities to draw on Our strengths • Excellent base of cutting edge research and facilities to draw on • Networked approach makes best use of available equipment, facilities and expertise • Investing in people and activities not bricks and mortar • Unique holdings of live mosquito cultures • Access to field sites and collaborations in many African countries. An African focus on an African problem! 11