1. Millions of people have a drug problem ! They can not get any !

2. Lack of Effective, Affordable and Easy-to-use Medicines, Vaccines & Diagnostic tools Increasing resistance to older medicines Discontinued production of effective medicines Existing –new- drugs are too expensive Very few new drugs are developed to tackle major diseases affecting the poorest countries (despite significant scientific/technological advances) >>> lack of R&D

3. Drug Development Outcome 1975-1999: 1393 new chemical entities marketed Tropical diseases: 13 Tuberculosis: 3 Trouiller et al., Lancet 2002, 359:2188-94 Halofantrine, Mefloquine, Artemeter, Atovaquone, Benznidazole, Nifurtimox, Albendazole, Eflornithine, Ivermectine, Oxamniquine, Praziquantel, Pentamidine isetionate, Liposomal Amphoterizin B.

4. The R&D Process Post- Marketing Clinical research Pre-clinical research Basic research Screening and optimization Synthesis, extraction Dosage & stability Toxicology-safety Phase I-II-III clinical studies Bioavailability Upscaling production Regulatory review Patients Scientific literature (patent applications) 2-5 years3-10 years Public sector Pharmaceutical Industry Cumulative efforts scientific community. Includes discovery research leading to the identification of targets and lead-compounds GAP

5. R&D is needed to ensure that new essential medicines, vaccines and diagnostics are developed and become available to people in developing countries. New effective drugs & diagnostic tests for –Malaria –Sleeping sickness & Chagas disease –Viceral leishmaniasis –TB Monitoring tools (VL & CD4) for HIV-patients on HAART Preventive/therapeutic vaccine against HIV-virus High priority needs

6. DNDi’s Founding Partners are: 1. Médecins Sans Frontières (MSF) 2. Oswaldo Cruz Foundation/Fiocruz (Brazil) 3. Indian Council of Medical Research (India) 4. Institut Pasteur (France) 5. Ministry of Health (Malaysia) 6. Kenya Medical Research Institute (Kenya) Objective is to develop and make available drugs for neglected diseases on a not-for-profit basis. It will achieve this by building a needs-driven portfolio of short, medium, and long-term R&D projects, raising awareness about the issue, and strengthening R&D capacity via the implementation of projects in countries where these diseases are endemic.

7. Changing Global Rules Ensuring access to essential medicines = public responsibility Define a needs-driven international R&D priority agenda Outline an agreement and clear rationale for sharing the burden of the cost of this R&D Commit all countries to contribute to R&D for health Establish and strengthen international mechanisms for exchanging and transferring research results, knowledge, and technology Deal with regulatory barriers to drug/vaccine development Ensure that developing country involvement in R&D is central, including through north-south and south-south collaboration, and through the conduct of such R&D in disease-endemic countries