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Dr. Jean-Herv é Bradol Research Director MSF Center for Reflection on Humanitarian Action & Knowledge. Medical Innovation in Humanitarian Situations: The Work of Médecins Sans Frontières. MSF Malaria Studies 1996-2004.
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Dr. Jean-Hervé Bradol Research DirectorMSF Center for Reflection on Humanitarian Action & Knowledge Medical Innovation in Humanitarian Situations: The Work of Médecins Sans Frontières
MSF Malaria Studies 1996-2004 • More than 12,000 patients were enrolled in 43 efficacy studies in 18 countries of Asia and Africa between 1996 and 2004. • This accounted for 1/4 of the overall research output in these countries during that period. • The vast majority of the studies were published in peer-reviewed journals Guthmann J.-P., Checchi F. et al., 2008, « Assessing Antimalarial Efficacy in a time of Change to Artemisinine-Based Combination Therapies : The Role of Médecins Sans Frontières », Plos Medicine, 5 (8), p. 1191-1199.
Requirements to be met: • The treatment must be accepted by the WHO • Reliable supply sources must be identified – they must be sustainable, of good quality and reasonably priced • Economic conditions must be created to finance the new protocol • Legal questions must be addressed (intellectual property) • Administrative authorisations from national authorities must be obtained on import and use • New treatment protocols must be written and staff trained
Cholera: diagnosis and treatment outside the hospital Jean François Corty Meningitis: from practitioner to prescriber Eugénie d’Alessandro Human African trypanosomiasis: moving beyond arsenic Jean François Corty Malaria: resistances treated by south-south mediation Suna Balkan and Jean-François Corty AIDS: a new pandemic requiring new medical and political practices Jean-Hervé Bradol and Elizabeth Szumilin Medical Innovation in Humanitarian SituationsThe Work of Médecins Sans FrontièresEdited by Jean-Hervé Bradol and Claudine Vidal • Innovations? • Jean-Hervé Bradol and Marc Le Pape • MSF “satellites”. A strategy underlying different medical practices • Claudine Vidal and Jacques Pinel • Measure, analyse, publish and innovate • Emmanuel Baron • Controversy policy • Marc Le Pape and Isabelle Defourny • Remarks • Nicolas Dodier
New drugs developed from 1975-2004 Total: 1,556 Tropical diseases: 18 1.3% TB: 3 Tropical diseases and tuberculosis account for 12% of the global disease burden, but only 1.3% of new drugs developed. Source: Chirac P, Torreele E. Lancet. 2006 May 12; 1560-1561.
Organizations Activities 2000: A Deserted R&D Landscape Specific TDR Unspecified CHALLENGE 4 GSK CHALLENGE 4 Launch & utilization Launch & utilization CHALLENGE 3 WRAIR CHALLENGE 3 Registration Phase 3 Phase 2 Phase 1 CHALLENGE 2 Regulatory toxicity & safety In vivo efficacy Lead optimization CHALLENGE 1 Lead identification Screening Visceral Leishmaniasis Cutaneous Leishmaniasis Chagas HAT
2007 Drug R&D Landscape for NTDs Organizations Activities Specific TDR CDND Unspecified TB Alliance NITD – PC dengue, TB IOWH CHALLENGE 4 MMV Launch & utilization GSK DNDi DD@D CHALLENGE 3 Sandler Center WRAIR Registration Phase 3 Phase 2 Phase 1 TB HAT Chagas Dengue Malaria Visceral Leishmaniasis Cutaneous Leishmaniasis CHALLENGE 2 Regulatory toxicity & safety In vivo efficacy Lead optimization CHALLENGE 1 Lead identification Screening
8 Combined PDP pipeline today includes 143 candidates 104 biopharmaceutical candidates in development... ... and 39 diagnostic & vector control candidates Diagnostics Pre Clinical 59 57% Feasibility 7 26% • Test • Development Phase I 15 14% 7 26% Evaluation 6 22% Phase II 12 12% CD4 Demonstration 1 4% FIND Phase III 10 10% • Country • Adoption IDRI 6 22% Drugs Registration 2 2% Vaccines Vector control Microbicides Launched 6 6% Early Stage IVCC • In • Development # candidates # candidates Notes: Includes products not funded by Gates Foundation. Biopharmaceutical candidates in development Include: IAVI, IPM, IVI, GATB, Aeras, MMV, MVI, MVP, PVS, DNDi, iOWH, PDVI, HHVI. Source: PDPs
Product Development Partnerships (PDPs): Filling the Gaps in Translational Research and Product Development