Post on 26-Mar-2015
Dr. Jean-Hervé BradolResearch 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
Medical Innovation in Humanitarian SituationsThe Work of Médecins Sans Frontières
Edited 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
• 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
Tropical diseases: 18
Source: Chirac P, Torreele E. Lancet. 2006 May 12; 1560-1561.
New drugs developed from 1975-2004 New drugs developed from 1975-2004
Tropical diseases and tuberculosis account for 12% of the global disease burden, but only 1.3% of new drugs developed.
TB: 3 1.3%1.3%1.3%1.3%
Total: 1,556Total: 1,556
Launch & utilization
CHALLENGE 3
CHALLENGE 4
SpecificActivitiesOrganizations
TDR
Unspecified
GSK
WRAIR
2000: A Deserted R&D Landscape
Screening
Lead identification
Lead optimization
In vivo efficacy
Regulatory toxicity & safety
Phase 1
Phase 2
Phase 3
Registration
CutaneousLeishmaniasis
CHALLENGE 1
CHALLENGE 2
VisceralLeishmaniasis
HAT Chagas
CHALLENGE 3
Launch &utilization
CHALLENGE 4
Screening
Lead identification
Lead optimization
In vivo efficacy
Regulatory toxicity & safety
Phase 1
Phase 2
Phase 3
Registration
Launch & utilization
HAT Chagas VisceralLeishmaniasis
CutaneousLeishmaniasis
Dengue Malaria TB
CHALLENGE 1
Sandler Center
IOWHMMVGSK
DD@D
CDNDTB Alliance
DNDi
Specific
ActivitiesOrganizationsTDR
NITD – PC dengue, TB
CHALLENGE 2
CHALLENGE 3
CHALLENGE 4
Unspecified
WRAIR
2007 Drug R&D Landscape for 2007 Drug R&D Landscape for NTDsNTDs
Combined PDP pipeline today includes 143 candidates
0 2 4 6 8
7Feasibility
7Test
•Development6Evaluation
1Demonstration
6Country
•Adoption
CD4
FIND
IDRI
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
4%
22%
26%
22%
104 biopharmaceutical candidates in development...
104 biopharmaceutical candidates in development...
... and 39 diagnostic & vector control candidates
... and 39 diagnostic & vector control candidates
0 20 40 60
59Pre Clinical
15Phase I
12Phase II
10Phase III
2Registration
6Launched
Drugs
Vaccines
Microbicides
# candidates
10%
12%
14%
57%
6%
2%
7
5
0 2 4 6 8
Early Stage
In
•Development
IVCC
# candidates
Diagnostics
Vector control
26%
8
20
Product Development Partnerships (PDPs): Filling the Gaps in Translational Research and
Product Development
HHVIHHVI
Vaccine Development ProgramVaccine Development Program