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