Transcript NfPI

Millions of people have
a drug problem !
They can not get any !
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
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.
The R&D Process
Scientific literature
(patent applications)
Pharmaceutical Industry
2-5 years
Basic
research
GAP
Cumulative efforts
scientific community.
Includes discovery
research leading to the
identification of targets
and lead-compounds
Public sector
Pre-clinical
research
3-10 years
GAP
Screening and
optimization
Synthesis, extraction
Dosage & stability
Toxicology-safety
Clinical
research
GAP
Phase I-II-III clinical
studies
Bioavailability
Upscaling production
Regulatory review
PostMarketing
Patients
High priority needs
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
Médecins Sans Frontières (MSF)
Oswaldo Cruz Foundation/Fiocruz (Brazil)
Indian Council of Medical Research (India)
Institut Pasteur (France)
Ministry of Health (Malaysia)
Kenya Medical Research Institute (Kenya)
DNDi’s Founding Partners are:
1.
2.
3.
4.
5.
6.
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.
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