Johanne Iversen and Unni

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Transcript Johanne Iversen and Unni

The importance of public-sector research in
R&D
Johanne Iversen and Unni Gopinathan
Outline
1. The role of public-sector research institutions
2. Appropriate licensing mechanisms for
managing the intellectual property from
publicly-funded research
3. Conclusions for the CEWG to consider
Total
Public-sector
% from
public sector
FDAapproved
drugs
1541
143
9.3%
Priority
review
348
66
19%
Other findings from new-drug applications from the
public sector
• 46% received priority review compared to 20%
from the private sector
• Accounted for 13.6% of NMEs
• Acccounted for 21.1% of NMEs which had
priority review
Stevens et al, NEJM 2011
Keller, R., Nat Rev 2010
Total R&D funding for tropical neglected
diseases in 2007
Moran, M., J. Guzman, et al. (2009). PLoS Med 6(2): e30
Goals of academic research
1. Science for the benefit of all
2. Management of innovation to meet global
needs
3. Reciprocal responsibility of science and
society
Manchester Manifesto, University of Manchester
Issues within current
managment of innovation and IP
1. Current innovation models do not reflect
global health needs
2. Who uses the research and for what purpose?
3. Restrictions in access to new science may lead
to duplication and waste
Manchester Manifesto, University of Manchester
Innovations originating from publicsector research will have a greater
impact on global health if
appropriate intellectual property
mechanisms are adopted
Harnessing the role of public-sector
research institutions
• Models for precompetitive research and
development platforms
• Open Source
Jon Soderstrom, Ashley J. Stevens et al
Academic research in relation
to other proposals
• Adding research capacity for product
development partnerships
• Removal of data exclusivity
• Patent pools
Conclusions
- The Consultative Expert Working Group
should consider:
- the increasing importance of public-sector research in drug
development
- exploring appropriate academic intellectual property
mechanisms which may strengthen other relevant
proposals
- exploring partnership models that can increase incentives
for R & D
- exploring models for precompetitive platform building
within public- sector research institutions
Final conclusion
Most important of all:
Innovative models must aim to meet the global
burden of disease