PRECOMPETITIVE COLLABORATIONS IN PHARMACEUTICAL INDUSTRY - Collaborative Computational Technologies for Biomedical Research - page 70

that all members of the consortia sign up to—even if it is only to agree to a
“no IP” policy as with the SGC. As part of the IP discussion, a range of likely
scenarios should be covered identifying the likely associated ownership of the
IP that would result from each scenario. Other legal issues should also be
specifi ed where appropriate.
4. Importance of Good Project Management and Governance The funders
of most large-scale collaborations now insist that project management tools
and milestones be used to plan and monitor the progression of a project. It is
also important to ensure that appropriately skilled individuals are given the
time and resources to implement the project plans. Any private company
spending millions of pounds (euros or dollars) would ensure that there were
individuals responsible for operational (as opposed to the technical/scientifi c)
management—the sums involved in large-scale precompetitive projects are no
different and have the same operational demands. Part of this is clearly defi n-
ing what each party will bring to the consortium, what they are accountable
for delivering and when it will be delivered, and monitoring this regularly. As
can be seen from the IMI and SGC examples, clear governance structures were
put in place which helped the smooth running of the consortium, and this is
also the case for the consortia listed in the Appendix.
One thing noted with the IMI example is the importance of defi ning where
clinical governance will reside for clinical studies undertaken by the
consortium.
5. Standards It is also important that standards for experiments, data
storage, and analysis and clear expectations on the level of recordkeeping are
agreed upon early on. Pharmaceutical companies operate in a highly regulated
environment where standards are clearly laid out whereas academic laborato-
ries do not have to operate to the same level of standard operating procedures.
However, if data obtained in the collaboration are to be used later for regula-
tory submissions, accurate and comprehensive recordkeeping will be required.
Alongside this resources should be explicitly requested for data mining, analy-
sis, storage, and so on—this can often be a major issue and yet consortia such
as the Coalition Against Major Diseases (CAMD) depend on having these
functions adequately resourced.
6. Have Clear Exit Strategy All projects should have a clearly defi ned exit
strategy—whether this is at the end of the natural life of the project or a refl ec-
tion of changing information or scientifi c priorities of one or more of the
individual parties involved. This is often hard to contemplate—just as no one
enters a marriage planning for divorce, no collaborator wants to entertain the
option of failure. But just as prenuptial agreements can save a lot of time,
angst, and lawyer's fees, so can agreed-upon exit strategies for large-scale col-
laborations. The strategy could also allow for fl exibility on behalf of the par-
ticipants to change the direction of the project as new data emerge.
7. Communication Internally it is important to ensure that there are clear
lines of communication between participants, and the use of collaborative
resources such as websites and social networking tools is recommended. It is