MODELS FOR COLLABORATIONS AND COMPUTATIONAL BIOLOGY - Collaborative Computational Technologies for Biomedical Research - page 44

competitive model, the need to collaborate is being embraced by the scientifi c
community.
As evidence of acceptance, several large-scale partnerships have emerged
over the last fi ve years, which demonstrate the utility and sensibility of leverag-
ing resources to (1) share cost and risk among the research community, (2)
develop standards to achieve more accurate measures of research, and (3)
expedite the advancement of scientifi c knowledge, for example.
Below are examples of large-scale partnerships that have proven successful
to advance research efforts. Some of these exemplar partnerships are private-
private (involve only privately held companies/organizations), while others
include one or more government entities—thus termed public-private part-
nerships. The PSTC and BC are two examples of U.S.-led large-scale consortia.
Examples of large-scale European initiatives include the Innovative Medicines
Initiative Undertaking (IMI) (see Chapter 4), the European Personalized
Medicine Association (EPEMED), and the Pistoia Alliance (see Chapter 1,
http://www.pistoiaalliance.org/overview ). Sections 3.4.1 - 3.4.4 provide detailed
descriptions of existing large - scale consortia.

3.4.1 Predictive Safety Testing Consortium

The PSTC is a unique public-private partnership led by the nonprofi t C - Path.
The mission of the PSTC is to bring together pharmaceutical companies to
share and validate each other's safety testing methods under advisement
of the FDA and its European counterpart, the EMA. The goal of the PSTC
is depicted in Figure 3.1 and can be summarized as an attempt to “create a
productive environment among private sector competitors while balancing
their needs with those of the FDA, academic scientists, and the public
health ” ( http://www.c-path.org/consortia.cfm ).
The 16 industry members of the PSTC share internally developed preclini-
cal safety biomarkers in fi ve workgroups: carcinogenicity, kidney, liver, muscle,
and vascular injury. For more detail see http://www.c-path.org/pstc.cfm.

3.4.2 Biomarkers Consortium

The BC is a precompetitive public-private partnership managed by The
Foundation for the NIH (FNIH) and the three founding members, the NIH,
the FDA, and PhRMA (the trade organization for the U.S. pharmaceutical
industry). In addition to the founding members of the consortium other part-
ners in the consortium include the Centers for Medicare & Medicaid Services
and the Biotechnology Industry Organization. The genesis for the BC was
initially with PhRMA, which in discussions with the NIH and the FDA realized
the need for robust and meaningful biomarkers, well characterized for use and
widely available to the research community [7].
The BC is the largest public-private consortium to date with participation
from a variety of stakeholders, including government, industry, academia,