PRECOMPETITIVE COLLABORATIONS IN PHARMACEUTICAL INDUSTRY - Collaborative Computational Technologies for Biomedical Research - page 80

SERIOUS ADVERSE EVENTS CONSORTIUM (SAEC):
WWW.SAECONSORTIUM.ORG

Members Abbott, Daiichi Sankyo, GSK, J & J, Novartis, Pfi zer,

Roche, Sanofi -Aventis, Takeda, Wellcome Trust,
Wyeth, Cerner, Columbia University, Dundee
University, DILIGEN, EUDRAGENE, Expression
Analysis, Malaga University, Illumina, U.S. VA Center
for Drug Safety

Objectives
and
deliverables

The SAEC aims to identify genes that
can infl uence adverse drug reactions.
This will be achieved by comparing genetic
sequences of individuals with well-characterized
adverse events with control individuals to
identify genetic variants that may be risk
factors for these events. During the pilot phase,
the focus has been on serious skin reactions and
drug - induced liver injury.

Description of
consortium

Sponsors of the SAEC contribute genetic and
phenotype data from individuals who have
had an adverse reaction to a drug together
with data from controls. These are assigned
to scientifi c collaborators for analysis to
determine if the adverse events can be
correlated with genetic variation. After full
analysis the results are made available to all
qualifi ed researchers on a nondiscriminatory
basis to maximize the speed of follow-on
discoveries and published as appropriate.
The SAEC is governed by a board of directors
which has management control over the property,
activities, and funds of the corporation. It is
made up of a director from each sponsoring
member and a chief executive offi cer.
The board structure allows for involvement
of other nonprofi t research and governmental
organizations via “ associate membership ” and it makes
decisions using a “ majority rules ” model. All key
research collaborations are formed via a rigorous “RFP
process, ” with fi nal selection determined by the scientifi c
management committee. The committee outlines
research strategies, well - defi ned research programs, and
advice on study design and methodology and data
release policies

Time frame 2007 - 2012