Biomedical Engineering Reference
In-Depth Information
Query
Interfaces
caB2B
Study Finder
caGRID
i2b2-caGRID cell
UCSF i2b2
Datamart
Local
Databases
HSD 1 -Mayo
HSD-WU
Ontology of Clinical Research (OCRe)
Data
Sources
Velos, Labmatrix, etc.
Sybase Database
mdLogix, etc.
Figure 16.1 Proposed Human Studies Database (HSDB) to enable sharing data
between CTSA awardee institutes.
16.2 ESTABLISHING TRANSLATIONAL RESEARCH
INFRASTRUCTURE
First, we have established a strong cooperative team across the research and
development (R&D) organization of the pharmaceutical companies of Johnson
& Johnson. We extended the team with open innovation partnerships with
Rutgers University and the Cancer Institute of New Jersey (CINJ). The infor-
matics and information technology group worked in close collaboration with
business partner stakeholders from discovery biology, translational medicine,
biomarker, and clinical organizations with a goal to develop a system which
enables democratic access to all the data generated during target validation,
biomarker discovery, preclinical and translational studies, and clinical
development.
Change management is an important aspect of successfully introducing a
paradigm shift within a large pharmaceutical organization. From the beginning
of the project we relied on the collective wisdom of biologists, pharmacologists,
and physicians from the therapeutic areas to guide us through the develop-
ment and eventually to help champion the adaptation of the newly developed
translational infrastructure.
16.3
WHY DATA WAREHOUSING
There are multiple approaches one can take to implement a translational data
repository. If an organization has established a set of strong primary data
source repositories such as databases for omics data from preclinical and clini-
cal studies and clinical databases, one can choose to develop a federated
system which will integrate all these sources into a translational system. Special
 
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