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Proceedings -Thursday, October 11, 2001
ThOB4
Automating Laboratory Data Management Practices for Improved
Knowledge Transfer in Drug Discovery and Product Development
John P. Helfrich, NuGenesis Technologies
Background
The drug discovery process is a team effort. Multi-group
collaboration is vital to optimizing, developing and promoting the
highest quality candidate to bring through the pipeline. Only high
quality candidates have the greatest probability of surviving the
test of early-phase clinical trails. The timely movement of data and
information between different R&#amp;D groups is vital for assessing
viable candidates and accelerating the "knowledge-base" transfer for
critical go/no go decisions.
To remain competitive, science-based companies need to achieve
higher returns on two fundamental elements of laboratory operation:
time and data. Unfortunately, the wealth of critical-path
information at a scientist's disposal can reside on different types
of information systems and in different software applications which
use proprietary formats. The NuGenesis Scientific Data Management
System (SDMS) is designed to unify data from any laboratory
instrument or Windows application to provide a truly application
independent data capture and unification system.
Premise
Compound knowledge and information in drug discovery resides in many
different groups, e.g., HTS, assay development, target ID and
validation, ADME/Tox, medicinal chemistry, process development,
analytical, stability, manufacturing and quality control. A vision
of efficiency is to create and enable a sharing environment where
knowledge and information are effectively used across the
enterprise. Companies are being forced to develop drugs at a greater
speed than ever before, with higher throughput, and yet control
costs. Thus, productivity is a vital issue in development. The new
culture is to abandon failing targets early in the process and focus
on the promising ones. This approach will become realized by the use
of novel, automated, ultra high throughput technologies that will
revolutionize the drug discovery process. Data management is thus
critical to successfully adopt this new strategy.
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In addition to a data explosion, another important factor to
consider is that today's biopharmaceutical research environment is
global; companies have different sites, and collaborate with other
companies around the world. For example, Pfizer has greater than 450
partnerships with external collaborators. These collaborations
enable 12,000 scientists at 6 sites to more effectively work on 156
drug development projects within 19 disease areas.
The NuGenesis SDMS system was demonstrated and detailed for its
ability to integrate data and communicate this information across
all boundaries. The SDMS gets the raw instrument and human readable
data, catalogs the data for retrieval, reprocessing and transfer to
anywhere at anytime. Data can be found instantly via the web and
used in presentations, submissions and publications. A data summary
report can be created, as illustrated below. This report gathers
disparate data, creates documents with all available data, and a
traceable link is included to the original data.
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Electronic signatures provide the ability to approve reports in the
NuGenesis VISION database. Thus, IP and 21CFR11 needs are satisfied.
Audit trails are maintained by Project and remain even if the
Project is deleted. Extraction templates provide the ability to
extract discrete values from reports for use in third party
applications. Knowledge transfer in this manner is proposed to
create more effective NDA by reducing the time to submission.
Links
Nugenesis Corporation
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