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Day 3
WeOC1
A "Platform" for Research Informatics:
Capture, Catalog, View, Share and Re-Use
John Helfrich, NuGenesis Technologies
Pharmaceutical Data and Information Landscape
There are many specific tools for creating, storing, accessing and utilizing data and
information within the spectrum of pharmaceutical drug development. These tools are used by different departments and functions
across the entire timeline of development. This patchwork process has
created many different software platforms for Information Technology to
support. Additional value can be generated when data are collected into
a data management platform.
In drug discovery there may be 5,000 compounds that are considered
within a variety of therapeutic arenas. Over the next several years, a
reasonable estimate is that 5-10 compounds reach the IND phase of
development. Another multiple year process of clinical trials may yield
only one or two marketable drugs. The path from 5,000 drugs to one drug
yields a tremendous amount of data. Rather than focus on only the data
from the one successful drug, the data from the 4,999 drugs that did not
make it through the process yields valuable data from a bioinformatics
perspective. These negative data provide interesting information on many
aspects such as structure activity relationships. Toward the goal of
reducing the timeframe for drug development, an in-silico predictive
process may be developed from the data collected and used very early in
development.
Pharmaceutical Industry Challenges
A goal from the perspective of an innovator pharmaceutical company is
determining how to maintain double digit growth. The challenges to reach
this goal are listed:
- Accelerate the discovery process to reduce cycle time to IND from six
years to three years
- Increase the number of New Chemical Entities (NCE) that reach clinical
trials from 1-2/year to 2-4/year
- Reduce the "time-to-market" from 12-15 years to under 10 years
- Reduce total drug discovery and development costs from ~$800M per drug
to under $400M per drug
- Insure a solid intellectual property and regulatory compliance
position
Several approaches for using research informatics in drug development
are presented within this session. First, a global perspective on
analytical data management is shared (a strategic overview from an
innovative company). Second, a focus on specific tools currently used for
data management. Finally, an overview of a system developed for
knowledge sharing and scientific knowledge management is presented.
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