Cognigen Corporation And Bristol-Myers Squibb Team Up To Bring e-Strategies To Drug Development
Partnership will Facilitate Exchange and Review of Data During U.S. Food and Drug Administration (FDA) Application Process
28-Oct-2000
BUFFALO, NEW YORK (October 24, 2000) -- Cognigen Corporation, a
global analytical communication company, today announced an Internet-based
collaboration with Bristol-Myers Squibb Company (NYSE: BMY) that is
expected to reduce the timeline for drug development.
Through a significant financial relationship that is expected to span more than
two and one-half years, Bristol-Myers Squibb will incorporate Cognigen's
Real Time Data Assembly and Internet-compatible PERSPECTIVE Hypertext
Data Analysis Mapping into its Phase II trials for drugs in the anti-infectives
portfolio.
"Right now, it takes most companies -- on average -- about six months and
mountains of paperwork to prepare and analyze data and write up the results for
submission to the FDA for approval," said Thaddeus Grasela, Pharm.D., Ph.D.,
president and CEO of Cognigen. "By taking advantage of our proprietary
programs and services, Bristol-Myers Squibb can reduce that time to 60 days
and potentially submit its applications to the FDA on CD-ROM disks, which is
in line with the FDA's desire to move to electronic submissions."
Bristol-Myers Squibb will use Cognigen's Real Time Data Assembly (RTDA)
-- an automated quality assurance program - to monitor drug exposure in
patients pharmacokinetic or "PK" data) and the effect the drugs have on the
physiology of the body, such as eradication of an infection (pharmacodynamic
or "PD" data).
Under previous drug trial procedures, data was analyzed after the trials were
completed and new studies had to be commissioned if flaws were discovered.
Cognigen's Real Time Data Assembly, however, provides for continuous
PK/PD feedback and observation during clinical trials. This now allows the test
data to be used to support scientific discussions at the FDA, helping to reduce
the number of studies required and thus reducing the costs associated with new
drug development.
Bristol-Myers Squibb will also incorporate Cognigen's proprietary
PERSPECTIVE Hypertext Data Analysis Mapping into its trial programs. The
e-reporting tool tracks, reviews and communicates complex results rapidly and
effectively, which eliminates the need to gather clinical trial information in
manuals that take months to review. The information can be viewed in "real
time" by various members of the analytical team at different geographical
locations via secure Internet portals. A report generated by PERSPECTIVE
can include text, figures, graphs, and tables, and show all the back up work
involved in developing conclusions about the new drug's capabilities. All
analytical components can be stored on CD-ROMs for submission to the FDA.
"We are pleased to partner with Cognigen in bringing e-strategies to our drug
development efforts," said Thorir Bjornsson, M.D., Ph.D., vice president clinical
pharmacology and experimental medicine, Bristol-Myers Squibb. "By
expediting our efforts in the FDA approval process, we believe we can know
more about our drugs earlier, and more quickly deliver critical anti-infective
drugs to the market. This can positively impact the lives of people who are
dealing with life-threatening illnesses."
With the ever rising costs of drug development, there is a need for business
solutions that hasten the clinical trial approval process by maximizing the
information obtained from the data collected in these trials. Cognigen's
comprehensive package of programs and services expedite data management,
analysis and communication throughout the drug development, approval and
marketing process.
"Cognigen's information-based e-business strategies are designed to create
change through informed decision making," Grasela said. "By collaborating with
Bristol-Myers Squibb, we can transform data and statistics into knowledge that
can be communicated in a clear, concise and rapid manner and be successful in
bringing new and critical anti-infective
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