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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