Cognigen Corporation and Bristol-Myers Squibb Team Up to Bring e-Strategies to Drug Development.Business Editors BUFFALO, N.Y.--(BUSINESS WIRE)--Oct. 25, 2000 Partnership Will Facilitate Exchange and Review of Data During Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Application Process Cognigen Corporation, a global analytical communication company, today announced an Internet-based collaboration with Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were Company (NYSE NYSE See: New York Stock Exchange :BMY BMY Bristol Myers Squibb ) 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 hypertext, technique for organizing computer databases or documents to facilitate the nonsequential retrieval of information. Related pieces of information are connected by preestablished or user-created links that allow a user to follow associative trails across the 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 CD-ROM: see compact disc. CD-ROM in full compact disc read-only memory Type of computer storage medium that is read optically (e.g., by a laser). 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 RTDA Retail Tobacco Dealers of America RTDA Retail Tobacco Distributors Association RTDA Real-Time Data Access RTDA Real-Time Data Assimilation RTDA real-time data analysis RTDA Reality Therapy Discipline Approach ) - 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 PK/PD Pharmacokinetic/Pharmacodynamic 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 Clinical pharmacology is the science of drugs and their clinical use. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world. 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 has·ten v. has·tened, has·ten·ing, has·tens v.intr. To move or act swiftly. v.tr. 1. To cause to hurry. 2. 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 ex·pe·dite tr.v. ex·pe·dit·ed, ex·pe·dit·ing, ex·pe·dites 1. To speed up the progress of; accelerate. 2. 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 drugs to the market faster than ever before." About Cognigen Corporation Cognigen Corporation, formerly Pharmaceutical Outcomes Research Inc., is a global analytical communication company that combines innovative software and analysis with advanced internet technology and human creativity to transform data and transcend boundaries. More information on Cognigen Corporation can be located at www.cognigencorp.com About Bristol-Myers Squibb Bristol-Myers Squibb Company is a $20 billion diversified global health and personal care company whose mission is to extend and enhance human life. |
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