PharmQuest announces cooperative agreement with FDA to co-develop a Carcinogenicity and Toxicology Data Management System
Mountain View, CA-September 25, 2002-PharmQuest Corporation announced today that they have executed a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration to develop a Toxicology and Carcinogenicity Data Management System.

Under this agreement, PharmQuest will collaborate with the FDA's Center for Drug Evaluation and Research (CDER) to develop a database for animal data equipped with electronic submissions and software tools to assist reviewers in the evaluation of the data.

The Toxicology and Carcinogenicity Data Management System will be designed to enable the FDA to store submitted data and assist reviewers in analyzing information across multiple datasets submitted to the agency.

The two-year CRADA partnership consists of a possible three-phase process led by Dr. Seema Handu, president and CEO of PharmQuest and Dr. Randy Levin, associate director of information management, FDA's CDER. 

"We anticipate that implementing systems like the Toxicology and Carcinogenicity Data Management System will help improve efficiency for data review," said Dr. Levin.

"This joint effort between the FDA and PharmQuest addresses the pressing need for electronic data management systems in drug development. Software solutions are becoming increasingly important in today's climate in which product development issues account for a significant number of rejections and failures," said Dr. Jere Goyan, PharmQuest's chairman of the board and former commissioner of the FDA. "Rejections are often a consequence of non-compliance and can result in significant delays in the approval process." 

Work on the Toxicology and Carcinogenicity Data Management System will be based on the infrastructure of PharmQuest's Product Development Management System (PDMS(tm)). PDMS(tm) is a web-based platform with an open-architecture framework that enables scientists to share and manage information across enterprises. PDMS(tm) provides access to private and public knowledge bases, which ensures regulatory compliance and facilitates early identification of failures. 

About PharmQuest
PharmQuest collaborates with the pharmaceutical and biotechnology industries to provide software that significantly improves efficiency and compliance in the product development process. PharmQuest's solutions employ an integrated family of applications facilitating workflow automation, process mapping, expert systems and knowledge bases. PharmQuest has focused on the area of software solutions for Pre-clinical Development and Chemistry, Manufacturing & Controls, forging major partnerships with three of the top twenty major Pharmaceutical companies, the Parenteral Drug Association (PDA), the International Pharmaceutical Excipients Council (IPEC), and the University of California, San Francisco. Information about PharmQuest is available at http://www.pharmquest.com. 

Contacts:
Melanie Chawathe
PharmQuest Corporation
Manager, Corporate Communications
650.210.3969
melanie@pharmquest.com 

Carolyn Bumgardner
Ogilvy Public Relations
415.677.2710
Carolyn.bumgardner@ogilvypr.com