CPS Assists Endo Pharmaceuticals in Updating Drug Development Guide

Wilmington, DE, July 31, 2005—Dr. Julie Eble, president and chief executive officer of Critical Path Services (CPS), announced that CPS had been selected by Endo Pharmaceuticals Inc. to update its Drug Development Guide. Endo, which is headquartered in Chadds Ford, PA, is a specialty pharmaceutical company with market leadership in pain management products. The Drug Development Guide is an internal document that outlines the current Endo process for developing a new chemical entity into a marketed drug. CPS facilitated production of Endo’s original drug guide in 2003.  

Alan Goldberg, Senior Director of Project Management for Endo, says, "As Endo expanded its role in bringing important new pain medications to market, we needed to create an in-house guide that our employees could refer to for approved procedures and background information. The guide also provides a valuable training tool for new employees." Goldberg and his colleagues worked closely with a CPS knowledge management consultant to develop an outline for the guide and establish key activities during each phase of the licensing process—from discovery, where promising new chemical entities are identified, through manufacture, marketing, and maintaining a safety database for an approved drug.

Goldberg then enlisted employees in various roles throughout Endo to meet with the CPS consultant to develop text for the guide. For each phase in the licensing process, the guide listed key goals, specific deliverables, common issues that might arise and tips for handling them, project activities, and portfolio management items. Appendices to the guide contained detailed background information on an extensive number of topics, such as creating an investigator’s brochure, sample tracking sheets for an IND submission, and links to FDA websites.

"Employee response to our original drug development guide was very enthusiastic," Goldberg observed. "Because of the value of this guide for our employees, we are committed to ensuring that the guide remains up-to-date and accurately reflects current internal procedures. We are especially grateful for the continuing assistance of CPS consultants and their technical writing staff with this undertaking."

As part of the original project, CPS also produced a management tracking tool based on key activities outlined in the guide. Dropdown menus were used to shorten the time required to enter the requested information by project management.

"We are extremely pleased to have a continuing partnership with Endo," says Eble, "and we look forward to collaborating with them again on future projects."

CPS is a scientific management company with offerings for the life sciences and chemical industries. These services include e-publishing, project management, knowledge management, analytical methods development, technical writing, and training. Founded in 2001, CPS is a privately financed company located in Wilmington, DE.