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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. CPS Completes Migration of Legacy Documents Wilmington, DE, April 29, 2005—Critical Path Services (CPS) recently completed the migration of thousands of electronic and paper documents into a Fortune 100 company’s database following its acquisition of a smaller company with complementary product offerings. The acquisition presented the Fortune 100 company with an excellent opportunity to expand its product line and global customer base; however, it also posed a huge challenge in terms of integrating product research and study data into the company’s searchable database. In July 2004, the CPS Document Management Team began the task of organizing thousands of individual documents from the acquisition into a searchable database. Dr. Julie Eble, president and chief executive officer of CPS, says, “As a company’s business expands, knowledge management becomes increasingly complex. It’s extremely important to organize the information stored in the company’s computer systems in a way that allows employees quick and easy access.” At the start of the project, the CPS team imported the electronic documents into Documentum placeholders created by the purchased company before the acquisition. Next they tackled the paper documents. Hundreds of pages were scanned, converted to electronic files, and quality-control checked for accuracy. After all the documents had been converted and reviewed, CPS imported them into the Fortune 100 company’s database, complying with the established file folders. Finally, each document was assigned a given set of properties and codes for use in querying data. “The CPS team worked diligently to manage this substantial task from beginning to end,” says Eble, “and the result was an accurate, searchable database that meets the needs of the employees of this very large company.” Critical Path Services Provides Additional Project and Time Management Training at ENDO Pharmaceuticals Wilmington, DE, August 4, 2004—Critical Path Services (CPS) has been selected to provide project and time management training at ENDO Pharmaceuticals’ Chadds Ford, Pennsylvania and Long Island, New York facilities. CPS conducted these classes for ENDO in the fall of 2003 and because of the exceptional response and high level of interest CPS has been asked to return and repeat these classes for other groups. Mr. Skip Ivison, Director of Human Resources for ENDO Pharmaceuticals, says, “We are pleased to have a resource like Critical Path Services available to us to provide expert training in these very important areas.” “Repeat business is important for a company,” says Dr. Julie Eble, President and Founder of CPS. “It is the strongest statement that a client can make that they value the quality of the products and services that you provide.” CPS offers two general types of courses, courses for employee skills development and courses specific for today’s regulatory and scientific issues. Courses for employee skills development include project management, time management, delegation skills, technical writing, conflict resolution, and negotiation skills. These courses are offered at the customer’s site using hands-on workshops and real projects or experiences selected from the attendees. Courses covering today’s regulatory issues include 21 courses covering topics from Overview of Drug Development to CMC Life-Cycle Management – a Global Regulatory Perspective. These courses are also offered at the customer’s site and they may be customized to fit the needs of the organization. CPS’s partner for these courses is Damaris Degraft-Johnson an expert in regulatory affairs. CPS’s latest addition to their scientific course offerings covers topics in genomic analysis. The participants in the course will review methods for analyzing large data sets generated using microarray chips. The course may be structured to cover both free and commercially available software approaches or may be targeted to specific technologies such as Affymetrix chips. The course instructor is Dana Robin Marshall, Ph.D., who has hands on experience with these techniques as well as faculty experience. Critical Path Services to Provide Electronic Regulatory Submission Solutions Wilmington, DE, April 20, 2004 – Critical Path Services LLC, (CPS) an area leader in providing contract solutions for technical writing, regulatory submissions, and scientific consulting to Life Science companies, announced today the purchase of software to publish electronic regulatory submissions at their office site in Wilmington. Now, Critical Path Services, LLC, is armed to help companies find their way through the maze of documents, document linking, bookmarking, cross-referencing, assembling, and publishing a mission-critical regulatory submission. One of the tools that CPS has chosen for this service is a suite of Adobe Acrobat Plug-Ins available from Datafarm, Inc. This suite of products greatly assists in the management of regulatory submissions for both industry and the regulatory agency. “We have extensive experience with more complex software solutions which our larger clients have purchased. However, the purchase of this software allows CPS to provide e-publishing services to those smaller companies who have chosen not to invest in their own licenses.” commented Julie Eble, Ph.D., founder and CEO of CPS. Dr. Eble added, “We’ve approached this endeavor with the same tenacity that we have approached other regulatory submission work. This is a value added service that we provide in order to help to eliminate human error experienced with the daunting task of paper regulatory submissions. E submissions, in general, will go a long way toward speeding safer solutions to market by enabling Life Sciences organizations to meet emerging global regulatory requirements and streamline the submission and review processes.” DeGraft-Johnson and CPS Join to Offer Courses in Regulatory Training Wilmington, DE, January 16, 2004—Critical Path Services (CPS) is pleased to announce that it has entered into an agreement with Damaris DeGraft-Johnson to provide regulatory training for professionals in drug development, clinical research and quality assurance. The courses will be offered through the Training Department of CPS. Regulatory course offerings include an overview of regulatory processes and requirements in the U.S., Canada, Europe, Japan, Latin America, Eastern Europe, Pacific Rim, and Middle East/Africa; preparing the Chemistry, Manufacturing & Controls (CMC) sections of global submissions; CMC life-cycle management; analytical methods and specifications, and responding to regulatory challenges. Contact Kim McEuen, CPS Operations Manager, at 302 255-4700 (x106) for additional information and a complete list of the courses offered. DeGraft-Johnson has held a variety of technical and managerial positions in the pharmaceutical and biotechnology industry. Most recently, she has been employed as a global regulatory consultant and as Adjunct Assistant Professor at Temple University School of Pharmacy (Quality Assurance/Regulatory Affairs Graduate Program). Previously, she was Senior Director and Head of the Worldwide Regulatory Affairs CMC group at DuPont Pharmaceuticals. Critical Path Services Wins Contract from DuPont Crop Protection for e-Publishing Wilmington, DE –January 6, 2004-- Critical Path Services (CPS), a leading provider of electronic publishing services for regulated industries, such as Agrichemical, Pharmaceutical and Biotechnology, announced today that they were selected as a DuPont Dossier Support Alliance Partner. Under this alliance, CPS will support all regulatory submissions on a global basis for DuPont Crop Protection Research & Development for a two-year period. Crop Protection is part of the Agriculture and Nutrition growth platform at DuPont. CPS has provided similar services to Crop Protection as a subcontractor for the past 24 months. Dr. Donald Morgan, Manager of Research Services in Research & Development for Crop Protection, says, “We are pleased to have Critical Path Services as our alliance partner for these important regulatory document submission services. CPS has demonstrated their capability to handle these services responsibly and efficiently for us, permitting us to redirect our resources toward other product development activities. We look forward to a seamless operation that will be transparent to the regulatory agencies with whom we interact.” “The alliance is important for two reasons,” says Dr. Julie Eble, President and Founder of CPS. “First, it is a validation of the quality and value of service that we have provided over the past two years for this client, and second, it is an opportunity for us to assist other clients in submitting their regulatory packages electronically.” In this role, CPS coordinates preparation of regulatory dossiers for electronic publication and submission both in Europe and the US. Over the past two years, CPS has been involved in submissions involving thousands of documents. The staff is experienced using Documentum, CoreDossier, CADDY and other electronic publishing tools. CPS Relocates to Wilmington Wilmington, DE, June 15, 2003—Critical Path Services (CPS) has announced that it will relocate its office from Newport to Wilmington in July to accommodate business growth. The company, which currently occupies approximately 1200 square feet of space on Market Street in Newport, has agreed to lease approximately 2300 square feet in the DEXSTA building on Foulk Road. Critical Path Services was founded by Dr. Julie Eble in 2001 to provide outsourced consulting services to the crop protection, chemical, pharmaceutical, and other related industries. “The new suite of offices accommodates our growing staff and offers a large conference room for meetings and our training programs,” says Eble. “And the location, near I-95 and Route 202, gives us easy access to clients in Delaware, Pennsylvania, and Maryland.” CPS currently employs 20 people. About Critical Path Services, LLC CPS is a scientific management company with offerings for the life science and chemical industries. These services include e-publishing, project management, knowledge management, analytical methods development, technical writing, and conducting training courses. Founded in 2001, CPS is a privately financed company located in Wilmington, Delaware.
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