To carry out the drug development process as efficiently and effectively as possible, "It will be necessary for the pharmaceutical company wishing to develop drugs rapidly from the Human Genome project to form alliances with many partners - in both biotechnology and academia." Jurgen Drews, chief of research Roche Holdings has said.¹

The reduction in the length of the drug development process, combined with a greater degree of specialization in the less scale-intensive biotechnology-oriented research, and the new marketing guidelines that facilitate DTC marketing, have all increased incentives for firms to participate in both development and marketing alliances. This ever-increasing number of business relationships coupled with the trend toward multi-party alliances continues to add to the workload of the manager.

When managing the many types of alliances (unilateral contract or simple license, bilateral contract or cross-license, equity joint venture, etc.), it is important to recognize the importance of effective, timely and accurate communication. In a survey mailed to executives involved in managing strategic alliances to measure structure and performance by Dr. Arvind Parkhe, of Indiana University, his empirical findings indicate a strong positive relationship between alliance performance and transparent behaviors and frequent interaction.²

These increasingly complex licensing relationships and the accelerating pace of business demand higher levels of collaboration in tighter timeframes. Citadon CW has proven to be the ideal environment for managing all of the documents, business processes, and interactions associated with simultaneously managing many different license and contract relationships.

Large pharmaceutical and biotechnology companies typically rely upon a feature-rich integrated solution for document management, project tracking, and business process automation to manage internal collaboration. However, many of these same companies lack a similar dedicated infrastructure for extending this functionality into the external, collaborative realm. To fill this void, encrypted e-mails, secure virtual private networks (VPNs), and file transfer protocol (FTP) sites remain the primary vehicles for information exchange.

Citadon CW provides a highly secure internet based collaboration environment with the rich functionality typically provided by behind the firewall document management solutions.

While rapid evolution in techniques and technologies has taken place in many areas of life sciences research and development, the final success of your products is often dependant upon the successful completion of a pilot conducted by employees of your client partner. Citadon CW allows you to increase your awareness and involvement in these trials while providing clear step-by-step guidance for your clients. This "electronic participation" allows you to stay on top of the status of your products during initial testing and/or deployment. With this greater visibility, you are able to address issues quickly, thereby increasing the probability of success during this critical period in your relationship with new customers.

Collaboration between life science organizations and their clinical development partners - such as investigators and clinical research organizations - is the most important step in the information chain of the clinical trial process.

Large pharmaceutical and biotechnology companies typically rely upon a feature-rich integrated solution for document management, progress tracking, and business process automation to manage the trials internally. However, many of these same companies lack a similar dedicated infrastructure for extending this functionality into the external activities of their partners. To fill this void, encrypted e-mails, secure virtual private networks (VPNs), and file transfer protocol (FTP) sites remain the primary vehicles for information exchange. Capturing this information in a secure, organized, automated fashion is still a challenge.

Citadon CW provides a highly secure internet based collaboration environment with the rich functionality typically provided by behind the firewall document management solutions. Citadon CW has industry leading capabilities that can help your organization comply with industry regulations, such as the Food and Drug Administration's (FDA) prescribed regulatory requirements for electronic records and signatures (21 CFR Part 11).

Working with its integration partner NNE, Citadon has already demonstrated the value of its collaboration solutions to the Biopharmaceutical Engineering & Construction market. Using Citadon's Collaboration Workplace™ (CW) to facilitate collaboration for design and construction, NNE recently completed building a new pharmaceutical manufacturing plant in just 14 ½ months, less than the half of the 36 months it had previously taken to build a new plant. NNE has been able to build reusable project collaboration modules to divide larger construction projects into smaller segments, which can be expedited as required. NNE predicts that with Citadon's collaboration tools, it could further reduce construction time from 36 months to 12 months.

"Being able to quickly build new manufacturing facilities to fast-track new life science solutions is a crucial competitive advantage for NNE. Citadon CW has proven to be the ideal tool to help us collaborate with our partners and bring new pharmaceutical products to market faster than ever before," said Bo Memhave, CIO of NNE. "By creating reusable processes, we can build collaboration solutions on demand, and Citadon CW's easy-to-use Windows interface makes it possible to bring in new partners with little or no training. We are pleased to be working with NTE and Citadon to bring this solution to more Scandinavian customers."

• Hold and authenticate an un-alterable version of all content used in regulatory submissions.
• Allow persons with appropriate access to annotate documents that have been used in submissions, maintaining the annotations separately from the submitted content therefore maintaining the integrity of the prior submission.
• Comprehensive document and action item tracking and audit trails, resulting in increased responsiveness and accountability across the entire organization or project team.
• Customize, configure, and update business processes to address the unique business requirements of each project and enterprise with a graphical business process design tool.
• Handle the online management and collaboration on all documents, including ensuring the right information at the right time.
• Seamless integration and data exchange with internal systems.
• Powerful document management capabilities, creating, deleting, modifying, and commenting on over 250 types of documents.
• A flexible security structure to ensure documents will only reach the people who are intended to see them.
• Centralized, secure access to critical documents for internal and external team members 24 by 7.
• Automated notifications and alerts keep projects on track.
• Ability to assign custom attributes, such as project codes and status, and link them to documents for richer searching and reporting.
• Automatically keep a complete audit history of all actions performed in the system, when they occurred and who took them.

Source: 1, 2 - Daniel Rodriguez, Valuing Biopharmaceutical Alliances, 1998.