SubscribeThe pharmaceutical industry is by far the most regulated of all industries.
While new technologies such as electronic records are helping to better manage the burden, for pharma manufacturers this still translates to enor-mous investments and high operational costs that are necessary to comply with ever stricter government regulations.
In short, pharmaceutical companies pay more than other manufacturers for their right to do busi-ness. Drug manufacturers are saddled with heavy burdens in every aspect of their business. New drug development costs millions of dollars in R&D investments that can stretch over a decade or more before they begin to pay off. Once a drug has been approved, its profit-making lifecycle is threatened by expiring patents, government-set pricing and counterfeit drugs. Also, regulators today are less willing than in the past to extend patent life. When a drug does receive final approval, manufactures must then embark on a costly technology transfer or "commercialization" of the drug to routine, large-scale manufacturing.
Delays in getting commercial manufacturing approved and running can amount to millions of dollars per day. On the way to new drug approval lies an important step: Clinical Trials. Clinical Trials makes up the longest and most critical phase of drug devel-opment in which experimental drugs emerge from the laboratory to be tested on human subjects. Each of the four phases of Clinical Development - from initial testing on humans to targeted patient groups to large scale target group testing - can take several years.
In each of the phases, patients must be provided with test medication. IT systems can be used to coordi-nate the complex processes and save valuable time. Werum's CT Management software application supports the development of a medica-tion from the simple formulation to bulk manufacturing to complex packaging instructions and distribution of patient kits.
Managing the supply of materials is critical to a clinical trial's success, as any error can result in an immediate voiding of all previous results. While solutions for clinical material supply management are available on the market, they are often complex and difficult to operate, or are based on leg-acy architectures, which can cause support problems. In light of ever shorter times to market for new products, these demands need to be ad-dressed with CT Supply Management functions that are seamlessly integrated into other processes.
The preparation of thousands of patient packs at the primary and secon-dary packaging stages alone is a logistical nightmare that leaves no room for error. Meeting this challenge means deploying a system that uses elec-tronic controls (e.g. electronic batch records) to record all relevant information throughout the CT supply chain, from manufacturing (master batch records) to packaging, labeling and shipping. Typical current CT Supply Management solutions only extend to keeping track of "order-manufacture-ship" and do not include detailed supply chain visibility down to the individual patient kit.
The Functionality of the PAS-X CT Software Suite Addresses all Phases of a Clinical Trial Supply
CT Supply Management Market Driver By Customer Needs
The market for CT solutions has developed rapidly over the past 5 years, driven by the need to cut time-to-commercialization costs while at the same time managing data whose complexity has increased by orders of magni-tude. Also, the size of clinical trials has grown as much as 4-fold and many studies have taken on a global rather than regional scope. These drivers, combined with pressures from government bodies like the FDA to move to electronic records, led to the creation of a market for auto-mated solutions.
Pharmaceutical companies, too, are actively driving the development of these solutions as they recognize the need to automate their processes or wean themselves off legacy or home grown solutions. Clinical trials management can be divided into four separate areas : Data Management, Study Management, Supply Management, and Supply Chain Optimization. Several solutions for CT Supply Management already exist on the market, including PMX CTM from Propack Data, POMS CMS from Honeywell and Clinicopia from InfoPro Solutions (now: Aptuit). However, this market is still immature and ripe for innovation as the acceptance of automated solutions grows. What counts is the degree of pharma industry experience and knowledge that a supplier can build into a new solution.
New CT Supply Management Solution Developed in Cooperation with Longtime Customer Altana
Werum, a leading supplier of MES software to the pharmaceutical industry, recently announced its PAS-X CT, a new solution for clinical trial supply management. With PAS-X CT, Werum drew on years of research, devel-opment and customer experience in pharmaceutical manufacturing to develop solution that specifically addresses supply management issues.
The goal of Werum's new development was to help customers improve the management and reliability of the critical and expensive processes sur-rounding clinical supply management, such as packaging, labeling and shipping.
In particular, special emphasis was placed on optimizing the CT supply chain by shortening the time to supply patient kits while complying with the challenge of 100% error-free process and products.
To understand real field requirements during development of its new solu-tion, Werum leveraged the experience and expertise of longtime customer Altana Pharma AG in defining the functional requirements.
These include the ability to model all business processes in a standardized way, improved system security, complete process documentation, and full compliance with GMP requirements.
Now that development of PAS-X CT is complete, Altana is currently rolling out its first implementa-tion. Before deciding on Werum's solution, Altana conducted a thorough inter-nal evaluation of its current method and analyzed its needs for the future.
The company determined that its existing mainframe-based solution no longer meets its growing needs, especially in terms of organizational growth, globalizing business processes, and maintaining electronic records.
A COTS solution was also ruled out due to the amount of customization necessary and functionalities not focused on Altana's particular needs and the fact that existing business processes might need to be adapted to the software's prescribed structures - a cardinal sin according to the selection requirements! In the end, Altana's decision to partner with Werum was based as much on its past experience with PAS-X as on Werum's flexibility and willingness to understand and implement Altana's requirements.
PAS-X CT Draws on Werum's Pharma Experience
To create PAS-X CT, Werum began by defining four primary functional ar-eas - Study Management, Manufacturing Process Management for CT Medications, Packaging and Labeling Process Management, and Ware-house and Shipping Management. Functional modules were then developed for specific tasks within each area. For example, Study Man-agement contains modules to administer study data, perform order and trial material scheduling, make material quantity calculations for studies, and manage treatment groups and phases when setting up packaging de-signs.
Information for these modules is centrally stored and is accessible by other CT modules. The functional area Management of Manufacturing Processes contains spe-cific modules for managing master batch records, weighing and dispensing, and detailed manufacturing functions such as electronic batch recording, in-process control, deviation and event management, equipment manage-ment, batch reports and tracking & tracing. For Packaging and Labeling, modules exist for automatic generation and electronic execution of packag-ing instructions and label design and printing, which includes local language support.
Finally, the Warehouse Management functional area features modules for expiry date control, material receiving, order picking, reservation, batch management, inventory units labeling and shipping. A graphical workflow engine allows users to design CT studies around specific processes while minimizing customization. One of the primary development goals, in fact, was to make the tool flexible enough to adopt itself to a user's processes instead of attempting to dictate a strict hierarchy of process structures.
To meet the needs of multinational pharmaceutical companies with facilities scattered around the globe, PAS-X CT was de-signed using a multi-tier architecture, allowing for multi-site development and management of concurrently running trials. For the development of PAS-X CT, Werum chose JCoffee®, its component-based Java development framework. JCoffee® provides extensive standard functionality for the de-velopment of large scale GMP-compliant software systems (e.g. user administration policy management, audit trail, electronic signature).
Altana Goes Live with PAS-X CT
Altana's cooperation with Werum in the development of PAS-X CT was part of an extensive CTS evaluation process involving other suppliers as well. After the decision for Werum was made, development continued based on the functional requirements set forth by Altana. With the recent success of the first site acceptance test, the company went live with the first implementation of PAS-X CT in September 2005.
In the meantime, Werum has approved the solution for general release on the market. Dr. Rango Dietrich, Senior Director of Pharmaceutical Sciences, discussed Altana's goals and selection strategy with ARC: "Our main objective was to identify a system that provides excellent IT support to established and streamlined business processes in the field of Clinical Supplies Preparation. This was achieved primarily by investigating business processes to identify the gaps where this support is needed. Based on these results, we were able to set up preliminary requirements in sufficient detail to formulate the first proposal requests." A short list of providers was generated and, based on set specs, Werum was chosen as a preferred provider.
This decision was based not only on Werum's existing Pharma and MES experience, but also on its proven competence in terms of soft factors such as reliability, commitment, responsiveness and customer orientation. Altana's search resulted in a lean system scaled and matched to the company's specific needs. Since data quality depends strongly on usability issues and software ergonomics, Altana insisted that these aspects be given priority from the very beginning. According to Dr. Dietrich, "Official standards such as ISO 9241 were taken into consideration to fulfill the vision of a system that doesn't require user manuals.
To achieve this, users must satisfy only two requirements: skills in working with Microsoft Windows and detailed skills in the preparation of clinical supplies. If these requirements are met, experience has shown that user manuals become unnecessary, highlighting the system's 'appeal' that users strive for in their day to day work." With PAS-X CT, Werum is confident that it has achieved its development goals of creating a CT material supply solution that integrates information flows between CTS processes while maintaining a high level of usability.
Analyst: David W. Humphrey
Editor: John Blanchard
Acronym Reference: For a complete list of industry acronyms, refer to our web page at www.arcweb.com/Community/terms/terms.htm
AI - Artificial Intelligence.
API - Application Program Interface.
APS - Advanced Planning & Scheduling.
B2B - Business-to-Business.
BPM - Business Process Management.
CAGR - Compound Annual Growth Rate.
CAS - Collaborative Automation System.
CMM - Collaborative Manufacturing Management.
CNC - Computer Numeric Control.
COTS - Commercial Off-the-Shelf.
CPG - Consumer Packaged Goods.
CPAS - Collaborative Process Automation System.
CPM - Collaborative Production Management.
CTS - Clinical Trial Supply Management.
EAM - Enterprise Asset Management.
ERP - Enterprise Resource Planning.
HMI - Human Machine Interface.
IMP - Investigational Medicinal Product.
IT - Information Technology.
LAN - Local Area Network.
MES - Manufacturing Execution System.
MRP - Materials Resource Planning.
OpX - Operational Excellence.
OLE - Object Linking & Embedding.
OPC - OLE for Process Control.
PAS - Process Automation System.
PLC - Programmable Logic Controller.
PLM - Product Lifecycle Management.
ROA - Return on Assets.
ROI - Return on Investment.
RPM - Real-time Performance Management.
SCE - Supply Chain Execution.
WMS - Warehouse Management System.