Lilly to implement Propack Data's clinical manufacturing solution
To address these challenges, Lilly has chosen Propack Data's Clinical Trial Management solution, PMX-CTM, to manage its global clinical manufacturing operations. Lilly will be implementing the solution suite at its Indianapolis, Indiana and Mont-Saint-Guibert, Belgium plants. Propack Data will provide Lilly with version 3.2 of the software, which has been developed in cooperation with three other major pharmaceutical companies.
PMX-CTM is a Web-based solution suite that is designed to help companies manage clinical production operations efficiently while meeting cGMP/FDA compliance requirements. It offers broad functionality through a wide array of modules designed to control every aspect of the manufacturing and packaging process, including master data management, scheduling, warehouse management, dispensing and line monitoring.
According to Christian Fortunel, President of Propack Data, the solution allows for customized implementation based on an individual company's needs and time frame. Lilly will implement several modules of the suite in a stepwise fashion beginning in June of this year, including EDB for product data management; EINLOP for planning and scheduling; DISY for weighing and dispensing; and PALETTI for material tracking.
EDB is an enterprise production management tool used to model business processes and is the basis of operation for all of the other modules within the suite. It manages all master manufacturing recipe definitions and also facilitates functions specific to clinical trial management such as study design and randomization.
The planning and scheduling module, EINLOP, allows users to plan operations and coordinate the release of information and materials to the floor to build patient kits. Lilly also will use DISY, a weighing and dispensing module designed to allow users to meet FDA compliance requirements, and PALETTI, a warehouse management and material tracking tool.
With this product, we'sre focusing on the clinical supply chain, mainly on the supply and materials management aspects, said Konradin Plate, Manager of Sales and Consulting for Propack Data. One of the major problems in clinical supply is the handling of the labels. With tens of thousands of unique labels per study, which need to be uniquely identifiable, it requires a completely different structure and functionality compared to standard supply chain management.
The standard packages that are available in this area are usually MRP packages, Plate said. They'sre classical supply chain and they get all confused and stumble over the problem of a huge quantity of very individual single products. It just can'st be handled by standard MRP functionality. Many companies believe the approach that Propack Data is taking is the correct one starting on the GMP compliance side, handling the material data, and then going from there into the planning level.
According to Fortunel, there are three main benefits to implementing a system like PMX-CTM: regulatory compliance, increased efficiency of operations and IT rationalization. There are a lot of disparate systems, in particular in the clinical environment because there are a lot of partners involved in the process and each one has its own database, he said. Our solution harmonizes this environment into one central database, so that all of the information is available to all of the participants within the study. And that measure of progress makes it very easy to justify the solution.
Site harmonization is one method by which pharmaceutical manufacturers can increase efficiency across their operations. Companies like Lilly are working on clinical supplies at several sites, usually in several countries, and there is a huge potential for improving time-to-market if they are able to harmonize operations across these sites, Plate said. That's a big challenge with different legacy systems and with different languages even. But it's also a big opportunity when you bring a system in of this type which actually shares information and processes over the various sites.
According to Plate, a large part of the discussion within companies considering a solution like PMX-CTM revolves around opportunities for harmonization rather than the nuts-and-bolts of the system itself. And that's particularly true for companies who are anticipating or experiencing a merger.
Some companies make strategic decisions toward systems like ours for exactly that reason, Plate said. They are basically saying: The functionality and the detail well you can do it from the left or from the right, it doesn'st really matter the big thing is to have harmonization over my whole corporation, including commercial manufacturing packaging, clinical studies, scale-up and R&D.
One challenge in designing a system like PMX-CTM, according to Plate, comes in making it responsive enough to handle the constant change that is inherent to the nature of clinical trials.
There is a requirement for a huge degree of flexibility, and that's in direct contradiction to having everything ordered and structured in a database system, he said. Somehow you have to, on the one side, meet the flexibility, and on the other side be able to provide a rigid GMP compliance structure. Our concept and success is based on the ability to provide both structure and flexibility. Being able to organize information both on a fuzzy level, in the beginning stages when you have rough information, and on a detailed level when you'sre actually in production.
Because the PMX-CTM suite shares overlapping functionalities and modules with Propack's PMX-MES solution, the transition from clinical trial to full-scale production is an efficient and seamless one. It's not just about making the clinical study faster, Fortunel said. It's about the scale-up too where you'sre going to try to take the process you have in place for small quantities and bring it up for larger quantities. It's important to have a single system, where you can just migrate the information and take the know-how into the next system. Every delay adds up.
Using Propack Data's solution, according to Fortunel, companies like Lilly can expect to perform clinical trials more efficiently and achieve a greater return on investment, particularly for global studies that involve an increasingly large number of patients across multiple countries, requiring more complex randomization.
We'sve designed our solutions to help our clients reduce their time-to-market and production costs and maximize quality, productivity and return on investments, while facilitating and simplifying regulatory compliance, Fortunel said.
For more information about Propack Data, visit the company's Web site at propack-data.com.