Manufacturing

Interview:

The pharma manufacturing challenge

12 June 2008

Shifting dynamics in the pharmaceutical industry require a new global approach to business and how lines of business are supported by IT, says Microsoft's Rüdiger Dorn.

According to global consultancy IMS Health, all four largest ‘blockbuster’ drugs will face generic competition by 2012. All the large pharmaceutical companies are under increasing pressure to replace expiring products with new compounds in the R&D pipeline. At the same time, merger and acquisition activities are likely to continue, and the ability to manage and integrate knowledge becomes critical. Additionally, pharmaceutical companies increasingly collaborate with each other and with other constituents in the broader healthcare ecosystem, so that boundaries between ‘internal’ and ‘external’ systems are blurring.

During mergers and acquisitions new systems are added by default, rather than according to a company-wide IT strategy. IT has to manage disparate teams and take care of numerous legacy systems. Establishing consistent systems that make information visible to everyone is a considerable challenge in this rapidly changing environment.

Dorn, Microsoft's managing director for the worldwide pharmaceutical sector, observes that pharmaceutical companies are increasing their global reach and search for the possibilities for outsourcing to partners in other geographies. As a result, IT systems are subject to even more complex and diverse policies and regulations. Decision makers are challenged with the techniques to comply with these rigid regulations, but in parallel to foster innovation and the adoption of new technologies. Global IT architectures need to allow for rigorous documentation to comply with guidelines such as Current Good Manufacturing Practice (cGMP).

Open, agile infrastructure architectures can address this challenge, and they are likely to evolve as the industry globalises further. Microsoft gets behind this process by supporting open standards that reduce the heterogeneity and complexity of IT architectures. This includes work with key vendors and standardisation bodies to design solutions that build on companies’ existing IT investments.

As companies strive to introduce new products, they focus on the future top line revenue by boosting investment in research and many are at the same time looking at the cost saving potential in the manufacturing process to generate the funds to invest back into R&D.

Across pharma manufacturing, plant information is held in a variety of different applications, such as manufacturing execution systems (MES) or laboratory information management systems (LIMS). Even worse, the systems may differ across plants, so bringing information together can be tedious and potentially result in multiple versions of the truth.

To reduce the time needed to turn data into knowledge, the industry needs to move away from disparate systems towards a uniform IT infrastructure, concludes Dorn. This does not necessarily require the consolidation of all information into one single database, but rather to use common building blocks like information exchange protocols, workflows and shared security and access control.

To maximise the value of information that is stored in one place others have to be able to access it and to be automatically notified in case that information may raise a critical production issue. The Microsoft solutions form a unified solution for managing unstructured and structured information across pharma manufacturing. Common tools like authentication and workflow services can be centrally deployed to allow users to rapidly gain insight into the information they are allowed to access. All information can be published and viewed in relation to the user’s job role and be effectively shared among the user community The key to productivity does not solely lie in the integration of information; systems need to allow employees to draw conclusions and act on this information. Ease of use and the appropriate level of detail are key requirements to help users turn information into knowledge. From a regulatory perspective it is important that the IT architecture centrally provides controls, audit trails, workflows, and revision history. This way all visualisations and the business decisions based upon this information are traceable, and the history of all content remains consistent for future reference.

For effective role-specific information visualisation, a range of elements is required: scorecards, graphs, spreadsheets, and reports. In an agile manufacturing environment these elements should be uniform and appropriately provided to the respective job role for reports, forecasts, comparisons, and simulations.

This piece first appeared as the pharma industry forum in the Spring issue of Prime magazine