Securing growth and innovation – how the Pharmaceutical industry can benefit from information technology

With major patents expiring in the upcoming years, many Pharmaceutical companies need to find innovative strategies to continue top line growth, but also to reduce the bottom line cost.  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.

Additionally, merger and acquisition activities are likely to continue, and the ability to manage and integrate knowledge becomes critical. 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.

How can IT help to extract value out of these increasingly heterogeneous IT systems?

The impact of patent expirations
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.

This means, companies have to find ways to increase their R&D productivity and a lot of the investment activities geared towards the future top line revenue are centred on boosting innovation. Many pharmaceutical companies are now looking at the cost saving potential in the manufacturing process to generate the funds to invest back into R&D. While manufacturing represents only around 20 per cent of the cost of any drug, most pharmaceutical companies agree on the existence of a significant cost saving potential in production. By reducing waste and driving down costs, companies can improve use of assets and raise return on investment – hence making more money available for R&D. 

The role of regulation
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 and consolidates further. Microsoft® supports this process by supporting open standards that reduce the heterogeneity and complexity of IT architectures. This includes work with key vendors and standardization bodies to design solutions that build on companies’ existing IT investments.

Cost of compliance
In any cost containment strategy in Pharmaceutical manufacturing cost of compliance is a critical element. Today production lines are set up monolithically so when shifting production capacity between plants, or run multi-product lines, the validation effort involved always needs to be considered. Also IT systems traditionally tend to be ‘hard wired’ resulting in tremendous costs to upgrade any component. In the future Service-oriented software architectures hold the promise of being able to work in conjunction with existing technology but also allowing modules to be rapidly added or removed.

Deployed right, the IT validation can be restricted to the module itself does not affect the overall system. With such a flexible IT infrastructure, manufacturing can gain agility as production capacity can be reallocated seamlessly, and new production technologies can be introduced more quickly. It can also reduce the costs of patching, maintaining and upgrading components of the system. In turn, a service based IT architecture can allow Pharma companies to increase operational efficiency of equipment and reduce downtime of lines.

Streamlining the production process
The industry is striving to reduce the manufacturing costs by reducing inventory and waste, better asset utilization and a decreased cost of compliance.
Recording, integrating, managing and sharing real time information about the manufacturing process is critical to achieve these business goals. Reducing decision making times can become a differentiator and pharmaceutical and biotech companies need to adopt a preventative, rather than reactive, approach to production problems.

The emerging open standards for plant floor IT systems are critical prerequisites as the can increase the data accuracy and reduce sample times, amplify the value of information by integrating the data into a single, real-time picture of the truth and accelerate decision making by providing the tools to globally share this knowledge.

Integrating information from heterogeneous IT systems
Across Pharma Manufacturing plant information is held in a variety of different applications, such as Manufacturing Execution Systems (MES), historians or Laboratory Information Management Systems (LIMS). Even worse, the systems differ may differ across plants, so bringing information together can be tedious and time consuming. It also creates the potential for human error as information often is copied and modified by recipients resulting potentially 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. This does not necessarily require to consolidate all information into one single database, but to use common building blocks like information exchange protocols, workflows and shared security and access control.

To maximize the value of information that is stored in one place others have to be able to access it and to be automatically be notified in case it may impose 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 Maintenance of the systems becomes easier as less system administrators can serve a large user community. New technologies like the virtualization of desktops and applications allow collapsing errors correction, patching testing and deployment times, thus increasing the ROI into the information systems.

Visualization
The key to productivity does not solely lie in the integration of information, but 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 that the IT architecture centrally provides controls, audit trails, workflows, and revision history. This way all visualizations 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 visualization 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.

Collaboration
In the past Pharmaceutical companies have invested largely into the automation of ‘default’ processes and rules have put in place to govern these processes. In the real world most of the management attention is spent on ‘handling exceptions’ where the process often becomes an unstructured and dynamic environment. 
In order to increase manufacturing agility, systems need to alert everyone automatically to anomalies in the process, so that employees can act quickly on the basis of common knowledge. Again, a centralized IT architecture can provide for collaboration tools that reduce room for error, and cut time from complex chains of communication. As an example a centralized IT system can deliver significant business value if it transfers an alert highlighted by a LIMS system and automatically routes it to everyone dealing with the batch in question.

In the same architecture the value of product specific knowledge can be amplified so the central repository that holds the data also acts as a secure communication system. This allows companies to develop communities between teams with equivalent roles across international plants who can share and compare product-specific knowledge with access to each others’ input. It is easy to see how the combined knowledge can exceed the sum of the individual parts and help to globally optimize the manufacturing process of Pharmaceutical products.

The need for a global approach
As the manufacturing process of Pharmaceutical products is truly global, companies need to move away from a plant-by-plant approach to a central IT management model.

A standardized IT architecture globally can be the foundation to capture manufacturing data, integrate information, increase its visibility, and encourage collaboration to raise the efficiency of production. Transparent information that offers auditors a single valid record of the production process reduces cost compliance. Innovation cycles can be accelerated by the faster deployment of composite modules in such a service based architecture ultimately leading to cheaper, more agile and higher quality production of Pharmaceutical products.