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Posted: 11/5/2009
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AstraZeneca Optimises Research Collaboration Solution with Interoperable Technology
Employees at AstraZeneca, a pharmaceutical company based in the United Kingdom (U.K.) use a system called the Global Electronic Library (GEL), to create, manage, publish, and track all Pharmaceutical Regulatory Documents. The GEL client, called GEL Explorer, was due for replacement and in 2007; AstraZeneca began reengineering the solution’s infrastructure. The new version of GEL Explorer will be delivered as a set of services based on interoperable Microsoft® technologies, including the Microsoft .NET 3.0 Framework and Windows® Communication Foundation. AstraZeneca believes that when this business-critical application is deployed, it will deliver multiple benefits—including reducing costs, enhancing drug research, increasing collaboration with external partners, and making it easier to comply with complex regulatory requirements.
Situation
AstraZeneca is a global pharmaceutical company based in the United Kingdom. It focuses on developing treatments for conditions such as cancer, cardiovascular disease, gastrointestinal disorders, and respiratory disease. Established in 1998 as a result of a merger between two pharmaceutical companies, AstraZeneca reported around U.S. $32 billion worth of sales in 2008. Research is vital to the quality and quantity of the company’s products. In 2008, AstraZeneca invested more than U.S. $5 billion in research and development (R&D). It employs around 65,000 people and has 17 R&D centres in eight countries.
Developing drugs is expensive and AstraZeneca employees spend much time creating submissions for the regulatory authorities that grant approval for manufacture and sales. Collaboration with colleagues and partners minimises the time and money employees spend on trials, new research, and collating information for submissions, making it cheaper and faster to develop high-quality products.
To support collaboration, the AstraZeneca IT team created a centralised document management system called the Global Electronic Library (GEL) in 2000. Based on Documentum Content Management software, the business-critical system provides researchers with client-based access to document databases and the tools to search, manually review, and author documents stored in GEL. Maintaining security and accuracy of data is vital.
While the solution has served business requirements effectively for several years, AstraZeneca wanted to address several new challenges. John Whiteway, Lead Application Architect, AstraZeneca, says: “Although the current GEL Explorer has been an outstanding success, the architecture couldn’t support rapid technical developments, and limited our responsiveness.” A recent review of operating costs and internal processes prompted AstraZeneca to look for ways to optimize the GEL system. “We wanted to reduce the cost of managing the solution, and update and align it to suit current business processes,” says Whiteway.
Requirements for a new solution included:
• Interoperability—increasingly, AstraZeneca will look to share cost and expertise with external partners so it’s vital that the GEL system is interoperable and flexible enough to accommodate a wide range of applications and data created on third-party systems.
• Flexibility—the systems and third-party applications that comprise the GEL solution are constantly evolving to suit business requirements and require time-consuming, expensive development. Integration between GEL Explorer and the applications and systems which comprise the GEL solution is critical.
Solution
In 2008, AstraZeneca conducted extensive research around the different ways of expanding GEL’s flexibility. Whiteway says: “We considered several options, including outsourcing the solution to a third party. The Documentum repository and services are based on Java, so using this technology for the GEL Explorer client solution would have made sense.”
But following a two-day workshop with Microsoft® and GEL stakeholders, Whiteway decided that only a software-plus-services approach to the new solution would deliver the flexibility that was needed, and only Microsoft technologies could provide the technical functions required. He says: “Employees have to be able to submit documents to GEL, and review each other’s work. It’s my responsibility to ensure that the new GEL Explorer has the technical functionality to meet these requirements and future demands from the business. The combination of AstraZeneca domain expertise and easy-to-use, high-performing Microsoft technologies maximises our chances of success.”
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Based on the Microsoft.NET Framework, Windows Communication Foundation, and other Microsoft technologies, GEL Explorer 6 will offer a flexible, interoperable, high performance, low cost solution. |
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John Whiteway
Lead Application Architect
AstraZeneca |
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The next version of the GEL solution—GEL Explorer 6—will work as set of services based on the Microsoft .NET 3 Framework and delivered with Windows® Communication Foundation technology. The connected services link to the Documentum repository and provide all of the GEL Explorer’s functionality, from basic tools for document management, to sophisticated search features.
Users can access the GEL Explorer application from their desktop using a client that looks similar to the Microsoft Office Outlook® desktop client. Contributors can create, edit, and submit documents in GEL, by opening a Microsoft Office Word document within the GEL Explorer user interface. Whenever a contributor submits content requiring input, a workflow is triggered and colleagues receive an email notification or a link to the document. Sensitive data is kept secure as user permissions are configured according to role and requirements and managed by AstraZeneca.
The user interface displays views of the document repository according to research families—for example, cardiovascular disease or respiratory disease. From here, users can perform highly targeted document searches using keywords. Fast ESP—an enterprise search technology from Microsoft—conducts sophisticated indexed searches of document contents to support contributors to quickly access the information they need and manage it as required.
One example of interoperability is in the creation of commercial stability reports required for drug submissions. Samantha Morris, Associate Director, GEL Projects, says: “Data on the shelf-life of drugs is recorded in a stability management Web application. The information is pulled automatically from this application into GEL to create Commercial Stability Reports in XML format. These reports can be incorporated in regulatory submissions to health authorities, and don’t require a contributor to manually enter in data from another AstraZeneca application.”
The new GEL Explorer will go live as part of the next major GEL System upgrade. It will be used by more than 10,000 people in 50 countries, 24 hours a day.
Benefits
Whiteway says: “Based on the Microsoft. NET Framework, Windows Communication Foundation, and other Microsoft technologies, GEL Explorer 6 will offer a flexible, interoperable, high performance, low cost solution to AstraZeneca. It will support our regulatory operations for many years to come.” GEL Explorer 6 offers an identical user experience to the previous version, removing the need for Whiteway’s team to retrain the large, dispersed user base. Interoperability ensures that researchers collaborate more effectively, content is reusable, research productivity is enhanced, and overall costs are reduced. The flexible, scalable environment will support the developer team to respond quickly to new business requests.
GEL Supports Close Collaboration on Drug Research
To ensure that applications submitted to the drug research authority contain all required documents, a regulatory manager creates a table of contents in GEL that detail the specific documents and support research required from different research areas or market segments. A team of specialists compile the documents using GEL functions, such as linking contributions from different business areas into one, virtual document.
Samantha Morris, Associate Director, GEL Projects, says: “Authors from widely differing functions in the business—for example, Product Discovery, Operations, and Manufacturing—are involved in different stages of the drug development lifecycle. GEL Explorer provides users with the ability to work with each other, authoring and reviewing documents in a familiar-looking, consistent, and controlled format.”
Content Is Reusable and Reduces Research Costs
Conducting clinical trials is time-consuming and expensive. It makes sense to focus new research on unknown factors, and where possible, incorporate pre-existing findings into submissions. With the GEL solution, this is possible. For example, a researcher in the United States can search for data on the outcome of a clinical trial held 10 years ago and incorporate relevant data into a current submission―saving time and the need to invest in a new trial. Another example is when an employee is collaborating on product development with a company that uses a different software application to document its research. The external colleague can submit documents to GEL and the content of the document is immediately useable by an AstraZeneca employee. “Re-using content and sharing data is an easy way to minimise costs so more funds can be allocated to essential research,” says Whiteway.
Interoperable Environment Enhances Productivity
Comprised as a set of services, GEL Explorer 6 will have a profound effect on research productivity. Whiteway says: “We’ve combined the facilities from different systems to create innovative functionality. Collaboration across previously insurmountable boundaries—technical, semantic, and organisational—is now a real possibility.” AstraZeneca can partner with the companies it chooses to, and is not restrained by problems integrating myriad systems and applications, or providing access to data held in third-party applications. “Innovative partnerships—with biotechnical companies and other pharmaceuticals—are the key to our business success,” says Whiteway.
Compliance with Pharmaceutical Regulatory Policies Is Simplified
GEL workflows support users to comply with the application processes, complex regulatory requirements, and quality controls influencing the pharmaceutical industry. As development and collaboration with other companies increases, AstraZeneca can still coordinate and monitor the exchange of data between partners, and control the quality of research and submissions carried out on behalf of the business.
Development Team Can Rapidly Respond to Business Requirements
With the interoperable environment, AstraZeneca IT team members can customise and connect third-party systems to GEL, support new workflows, and incorporate business processes and rules easily. This helps IT employees to be agile and responsive to business needs, reduces the development cycle, and ensures that financial and human resources are used to the best advantage. This is more important than ever in the current economic climate.
Microsoft .NET Framework 3.0
.NET Framework 3.0 is Microsoft’s managed-code programming model for developing software on the Windows platform. It builds on the .NET Framework 2.0, combining the power of the existing .NET Framework 2.0 application programming interfaces with new technologies for building applications that provide visually stunning user experiences, seamless interoperable communications, and the ability to model a range of business processes. The .NET Framework 3.0 includes Windows Presentation Foundation, Windows Communication Foundation, Windows Workflow Foundation, and Windows CardSpace technologies. It provides a consistent and familiar development experience, bringing new technology to the millions of developers programming in managed code today.
For more information about the .NET Framework 3.0, please go to:
www.microsoft.com/netframework
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Document published October 2009
