The new biopharmaceutical blueprint

More than ever, drug makers need to be fleet and flexible — and they need their software to be the same. Today's integration approaches do not support the level of responsiveness that firms need to react to the changing regulatory and competitive landscape in which they operate. However, by breaking down an application into 'services', IT providers may have hit on a way for their software to drive innovation at every point in the value chain.

Bringing a pharmaceutical or biologic to market takes more than just good science: it takes an agile business that can respond to the changing market and environment by aligning business processes with flexible IT. Separate challenges confront R&D, manufacturing and sales and marketing. R&D is compelled to accelerate time-to-market of novel treatments and extend its reach in global markets. Likewise, manufacturing is undergoing sweeping changes, incorporating more efficient, quality-centric methods, and streamlining processes that scale across regions and partners. Financial and regulatory demands on sales and marketing are forcing companies to evaluate ways to increase sales effectiveness, such as multichannel business models, direct-to-consumer marketing, partnering and new customer models. Technology integration challenges hamper all of these areas. Service-oriented architecture (SOA) can help address these systems' integration challenges across the organization, and serve as the new blueprint to help companies align business and IT. This article will demonstrate how SOA can address challenges in manufacturing and is intended for business executives to explore how SOA can help them effectively respond to today's evolving and complex business models.

Introduction

Biotechnology and pharmaceutical companies (biopharma) are challenged today by complex scientific information and the need to make faster business decisions — all in the context of a global marketplace. Many organizations are actively collaborating and partnering to augment their core competencies, and extend business beyond organizational and geographic boundaries. Companies have invested in many forms of technology to enable business processes, integrate their organization and support innovation.

Figure 1 Todays release process involves many manual, iterative processes.

Businesses seek flexibility within a compliant environment — their processes are not static — and they endeavour to constantly improve the way they implement their strategy. IT solutions need to support that flexibility. Today's integration approaches do not support the level of responsiveness for continuous improvement. SOA has the potential to dramatically address this challenge and benefit an organization when:

• Business users exchange information across multiple systems.

• Business processes span several applications across partners.

• Businesses are transitioning to newly merged or acquired business owners

• Business users need information in near real-time.

• Point-to-point solutions prevail with fixed interfaces that are costly to maintain.

But what is SOA, and how can this architectural approach provide an organization with the levels of efficiency and responsiveness it needs to effectively compete in today's changing market?

Service-oriented architecture

SOA is a style of developing and integrating software. It involves breaking an application down into common, repeatable 'services' that can be used by other applications, both internal and external, in an organization — independent of the applications and computing platforms on which the business and its partners rely. Using this approach, enterprises can assemble and reassemble these open, standards-based services to extend and improve integration among existing applications. SOA can also support collaboration, build new capabilities and drive innovation at every point in the value chain.

Figure 2 A revised product-release process.

The power behind SOA is the ability to share services through system-to-system interactions that could improve efforts to adapt end-to-end processes. SOA helps automate process steps; remove redundancy; use messaging and alerts to trigger essential people-powered workflow; and enable new capabilities. When a company adds new applications and retires old ones, SOA can help facilitate the transition and migration. With time, services may be modified, shared and recombined to streamline activities across yet more applications. This approach allows companies to more efficiently automate regulated and compliance-driven activities?— freeing people to perform higher-level activities and providing an integrated business view to authorized staff across departments and organizations. In time, SOA can support continuous improvement through monitoring and redesigning processes linked to technology services.

SOA offers an integrated, collaborative approach to aligning business and IT services and supports evolving business needs. The business must be actively involved, however, to identify the processes that must be managed on an ongoing basis. Current IT integration methods can continue to exist because SOA preserves legacy systems through the use of services. SOA can be applied using a small, step-wise approach that can grow as companies add more processes and applications. As a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners. SOA is easier to understand through real-life examples. Below, the authors examine an industry-specific critical issue within the manufacturing organization to show where SOA approaches enhance information sharing for internal systems and support tighter integration with manufacturing business partners.

Figure 3 A closer look at an enterprise content management system providing SOA.

Improving the product-release process

Today's regulatory agenda demands 'quality by design' — a proactive approach that addresses compliance issues before they occur. Customers and regulators want nothing less than continuous supply, reliable product safety controls and the ability to track issues efficiently. More parties are involved in manufacturing, as more complex products require more communication, which exposes the industry to risk from local variations and monitoring procedures managed by global partners. The authors will focus the discussion on a real-life scenario of getting manufactured products released into the market.

Biopharma manufacturing is striving to create tighter integration among all the players: suppliers, technical development, manufacturing facilities, comarketing, logistics and markets. At the same time, manufacturing is an inherently changing environment. The authors will look at one part of the release process and examine the many systems supporting this process. Companies often experience integration challenges when there is:

• One enterprise resource planning (ERP) application with many instances internally or externally at manufacturing sites.

• Many ERP instances with many best-of-breed applications.

• Different systems for each department discipline involved in the manufacturing process.

• A reliance on paper being generated from these different systems, with the legal requirement to retain the paper and show an audit trail for each released batch.

• Loosely enforced global IT standards within the organization or with partners.

Managing the product-release process today

The release process is complex and involves massive amounts of information from various sources. All compliance-based processes must come together at this point before a batch is released to the market. Staff is involved across the organization and outside the company that includes quality control (QC), in-house or third-party manufacturing, engineering, quality assurance (QA) and supply-chain operations. Figure 1 shows how a typical release process occurs today.

This process is triggered as a batch is completed. Today, the process is slow and inefficient because it is still largely paper-based, with many applications. It relies on humans to push the paper to its next step or to transfer the information manually from one system to the next. Documents can become lost and can be difficult to trace during critical stages. Stand-alone applications may only have partial information, and the manual entry of information into multiple systems can lead to redundant or even conflicting data. Each discipline has its own reports to document the manufacturing of the batch. It is the collective set of documents from all activities and departments that comprises the information and basis to know whether or not the batch should be released. There are many document-related activities and issues that can occur as documents are collected. What Figure 1 does not depict is the iterative nature of document generation and collection loops that can prolong the process if no triggers exist to alert staff about ongoing issues or corrective actions. The result is a process that is difficult to measure and manage.

Streamlining the product-release process

To support good manufacturing practices (GMPs) of global regulators such as FDA in the US and the European Medicines Agency in Europe, staff and equipment must be in compliance at all times. Compliance is often supported through business processes such as those presented in Figure 1. In many cases, to improve this process, companies need to eliminate paper, and have systems that can store and share required reports and documents systematically from system to system. Ideally, this level of integration ideally would not impose custom programming requirements on the systems actually generating the reports. Figure 2 shows how the process improves with an SOA-enabled enterprise content management system (ECMS) that manages data stored in a database (structured data) and documents stored in a document store or repository (unstructured data).

Integrated systems, as shown in Figure 2, provide a number of advantages:

• The departments supporting the batch-release process continue to use their existing systems with a new efficiency that allows staff to focus on value-add activity. These systems communicate to an SOA-enabled content management system to store any required reports.

• Paper generation and movement can be eliminated, removing the uncertainty that can potentially reduce overall cycle time.

• The system can help manage the process; for example, only allowing the process to continue when all of the proper documents have been generated, collected and stored appropriately.

• The qualified person who is responsible for releasing the batch, can now more easily see if there are open deviations in the documentation collected.

• The development of a more efficient and effective process platform is possible by integrating the supporting systems using SOA.

Previously, this platform development often required custom, point-to-point programming dependent upon proprietary platforms and programming interfaces provided by the software vendor. This has been notoriously difficult, complicated by the nature of storing documents and reports from various sources, in a variety of formats. The complexity is only increased when the process requires the integration of multiple business partners worldwide. There are many software solutions for enterprise content management. If the solution provides SOA services, a company such as IBM can provide the level of integration shown above with a compelling integration approach for both the sponsor's and the business partner's IT departments. Figure 3 shows how this level of systems integration can be achieved using SOA.

Using Figure 3 and continuing with the example:

• If the QA person had closed the release blocking incidents and wanted to publish an incident status report, he or she would use the Corrective and Preventive Actions (CAPA) system as normally done. The CAPA system would generate the report, use the SOA service from the content management system and 'store document' to store the report associated with the batch.

• The qualified person who reviews all the documents in the content management system and wants to set the release decision would do so in the ERP system, as is done today. However, when the production order needs to be published, the ERP system would do so using the SOA service from the content management system and 'store document' to store the report associated with the batch.

• If the QC department was releasing the batch and wanted to generate the certificate of analysis, it would do so in the laboratory information management system (LIMS), as is normally done. The LIMS would use the SOA service from the content management system and 'store document' to store the report associated with the batch.

The SOA-enabled ECMS provides a standards-based approach, allowing other systems to deposit reports and documents and maintain those documents over time. This approach involves defining SOA services for distinct document-management functions such as depositing a document or report, or retrieving one. In our example, not only can the initial batch documents be stored, but downstream documents that must be retained, such as the certificate of analysis and electronic batch records, can be stored collectively by any system participating in the process. This can help simplify the generation of regulated documents. It enables staff to resolve issues that are tracked in the CAPA system and not have to chase after supporting documents.

The value of SOA

SOA delivers tighter internal integration among players. The SOA-enabled ECMS solution is one example of how SOA can impact the manufacturing environment. SOA brings value to the overall organization as follows:

• Reusable data/repeatable processes: SOA establishes an environment that supports the evolution to quality by design and continuous 'real-time' QA to help build in efficiency within the organization and with global partners. Using a service-driven approach, such as SOA, enables processes that help departments, manufacturing sites, and organizations adapt to changes in the environment.

• Reuse of SOA services: in this example, services can be reused by any application producing documentation for the manufacturing process, which represents a common, high-impact process. Consider how valuable SOA services would be for other central or key applications such as ERP.

• Facilitated business process change: SOA services make it easier to adapt to changes in the business processes required for manufacturing. SOA makes system functionality more granular, so the process activities that use them can be easily accessed and applied to other systems. IT systems become more flexible and reduce development times as SOA services are reused.

• Improved risk management: an SOA framework can also help monitor execution of a process. The same SOA services that connect two business applications can also support any of the monitoring applications.

• Support for automated processes across applications: SOA allows process management or workflow systems to 'talk' to required applications needed to support the process. This helps reduce administrative burden and increase compliance. It also allows processes to extend into new areas of the organizations or to external partners.

• Efficient partnerships: business partners can be integrated with the biopharma company in a nonintrusive manner using industry-standard interfaces. Business partners do not need to change their current software, nor does the biopharma company. SOA offers a way to integrate without wholesale change to existing applications.

• New business strategies: SOA offers connectivity options for new partners and allows companies to explore new product capabilities. Support systems can be built more easily using portal technology and SOA services.

Conclusion

Although the biopharma industry is actively addressing its challenges, many environments are not scalable or responsive enough to meet future demands or to efficiently compete on a global scale. SOA enables companies to simplify the complex nature of today's biopharma business to facilitate 'smart' system interactions and 'built-in' compliance.

SOA can be a little daunting to an organization. Similar to anything else of this scale, it must be applied with a sense of vision, purpose and strategy that involves:

• Focusing on a business problem and using SOA to solve it.

• Focusing on revenue-generating capabilities or on areas where inefficiencies affect overall costs.

• Thinking long-term. Once a company makes its initial investment in an SOA architecture, additions or changes can become much less expensive (and faster) to integrate. The return and benefits on this initial investment can be dramatic.

• Addressing governance, which is an enterprise approach to managing services inside and outside the organization.

SOA allows a step-wise approach to preserving internal investments and aligning the business with the technology that supports it. Once companies begin using SOA services to manage a small portion of their environment, they can scale this efficiency through reusable information and repeatable processes across other departments and with partners. They can then proactively respond to today's changing regulatory environment and competitive landscapes

The collaborative nature of SOA can help address a new level of partnering and global reach that is necessary to stay competitive in the biopharma industry both for today and the future. The authors expect that biopharma leaders will make SOA a critical part of their organizational strategies to help them reach out to other organizations and bring the intended benefits to society on a global scale.

Pieter Deurinck is a managing consultant and worldwide solutions architect for the life sciences/pharmaceuticals team at IBM (Belgium).

Jay DiMare is an associate partner at IBM Global Business Services.

Michael Ricci is a global relationship partner at IBM Global Business Services.

Kathleen Martin is a managing consultant for the life sciences/pharmaceuticals team at the IBM Institute for Business Value.