Facilitating Data Management at an Enterprise Level

Pharmaceutical companies can no longer afford to delay the implementation of next generation tools to help them manage the increasing amount of data generated by their organizations. Working with multiple, disparate systems with minimal to no integration is no longer an option. Pharmaceutical companies need tools that help them improve enterprise-wide communications, reach critical decisions faster and produce timely, accurate reports on how compounds are progressing, all while maximizing return on investment, shortening the pipeline life cycle and cutting costs. The challenge is to successfully streamline and integrate the flow of data so that management has the information they need to make timely decisions. The solution begins with a purpose-built, enterprise-level laboratory information management system (LIMS).

The challenge

With drug development times of approximately 15 years and subsequent costs approaching $2 billion by 2010, pharmaceutical companies are increasingly in search of processes that can help them consistently deliver a return on investment during the patent life of a drug. Enterprise level LIMS are key contributors in this effort. Delivering advanced functionality that is specific to each stage of the drug development process, sophisticated, purpose-built LIMS streamline processes and help reduce costs, and present organizations with unique integration opportunities. Purpose-built LIMS provide superior capabilities by delivering real-time analysis and reports, facilitating regulatory compliance and product quality, integrating with the company's broader network and providing secure access to key data throughout the organization.

Historically, industry standard LIMS have only delivered 30-40 percent of specific functionality targeted to each user's needs, requiring extensive customization to make that LIMS function in that particular setting. Such customization is commonly only possible through the use of proprietary programming languages that are developed and provided by the LIMS vendor. The combination of minimal industry-specific functionality and often outdated and/or costly proprietary languages has been particularly troublesome in the pharmaceutical industry. In addition, pharmaceutical laboratories normally create their own user documentation, design documentation, validation scripts and help files. As a consequence, the implementation of LIMS in various laboratory settings has been, almost without exception, a long, costly and painful process not only during installation, but also in operating and maintaining the system over the years.

The growing mandates of global regulatory compliance and long-term data traceability, as well as the complexity of laboratory testing and emphasis on batch versus sample management, have forced pharmaceutical manufacturers into lengthy, expensive adaptations of generic LIMS to meet their specific requirements. Extensive and costly customization, validation and implementation periods, in many cases lasting 36 months or more, have become routine, resulting in decreased productivity. However, with the increasingly higher costs of bringing a new drug to market, pharmaceutical manufacturers cannot afford to delay the implementation of next generation tools that will make them more productive.

Integrated LIMS

At Thermo Fisher Scientific, we have developed a portfolio of LIMS that meet the needs of customers at every stage of the drug development process. This is particularly true in the pharmaceuticals industry where laboratory requirements are unique in research and development, discovery, and manufacturing. There is no single system that could answer the unique needs of these laboratories, so it is important to develop, with the help of individual customers, purpose-built LIMS for each area of the pharmaceutical value chain.

Purpose-built LIMS for pharmaceutical applications are particularly relevant. According to the 2008 Strategic Analysis of the US Laboratory Information Management Systems Market, by Frost & Sullivan, preconfigured solutions with test methods for specified industries will drive growth across all markets. The more functionality included in the core product out-of-the-box, the less risk, lower costs and less time involved in the implementation, validation and support of the applications. The objective of purpose-built LIMS solutions is to deliver as much domain-specific functionality as possible that addresses the critical needs of the laboratory and delivers the increased enterprise-level access that multi-site/multi-user organizations are looking for. According to the same Frost & Sullivan report, market growth indicators for LIMS solutions providers are focused on providing customers with not only purpose-built LIMS that are fully integrated with other laboratory equipment, but also LIMS that easily align with global enterprise solutions.

A coherent strategy that can integrate data from a LIMS, chromatography data system (CDS), enterprise resource planning (ERP), manufacturing enterprise system (MES), electronic laboratory notebooks (ELN), and other sources across the enterprise is a key business driver. Modern LIMS serve as common platform frameworks that other informatics solutions, instrumentation, enterprise systems and enterprise communications tools can plug into to share common functions, without having to build them from scratch for each product.

Conclusion

The world of laboratory informatics is changing to meet the needs of pharmaceutical companies, which are continually searching for ways to reduce costs, accelerate time-to-market and respond to increasing regulatory requirements. LIMS can help pharmaceutical companies to respond with more certainty to the many unforeseen challenges that can often make or break a company. Enterprise level integration is particularly relevant in today's business climate, where near instantaneous response is required by pharmaceutical companies to protect the public and the environment. LIMS help bring key business knowledge originating in the laboratory to management at all levels of the enterprise.

Seamless enterprise-wide integration is a necessity because it enables key knowledge originating in the laboratory to be available to management in real time. Integrating the enterprise will facilitate better planning, data quality, collaboration and end-to-end report generation, all with the goal of providing management dashboard views of key business metrics, which are essential to effectively run operations, and thereby enabling management to have the critical data they need before, not after, any point of crisis.

Dave Champagne was named Vice President and General Manager of Thermo Fisher Scientific's Informatics business in April 2005. He joined Thermo Fisher in April 2003 as Director of Global Services for Informatics, and was later promoted to commercial director for the company's Informatics and Services division. Champagne's career includes 13 years at Lotus Development Corporation and two roles as chief executive officer for early-stage software companies.

For more information about Thermo Scientific informatics solutions, please call +1 44 1619423000, e-mail marketing.informatics@thermofisher.com or visit www.thermo.com/informatics. Thermo Scientific is part of Thermo Fisher Scientific, the world leader in serving science.

CONNECTS

In response to market growth indicators, Thermo Fisher Scientific has introduced a new Informatics initiative aimed at bridging the gap between laboratory-generated data and the enterprise level information that is required for mission critical management decisions. Because of the breadth of our company's product offerings, and our strategic partnerships, we are uniquely positioned to offer Thermo Scientific CONNECTS, an enterprise level solution set that allows companies to more fully integrate the work of the laboratory into the enterprise.

CONNECTS enables our customers to extend the business of science from the laboratory throughout the enterprise, providing both the integration of instruments and systems, and the interoperability necessary to transform data into relevant business drivers. In facilitating this enterprise-wide integration of systems, management will have the information they need to have early insight into how pipeline drugs or compounds are progressing on a routine basis, and also have the critical data they need before, not after, any point of crisis that may affect operations, shareholder value or the safety of the consumer.