Integrating Laboratory Data into the Enterprise to Accelerate New Product Development and Improve Business Management

PHILADELPHIA, Penn., (September 5 2007) – Thermo Fisher Scientific Inc., the world leader in serving science, discusses how the pharmaceutical industry is placing a greater focus on integration of the laboratory within the enterprise to improve business management.  Dave Leitham, director of Informatics products, explains how organizations are taking advantage of their data management systems and expanding them beyond the laboratory.

Integration of knowledge, systems and data is becoming more and more important, especially in the global economy where organizations are increasingly multinational and multicultural.   Global connectivity, both between laboratories and within the rest of the enterprise, is becoming a driving factor to ensure the laboratory does not remain an isolated silo.  Pharmaceutical industry professionals are anxious to break down data silos and electronically capture information generated in the laboratory to give that data meaningful context for more effective decision-making, collaboration and knowledge management.

New Product Development Challenge

The pharmaceutical industry is faced with the challenge of maintaining a continuous stream of new products under fierce regulatory and time constraints,   This is particularly difficult because of the overall low probability of technical success, coupled with high development costs associated with successful products.   The result is that New Product Development (NPD) is confronted with the challenge of uncertain market impact, a scarcity of good new product ideas, and limited human and capital resources available to develop them.

Reduced Time to Market Through Integration

Speed to market with respect to new products is critical to the competitiveness of all pharmaceutical companies.   The challenge is how to improve the NPD process in order to be the first to launch or file a patent.  The importance of data in the NPD process is to define what is valuable (and what is not) as early on in the process as possible and to share it with all research scientists across the organization.  The result is to identify which compounds in the pipeline will become successful and expedite the discovery process by making more efficient and informed decisions in the NPD analysis.

In the life sciences industry, the blockbuster business model is now challenged.  The emphasis  now lies on leveraging the optimal business intelligence, in order to identify which compounds in the pipeline will become the cash generators.  As a result, the pharmaceutical industry needs to make more efficient decisions for its NPD analysis.  

At present however, the real problem of evaluating and selecting which new products to develop and then of sequencing or of scheduling them is exacerbated by the avalanche of data that is generated by from the multiple laboratories operated globally.   Paula Hollywood of ARC explains “Enterprises are seeking efficient and cost effective solutions to handle this increase in the amount of data and ensure regulatory compliance.” Within the development process, the issue of which data is important challenges the enterprise on a daily basis. It is therefore imperative that the laboratory, from which the raw data emerges, provides an accurate and valuable stream of information to the organization.  It is for this reason that enterprise integration and data management are so important.  

Laboratory information management systems (LIMS), the software solutions that aggregate, store and manage data generated by discovery, R&D and QA/QC labs, play a critical role in integrating the data across the entire organization. At Thermo Fisher Scientific we’ve developed four purpose-built LIMS with specific functionality depending on the environment. For drug researchers involved in early R&D, where flexibility is critical, we provide Nautilus LIMS™.  Galileo LIMS™ was developed to automate the more tedious manual calculations and record-keeping routinely associated with in-vitro research, automating high throughput ADME screening and flagging of suspect data sets.  Watson LIMS™ is used in the area of drug development and manages simple and complex clinical and pre-clinical toxicokinetic (TK) studies, and the data from complex bioanalytical processes.  Darwin LIMS™ is designed specifically for pharmaceutical manufacturing R&D QA/QC with core functionality baked in to allow users to conduct stability, dissolution, content uniformity and other standard studies.      

Integration within the Enterprise

The pharmaceutical industry is truly global, with companies developing, outsourcing, manufacturing and marketing their products around the world.  In addition, user demands for standard business tools have led to a need for LIMS to demonstrate interoperability with other enterprise business systems.

For Thermo Fisher Scientific part of the platform is Integration Manager.  It offers not just instrument integration but also a common point from which one can link the LIMS into Enterprise Resource Planning (ERP) systems such as SAP, including such aspects as asset management and workflow.  

Horizontal solutions like Thermo Scientific’s Integration Manager (which provides a plug-and-play approach to integration of both hardware and software data sources with Thermo Scientific’s LIMS products) and Retriever (which provides extensive reporting capabilities across Thermo Scientific’s suite of products) are key to the enablement of automation, data sharing, collaboration and integration across multiple data sources and products, both hardware and software.

Business intelligence is always evolving and is idiosyncratic to the user.   Thus the requirements of pharmaceutical and life science customers are unique to these industries.  Offering different LIMS for stages of the pharmaceutical industries is one of Thermo Fisher’s strengths.  Although the products have different applications, the underlying platform homogeneity of the solutions offers the best of both worlds. The same underlying technologies provide different business intelligence.  

Technology Drivers
Where workflow is organized around sample analysis, for example in a quality control laboratory, vendors of LIMS can offer common software across all the laboratories in the enterprise, thus integrating the flow of information across them all. Large multi-national companies need to pull disparate operations together to achieve better overall workflow, better access to information and to break down information barriers. Web-based access to information is important to this effort - part of Thermo Fisher Scientific’s ‘sophisticated dashboarding technology’ offers the ability to deliver information outside the laboratory, but with security settings to control who can access  what information.

Industry Needs
Life sciences, pharma and biotech are all important industries for Thermo Fisher, and informatics is an important part of our company’s strategy to integrate the lab with end-to-end solutions. We have a portfolio of informatics solutions for the pharmaceutical industry because they address the complexity and variety of work being done in laboratories, from discovery through to manufacturing QA/QC. Not only that, pharmaceutical companies need solutions that address regulatory compliance, long-term data traceability, batch management, and other issues.

Pharmaceutical companies in particular have been forced into lengthy, costly customizations of generic LIMS to meet their specific needs. With products like our Darwin LIMS for Pharma manufacturing R&D and QA/QC, we decided to meet core requirements – for stability and environmental monitoring, for example – with standard, out-of-the-box functionality. This greatly reduces customization and its inherent risks.

Open Standards
Thermo Fisher is leading the industry in the effort to create open standards. We’re moving our solutions to the Microsoft .NET platform, using service oriented architecture (SOA) and shifting away from proprietary programming languages in an effort to increase interoperability. Our open, unified architecture share an XML-based middleware layer that will be performance-tuned to communicate and work seamlessly with all major instruments and automation available in the marketplace, whether they are Thermo Scientific solutions or those of a competitor. 

Customers today operate in a heterogeneous technology environment and their success, as well as ours, is dependent on ensuring that all these technologies can work together as seamlessly as possible. Proprietary languages make interoperability difficult – and quite frankly are difficult to support over time. The trend is to open up to cooperation with other vendors who provide other key software and hardware essential to the user’s business. That’s one of the reasons we’ve joined the Microsoft BioIT Alliance. We’ll be at the forefront of developing industry-wide conventions for sharing data. The Alliance brings together science and technology leaders to consider innovative ways to address challenges of integration, collaboration and knowledge management.

In addition to our portfolio of purpose-built LIMS for the pharmaceutical industry Thermo Scientific offers Atlas CDS™ (chromatography data system) - an enterprise solution that gathers data from all the chromatography instruments in labs.  We’re able to integrate Atlas with our LIMS for greater productivity. Thermo Scientific EP and Kinetica are applications for DMPK analysis.. While providing functionality for compliance with regulations such as the FDA’s 21 CFR Part 11, our out-of-the-box solutions address specific requirements for different pharmaceutical applications.

Thermo Scientific Retriever™ tool - the reporting and business information platform, will be able to work in a platform aware mode but can also access information from any relevant database, thus allowing users to access data for business intelligence reasons.  Retriever is a fully web-based data enterprise reporting tool which allows real-time access to data from any informatics system directly and securely by appropriate people within the organization.

The combination of these solutions means pharmaceutical customers get the application-specific functionality they need in the laboratories where they need it, without extensive, time-consuming and costly customizations. We aim to provide as much as 70-80 percent of the user’s requirements for a particular laboratory or application, whereas a generic LIMS may only meet about 30-40 percent of functionality prior to customization.

Benefits
Intelligence from the data stored in these systems allows the business to identify which laboratories within the organization are most efficient.   It allows them to identify which laboratories have most backlogs.  Decision-making is facilitated by immediate access to data.

Several industry observers agree the LIMS market is growing in the range of 8-10 percent. The growth drivers include consolidation and standardisation projects that will replace numerous, smaller existing LIMS installations at large pharmaceutical companies. Investment in India and China will be important, as well as growth in aftermarket support and service. We see opportunity in interoperability via open standards. As we’ve mentioned, customers are looking to partner with vendors who can help them create a unified laboratory, where instruments, automation, equipment, enterprise systems (i.e. ERP) communicate seamlessly via software applications. Thermo Scientific informatics solutions are increasingly designed and developed using proven, open technologies to serve as the platform for this laboratory integration.

Dave Leitham is Director, Informatics Products, Thermo Fisher Scientific, 1601 Cherry St., Ste. 1200, Philadelphia, PA 19102, U.S.A.; tel.: 215-964-6020; fax: 215-964-6021; e-mail: marketing.informatics@thermofisher.com

For more information about Thermo Scientific informatics solutions please call on +1 866-463-6522, 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.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With an annual revenue rate of more than $9 billion, we employ 30,000 people and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. Visit www.thermofisher.com.