Executive Insight: LIMS

Thermo Fisher Scientific, the world leader in serving science, is the market leader in laboratory software and related services, providing enterprise-wide, multi-laboratory solutions that have become the corporate standard at leading organisations. The company’s Thermo Scientific laboratory information management systems (LIMS) and chromatography data systems (CDS) facilitate lab data in the world’s leading pharmaceutical companies, petrochemical and chemical plants, food and beverage manufacturers, and other major industries. To support its global installations, Thermo Fisher provides implementation, validation, training, maintenance and support from the industry’s largest worldwide informatics services network.

NGP. What is a laboratory information management system, and how are pharma companies using LIMS solutions to their advantage?

DC. LIMS were first developed nearly three decades ago, and can trace their heritage to environmental labs. At the time, they were used primarily as individual computing solutions to store and provide access to lab data. Today, they have evolved into systems that are deployed in multiple industries on an enterprise-level, so that the data can be accessed and used to drive business decisions. We often say that for pharmaceutical companies, until the drug is on the market, the data is their most important asset. LIMS is the tool to manage that critical data.

KS. Beyond storing and retrieving results, LIMS today deliver real-time analysis and reports, monitor regulatory compliance and product quality that are essential to a pharmaceutical company, integrate with an organization’s broader network, and provide secure access to data throughout a global enterprise. In the pharmaceutical industry, they are critical applications.

NGP. What geographic territories do your LIMS solutions address? Are there any particular issues within the EU that your customers are facing, and how are your LIMS solutions addressing these challenges?

DC. The pharmaceutical industry is truly global, with companies developing, manufacturing and marketing their products around the world. Therefore, our solutions are available in all regions, in multiple languages, and because we have the largest services and support organisation in our industry, we’re able to provide local coverage in many regions. The pharmaceutical industry is a significant portion of our installed base, so we also develop our products to address international regulations, such as from ICH.

KS. We’re seeing more activity in Eastern Europe in biotech, pharma and environmental markets. We’re able to deliver our tested solutions, proven in the mature markets of North America and Western Europe, and help Eastern European companies immediately come up to speed from a technology perspective.

NGP. Thermo Fisher Scientific’s informatics business has placed a special focus on creating and implementing LIMS tailored to the needs of the pharma industry. Why is this? What is unique about the pharma industry’s requirements?

KS. The life sciences, pharma, biotech – these 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.

DC. Pharmaceutical companies in particular have been forced into lengthy, costly customisations 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 customisation and its inherent risks. MDS Pharma Services, a contract research organisation, selected our Watson LIMS for their Bioanalytical labs because they did not want to invest a lot of time and money into “specialising” or custom-designing an application to fit their needs (see sidebar).

NGP. What other LIMS does Thermo Fisher Scientific provide for this market?

KS. In addition to Darwin and Watson LIMS, Thermo Scientific solutions for the pharmaceutical industry include Galileo LIMS, Nautilus LIMS, our Atlas chromatography data system, GRAMS desktop spectroscopy software and Enterprise Pharmacology Series and Kinetica applications. While providing functionality for compliance with regulations such as the US Food & Drug Administration’s 21 CFR Part 11, our purpose-built solutions also address specific requirements for different pharmaceutical applications. Watson, for example, is recognised as the most-used LIMS for bioanalytical laboratories. Galileo is purpose-built for in vitro ADMET experiments. Nautilus is a product that many industries use, but its flexibility, patented workflows and plate-handling have made it ideal for biotech and drug discovery labs. EP and Kinetica are applications for DMPK analysis. And Atlas is an enterprise solution to gather data from all the chromatography instruments in pharmaceutical labs. We’re able to integrate Atlas with our LIMS for greater productivity.

DC. 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 customisations. 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 customisation.

NGP. What is Thermo Fisher Scientific’s strategy regarding open standards?

DC. We’re 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 will 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 a competitor’s.

KS. Customers 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.

NGP. How is LIMS developing?

DC. 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 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 Champagne joined Thermo Fisher Scientific in April 2003 and has led informatics since April 2005. His career includes 13 years at Lotus Development Corporation and two roles as chief executive officer for early-stage software companies. Champagne is a graduate of the University of Massachusetts with a BS in Industrial Engineering and earned his MBA from Bryant University, Rhode Island.

Kim Shah has more than 20 years experience in high tech marketing and management. Prior to joining Thermo Fisher Scientific in November 2006, Shah held leadership roles at Convoq, Inso Corporation, Lotus Development, and Micrografx. Shah earned a Masters in Management from the Sloan School at MIT and a B.Sc. in Aeronautics from Imperial College, University of London.

Find out more: www.thermo.com/informatics

Dave Champagne: “We aim to provide as much as 70-80 percent of the user’s requirements for a particular laboratory or application out of the box”

Kim Shah: “We’ll be at the forefront of developing industry-wide conventions for sharing data”

Q&A

The customer’s story

Talking with Merry Danley, Associate Director, Bioanalytical Technical Operations & QC for MDS Pharma Services. MDS uses Watson LIMS from Thermo Fisher Scientific

Q. Describe the laboratories where Watson is implemented. What is the main purpose/primary function of these labs?

A. MDS Pharma Services has five bioanalytical laboratories using the same Watson LIMS database. With laboratories all over the world, MDS Pharma Services offers complete bioanalytical services by supporting our clients in their drug development programmes.

Q. What types of samples are handled by Watson?

A. MDS Pharma Services uses Watson to support the bioanalyis of samples generated in clinical (human) and nonclinical (animal) trials to test the safety and efficacy of new pharmaceuticals. The purpose of Watson LIMS for MDS Pharma Services is to provide our clients a secure database, which quantitates or measures a particular compound in biological samples. MDS Pharma Services also utilises Watson to handle sample storage conditions and method validation.

Q. How many samples are tested per day or year?

A. MDS Pharma Services assays over 500,000 samples per year using Watson LIMS.

Q. What problems/challenges were you facing that led you to look for a LIMS solution?

A. Each of our laboratories was using different LIMS systems. We needed a global solution that would meet the user requirements, comply with the predicate rules of various global regulatory agencies and provide a centralised database to easily share and view data from across the world.

Q. Prior to implementing Watson, how did you manage data in your labs?

A. Each laboratory had a homegrown LIMS product to manage the data. Some data analysis was done on spreadsheets or other macro-type programs. There was no centralised storage of any of our bioanalytical data.

Q. Why was Watson selected as your company standard?

A. Watson is the industry standard bioanalytical LIMS – there is no other LIMS product that handles and processes bioanalytical data as well as Watson. It was designed specifically for bioanalytical work, yet the software is not too restricting as it works well for both contract research organisations (CROs) like MDS Pharma Services, but also pharmaceutical companies, biotech companies and other bioanalytical labs.

Q. What evaluation criteria did you use?

A. MDS Pharma Services evaluated the options of upgrading our homegrown system, implementing a highly customisable system or purchasing a purpose-built, proven system such as Watson. After a detailed operational and financial evaluation of the options, we decided that we would be looking for the purpose-built system that that would be used essentially “out of the box”. We did not want to invest a lot of time and money into “specialising” or custom-designing an application to fit our needs even though we recognised our operation would have to adjust some to match the software's workflow. It was critical that the network environment be “tiered” such that you could easily deploy one or two users as easily as 600-800 users on the system.

Q. Which version of Watson have you deployed?

A. We are on Watson 6.3 and are upgrading to Watson 7.3 in the next few months.

Q. Watson is marketed as an “out-of-the-box” solution with minimal customisation required. Based on your experience, what are the benefits of deploying a COTS (commercial off-the-shelf) solution?

A. A COTS system with minimal customisation benefits the company purchasing the system. Each additional “customisation” required by a system adds cost in areas such as: software validation resources, quality assurance resources, IT resources, project time, and hardware. If you purchase a system that is configurable versus customised, you will have earlier recognition of benefits. These benefits can include quicker project planning time, less validation time, less resource time and less specialised IT services. Highly customised solutions are often complex in administration, configuration and usability. One aspect that is critical in a complex business environment is the ability to train users easily. New users can be trained on Watson LIMS very quickly with its intuitive menus and functional focused design.

Q. How important was workflow?

A. In a laboratory processing as many as 8,000 samples per week, workflow is extremely important. Not only are you concerned about high throughput of the samples, but the quality and error-free data you are producing. A good software solution will build on your existing workflow and streamline that to make your laboratory more efficient. Watson gives us the ability to not only process the data and samples efficiently, but also the reliability and quality of the data due to the defined workflow, which minimises errors and downtime. The new functionality that Watson provided us, allowed us to achieve new efficiencies and increase our overall business value.

Q. What cost, time and resource savings were realised as a result of this implementation?

A. The implementation of Watson LIMS enabled us to retire legacy systems. In addition we have our servers that support all of our laboratories in a secured data centre, which decreases support and IT costs. Watson also has two-way interfaces to our data sources, eliminating the need for extra data verification steps during the workflow of the laboratory data.

Q. And quality or application performance improvements and improvement in laboratory/department performance?

A. Using Watson has allowed us to standardise data, not only between the MDS Pharma Services bioanalytical sites, but also with many of our customers. We can easily share data in any type of format with our clients. If our clients also use Watson LIMS, which many of them do, it streamlines the data transfer steps even more. Watson LIMS has also provided us the ability to share data between laboratories easily, including the ability to easily transfer methods from one site to another. Thermo Fisher Scientific has continued to build new functionality and regularly upgrades the system to meet current and emerging regulatory requirements. Watson has improved our auditing abilities and provides a solution that produces data as intended. In addition, any authorised user can access the data or critical documents from anywhere and at anytime.

Q. What has been the users’ reaction to Watson?

A. MDS Pharma Services has ~550 users. The laboratory scientists, quality assurance, and data support all appreciate the extra functionality Watson has provided. The system consistently produces intended results in a compliant manner, and in a high throughput laboratory like MDS Pharma Services that is a critical requirement. From an IT standpoint the system also integrated seamlessly with existing databases, operating systems and hardware.

Q. How has this integration benefited your organisation?

A. We use a lot of mass spectrometers and Watson LIMS has great instrument integration for these instruments. We also utilise other interfaces, specifically for other types of analysis such as immunoassay and biomarkers, ICP/MS, and RIA.

Q. In order to implement Watson, did you have to change some of the processes within your labs to conform to the software?

A. We constantly streamline and try to make our processes efficient. It is important to utilise and make use of the software that drives the workflow. If you can do that, it will reduce lead-time on a project and improve the quality of the laboratory.

Q. What services, if any, did Thermo Fisher Scientific provide as part of the implementation?

A. Thermo Fisher Scientific provided many resources in the implementation. Specifically, they handled the installation, including software validation, as well as training services.

Merry Danley: “MDS Pharma Services assays over 500,000 samples per year using Watson LIMS”