from Integration to A data integration discussion with Dave Champagne, VP and General Manager of Informatics at Thermo Fisher Scientific contents

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1 contents from Integration to Dave Champagne photographed for Future Pharmaceuticals by Irvin Serrano Innovation A data integration discussion with Dave Champagne, VP and General Manager of Informatics at Thermo Fisher Scientific 4 FUTURE PHARMACEUTICALS Driving the Industry Forward.

2 contents For the latest executive insight and industry expertise, log on to Editor s Note 14 From Integration to Innovation Future Pharmaceuticals speaks with Dave Champagne, VP and General Manager of Informatics at Thermo Fisher Scientific, and Thor-Gunnar Steinsli, LIMS Manager and Chief Engineer at HUNT Research Center and Biobank, about data integration: the benefits of data, instrument and enterprise integration strategies and challenges at life sciences companies 20 Reaping the Benefits of Integration Dave Champagne, Vice President and General Manager, Informatics, Thermo Fisher Scientific, explains how enterprise-level Laboratory Information Management Systems (LIMS) can be used to help pharmaceutical companies leverage laboratory-generated data for mission-critical management decisions Laboratory information systems 24 A Single Solution Steven Neri, Director of Pharma Business Development at LabWare, clarifies laboratory automation solutions and why LabWare only delivers one product 28 Approach Data From a New Angle Simon Wood, Executive Director of Marketing and Education, STARLIMS Corp., clarifies the integrated laboratory informatics approach and how to receive the most from your data and IT resources 30 Breaking New Ground Future Pharmaceuticals interviews Norbert Bittner, Managing Director at Up to Data Professional Services, about breaking new ground in bioanalytical submissions and specifically the istudyreporter Bioanalytics, the first purpose-built automated solution for regulatory reporting of Watson LIMS data 30 Drug discovery 34 Discovering Academia Stephen Frye, Professor and Director of the Center for Integrative Chemical Biology and Drug Discovery at the University of North Carolina, Chapel Hill, and Bill Janzen, Professor and Director of Assay Development and Compound Profiling at the Center, clarify where academia fits into drug discovery and why pharma companies should take notice 38 An Apt Analysis Andrew Altman, Vice President and General Manager LC/LCMS (Liquid Chromatography/Mass Spectrometry) for Thermo Fisher Scientific, discusses liquid chromatography solutions and where new technologies will be taking this method in the future 40 A Complete Lab Andrew Altman, Vice President and General Manager of Liquid Chromatography/ Mass Spectrometry for Thermo Fisher Scientific, explains Thermo Scientific solutions and how one customer compared them to a complete breakfast 42 Doing More With Less Learn how to improve lab productivity by consolidating services from Shawn Laymon, Director of Market Strategy and Business Development for OneSource Laboratory Services at PerkinElmer, Inc FUTURE PHARMACEUTICALS Driving the Industry Forward.

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4 Future Pharmaceuticals speaks with Dave Champagne, VP and General Manager of Informatics at Thermo Fisher Scientific, and Thor-Gunnar Steinsli, LIMS Manager and Chief Engineer at HUNT Research Center and Biobank, about data integration: the benefits of data, instrument and enterprise integration strategies and challenges at life sciences companies. from Integration to Innovation Contributed by Thermo Fisher Scientific and edited by Jan Iverson, Editor-in-Chief Photographs of Dave Champagne were exclusively shot for FP by Irvin Serrano 15

5 From Integration to Innovation Future Pharmaceuticals Thermo Fisher Scientific is a major player in many aspects of the life sciences business. What are some of the industry trends and challenges your customers are facing? Dave Champagne Thermo Fisher Scientific has customers around the world in pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. The focus of our product innovations is to help solve analytical challenges for our customers, from routine testing to complex research and discovery. The Thermo Scientific brand represents a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. With the average costs of bringing new drugs to market now approaching $800 million, pharmaceutical companies must continuously upgrade their technological capabilities and invest in the data management solutions that will help them integrate processes and data in order to provide the right information at the right time to the scientists and managers needing it. One of the trends affecting our Informatics business is that pharmaceutical companies are increasingly coming to view their Laboratory Information Management Systems investments as central to this process. Certainly, one of the biggest challenges facing life sciences companies has to do with managing the ever-growing volume of data and connecting all of the disparate sources of data throughout an organization. In addition, as pharmaceutical companies look to form strategic partnerships with external organizations such as CROs, biobanks and hospitals to advance science, it s imperative that tools and systems foster collaboration and communication. This is particularly important when translating the huge amount of laboratory-generated data into useful information. Management at all levels of an organization is where that data is most needed. Life sciences companies are looking for ways that enable management to make timely and effective decisions. With multiple applications across a global enterprise generating reams of data that sit in separate silos, aggregating and mining this data is a very real and complex problem. In some parts of many companies, manual processes are still being used for collecting, analyzing and reporting this data. More often than not, creating the reports necessary to distill this vast amount of data into relevant information can be extremely tedious and time-consuming. For example, if a scientist whether at a CRO, biobank or pharmaceutical company is performing the administrative tasks of creating reports in order to make sense of the mountain of data that s collected, then that company is losing time and money in activities that are not furthering the scientific work of the lab. Also, data formats are inconsistent across lab applications, instruments and different organizations, so when it comes to creating reports, there is no central place for gathering and collating all of the data so that it s useful to all parties. These are unnecessary barriers that stand in the way of life science executives as they try to make the most effective business decisions. One of the ways to address this challenge is to implement market-specific, high-performance LIMS with expandable capacity and functionality that delivers time and cost-saving efficiencies. With the benefits of a LIMS that is fully integrated with the most critical business systems, pharmaceutical companies can look forward to increasing the pace of the drug development process, to secure seamless communications with the FDA and to improving their time to market. Our customers are asking for better ways to access, share and use the data they generate so that it has a direct impact on the business, not just the lab. 16 FUTURE PHARMACEUTICALS Driving the Industry Forward.

6 Dave Champagne addresses the challenges of data integration. FP How does this data integration problem affect your customers on a day-to-day basis? DC Even as drug development costs continue to climb, the low approval rates of new molecular entities have remained fairly consistent. Since this current challenge will not be resolved quickly, drug development organizations are refocusing their research dollars to ensure that the right drugs move through their pipeline. This is where the data challenges have a direct impact on our customers because to make this happen, the right kinds of information have to be available to the right people across an organization so that collaborative decisions are made as quickly as possible to move in one direction or another. There s no doubt that our life science customers are facing integration challenges - from discovery to manufacturing. For example, once a promising drug candidate has been identified, pharmaceutical companies must move quickly to collect all the information necessary to push that drug candidate through to FDA approval. Then they need to correlate these findings with other external sources of information to accurately track the performance of a treatment in humans and correlate that information with the in vitro and animal in vivo studies they have performed in the laboratory. As this information can come from many different sources including hospitals and CROs, connecting the sources of the data and integrating this information into the analytical process becomes crucial in order for scientists to most effectively and efficiently interpret their data and make decisions about new drug entities and the therapeutic options they deliver. While patient data comes from the clinic, the initial laboratory data comes from a combination of CROs and the pharmaceutical company s own internal laboratories. Connecting all of this information, especially from external sources, is not trivial, and it is a critical part of the process since it will drive future decisions about which compounds to synthesize and test. By integrating this information from all of these sources and presenting it in a way that is clear to researchers, drug development organizations are able to make faster, more informed decisions. If we look at the needs of pharmaceutical manufacturing, where it is critical that all data is associated with the batch record, we can see that integrating data and connecting all of the sources of information is of enormous importance. Data needs to be synthesized from the existing ERP (Enterprise Resource Planning), PIMS (Process Information Management System), MES (Manufacturing Enterprise System) and LIMS to ensure that the end product meets quality standards and that any issues with the product s stability, percent label claim or content uniformity are elevated to the batch level to prevent costly product recalls, product loss and unplanned downtime. The integration of this information is even more critical in biopharmaceutical manufacturing, where unplanned downtime is not an option. Take, for example, a typical fermentation plant with three reactors. Recognizing and containing a contamination in samples from reactor A before it is used to seed the remaining reactors will prevent a complete shutdown of all operations. By integrating the sources of data and enabling the connectivity of the disparate data files, the laboratory can determine if the source of the contamination is in the reactor or was introduced to the batch after the sample was taken and brought to the laboratory. In order for our customers to continue to make the greatest contribution to human health, as well as build shareholder value and consumer confidence, they need to make sure that the right information is available in real time to the right people. Whether the challenge is trying to track the progression of a promising drug candidate through the pipeline, or reviewing environmental monitoring data associated with a batch, the solution can be found in the integration of multiple data sources and the visualization of information. These challenges involve entirely different operating systems 17

7 From Integration to Innovation HUNT Research Centre and Biobank and instrument software with different data formats, which is why it s important for a solutions provider like Thermo Fisher to have the capabilities to design and deliver an appropriate approach to the integration process. FP What is Thermo Fisher Scientific doing to address some of these challenges? DC Pharmaceutical companies are increasingly turning to the revolutionary advances LIMS suppliers are making in order to improve their laboratory workflows and harmonize their processes not just internally, but also with external partners. We now have an opportunity to leverage our company s wide range of capabilities to help bridge the gap between laboratory generated data and the enterprise-level information that is required for mission-critical management decisions. By taking the broad view of our capabilities, we can address these barriers and help facilitate improved decision making and collaboration. We are unique in being able to offer these capabilities and to help our customers respond with more certainty to the many unforeseen challenges that can often make or break a company. Thermo Scientific CONNECTS is a set of offerings that encompasses the company s breadth of Informatics solutions, such as LIMS, CDS and ELN capabilities, as well as expertise in enterprise systems integration to help streamline and improve the transfer of knowledge between laboratory generated data and enterprise-level information systems. With our CONNECTS approach, we help our customers design and implement application specific workflows, and in the process transform laboratory data into relevant business information. The end result is that we help our customers maximize their systems investments so they can better support critical management decisions. HUNT Biobank is a vivid example of the benefits of this type of integrated solution who helped us secure Microsoft s prestigious Pharmaceutical and Life Sciences Innovation Award in Discovery and Product Innovation (for more information, visit Microsoft selected Norway-based Hunt Research Centre and Biobank in recognition of its use of Thermo Scientific Nautilus LIMS to better manage and analyze the large amounts of real-time medical data and provide valuable insight into disease status and progression. FP Please tell us a little bit about the work at HUNT Biobank. How are these integration challenges affecting your organization? Thor-Gunnar Steinsli The HUNT study is one of the largest population-based health studies ever performed, involving approximately 120,000 people across Mid-Norway with the goal of answering one of the most pressing questions of the 21st century: What are the major causes of our most common diseases, and how can we develop better preventive strategies while using modern medicine to improve our health status? HUNT offers valuable insight into disease status and progression, particularly in relation to quality of life measures, exposure, environmental factors, physical and mental status, education, occupation, as well as extensive genetic information. HUNT has run three studies HUNT 1, 2, and 3, on the same population spanning almost 25 years, progressively increasing the study s complexity. In order to accommodate for the vast scope of HUNT 3, including an ambitious blood-sampling protocol, we required a comprehensive solution to facilitate our ability to gather, store, manage, track and retrieve data securely, and yield real-time, dependable analysis and reports. In order to achieve this challenging objective, we implemented a wide array of technologically innovative solutions, including an in- 18 FUTURE PHARMACEUTICALS Driving the Industry Forward.

8 Dave Champagne assures customers an end-to-end solution. HUNT 3 HUNT 3 is the most ambitious HUNT study to date, with 110,000 individuals invited to participate in the study. Data was collected through questionnaires, clinical examinations and blood and urine collection samples. HUNT 3 incorporates over 130 sub-studies, including: status in subjective health, diabetes, lung, cardiovascular, thyroid, muscle and skeletal diseases, mental diseases, prostate complaints, urinary incontinence, female reproductive disorders and gynecological diseases. Participants also provided information on environmental factors, such as residence, size of household, education, occupation and personal habits relating to food, drug and alcohol intake, as well physical activity. tegrated LIMS solution using Thermo Scientific Nautilus LIMS. This deployment has enabled efficient management and real-time reporting of data while ensuring uninterrupted, dependable transmission of information between the HUNT Biobank and the HUNT Research Centre, as well as the ability to link this information to national health registries in the future. FP How has HUNT benefited from this solution? TS Prior to this implementation, the biobank database consisted of different types of files, including manual files, text files and Excel spreadsheets, requiring long hours of manual capture, calculation and verification of data and considerably jeopardizing data integrity, searchability and accessibility. We also needed an accessible, searchable system to manage the large volume of samples, since our current systems and processes would not support our efforts much longer. In addition, our laboratories are highly automated, and one requirement for the latest HUNT 3 study was to integrate the LIMS directly with our existing robotics to facilitate automated data management, giving HUNT the power to receive and return results quickly and efficiently. All information associated with HUNT 3 study samples is managed by Nautilus LIMS. The system provides clinical follow-up, data handling and quality control following data collection and distributes coded data files to various research groups for a complete end-to-end solution that is secure and auditable as well as accessible. Productivity, throughput and accuracy have all increased throughout our organization. By integrating Nautilus LIMS with the extensive HUNT database and the consented use of each study participant s personal identity number, it is possible to integrate this information with different national and regional health registries, including the Cause of Death Registry, the Cancer Registry, Hospital Registration Registries and the Population Census Registry. Thus, the HUNT studies may become a major data resource for research purposes and health planning in Norway. Nautilus strongly supports the possibility of making this data available for research groups. Furthermore, the quality of data provided in collaboration and communication among the scientists has improved significantly. This type of access to data would not be possible without the highly integrated systems put in place and enabled by the integrated LIMS solution. DC HUNT is a great example of how we ve helped our customers improve efficiency, data reliability and collaboration, thereby helping them to better serve the research community. Thermo Fisher s vision for enabling knowledge-driven discoveries utilizes the company s market-leading technologies to help life sciences companies, biobanks and CROs integrate their systems, which can dramatically enhance collaboration and increase information sharing and learning. As our company has such a broad array of customers around the world, and capabilities across a spectrum of customer applications, we re able to offer an end-to-end solution that facilitates the integration of various instruments and systems, along with the interoperability necessary to transform data into relevant business drivers. By offering this complete solution, we re able to help our customers expand the business of science from the laboratory throughout the enterprise. Furthermore, by effectively integrating laboratory informatics data with enterprise systems, life sciences executives can have access to just the right data to make better business decisions. For more information about Thermo Fisher Scientific CONNECTS, please visit To learn more about HUNT Biobank and study, you may download a case study by visiting or by visiting FP 19

9 Reaping the Benefits of Integration With pressure to cut costs, shorten the pipeline lifecycle and maximize return on investment, 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. Working with multiple disparate systems with minimal to no integration is no longer an option. Pharmaceutical companies can no longer afford to delay the implementation of next-generation tools that will help them increase productivity. To streamline the flow of information successfully, the solution begins with an enterprise-level Laboratory Information Management System. Historically, industry standard LIMS have only delivered 30 to 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 often 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 For example, 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. With the increasingly higher costs of bringing a new drug to market, pharmaceutical manufacturers cannot afford the gap in data and knowledge this can produce. Additionally, 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 Laboratory Information Management Systems (LIMS) are key contributors in this effort. Delivering advanced functionality that is specific to each stage of the drug development process, sophisticated, purposebuilt LIMS streamline processes and costs and present organizations have unique integration opportunities. These 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. We believe that the challenges facing pharmaceutical companies can be ideally addressed using purpose-built solutions that provide as much functionality as possible out of the box to meet the particular needs of our customers at every stage of the drug development process. There is no single system that could answer the unique needs of these laboratories, so our position has been to develop, with the help of our customers, purpose-built LIMS for each area of the pharmaceutical value chain. When the required functionality is built into the base system as standard, it eliminates the need for user-specific customizations during implementation. This, in turn, results in reduced validation time, shortened deployment and easier ongoing support. Purpose-built LIMS for pharmaceutical applications are particularly relevant. According to the 2008 Strategic Analysis of the U.S. 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. 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. At Thermo Fisher Scientific, our objective in developing purpose-built LIMS solutions is to deliver the domain-specific functionality that addresses the critical needs of the laboratory and also delivers the increased enterprise-level access that multisite/multi-user organizations are looking for. 20 FUTURE PHARMACEUTICALS Driving the Industry Forward.

10 Thermo Fisher Scientific Dave Champagne, Vice President and General Manager, Informatics, Thermo Fisher Scientific, explains how enterprise-level Laboratory Information Management Systems (LIMS) can be used to help pharmaceutical companies leverage laboratory-generated data for mission-critical management decisions 21

11 Reaping the benefits of integration Elevating the Role of LIMS into the Enterprise 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. 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. Today, global deployments of LIMS solutions have become more consistent and more rapid. The implementation of purpose-built LIMS across the enterprise allows for more simplified system upgrades, minimized project risks and enhanced compliance. In addition, industry-specific solutions facilitate enterprise-wide application and training. These multifaceted benefits help lower the total cost of ownership of the solution, which is critical to pharmaceutical companies that are under everincreasing pressures to contain costs and increase efficiency. This goal can be achieved by integrating the LIMS with instrumentation and enterprise systems, which can facilitate the global harmonization of business processes, automation of operations and consolidation of data management in a single system allowing for near-instant decision making. Meeting the Integration Challenge In response to the needs of our customers and these 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 enterpriselevel 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 interoperability necessary to transform data into relevant business drivers. Seamless enterprisewide integration is a necessity because it enables key knowledge originating in the laboratory to be available to management in real time. Integrating the laboratory with 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. By investing in 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, but 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. Thermo Fisher s 25 years of integrating laboratory informatics with the enterprise has been built and strengthened by its ongoing partnership with industry leaders such as Microsoft, Oracle and Symyx, as well as with members of our Global Partner Alliance program. With CONNECTS, we bring a strategic vision and the resources to help facilitate management-level discussion about the necessity of integrating the various sources of data, including laboratory and related instrumentation, enterprise systems (like MES, PIMS and ERP) and enterprise communication tools (like SharePoint, BizTalk and Document Management Systems), thereby elevating the role of the laboratory in the day-to-day mission-critical decisions required of management throughout the enterprise. Conclusion 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. With CONNECTS, our goal is to help bring key business knowledge originating in the laboratory to management at all levels of the enterprise. The integration of the entire enterprise will facilitate better data correlation and collaboration, end-to-end report generation, more secure data exchanges. The goal of this integration is to provide management with a dashboard view of the key business metrics essential to running the Portfolio of LIMS Thermo fisher Scientific has developed a portfolio of purpose-built LIMS that meet the unique needs of our customers at every stage of the drug development process. For bioanalytical laboratories and CROs, Watson LIMS provides the detailed protocols necessary for DMPK drug discovery; Galileo LIMS enables high-throughput compound screening for in vitro ADME studies; Nautilus LIMS is designed for flexible environments preferred by research organizations. Darwin LIMS, designed specifically for pharmaceutical manufacturing R&D and QA/QC labs, helps meet FDA regulations, achieves significant cost savings in validation efforts and generates costs savings in personnel and production time. Darwin LIMS also includes built-in dashboardready functionality to allow lab managers to make faster, more informed decisions. business, enabling management to have the critical data they need before, not after, any point of crisis. At Thermo Fisher, we have an opportunity to leverage our expertise, people and products to help our customers now respond with more certainty to the many unforeseen challenges that can often make or break a company. We believe it s within our power and our responsibility to lead the market in transforming laboratory data into the most relevant business drivers for those companies committed to the advancement and integrity of science, and to the health and safety of the world we live in. For more information about Thermo Fisher Scientific s Informatics solutions, marketing.informatics@thermofisher.com or visit www. thermo.com/informatics. FP Dave Champagne was named Vice President and General Manager of Thermo Fisher Scientific s Informatics business in April Champagne s career includes 13 years at Lotus Development Corporation and two roles as chief executive officer for early-stage software companies. A graduate of the University of Massachusetts with a BS in Industrial Engineering and an MBA from Bryant University. Mr. Champagne built his career in enterprise software organizations. While at Lotus, which was acquired by IBM during Champagne s tenure, he led a global support and service organization of over 1,200 service professionals that addressed the needs of customers in more than 80 countries. 22 FUTURE PHARMACEUTICALS Driving the Industry Forward.

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