LIMSource: What's New - May to June 2004

• Arnold O. Beckman, Ph.D. - Great Man of Science and Humanity Dead at Age 104
• Ireland's Largest Independent Bioanalytical Laboratory Reports Swift Implementation and Validation of InnaPhase Corporation's Watson LIMS
• LIMS Contract Win Success for Autoscribe
• Thermo Announces Major Enhancements to eRecordManager LDMS
• StarLIMS Announces Legacy LIMS Replacement at Thai Refinery
• GenoLogics Announces the Release of ProteusLIMS
• InnaPhase Corporation Named Finalists in Four Categories for the 2004 American Business Awards
• Applied Biosystems Announces SDS Software v2.2 Enterprise Edition
• InnaPhase Corporation Launches Newton LIMS in Asia at Interphex Japan
• Thermo Electron Acquires US Counseling Services, Inc.
• Bruker Daltonics Announces PharmaTools Product Suite
• Scientific Software Announces EZChrom Elite Support for Windows Terminal Services
• CyberLAB Enterprise Content Management System Successfully Implemented by Organon Development GmbH Germany
• Labtronics Introduces New LimsLink 3.2
• TraxStar Releases New Versions of QATrax
• Labtronics Introduces Nexxis CIM
• SAP Adds Adaptive Computing Capabilities to SAP NetWeaver
• National Instruments Introduces LabVIEW 7.1 which Extends Express Technology for Automated Instrumentation and Real-Time Systems
• Advanced Chemistry Development Designs an Automated Approach to Analytical Data Management
• Microsoft and SAP Collaborate for Web Services
• Bruker BioSciences Reports First Quarter 2004 Revenue
• SDI Ranks the Top 30 Analytical and Life Science Instrument Companies of 2003
• ARC Sees ERP Market Turning Positive with Expanding European Union
• FDA Releases Three New Risk Management Draft Guidances
• FDA Sets Regulatory Sights on Supplement Industry

Arnold O. Beckman, Ph.D. - Great Man of Science and Humanity Dead at Age 104

Arnold Orville Beckman, Ph.D., the founder and chairman emeritus of Beckman Instruments, Inc. (now known as Beckman Coulter, Inc., headquartered in Fullerton, Calif.) died in his sleep on May 18, 2004 at Scripps Green Hospital in La Jolla, Calif. He was 104. Beckman, a resident of Corona Del Mar, Calif., was born the son of a blacksmith on April 10, 1900 in Cullom, Ill. and became the friend of world leaders. Of all his scientific innovations, Beckman was perhaps best known for inventing the pH meter, an instrument that changed an industry and served as the foundation for the company that still bears his name. In addition to his business and scientific achievements, Beckman was recognized as a great philanthropist. Through the Arnold and Mabel Beckman Foundation, which he formed with his wife, Mabel, in 1977, Beckman contributed more than $400 million in support of scientific research and education. Foundation board chairman Ambassador George Argyros said, "Arnold Beckman exemplifies the meaning of the word humanitarian. Combined with his unwavering enthusiasm for life, his keen sense of humor and his strong moral and ethical principles, he is a national icon. He has been my close, long-time friend and mentor. Simply put, Arnold Beckman was truly one of the great Horatio Alger heroes of the 20th century. He will be sorely missed, not only by myself, but by everyone who has had the privilege to know him, and whose lives have been touched by his intellect, inventiveness and his wonderful vision and generosity." Dozens of awards and honors attest to the admiration of Beckman's peers in science, industry and philanthropy. Most recently, Beckman was given the 2004 Lifetime Achievement Award from the National Inventor's Hall of Fame and his pH meter, one of Beckman's revolutionary inventions, was designated as a National Historic Chemical Landmark by the American Chemical Society. During his life he was recognized for his accomplishments by many, including two American presidents. President Reagan presented him with the 1988 National Medal of Technology and the 1989 Presidential Citizens Medal. President Bush awarded him the 1989 National Medal of Science. In 1999, Beckman received the Public Welfare Medal from the National Academy of Sciences. Beckman earned his bachelor's degree in chemical engineering and master's degree in physical chemistry at the University of Illinois at Urbana-Champaign, and his doctorate in photochemistry at the California Institute of Technology in Pasadena, Calif., where he taught from 1928 until 1940. He founded Beckman Instruments, Inc. in 1935 with his first commercial product he invented, the pH meter. It earned him a place in the National Inventors Hall of Fame in 1987. In total, Beckman registered 14 patents. Arnold O. Beckman, Ph.D., is survived by his son, Arnold Stone Beckman, daughter Patricia Beckman, two grandchildren and four great-grandchildren. His wife Mabel Meinzer Beckman died in 1989. Beckman will be put to rest in his birthplace of Cullom, Ill., with his wife Mabel. His family has requested that in lieu of flowers, donations be made to the Beckman Young Investigators Fund, c/o the Arnold and Mabel Beckman Foundation at 100 Academy Dr., Irvine, CA 92612, 949.721.2222. For more information, visit http://www.beckman-foundation.com.

Ireland's Largest Independent Bioanalytical Laboratory Reports Swift Implementation and Validation of InnaPhase Corporation's Watson LIMS

InnaPhase Corporation, a world-leading provider of enterprise LIMS solutions, has announced that BioClin Research Laboratories Ltd., a leading contract research organization (CRO) located in Athlone, Ireland, has successfully implemented and validated Watson LIMS in its bioanalytical facility. "Implementation of an industry-standard such as Watson LIMS has significantly improved throughput of our data and is a huge step in the automation of our bioanalytical laboratory," said Brian McKenna, Ph.D., Scientific Director of BioClin. "The system allows us to deliver accurate, high-quality results to our clients in the shortest possible timeframe." Watson is a purpose-built LIMS designed specifically to support DMPK/Bioanalytical studies in drug development. It was developed by InnaPhase in conjunction with the world's major pharmaceutical companies to accelerate bioanalysis and sample management in drug development. Watson and the other LIMS in InnaPhase's Pharma LIMS Suite -- Newton for QC and Galileo for in vitro testing -- are designed with more pharma-specific functionality than generic information management systems. BioClin Research Laboratories is Ireland's largest, independent, GLP-certified bioanalytical laboratory specializing in the analysis of biological samples for the Pharmaceutical, Veterinary, Biotechnology and Medical Device industries. For details, visit http://www.innaphase.com.

LIMS Contract Win Success for Autoscribe

UK software developer Autoscribe has announced one of the fastest and successful trading periods of its twenty three year history. Since December 2003, eleven Matrix LIMS software packages have been ordered by leading laboratories throughout the world. Five systems have been implemented already and the rest are due for completion by the end of June. One key customer with Autoscribe, has placed its fifth successive order. Companies from France, Greece and Holland have also ordered the latest Matrix LIMS package. All deals include pre and post sales service, full implementation of the software, and configuration at the point of use. Managing Director, John Boother says: “We are absolutely delighted with the recent sales. This has been the fastest period of growth in our recent history and reflects the commitment to our core customers in the pharmaceutical, food and general scientific sectors who demand flexible LIMS solutions that are easy to use and configure. It is further testament to our dedicated engineering sales and support team who ensure customers receive the most appropriate and cost-effective system for their needs.” The global LIMS market is extremely competitive. Current estimates by the ARC Advisory Group value it at $290m with a projected growth of 4.8 per cent over the next five years. For details, visit http://www.autoscribe.co.uk.

Thermo Announces Major Enhancements to eRecordManager LDMS

Thermo Electron Corporation has announced the release of a host of significant extensions to its leading eRecordManager Laboratory Data Management System (LDMS), including conversion capability for data formats
from Agilent instrumentation and legacy Hewlett-Packard Chromatography Data Systems. eRecordManager is Thermo's award-winning solution that helps customers to capture, store and index large volumes of laboratory instrument data. Along with the original data, the content of each stored record is converted into XML to preserve its scientific meaning and allow better research collaboration and knowledge management. This latest release, eRecordManager GAML Converter Update 2004 R1, adds support for the several additional instrument data formats. Thermo has also enhanced a number of existing converters for more advanced functionality and support of a wider range of instrumentation. Thermo is committed to providing converters for all commonly used instrument data formats. By storing both the original proprietary instrument files and converting their content into XML, eRecordManager provides analytical research and life science organizations the ability to share, compare, query and visualize instrument data, with or without the original instrument hardware or software. For details, visit http://www.thermo.com/informatics.

StarLIMS Announces Legacy LIMS Replacement at Thai Refinery

The Alliance Refining Co Ltd (ARC) based in Rayong, Thailand, has decided to replace its 8 year old legacy LIMS with STARLIMS. The replacement was based on STARLIMS focus on the petrochemical industry and future-proof of its solution. ARC is expecting tangible benefits including higher laboratory throughput and improved resource utilization as a direct result of the added functionality of STARLIMS. Intangible benefits will include higher job
satisfaction due to the use of state-of-the-art information processing and better service management tools made available with STARLIMS. ARC is an operating alliance between Star Petroleum Refining Company Limited (SPRC), a joint venture between Chevron Texaco (Caltex) and the Petroleum Authority of Thailand and Rayong Refinery Company Limited (RRC), a joint venture between Shell and the Petroleum Authority of Thailand. STARLIMS is a full featured, flexible, multilingual LIMS thatprovides complet traceability for regulatory compliance. For details, visit http://www.starlims.com.

GenoLogics Announces the Release of ProteusLIMS

GenoLogics has announced the release of ProteusLIMS version 1.0. ProteusLIMS specializes in meeting the needs of researchers involved in the study of proteomics. ProteusLIMS is an end-to-end product suite that provides a robust laboratory data integration solution. ProteusLIMS is designed to manage the large volumes of data generated in the emerging field of proteomics research, where scientists undertake complex studies of proteins to develop disease diagnostics and find new targets for drug development. "Proteomics is the next big thing after genomics," says GenoLogics CEO James DeGreef. "Proteomics technologies provide the most direct way to identify and study drug targets". In proteomics, researchers are faced with enormous amounts of data and increasingly complex and disintegrated research instruments. GenoLogics' ProteusLIMS manages data from all parts of the research process, as well as the research process itself, enabling higher productivity. With ProteusLIMS, researchers have more time to focus on their research. ProteusLIMS has been designed and built from the ground up to be compatible with any computing platform and scientific instrumentation platform. For details, visit http://www.genologics.com.

InnaPhase Corporation Named Finalists in Four Categories for the 2004 American Business Awards

InnaPhase Corporation has been named a Finalist in four categories for the second annual American Business Awards. InnaPhase was selected as a finalist for Best Overall Company, Most Innovative Company, Best Executive, and Best Product Development Organization - each of the categories for which it was nominated. Winners were announced at a ceremony in New York City on May 10. Hailed by the New York Post as "the business world's own Oscars," the American Business Awards are the first national, all-encompassing business awards program honoring great performances in the workplace. More than 800 nominations from companies of all sizes and in virtually every industry were submitted this year for consideration in more than 40 categories. "It is a thrill to see our hard work, our business strategy and our development efforts rewarded with this recognition from the American Business Awards," said Jo Webber, Ph.D., who, as president and chief executive officer of InnaPhase Corporation, is a Finalist for Best Executive. "Coupled with awards we've received from the Philadelphia Chamber of Commerce, the Deloitte Technology Fast 50 Program, and most recently the Technology Innovation Award from Frost & Sullivan, we feel our approach to the market and our products are being validated by these influential third parties." Winners of the American Business Awards receive a Stevie trophy, named for the Greek word for "crowned." The Awards' Board of Distinguished Judges & Advisors and their staffs select Stevie winners from among the Finalists. For details, visit http//www.innaphase.com.

Applied Biosystems Announces SDS Software v2.2 Enterprise Edition

The Enterprise edition of Sequence Detection System (SDS) Software v2.2 is a high-throughput application for storage, organization, and analysis of large amounts of gene expression and genotyping data on the Applied
Biosystems 7900HT Real-time PCR System. SDS software v2.2 Enterprise edition is the only edition of SDS software that supports 21 CFR part 11, providing security, auditing functions, electronic signatures, and
electronic record-keeping. These features eliminate traditional paper records and reduce vulnerability to signature fraud and report misfiling, which increases the speed of information exchange and data searching. The results are reduced storage costs, better data integration, and superior product quality. The SNP Manager and Relative Quantification (RQ) Manager are optional v2.2 software packages that eliminate data analysis bottlenecks in high-throughput SNP and gene expression research by allowing significantly more plates to be analyzed simultaneously. This reduces hands-on analysis time and simplifies the data analysis workflow. Two additional features streamline performance in high-throughput laboratories and reduce hands-on time. The Automation Controller automates each run. The Plate Utility automatically creates plate documents and support various file types, including the Assay Information Files (AIFs) provided with TaqMan Assays-on-Demand Products. The Enterprise Edition supports features in the Standard Edition SDS Software v2.2, including the auto CT feature, which automatically determines optimal baseline and threshold settings; and the automated allele-calling feature for allelic discrimination (SNP genotyping) assays. The Enterprise Edition also supports all TaqMan Low-Density Arrays for immune profiling and disease characterization studies. For details, visit http://www.appliedbiosystems.com.

InnaPhase Corporation Launches Newton LIMS in Asia at Interphex Japan

InnaPhase Corporation launched its Newton Pharmaceutical LIMS to the Asia-Pacific market during Interphex Japan 2004, a leading pharmaceutical industry expo and conference that was held in Tokyo May 19-21. InnaPhase exhibited their Newton LIMS and Watson LIMS for bioanalysis, part of the company's Pharma LIMS Suite, in the Sumisho Electronics Co. Ltd. (SSE) booth in the Pharma IT Solutions Expo section of the Interphex conference. For details, visit http//www.innaphase.com.

Thermo Electron Acquires US Counseling Services, Inc.

Thermo Electron Corporation has purchased US Counseling Services, Inc. (USCS) for $77.9 million in cash, subject to a post-closing adjustment. Thermo's net purchase price is $74.7 million, after adjusting for $3.2 million in cash acquired with the business. As one of the largest scientific instruments companies in the world, Thermo
has historically provided maintenance and repair services to customers. In November 2003, Thermo added to this capability by acquiring LMSi, bringing instrument and computer systems validation, metrology, and certification, as well as a range of associated consulting services. Now, with the addition of USCS, Thermo has augmented its service business to provide critical asset management skills, furthering Thermo's strategy to become the
most comprehensive service provider to scientific laboratories worldwide. Based in Brookfield, Wisconsin, USCS is a leader in equipment asset management services in the pharmaceutical and healthcare industries. The
company has successfully established a growing market position, providing a wide range of asset management
services, including instrument and equipment maintenance management, physical inventory tracking, and cost-of ownership analysis to help customers improve the performance of their laboratory or facility. USCS was founded in 1969 and employs 175 people. The company had revenues of approximately $57.0 million in 2003. For details, visit http://www.thermo.com/informatics.

Bruker Daltonics Announces PharmaTools Product Suite

Bruker Daltonics, has announced the PharmaTools suite of products which are primarily tailored towards the demanding requirements of customers in the pharmaceutical and biotech industries who require very high reliability and uptime, excellent training, service and support, and vendor assistance for operating in a regulated environments. An important new capability in PharmaTools is a new library search capability, that includes a setup to automatically build up libraries, e.g. for natural compounds, have multi-user access to the library (e.g. from various countries), and automatically screen for compounds in the library. The specificity is enhanced by combined searches with positive/negative polarity ESI-measurements, as well as MS and MS/MS data of the same compound. These libraries can be particularly powerful in drug discovery. The PharmaTools suite also offers the validation products IQ (installation qualification) and OQ/PV (operational qualification and performance verification). These products increase productivity by ensuring consistent performance of the instruments over time. For customers in regulated environments, the PharmaTools suite now includes support software for 21 CFR Part 11 compliance, including audit trails, user management, result history, electronic signatures, and data security. For details, visit http://www.bruker-biosciences.com.

Scientific Software Announces EZChrom Elite Support for Windows Terminal Services

Scientific Software, Inc. (SSI), a world leader in providing software solutions to the scientific community, has announced that its EZChrom Elite version 3.1.4 Chromatography Data System (CDS) can operate using Microsoft’s Windows 2003 Server with Windows Terminal Services. Under this Microsoft system, EZChrom Elite can be deployed as a thin client application and provide the regulated laboratory with a number of key benefits. Using Windows Terminal Services, the EZChrom Elite client/server software is installed only on the Windows 2003 Server. Clients on the network can access and run the EZChrom Elite application without the need to load the native application on the client, thereby greatly simplifying the validation and administration requirements for the system. Thin clients, only having Microsoft Windows Terminal Services Client Application Licenses, can connect to the central server and run EZChrom Elite to acquire and analyze data and generate reports while controlling more than 250 different chromatography systems. EZChrom Elite version 3.1.4 can be used on Client/Server or Stand-Alone configurations to support operations from single instrument/single user to enterprise wide operations. It operates under Windows NT, Windows 2000, Windows XP, and Windows 2003 Server environments. For details, visit http://www.scisw.com.

CyberLAB Enterprise Content Management System Successfully Implemented by Organon Development GmbH Germany

Scientific Software, Inc., (SSI) has announced that Organon Development GmbH successfully and satisfactorily implemented CyberLAB in less than six months to manage its instrument data. SSI's CyberLAB Enterprise Content Management System (ECMS) is the platform technology in Organon's data management strategy towards development of a secure, FDA 21 CFR Part 11 compliant, paperless laboratory and document management environment. Organon Development is using CyberLAB ECMS for electronic storage of both human and machine readable data. Key requirements are features like generation of a secure automated audit trail for electronic records and east retrieval functionality or records, audit trail and meta data. Organon is aiming to further implement their data management strategy at other sites to capitalize on improved intellectual property protection, FDA compliance, operation efficiency and productivity. "CyberLAB has proven to best fulfill our data management needs and technology requirements due to its features, its user friendliness and its non-proprietary, web-based software platform; it is an important milestone to move to the next stage: a less paper and more efficient laboratory," said Alexander Debets, PhD, General Manager of Organon Development GmbH. Organon creates and markets prescription medicines that improve the health and quality of human life. Scientific Software, Inc. is a world leader in the development, sale and support of software systems to the scientific community. For details, visit http://www.organon.com or http://www.scisw.com.

Labtronics Introduces New LimsLink 3.2

Labtronics Inc. has announced the release of the newest version of LimsLink, their LIMS interfacing software. LimsLink Version 3.2 includes new features and enhancements that reflect the need for secure and efficient management of laboratory instrument data. Enhanced security features and new data management, data collection and reporting capabilities are included as well as: extended support for 21 CFR Part 11 compliance with enhancements to electronic signatures and the audit trail system; a new module for interacting with Oracle and SQL Server databases; a powerful TCP/IP data collector that collects instrument data from any location on an internal network, an Intranet or the Internet; and, electronic capture of any reports generated by any instrument data system. Developed and tested for Windows XP Professional and Windows 2000 platforms, LimsLink 3.2 is a complete instrument to LIMS interfacing solution. For details, visit http://www.labtronics.com.

TraxStar Releases New Versions of QATrax

New releases of QATrax Global and QATrax Enterprise Editions were distributed to customers in April. QATrax Global Edition increases visibility over test lab workflow from around the globe. Additionally, with QATrax Enterprise Edition, mangers can now effectively manage global projects where testing is spread across several labs. High visibility is provided for research usage, in a single lab with Global Edition and across groups of labs with Enterprise Edition. Scheduling and Re-Scheduling is the core functionality offered by QATrax. QATrax integrates this functionality into the test request and testing process, rewarding management, engineers and technicians with real-time visibility, which is central to efficient test lab management and effective testing. Decisions made from the vantage of real-time visibility reduce the uncertainty in the product testing cycle which, in turn, result in fewer delays in getting product to market. TraxStar develops custom and off-the-shelf solutions (QATrax, StaffTrax, TempTrax and QCPro). TraxStar products are workflow automation solutions that improve a company's operating efficiencies. For details, visit http://www.traxstar.com.

Labtronics Introduces Nexxis CIM

Labtronics Inc has introduced Nexxis CIM, a Chemical Inventory Management system. Nexxis CIM can guarantee the accuracy of the data in the system because it collects inventory related data directly from laboratory instruments. For example, when a technician weighs out a chemical, the weight is transferred directly from the balance to Nexxis CIM where it is automatically deducted from the inventory. Nexxis CIM also provides full control over laboratory operating procedures. If an analyst is running a test that requires a reagent, Nexxis CIM can automatically check the expiry date and prevent the analyst from continuing if the reagent has expired. Steps for preparing reagents and formulations can be controlled by Nexxis CIM, ensuring that all of the steps are followed and proper amounts of each ingredient are always used and recorded. Batch numbers for reagents can be automatically stored along with sample results so that information about the chemicals used for an analysis can be reviewed at any time. For details, visit http://www.labtronics.com.

SAP Adds Adaptive Computing Capabilities to SAP NetWeaver

SAP AG has announced that it will introduce innovative adaptive computing capabilities to the SAP NetWeaver integration and application platform to help customers leverage existing investments, drive enhanced customer efficiencies and improve flexibility. In support of this initiative, SAP is working closely with industry leaders including Dell, Fujitsu and Fujitsu Siemens Computers, HP, IBM, Intel Corporation, Network Appliance, Sun Microsystems and T-Systems to help customers leverage hardware resources in a way that maximizes server and database performance. SAP NetWeaver, the integration and application platform that drives business change, will offer adaptive computing capabilities to match computing demand with hardware to maximize the efficiency of customers’ technology resources. The adaptive computing capabilities of the SAP NetWeaver technology platform, which bridges software and hardware, help customers consolidate and streamline their IT infrastructure to better manage concurrent demand for hardware resources more efficiently. Software solutions are decoupled from their hardware infrastructure, enabling a more flexible use of hardware resources by matching the performance needs of business applications across the enterprise. With adaptive computing capabilities, customers can run any application on any server at any time, driving system performance at a low cost of operation. SAP has developed unique adaptive computing features within SAP NetWeaver, such as shared services and service virtualization, which assign business applications to underlying hardware within minutes. Adaptive Computing capabilities provide a central operating point to control, observe and manage SAP business solutions to help customers streamline their IT operations. First demonstrated as a proof-of-concept in June 2003, SAP’s adaptive computing capabilities will be available in June 2004. For details, visit http://service.sap.com/adaptive.

National Instruments Introduces LabVIEW 7.1 which Extends Express Technology for Automated Instrumentation and Real-Time Systems

National Instruments has announced LabVIEW 7.1, a significant upgrade to the family of LabVIEW graphical development products. LabVIEW 7.1 extends Express technology to automated instrumentation and real-time applications with new Express VIs for NI modular instruments and NI-DAQmx, advanced debugging and low-level execution timing for the LabVIEW 7.1 Real-Time Module. With LabVIEW 7.1, NI continues to advance automated instrumentation for hardware platforms ranging from high-performance modular instruments to real-time data acquisition systems and handheld devices. With five new Express VIs for NI digitizers, signal generators and high-speed digital I/O, engineers can configure sophisticated measurements and acquire data with just a few mouse clicks. The redesigned NI-DAQmx measurement services software in LabVIEW 7.1, available in real-time applications for the first time, increases performance of single-loop PID applications by 30 percent and simplifies hardware-timed loop implementation. In addition, the new LabVIEW 7.1 PDA Module delivers more data acquisition functionality, including faster multichannel acquisition and analog and digital triggering. LabVIEW 7.1 also introduces advanced execution timing and graphical debugging for low-level control and visibility of real-time system execution. With the new timed loop, an enhanced while loop in LabVIEW, engineers can specify precise timing of code segments, coordinate multiple time-critical activities and define priority-based loops for creating multirate applications. In addition to speeding development of real-time applications on existing platforms, this release extends LabVIEW Real-Time to run on certified desktop PCs. For details, visit http://www.ni.com.

Advanced Chemistry Development Designs an Automated Approach to Analytical Data Management

Advanced Chemistry Development, Inc. has released ACD/Automation Server, a utility that provides automated data collection, processing, and database population throughout the enterprise using ACD/Labs tools and user-written programs. ACD/Automation Server is comprised of two subsystems that communicate with each other to produce an intelligent data control package. The "scan" subsystem contains web and file system crawlers that scan the internet and local or shared network folders looking for new, deleted, or modified files of a user-defined type. When changes are made to the files being monitored, a notification is sent to the "update" subsystem, which then populates and synchronizes the relevant database(s) with the new information. In addition to database population, ACD/Automation Server initiates macro-driven data processing through ACD/SpecManager SQL and other ACD/Labs software modules that facilitate macro design. Based on an Oracle client-server architecture that enables several users to work with a database simultaneously, ACD/SpecManager SQL becomes the central control point for analyzing, processing, and databasing spectroscopic, chromatographic, and other analytical curve data. Through ACD/Automation Server, data obtained from any analytical technique can be automatically processed and stored for later retrieval whether through thick client applications for the expert to manipulate and edit the data or through ACD/Web Librarian, a web-based application for scientists wishing to view the data. ACD/Automation Server also creates and updates index databases for the changes recognized by the system. These databases are smaller in size than the original data, and improve the speed of subsequent searches by removing the need to rescan the original data each time a search is executed. For details, visit http://www.acdlabs.com.

Microsoft and SAP Collaborate for Web Services

Microsoft Corp. and SAP AG have announced an expansion of their relationship for Web services as the foundation for the next generation of enterprise software. The two companies detailed a road map for deeper integration between Microsoft .NET and SAP NetWeaver, the companies’ respective strategic platform initiatives. They want to help their customers get more out of SAP applications and technologies that are used with Microsoft .NET. The jointly developed solutions will greatly enhance access to SAP NetWeaver functionality for developers using Microsoft Visual Studio .NET, and will increase the interoperability between SAP solutions and the Microsoft Office System. For details, visit http://www.microsoft.com or http://www.sap.com.

Bruker BioSciences Reports First Quarter 2004 Revenue

Bruker BioSciences Corporation has reported its financial results for the first quarter of 2004 which ended on March 31, 2004. On July 1, 2003 Bruker Daltonics Inc. merged with Bruker AXS Inc. to form Bruker BioSciences Corporation. All results for periods prior to this merger are historical combined results of the two previously separate companies. For the first quarter of 2004, Bruker BioSciences reported an 8% increase in revenue to $68.2 million, compared to revenue of $63.1 million in the first quarter of 2003. After eliminating $7.0 million in currency effects, first quarter 2004 revenue decreased 3% compared to first quarter 2003 revenue. Revenue after eliminating currency effects is a non-GAAP financial measure that excludes the impact of currency effects when comparing period-to-period operating results, which include sales outside the United States into U.S. Dollars. In the first quarter of 2004, GAAP net income was $1.0 million, or $0.01 per diluted share, compared to a net loss of $(1.6) million, or $(0.02) per diluted share, in the first quarter of 2003. In the first quarter of 2004, adjusted net income, as defined below, was $1.2 million, or $0.01 per diluted share, compared to adjusted net income of $1.2 million, or $0.02 per diluted share, in the first quarter of 2003. Adjusted net income is a non-GAAP financial measure that excludes the amortization of acquisition-related assets, other special charges, and adjustments for the pre-merger minority interest in Bruker AXS. Adjusted EBITDA was $6.4 million for the first quarter 2004, compared to $5.8 million for the first quarter 2003. Adjusted EBITDA, a non-GAAP financial measure, is GAAP operating income (loss) excluding depreciation and amortization expense and other special charges. For details, visit http://www.bruker-biosciences.com.

SDI Ranks the Top 30 Analytical and Life Science Instrument Companies of 2003

Applied Biosystems was the largest analytical and life science instrument company in 2003, with revenues of $1.67 billion for the calendar year, according to Instrument Business Outlook's (IBO) annual ranking of the top 30 analytical and life science instrument companies, which appears in the April 15 edition of IBO. The top five companies of 2003 were Applied Biosystems, Agilent Technologies, Thermo Electron, PerkinElmer and Waters Corporation. The top 30 companies posted combined worldwide 2003 analytical and life science instrument revenues in excess of $14 billion, accounting for more than 50% of the total analytical and life science instrument market. On average, calendar year 2003 instrument sales for the top 30 companies increased 7.1% from 2002. The three fastest-growing companies among the top 30 were Spectris plc, QIAGEN NV and Dionex. IBO ranks companies according to their annual sales of analytical instrument systems and associated products and services, including product line acquisitions and divestitures completed during the year. Analytical and life science instrument techniques include mass spectrometry, chromatography, spectroscopy, physical testing techniques as well as DNA sequencing, microarrays and other bioinstrumentation systems. IBO is a twice-monthly publication of Strategic Directions International, Inc. (SDI), a management and marketing research firm dedicated to the analytical and life science instrument industry. SDI is a leading source of information on the market for analytical and life science instrumentation and equipment for laboratory and on-site applications. For details, visit http://www.strategic-directions.com.

ARC Sees ERP Market Turning Positive with Expanding European Union

The European Union, previously known as the European Community, is currently comprised of fifteen countries and some 370 million people with 11 official languages, and share the common institutions and policies that have brought EMEA to be the leading geographical region implementing ERP solutions. The worldwide market for ERP was $9.10 billion in 2003 and is forecasted to be over $12 billion in 2008, growing at a Compounded Annual Growth Rate (CAGR) of 5.7 percent over the next five years, according to a new ARC Advisory Group study. The European Union economically surpassed North America as the leading ERP region in 2002, and it continues that trend in 2003. "The European Union is the largest economic entity in the world and it is now solidified even further by the single currency, the euro. The European Union will become even a larger economic entity in 2004, and it is a key element of the growing ERP market," according to ARC Analyst Steve Clouther , the principal author of ARC's "ERP Software and Services Worldwide Outlook." For details, visit http://www.arcweb.com.

FDA Releases Three New Risk Management Draft Guidances

Following up on risk management concept papers issued last spring, the FDA has released three draft guidances to help drug manufacturers achieve more benefits from drug and biologic products while minimizing their risks. The guidance documents — “Premarketing Risk Assessment,” “Development and Use of Risk Minimization Action Plans,” and “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” — describe safety issues that can arise throughout aproduct’s life cycle, including development, review, approval and market availability, according to the FDA. The guidances are designed to bring more transparency to what the agency already is doing, said Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research. The recommendations, which are voluntary, would not add to the length of the drug development process, Galson said in a recent teleconference.To view a copy of "Premarketing Risk Assessment," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0187-gdl0001.doc. To view a copy of “Guidance for Industry: Development and Use of Risk Minimization Action Plans,” go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0188-gdl0001.pdf. To view a copy of “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0189-gdl0001-5767dft.doc.

FDA Sets Regulatory Sights on Supplement Industry

Shortly after its final rule banning dietary supplements containing ephedra took effect, the FDA has settled the cross hairs of its regulatory sights firmly on the rest of the supplement industry, saying it will more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe. The agency intends to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately, acting FDA Commissioner Lester Crawford said in a speech in Washington, D.C. The agency expects to provide more details about its plans for regulating dietary supplements soon, he added. DSHEA was enacted by Congress to ensure Americans access to dietary supplements and to give the FDA the regulatory authority to act against supplements or supplement ingredients that pose safety risks, are marketed with false or misleading claims, or are adulterated or misbranded. For details, visit http://www.fda.gov.


	What's New - May to June 2004 The following is a wrap-up of news of interest during the months of May to June 2004