LIMSource: What's New Right Now

• SDI Releases 9th Annual Survey of LIMS in North America
• LabVantage’s Sapphire Enterprise LIMS Selected by Coors Brewing Company
• Computing Solutions Introduces Representative Averaging and Automatic Trend Notification in LabSoft LIMS v7.14
• GenoLogics Life Sciences Software Introduces New Product Suite and Announces ProteusLIMS Version 1.5
• University of Texas Medical Branch Proteomic Center Selects GenoLogic's Life Sciences Software as a Data Collaboration Partner
• InnaPhase Corporation Named One of the Delaware Valley's Fastest Growing Technology Companies in Deloitte Technology Fast 50 Program
• Bio-Rad Launches Affordable Spectral Database for College Chemistry Curriculum
• KnowItAll 4.1 Offers a Pioneering Tool to Visualize and Compare Pharma Data
• Group Logic Announces New Mac OS X Print Accounting Solution Add-on to ExtremeZ-IP Print Server Helps Track Usage and Project Costs
• Group Logic Announces Stand-Alone ExtremeZ-IP Print Server 4.0
• Group Logic Announces ExtremeZ-IP File Server Version 4.0
• Scientific Software Announces New Software Control of Varian 3900 GC
• Agilent Technologies Introduces Method for Chemical Fingerprinting of Microscopic Materials from Crime Scenes
• Icoria, Inc. Expands Partnership with Agilent Technologies to Include $11.7 Million ATP Grant for Informatics
• P-Wave Receives "Build a Better Berks" Award from the Berks County Chamber of Commerce
• Bruker Daltonics NBC Business Receives Frost & Sullivan Product Innovation Award for Chemical and
Biological Agent Detectors
• AACC Online Database of "Young's Effects" Interactions Now Available
• SAP’s New Version of Business One for SMB
• SAP and Infineon Introduce Solution for RFID
• Supplier-Provided Automation Services Market Predicted to Approach $15 Billion by 2008
• Citizens Petition Urges Elimination of FDA's Part 11 Rule
• FDA Enforcement of Part 11 in Clinical Trials to Lessen
• Cornerstone of cGMP Initiative is Quality Systems Approach
• Both cGMP and Quality System Rules Apply to Some Combo Products
• Final Report on Drug Manufacturing Regulation Issued
• FDA Strategic Action Plan Centered on Drug Development
• Innovative Manufacturing Tools Encouraged in PAT Guidance
• FDA Issues Guidance on Sterile Drug Manufacturing
• FDA Clears RFID Chip for Human Use
• Bill Would Compel Release of All Clinical Trial Data
• FDA Sued by Pharmacies Over Guidance on Drug Compounding
• FDA Releases Final Guidance on Vaccine Labelling
• InnaPhase Acquired by Thermo Electron Corporation
• Autoscribe Releases New Version of Software that Manages Customer Complaints
• STARLIMS Supports California 's BSE Testing Program
• Siemens A&D's New RFID for UHF
• Northwest Analytical and CA-CSS Partner for SPC in Asia
• Scientific Software Introduces Enterprise Content Manager
• Scientific Software Accelerates Business Processes with New BPM Solution
• Labtronics Releases LimsLinkExpress to Reduce the Cost of Instrument to LIMS Interfacing
• National Instruments Introduces New Analytical Instrument Drivers for LabVIEW
• SAP Invests EUR 10 million for Global Support Center in China
• GenoLogics Life Science Software Announces a New Chief Executive Officer
• ARC Research Sees Need to Automate Data Collection Fueling Growth in Fixed vs. Portable RFID Readers
• House Mulls Law to Create Mandatory Registry for all Trial Data
• Generic Drug Industry May be Headed for Consolidation
• PerkinElmer Boosts LIMS Productivity with New Labworks Graphical User Interface
• STARLIMS Corporation Awarded GSA Schedule 70 Contract for LIMS Award Facilitates a Simplified Purchase of LIMS by Federal Customers
• STARLIMS and Orion Systems International Partner for Public Health
• Autoscribe Introduces Software Module for Managing Calibration and Maintenance Routines
• Resource Management and Scheduling Focus of Newest Release of QATrax
• New LIMS Industry Study Confirms Standardization Reduces Total Cost of Ownership
• Thermo Electron Appoints Global Sales Director for Informatics Business
• Scientific Software Announces EZChrom Elite Support for Windows XP Service Pack 2
• Agilent Technologies Introduces Pharmaceutical Method Validation Software
• Agilent Technologies to Acquire Silicon Genetics, Leading Provider of Life Science Informatics
• ChemSW Releases New, Configurable Chemical Inventory System for Multinational, Multisite Applications
• EarthSoft Announces EQuIS Data Processor Microsoft .Net Certification
• Atrium Research Delivers First Industry Report on Emerging Market for Electronic Laboratory Notebooks
• Nonlinear Dynamics and Matrix Science Integrate Leading Proteomics Software Products
• Labtronics Introduces Analyze XLerator for Excel
• Labtronics Releases Nexxis ST Solution for Laboratory Sample Tracking
• Labtronics Releases New Version of LimsLinkCDS
• Acsis Launches RFID Quickstart for CPG & Pharma
• Bruker BioSpin Announces World's First Actively-Shielded 900 MHz NMR Magnet
• Bruker Announces New NMR Sample Rail Automates Preparation for Increased Throughput
• Bruker Introduces New NMR Accessory that Automatically Tunes CryoProbe
• FDA Considers Guidance on Pharmacogenomic Combination Products
• FDA Issues Guidance for Engaging Biotech Clinical Trial Consultants
• FDA to Re-open 1996 Draft Guidance on Obesity Drugs

SDI Releases 9th Annual Survey of LIMS in North America

In the ninth end-user LIMS study published by Strategic Directions International, Inc., LIMS managers share their views and experiences regarding their current LIMS. In a market where technological advances continue to impact laboratory needs and requirements, LIMS end-users rely on comparisons with other LIMS end-users to assist in their evaluations and purchases. Information for this report is based on a survey of nearly 550 North American LIMS end-users conducted in early 2004. LIMS managers in all industries were asked to give their insights regarding their use and experience with LIMS. The largest groups of respondents are in pharmaceuticals and agriculture/food & beverage. Topics addressed in this study include, but are not limited to: LIMS type, hardware platforms, network management, database management, instrument interfacing, upgrading, installation, service contracts, and product and supplier evaluations. Where appropriate, data is segmented to portray the attitudes and trends of specific industrial groups and other laboratory characteristics. Respondents rated their LIMS supplier and product on different factors of importance and the level of satisfaction/performance. These ratings were then compiled to arrive at an overall standing for each product and supplier. Detailed satisfaction ratings are presented for both labs with less than or equal to 20 concurrent users and more than 21 concurrent users for both the supplier and products. Both supplier and product comparison ratings are presented for: Applied Biosystems, ChemWare, InnaPhase, Khemia, LabVantage Solutions, LabWare, Northwest Analytical, PerkinElmer, PROMIUM, StarLIMS, Thermo Electron, and Zumatrix. Perhaps, the most valuable data to emerge from this survey is LIMS end-user perceptions of their LIMS product and supplier, as well as what factors they find most important. Survey respondents rated their LIMS product on 28 features and functions, and their LIMS supplier on 19 different supplier factors. The following table lists the top 10 supplier and product factors, which resulted from the ratings. The top three supplier factors respondents rated the most important were Service Expertise, Company Long-Term Commitment and Service Response Time. Despite some weaknesses, respondents were generally satisfied with their LIMS vendor’s overall performance. The above information, and more, can be found in SDi’s 9th Annual North American LIMS Survey. Data provided by lab managers is based on actual installed LIMS, as well as planned purchases. Presentations highlight recent and upcoming changes in specific areas of the marketplace as well as supplier and product ratings for customer satisfaction. The print version is available for $4,995 and the print/electronic version is available for $6,745. The abridged version of the report (Labs on LIMS 2004, a special report for end-users) is available for $625. For details, visit http://www.strategic-directions.com.

LabVantage’s Sapphire Enterprise LIMS Selected by Coors Brewing Company

LabVantage Solutions, Inc., a leading provider of Enterprise LIMS and Life Sciences LIMS solutions, has announced that Coors Brewing Company, the third-largest brewer in the United States, has completed a complex implementation of LabVantage’s Sapphire Enterprise LIMS solution, as an integral component of its Quality & Productivity Initiative Project. The LabVantage solution for Coors Brewing is an enterprise-wide laboratory software solution that addresses distinct business needs. Sapphire’s architecture enables companies to share real-time quality control information through corporate intranets. This sharing significantly reduces quality system complexities, at a fraction of traditional IT costs .The Sapphire solution provides companies with: Consolidation of multiple, disparate operating unit databases; Standardization / automation of processes across business units; Automation of data entry from lab instrumentation, to decrease transcription time, and improve accuracy; Automation of result limit checking to drastically reduce response time; Interface with related manufacturing systems; Ability to track sample status through the entire testing process, helping to identify bottlenecks, and provide better customer service; and, Dynamic ad-hoc reporting capabilities. For details, visit http://www.labvantage.com.

Computing Solutions Introduces Representative Averaging and Automatic Trend Notification in LabSoft LIMS v7.14

Computing Solutions, Inc. (CSI), a premier LIMS provider, has announced the release of LabSoft LIMS v7.14. Version 7.14 enhances the data management provided to the user with representative averaging and automatic trend notification features. The representative averaging feature allows lab technicians to select the most representative data when calculating an average for multiple test values of a given sample/grab. The calculation creates a value that represents the multiple test values recorded for a particular sample. All test values (whether marked representative or not) are stored in the LabSoft LIMS database and can be accessed by various tools. The representative calculation is determined by averaging the test values that are ‘marked’ representative. Representative data gives a company the ability to calculate and monitor verification and sample data. Verification data establishes the stability of the data collecting instruments and sample data provides accurate representations of the test values from a sample/grab. Trend notification is an automatic service that runs a Control Chart to determine if data is trending or Out of Spec. Notices and E-mail notifications can be generated based on the Control Chart analysis. For details, visit http://www.labsoftlims.com.

GenoLogics Life Sciences Software Introduces New Product Suite and Announces ProteusLIMS Version 1.5

GenoLogics, developers of proteomics laboratory information management system ProteusLIMS, has announced the release of an extensive product suite including: ProteusLIMS Global Server, ProteusLIMS Enterprise, and ProteusLIMS Workstation. ProteusLIMS Global Server supports facilities that operate several separate laboratories and require integrated data management and extensive scientific instrument integration. ProteusLIMS Enterprise is a fully scalable, configurable solution for high-throughput facilities. ProteusLIMS Workstation is designed for small laboratories that require workflow and sample tracking, and is built to operate out-of-the-box.
New ProteusLIMS Version 1.5 features To supplement this new product suite offering, each ProteusLIMS edition has the following new functionality: Users can easily configure scientific instruments, workflows and
data; Advanced gel support, including multi-dimensional gels; Intuitive gel spot identification, annotation and view of downstream data; Flexible sample tracking and workflows; and, Increased traceability of workflows and processes. ProteusLIMS is designed to manage the large volumes of data generated in the emerging field of proteomics, where scientists undertake complex studies of proteins to develop disease diagnostics and find new targets for drug development. ProteusLIMS is the first commercially available LIMS that specializes in meeting the needs of proteomics researchers. ProteusLIMS offers an end-to-end product suite that meets the needs of facilities of any size. For details, visit http://www.genologics.com.

University of Texas Medical Branch Proteomic Center Selects GenoLogic's Life Sciences Software as a Data Collaboration Partner

GenoLogics, developers of proteomics laboratory information management system ProteusLIMS, has announced that the University of Texas Medical Branch (UTMB) has purchased ProteusLIMS. The UTMB National Heart, Lung, and Blood Institute (NHLBI) Proteomics Center is part of a consortium of 10 collaborative proteomics centers advancing knowledge of heart, lung, blood and sleep, health and disease. Funded by the US National Institute of Health, The NHLBI develops novel proteomics technologies within a consortium of research centers, including the UTMB Proteomics Center. ProteusLIMS will tie together disparate pools of data into a single integrated platform. 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. ProteusLIMS Global Server supports facilities that operate several laboratories and require integrated data and scientific instrument integration. ProteusLIMS Enterprise is a fully scalable, configurable solution for high-throughput facilities. ProteusLIMS Workstation is designed for small laboratories that require workflow and sample tracking, and is built to operate out-of-the-box.For details, visit http://www.genologics.com.

InnaPhase Corporation Named One of the Delaware Valley's Fastest Growing Technology Companies in Deloitte Technology Fast 50 Program

InnaPhase Corporation, acquired by Thermo Electron Corporation in September, has been named to Deloitte's prestigious 2003 Technology Fast 50 Program for the Delaware Valley, a ranking of the 50 fastest growing technology companies in the area by Deloitte & Touche LLP, one the nation's leading professional services
firms. Rankings are based on the percentage of growth in fiscal year revenues over five years, from 1999-2003. InnaPhase increased its revenues during this five-year period by 1,735 percent, resulting in a ranking of 7th overall in the Fast 50 for Delaware Valley. To qualify for the Technology Fast 50, companies must have had operating revenues of at least $50,000 in 1999 and $1,000,000 in 2003, must be public or private companies headquartered in North America, and be a "technology company" defined as owning proprietary technology that contributes to a significant portion of the company's operating revenues (using other companies' technology in a unique way does not qualify); and/or devoting a significant proportion of revenues to research and development of technology. Winners of the 19 regional Technology Fast 50 programs in the United States and Canada are automatically entered in the Deloitte Technology Fast 500 program, which ranks North America's top 500 fastest growing technology companies. For more information on the Deloitte Fast 50 or Fast 500 programs, visit http://www.fast500.com. For more information about InnaPhase and Thermo, visit
http://www.thermo.com/informatics.

Bio-Rad Launches Affordable Spectral Database for College Chemistry Curriculum

Bio-Rad Laboratories, Inc. has announced the release of the IQ Academic Spectral Database, a convenient collection of infrared (IR) and nuclear magnetic resonance (NMR) spectra of organic compounds for teachers and students.
With the affordable IQ Academic Spectral Database, students and teachers can access high-quality spectra used by major companies and research institutions throughout the world. The database includes IR and NMR spectra for over 1,200 specially selected compounds that cover a broad range of chemical classes useful within the chemistry curriculum. Each compound contains cross-referenced spectral data for IR, 1H NMR, and 13CNMR and value-added information, such as technique, molecular formula, molecular weight, CAS Registry Number, melting point, and boiling point. Enlarge screen capture. Each spectral record in the IQ Academic Spectral Database also contains a web link to supplemental information on that compound or class of compounds from Sadtler's world-renowned spectral handbooks. These essential handbooks for IR and NMR highlight pertinent peak information to distinguish between chemical classes that can be useful spectral interpretation. The IQ Database can be used in conjunction with Bio-Rad's KnowItAll Academic Edition, a software package that includes chemistry and spectroscopy tools and is offered for free to teachers and students at http://www.knowitall.com/academic.

KnowItAll 4.1 Offers a Pioneering Tool to Visualize and Compare Pharma Data

Bio-Rad Laboratories, Inc. has announced the addition of the CompareIt application to version 4.1 of its KnowItAll Informatics System. Pharmaceutical researchers can use this tool to visualize and compare numeric data between multiple databases. Within pharmaceutical research, comparisons are regularly needed across different research datasets in order to compare predicted values to experimental laboratory results and visualize the relationships between different experimental values between datasets. Using the CompareIt application, users can select any two property fields from multiple databases for comparison. For example, a researcher might choose to compare ADME response data (e.g., Blood-Brain Barrier) to molecular physical property data (e.g., Polar Surface Area, logP, etc.) or to other ADME response data (e.g., Human Intestinal Absorption). Once the researcher selects the fields to be compared, the CompareIt application generates a scatter-plot diagram of one variable versus the other. Selecting any point or group of points will immediately display the compounds associated with that record, with an easy pop-up view of all the data associated with the compound. From this scatter plot comparison, the researcher can visualize trends and segregate data that follows a desired trend from that which does not. The data input for this application can be either KnowItAll user-generated or reference databases containing experimental data, calculated results, or both. The CompareIt application is fully integrated with all other applications in the KnowItAll environment, including searching, reporting, and prediction. The CompareIt application is part of Bio-Rad's award-winning KnowItAll Informatics System, a complete ADME/Tox prediction system, including the largest single collection of pre-built, "global" prediction models, tools to build models using proprietary user-generated data, powerful validation tools to verify models, and integrated tools for structure drawing, database management, datamining, and reporting. For details, visit http://www.bio-rad.com.

Group Logic Announces New Mac OS X Print Accounting Solution Add-on to ExtremeZ-IP Print Server Helps Track Usage and Project Costs

Group Logic, developer of network workflow software products, has announced ExtremeZ-IP Print Accounting Add-on, a new product in its ExtremeZ-IP product line. Available to customers later in the year, this new software works in conjunction with ExtremeZ-IP Print Server to deliver increased control over enterprise-wide printing through advanced tracking features that more accurately measure and allocate the costs associated with expensive printing resources. With ExtremeZ-IP Print Accounting Add-on, users are prompted within the Mac OS X print dialog for project or cost codes prior to output. These codes are immediately validated against a centralized list before printing occurs. Flexibility in account code and validation configurations allows customization for each print queue on a server. Compatible with standard off-the-shelf software packages, this software is capable of exporting the log data, up to 13 fields and five account codes for each job, in tab-delimited format for import with customers job-management and accounting programs. For details, visit http://www.grouplogic.com.

Group Logic Announces Stand-Alone ExtremeZ-IP Print Server 4.0

Group Logic has announced an upgraded, stand -alone version of its ExtremeZ-IP Print Server software product. Available to customers later in the year, this major upgrade allows customers to utilize ExtremeZ-IP Print Server 4.0 both in conjunction with and independently of its ExtremeZ-IP File Server Product. Fully compatible with Apple's Mac OS X, ExtremeZ-IP Print Server allows Mac and Windows clients to print via TCP/IP to printers and other PostScript devices. The 4.0 stand-alone print server product offers users a number of new features, including support for Apple Remote Desktop; multiple print queue management; shared Windows print servers to Macs; detailed logging of print jobs; rendezvous support; and, Mac OS 9 support of Apple LaserWriter and Adobe PS printers. ExtremeZ-IP Print Server 4.0 provides compatibility with Mac OS 9 and seamless integration with the Mac OS X printing architecture. This compatibility allows users who operate Mac OS X and Windows print servers to completely re move AppleTalk from their network. Mac clients spool PostScript print jobs using the TCP/IP protocol to printers and other devices managed by Wind ows 2003/2000/XP/NT servers. Print jobs are then delivered to printers and P ostScript processing applications. With ExtremeZ-IP Print Server, Mac users gain speed and efficiencies of TCP/IP, while gaining support of the latest Apple technologies through their Windows print server. For details, visit http://www.grouplogic.com.

Group Logic Announces ExtremeZ-IP File Server Version 4.0

Group Logic has announced version 4.0 of its ExtremeZ-IP File Server software product. Available to customers later this year, this major upgrade introduces a new product architecture as wel l as significant improvements in the product's scalability, performance and compatibility with Mac OS X. ExtremeZ-IP, a robust file server software, is the only AppleShare file server on the market that fully integrates both Mac OS X and Mac OS 9 with Windows 2003/2000 Server versions as well as Windows 2003 Storage Server and Windows XP Professional. With over 30 new features, version 4.0 marks a significant milestone for the ExtremeZ-IP product line. Through a re-architected internal structure and advanced caching strategy, 4.0 gives customers immediate startup, higher availability and radically reduced memory usage, as well as superior performance under load. New active-active clustering capabilities allow customers to distribute multiple virtual Mac file servers across multiple nodes, with immediate failover. This translates into improved uptime, and flexibility in failover options and functionality. Bundled into the 4.0 upgrade is the product's support of Kerberos – the network authentication protocol adopted as a standard part of Windows 200 0/2003 and Active Directory and adopted by Apple in Mac OS X. Incorporating this protocol in ExtremeZ-IP protects user names and passwords on the network without requiring multiple user logins. For IT administrators, it streamlines the process of managing user accounts by administering both Mac and Active Directory accounts concurrently and with the same high level of security while maintaining the ease of use for clients and end users. Group Lo ic's ExtremeZ-IP product is the only AppleShare (AFP) server for Windows on the market that supports Kerberos. The 4.0 upgrade is aligned to support Mac OS 10.3 Panther and will be updated to be fully compatible with Mac OS 10.4 Tiger when it ships next year. For details, visit http://www.grouplogic.com.

Scientific Software, Inc. Announces New Software Control of Varian 3900 GC

Scientific Software, Inc., a leader in providing innovative software solutions to the scientific community, has released new control software for the EZChrom Elite Chromatography Data Systems and the OpenLAB Laboratory Software Framework to control the Varian 3900 GC from Varian Instruments Associates. The new control software allows EZChrom Elite or OpenLAB to fully control the 3900 GC with instrument control of the GC and related autosamplers. Software control of the 3900 GC allows users to create a single software method to provide data analysis and reporting as well as control of instrument running conditions. Data from the detector is collected and analyzed with a full range of reporting options. The Control Software supports instrument parameters such as split/splitless mode, multiple on column injectors, inlet temperature control, column oven temperature, FID and TCD detectors, and other important 3900 GC settings. The EZChrom Elite CDS and the OpenLAB Laboratory Software Framework from SSI each control more than 260 different chromatographs from leading hardware vendors. For details, visit http://www.scisw.com.

Agilent Technologies Introduces Method for Chemical Fingerprinting of Microscopic Materials from Crime Scenes

Agilent Technologies Inc. has announced a method for analyzing forensic samples with significant advantages in speed, sensitivity and sample use over traditional techniques. It can characterize microscopic samples such as glass shards and clothing fibers at the parts per billion (ppb) level, providing an elemental "fingerprint" that can help investigators determine the origin of a material, sometimes down to the brand or manufacturer. Forensic investigators currently rely on various techniques to characterize physical evidence, including microscopy, refractive index, Fourier transform infrared and X-ray fluorescence. These techniques have drawbacks when analyzing small samples or discriminating between materials with physical, chemical and visual similarities. Some require extensive sample preparation, a time-consuming process that uses hazardous substances, increases the risk of contamination and destroys significant amounts of sample. Other techniques may have difficulty distinguishing materials that are chemically inert; of the same brand, color or matrix; or from different batches of the same manufacturing run. Developed with New Wave Research of Fremont, Calif., Agilent's method uses laser ablation inductively coupled plasma-mass spectrometry (LA-ICP-MS) to overcome the limitations associated with traditional techniques. In LA-ICP-MS, a powerful pulsed laser focuses on and vaporizes a small amount of a solid sample. A gas stream carries the resultant sample vapor into a high-temperature plasma (the ICP) where the sample is ionized before extraction into the mass spectrometer for analysis. LA-ICP-MS for forensic analysis enables accurate discrimination of similar samples by identifying trace elemental and isotopic characteristics at ppb levels; reduced analysis time by eliminating sample preparation steps; very low sample consumption (often less than one microgram); and, analysis of the layers of a material such as those in adhesive tape. The ability to analyze microscopic specimens can help investigators link a suspect to the crime scene. If a sample is small, it is more likely to be transported from a crime scene undetected by the criminal. Shattered glass, for example, produces tiny shards that may become embedded in clothing and shoes, "tagging" a criminal with a unique marker. Agilent's method uses a New Wave Research Merchantek UP-213 LA system coupled to an Agilent 7500s ICP-MS instrument. Further information is available by requesting Agilent application notes "Methods for the Forensic Analysis of Adhesive Tape Samples by LA-ICP-MS," publication 5989-1566EN, and "Analysis of Forensic Glass Samples by Laser Ablation ICP-MS," publication 5989-1567EN. These notes can be obtained without charge from http://www.agilent.com/chem/forensics.

Icoria, Inc. Expands Partnership with Agilent Technologies to Include $11.7 Million ATP Grant for Informatics

Icoria, Inc., a biotechnology company, has announced that Agilent Technologies has been approved by the National Institute of Standards and Technology (NIST) Advanced Technology Program (ATP) to partner with Icoria in its continuing work on the $11.7 million ATP grant previously awarded in June of 2002 to Icoria and LION bioscience AG, who has since withdrawn from participation. The grant remains the largest ever awarded by the ATP in the area of bioinformatics. The goal of this grant is to support the development of a Target Assessment Technologies Suite (TATS) for the improved discovery and validation of targets for product development in the pharmaceutical and life sciences. In addition to substantial capabilities in software engineering and commercialization, Agilent brings to the agreement a data association framework called Agilent Synapsia Informatics Workbench that provides scientists with the ability to better understand and utilize vast amounts of genomic, proteomic, toxicologic, and drug efficacy data. The framework will be further enhanced to support integrated biological research with funding from this grant. The companies believe that Agilent's software development capabilities match well with Icoria's systems biology measurement technologies and data coherence analysis platform to address the goals of this grant, including the development of a commercializable software product. In conjunction with the ATP grant, Icoria also announced the successful completion of the first formal milestone objective associated with this grant. The completed milestone was for the development, validation, and analysis of a coherent data set, the first of three to be developed under the grant. The data set is based on Icoria's investigation of liver injury in rats induced by acetaminophen, a common pain reliever. This work also involved the discovery of biomarkers indicative of hepatoxicity (liver toxicity). For details, visit http://www.icoria.com or http://www.agilent.com.

P-Wave Receives "Build a Better Berks" Award from the Berks County Chamber of Commerce

P-Wave, Inc., a document and workflow management company located in Berks County Pennsylvania whose LabCORE technology serves FDA and EPA regulated industries, recently accepted the Berks County Chamber of Commerce’s “Build a Better Berks” award for September 2004. The award recognizes Berks County businesses and organizations that continue to express confidence in their future in Berks County by expanding their operations in the area. The Chamber recognized P-Wave due to P-Wave’s 20 per cent employment increase over the past 12 months. According to P-Wave’s President Mark Ferrero, “with the increased growth from LabCORE, P-Wave plans to add 20 new jobs in Berks County, Pennsylvania over the next four years.” For details, visit http://www.labcore.com.

Bruker Daltonics NBC Business Receives Frost & Sullivan Product Innovation Award for Chemical and
Biological Agent Detectors

Bruker BioSciences Corporation has announced that Frost & Sullivan has selected the company's Bruker Daltonics subsidiary for their 2004 Product Innovation Award in the Chemical & Biological Agent Detector Markets. Frost & Sullivan Industry Analyst Matthew Farr stated: "Bruker Daltonics has more than two decades of Nuclear, Biological and Chemical (NBC) detection experience. This experience has led Bruker Daltonics to develop a broad range of NBC detection products based on several technology platforms." Bruker Daltonics' NBC product line includes a nuclear radiation detector, the hand-held SVG-2, which can be vehicle mounted. The SVG-2 incorporates sensors for detecting gamma and neutron radiation. Bruker Daltonics also produces two complementary biological agent detectors: the Chemical Biological Mass Spectrometer (CBMS) can detect and classify biological agents in as little as three minutes without operator intervention. The CBMS is used in the US Army's Biological Integrated Detections System. The new APSIS is a fieldable DNA microarray system for the subsequent identification of harmful pathogens. For details, visit http://www.bruker-biosciences.com.

AACC Online Database of "Young's Effects" Interactions Now Available

Young's Effects Online, launched by the American Association for Clinical Chemists (AACC), is now available to doctors, laboratorians and pharmacists who need instant access to check the interactions of drugs, diseases,
preanalytical conditions and herbs on lab tests. The data is based on the "Young's Effects" standard reference texts by Dr. Donald S. Young. Benefits include updated and more comprehensive data, portability, searchability,
and reduced subscription cost. Potential subscribers can visit http://www.fxol.org for a free trial subscription.

SAP’s New Version of Business One for SMB

SAP AG has announced a new version of SAP Business One with new capabilities including integrated material requirements planning (MRP) and other enhancements for small and midsize businesses (SMBs). Included are enhancements to its embedded customer relationship management (CRM). Other improvements will make it easier for businesses to customize the solution to manage additional or changing areas of the business. New database options include Sybase Adaptive Server Enterprise (ASE) and IBM DB2 Universal Database (UDB) Express edition, in addition to Microsoft SQL Server. For details, visit http://www.sap.com.

SAP and Infineon Introduce Solution for RFID

SAP AG and Infineon Technologies AG have announced a new radio frequency identification (RFID) offering for connecting and managing RFID hardware and software from multiple vendors. Based on the SAP NetWeaver technology platform and Infineon's RFID You-R OPEN (OPerating ENvironment) device integration platform, the new offering will help companies deploy RFID hardware, devices, tags and software components for RFID-enabled business processes. For details, visit http://www.sap.com.

Supplier-Provided Automation Services Market Predicted to Approach $15 Billion by 2008

Service is the fastest growing segment of the automation market today, and with good reason. The vast pools of engineering expertise that used to exist at major user companies have shrunk to critically low levels. Many of the automation services that are required throughout the lifecycle of a plant or factory can no longer be performed in-house. Users are looking to the next logical choice for these services -- the suppliers that provide them with the automation products, systems, and software that keep their plants running. The worldwide market for supplier-provided automation services is expected to grow at a Compounded Annual Growth Rate (CAGR) of 9.1 percent over the next five years. The market was $9.2 billion in 2003 and is forecasted to be close to $15 billion in 2008, according to a new ARC Advisory Group study. "More suppliers today are taking on the task of supervising entire automation implementation projects, acting as the main automation vendor or supplier that coordinates activities between the systems integrators, smaller suppliers, and the user. This simplifies things for the user because the main automation supplier provides a single point of responsibility for the success of the project, saving time and money," according to ARC Research Director Larry O'Brien, the principal author of ARC's "Supplier-Provided Automation Services Worldwide Outlook" report. While project services are being increasingly outsourced to automation suppliers, the real benefits for users lie in the increasingly broad spectrum of after market services being offered. Users today are focusing more than ever on achieving superior return on assets and asset utilization. This also means driving optimum levels of performance from the control system and the automation and plant or factory equipment infrastructure. Again, automation suppliers are stepping in to fill this void with a range of both products and services designed to help users achieve a vision of Real-time Performance Management (RPM). The adoption of standard, commercial-off-the-shelf (COTS) products and components drastically reduced the cost of hardware and eliminated most of the proprietary competitive advantage that automation suppliers could build into their hardware. With hardware no longer a competitive differentiator, suppliers looked to their software and service offerings as well as vertical industry expertise to make up for the losses experienced in the hardware business. The scope of services offered has widened considerably over the past several years. Services have emerged as a lucrative business addition. When coupled with areas requiring high domain expertise they can generate high margin business for suppliers. For more information on this study, visit http://www.arcweb.con/res/autosvs.

Citizens Petition Urges Elimination of FDA's Part 11 Rule

An industry group has filed a citizen's petition urging the FDA to do away with 21 CFR Part 11, saying laws passed since the rule was introduced adequately address issues surrounding the integrity of electronic records and data. The petition, submitted by the Industry Coalition on 21 CFR Part 11, essentially echoes the stance adopted in comments made in July by PhRMA. Others in the industry — most notably consultants who offer guidance on how to conform to the regulation — argue that the problems with Part 11 stem less from the regulation itself and more from companies' desire to lessen their regulatory burden and from ignorance on the part of FDA officials. Some industry organizations, however, have argued that Part 11 is inhibiting the advancement of technology, and those arguments appear to have resounded in the ears of regulators, according to one consultant. For details, visit http://www.fda.gov.

FDA Enforcement of Part 11 in Clinical Trials to Lessen

The FDA will not, for the most part, enforce 21 CFR Part 11 rules related to computerized systems used in clinical trials, according to a recent draft guidance. Instead, the agency will allow companies to continue meeting the standards of the predicate rules, defined as the underlying requirements in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act and FDA regulations other than Part 11. "FDA does not intend to take enforcement action to enforce compliance with these requirements of Part 11 while the agency re-examines Part 11," the guidance states - a stance that appears to support the growing belief that the agency intends to scrap Part 11 in favor of the predicate rules, as urged by a growing number of companies and industry groups. The guidance is designed to address how agency expectations and regulations regarding data quality might be satisfied where computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical data. Comments on the draft guidance will be accepted until Dec. 3 and can be submitted electronically, for Docket No. 2004D-0440, at http://www.fda.gov/dockets/ecomments. To view "Draft Guidance for Industry on Computerized Systems Used in Clinical Trials" go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0440-gdl0001.pdf.

Cornerstone of cGMP Initiative is Quality Systems Approach

Pharmaceutical firms need to start building quality into their products and eschew the idea that testing alone can be relied upon to ensure product quality — that's the overarching philosophy of the FDA's draft guidance on implementing a quality systems approach to drug manufacturing. Described by Center for Drug Evaluation and Research official David Horowitz as the cornerstone of the FDA's broad pharmaceutical manufacturing initiative, the quality systems draft guidance lays out a comprehensive approach that drugmakers can take to develop robust, modern quality systems that are fully compliant with the agency's current good manufacturing practice (cGMP) regulations. Released as part of the FDA's massive cGMP information package, the draft guidance is intended to serve as a bridge between the agency's 1978 good manufacturing regulations and its current understanding of quality systems. In addition to spelling out the FDA's philosophy on quality systems, the guidance is also intended to further the agency's efforts to harmonize cGMPs with other widely used quality management systems, such as ISO 9000, non-U.S. pharmaceutical quality management regulations and the FDA's medical device quality system regulation. For details, visit http://www.fda.gov.

Both cGMP and Quality System Rules Apply to Some Combo Products

Companies that manufacture single-entity or co-packaged combination products must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released as part of the FDA's pharmaceutical current good manufacturing practice (cGMP) initiative. Drug manufacturers and devicemakers currently fall under different manufacturing standards, with drug firms governed by cGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) and device firms regulated under the quality system (QS) regulation (21 CFR Part 820). Although there is considerable overlap between the two sets of regulations, there are also some distinct differences because each was tailored to the characteristics of the products for which they were drafted. Because the cGMP and QS regulations aren't identical, the compliance waters can be murky for manufacturers when it comes to producing combination products consisting of a drug or biologic and a medical device. The FDA has yet to promulgate cGMP regulations specifically for combination products. As such, manufacturers are subject to either cGMP or QS regulations, or a combination of the two standards, depending on specific nature of the product, the agency said. For details, visit http://www.fda.gov.

Final Report on Drug Manufacturing Regulation Issued

The FDA this fall will start using a risk-based approach for prioritizing site inspections for certain pharmaceutical products, the agency announced in a final report on its current good manufacturing practice (cGMP) initiative.
The frequency and/or scope of manufacturing inspections will be reduced for firms the FDA determines have succeeded in implementing effective quality systems approaches, according to the report, which caps the agency's "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" initiative launched in August 2002. "We hope that this approach will create positive incentives for other firms to implement effective quality systems at their manufacturing sites," the report said. For details, visit http://www.fda.gov.

FDA Strategic Action Plan Centered on Drug Development

The cost of bringing a new drug to market — estimated to be between $800 million and $1.7 billion — is a major barrier to firms considering investing in innovative higher-risk drugs or therapies for diseases that are uncommon or that predominantly afflict the poor, according to a new FDA report. Product development over the past decade has slowed significantly in areas crucial to public health, such as developing new antibiotics, as sponsors face serious product development challenges and uncertainties, the FDA said in a recently released report on implementation of the agency's strategic action plan. The year 2000 marked the start of a slowdown in new drug and biologic submissions to regulatory agencies worldwide despite research milestones, such as the mapping of the human genome, the FDA said. "At a time when basic biomedical knowledge is increasing exponentially, the gap between bench discovery and bedside applications appears to be expanding," the report said. "We urgently need a new product development toolkit containing powerful new scientific and technical methods, such as animal- or computer-based predictive models, new biomarkers for safety and effectiveness and new clinical evaluation techniques," the report added. The FDA is addressing this problem through its Critical Path Initiative. Announced in March, the initiative aims to streamline the drug development process by better predicting product failures earlier during clinical trials and reducing development uncertainties in areas such as product safety and manufacturing potential. This fall, the report said, the FDA will announce a new National Critical Path Challenges List that will identify key opportunities to improve the efficiency of product development. To view the FDA's report, titled "Progress and Priorities 2004," go to http://www.fda.gov/oc/initiatives/reports/priorities2004.html.

Innovative Manufacturing Tools Encouraged in PAT Guidance

Drugmakers should use cutting-edge scientific and engineering knowledge, coupled with the best principles of quality management, in their manufacturing process to respond to the challenges of new discoveries and ways of doing business, the FDA said in a final guidance on process analytical technologies (PAT). The FDA issued the guidance encouraging the use of a PAT framework along with several other guidances as part of the agency's two-year strategic plan to modernize the regulation of manufacturing and product quality. The PAT system can be used for designing, analyzing and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, the guidance said. The goal is to ensure final product quality, the guidance added. Significant opportunities exist for improving pharmaceutical development, manufacturing and quality assurance through innovation in product and process development, process analysis and process control, according to the PAT guidance. To view the guidance "Process Analytical Technology — A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance" go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0380-gdl0002.pdf.

FDA Issues Guidance on Sterile Drug Manufacturing

Limiting the exposure of sterile product elements, maintaining the highest degree of environmental control, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance. "Personnel and material flow should be optimized to prevent unnecessary activities that could increase the potential for introducing contaminants to exposed product[s], container closures or the surrounding environment," the guidance stated. The 63-page document, issued as part of the agency's pharmaceutical current good manufacturing practices (cGMPs) initiative, replaces a draft guidance issued in September 2003 and focuses on cGMP expectations for aseptic drug processing facilities. Sterile drug products are a high priority in the FDA's risk-based inspection program, and the agency hopes the final guidance will lead to a reduction in manufacturing problems in this class of pharmaceuticals. To view "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice" go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0382-gdl0002.pdf.

FDA Clears RFID Chip for Human Use

Applied Digital and Digital Angel Corporation has announced that VeriChip has been cleared by the U.S. Food and Drug Administration (FDA) for medical uses in the United States. The FDA clearance follows the completion of a de novo application review. VeriChip is an implantable radio frequency identification (RFID) microchip for human use. The VeriChip Health Information Microtransponder System consists of an implantable RFID microtransponder, an inserter, a proprietary hand-held scanner, and secure database containing the patient approved healthcare information. About the size of a grain of rice, VeriChip is a subdermal radio frequency microchip. Once inserted under the skin in a brief outpatient procedure, the VeriChip cannot be seen by the human eye. Each VeriChip contains a unique 16-digit verification number that is captured by briefly passing a proprietary scanner over the insertion site. The captured 16 digit number links to the database via encrypted Internet access. The previously stored information is then conveyed via the internet to the registered requesting healthcare provider. Digital Angel Corporation is the manufacturer of VeriChip and has licensed the technology to VeriChip Corporation, a wholly owned subsidiary of Applied Digital, for human applications.For details, visit http://www.digitalangelcorp.com.

Bill Would Compel Release of All Clinical Trial Data

House and Senate lawmakers have introduced legislation that would mandate registration of clinical trials for human drugs, biologics and medical devices at an existing NIH online database, as well as restrict the use of study data in promotional materials for sponsors that don't register their trials. The Fair Access to Clinical Trials Act (FACT Act), H.R. 5252/S. 2933, would expand the federal government's ClinicalTrials.gov registry, managed by NIH's National Library of Medicine, by requiring researchers to report all trial results to the database to obtain approval from U.S.-based institutional review boards. The FACT Act contains an enforcement mechanism that includes civil monetary penalties. Manufacturers that do not comply with the reporting requirement could face fines of as much as $10,000 per day. Nonprofit organizations in violation of the law could be fined a maximum of $15,000. For details, visit http://www.fda.gov.

FDA Sued by Pharmacies Over Guidance on Drug Compounding

A coalition of 10 pharmacies engaged in drug compounding has sued the FDA to continue filling prescriptions using pure "bulk ingredients" that are manufactured in agency-approved facilities. The suit, filed in the U.S. District Court for the Western District of Texas, stems from a July 2003 FDA compliance policy guideline (CPG) that made the use of bulk ingredients in the preparation of drugs for animals illegal, according to the coalition. The FDA has waged an aggressive inspection campaign to enforce the CPG, according to the coalition. The group alleges the agency is illegally enforcing an arbitrary regulation it never had the authority to issue. The FDA's actions are meant to intimidate law-abiding pharmacists to quit compounding medications prescribed by doctors and veterinarians, the coalition added. According to the guidance, the FDA is greatly concerned about veterinarians and pharmacies that are engaged in manufacturing and distributing unapproved new animal drugs in a manner that is outside the bounds of traditional pharmacy practice and that violate the Federal Food, Drug and Cosmetic Act. For details, visit http://www.fda.gov.

FDA Releases Final Guidance on Vaccine Labelling

The FDA has issued a final guidance document that details the vaccine labeling process, describes the agency's review of childhood vaccine labeling under section 314 of the National Childhood Vaccine Injury Act, and discusses the type of data FDA examines when determining the adequacy of vaccine labeling. To view "Guidance for Industry on Food and Drug Administration Review of Vaccine Labeling Requirements for Warnings, Use Instructions and Precautionary Information" go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0414-gdl0001.pdf.

InnaPhase Acquired by Thermo Electron Corporation

Thermo Electron Corporation, a world leader in analytical instruments, has announced the acquisition of InnaPhase Corporation, a premier supplier of Laboratory Information Management Systems (LIMS) for the pharmaceutical and biotechnology markets, for approximately $65 million in cash, subject to a post-closing adjustment. Headquartered in Philadelphia, InnaPhase has over 100 employees and expects revenues of approximately $26 million in 2004. With this acquisition, Thermo extends its position as the largest provider of LIMS products and services in the world. InnaPhase's flagship Watson LIMS is the leading product in drug development laboratories and the industry standard for bioanalytical applications. InnaPhase's products will be integrated with Thermo's informatics product line, which includes SampleManager, the leading LIMS for large analytical laboratories. "The InnaPhase team brings deep industry expertise and world-class software development capabilities,” commented Marijn E. Dekkers, Ph.D., president and CEO of Thermo Electron Corporation. "The addition of InnaPhase's pharmaceutical LIMS technology broadens and strengthens the array of solutions that Thermo is able to provide its customers in key applications such as proteomics and ADME/TOX. As customers continue to standardize on informatics products and vendors, Thermo is strategically positioned to offer a broad portfolio of integrated solutions with the industry expertise and resources required for successful implementations." "Bringing together the proven, innovative products and the industry knowledge represented by people from both organizations - along with Thermo's best-in-class instrument, equipment and service capabilities – will allow us to provide a breadth of solutions for our customers that is unequaled in the industry," commented Jo Webber, Ph.D., former CEO of InnaPhase. She has been newly appointed to general manager of Thermo's informatics business. For details, visit http://www.thermo.com/informatics or http://www.innaphase.com.

Autoscribe Releases New Version of Software that Manages Customer Complaints

Autoscribe has released a new version of software for handling customer complaints (CCMS). Designed to track and trace the status of a complaint from notification through to resolution the software also assists in identifying spurious claims from serial complainers. It has the potential to cut fraud, identify acts of extortion and deliberate
product contamination, and to highlight production faults that are leading to repeated complaints. The system deals with every aspect of complaint management. For example, it can be linked to word processing packages to facilitate the production of standard acknowledgement letters, and to other packages, such as image capturing software, which will allow a photograph of the faulty product to be linked to the relevant complaint. Where complaints might lead to court action, the system assists in maintaining the full traceability of evidence, a factor which may prove vital in establishing and fighting a defence. The CCMS can also allocate a laboratory testing regime to the sample or product that has resulted in a complaint where relevant. The testing regime can be assigned automatically or on an ad hoc basis. Test results are easily compared against expected values and product specifications. Once completed, the test findings can be easily incorporated into reports for the customer and the complainer. Statistical analysis can also be applied to the results of several tests to identify trends in complaints, or steps that may need to be taken to prevent the recurrence of a specific problem. For details, visit http://www.autoscribe.co.uk.

STARLIMS Supports California 's BSE Testing Program

STARLIMS Corporation has announced the California Animal Health and Food Safety Labs (CAHFS) at the
University of California, Davis, is operating the Company's LIMS system to assist in sample analysis of Bovine Spongiform Encephalopathy (BSE). Earlier this year, the U.S. Department of Agriculture's (USDA) Animal and
Plant Health Inspection Service (APHIS), in cooperation with the Food Safety Inspection Service (FSIS) and the Food and Drug Administration, (FDA) declared a major acceleration in the nation's BSE testing program. In this
announcement, CAHFS and a limited number of other regional analytical laboratories were certified to perform accelerated BSE testing. Within two months of this announcement, the participating laboratories were required to
be able to begin testing some 268,000 animals for BSE. "When CAHFS was chosen as one of the testing laboratories for the new BSE surveillance program, we quickly decided to partner with a LIMS provider that could meet our increased needs for data integration and interoperability," said Jay Ross, IT Manager at CAHFS, UC Davis. "In addition, CAHFS required a LIMS that would compliment the need to implement a very streamlined and efficient laboratory. By working with STARLIMS, we have been able to implement a fully functional LIMS, within very tight time parameters." The STARLIMS solution at CAHFS was established within the designated time frame of two months. STARLIMS receives samples submitted by USDA personnel from sampling facilities and slaughterhouses. The accepted samples are identified and tracked in STARLIMS, rapid ELISA (Enzyme-Linked Immunosorbent Assay) tests are scheduled and results are imported directly from the plate readers. For positive samples, confirmation tests are scheduled and samples are shipped to USDA's National Veterinary Services Laboratory in Ames, Iowa. All results are reported according to USDA and CAHFS standards in electronic form, using XML files, faxes, or e-mails in accordance with the requirements of the receiving parties. For details visit http://cahfs.ucdavis.edu or http://www.starlims.com.

Siemens A&D's New RFID for UHF

Siemens Automation and Drives (A&D) is expanding its RFID (Radio Frequency Identification) systems offering into the UHF range. UHF technology allows large distances between readers and RFID tags attached to the product or item. For the UHF range, A&D is developing a new RFID product family that will allow it to be used throughout the world. The offering will consist of stationary and handheld reader designs with corresponding tags for various environmental conditions. The functionality corresponds to the requirements of the EPC Global and ISO/IEC 18000-6 standards. The new readers will communicate via TCP/IP with PC or Simatic controllers as servers. They will allow for remote engineering and can also perform diagnostics using the remote control unit. Commercial release is expected to coincide with the availability of EPC Gen2 tags in the middle of 2005 following the pilot customer phase currently underway. Siemens A&D is one of several Siemens business units involved in RFID, the others including Siemens Logistics and Assembly Systems and Siemens Business Services. The Automation side of the business has offered physical layer RFID solutions to manufacturing customers in segments such as automotive for years. Now it appears they are timing their entry into the EPCglobal-driven supply chain realm to coincide with availability of the first truly interoperable EPCglobal standard, UHF Gen 2. For details, visit http://www.siemens.com.

Northwest Analytical and CA-CSS Partner for SPC in Asia

Northwest Analytical, Inc. (NWA), a supplier of statistical process control (SPC) software, signed a mutually exclusive partnering agreement with CA-China Soft Software Technology Co., Ltd. (CA-CSS). NWA is the exclusive provider of SPC software to CA-CSS. CA-CSS will serve as the exclusive general agent to sell, service, and provide training and support for all NWA products in the People's Republic of China. The agreement is effective immediately. NWA's SPC software will be internationalized for the Asian market and integrated with CA-CSS technologies to bring manufacturing process analysis, monitoring, data collection, and web-based reporting capabilities to the CA-CSS manufacturing systems offering. The primary business of CA-CSS is to create, sell and support ES/1, a family of software solutions for Supply Chain Execution (SCE) and supports many languages including Simple Chinese, Traditional Chinese, Japanese, and Korean. For details, visit http://www.nwasoft.com.

Scientific Software Introduces Enterprise Content Manager

Scientific Software, Inc. has announced a new, cost-effective solution for enterprise content management (ECM). Scientific Software Enterprise Content Manager (formerly known as CyberLAB ECMS) is an ECM software platform that provides a secure, central repository and rich content services to create, capture, manage, archive, and re-use business critical information. ECM offers a low total cost of ownership in terms of software license fees, training, consulting and ongoing system maintenance; management of both human-readable and raw data from analytical instruments and measurement devices (e.g. medical imaging/DICOM devices, chromatography systems, NMR, mass spectroscopy) as well as any document type such as Word, Excel, PowerPoint, Outlook emails and images; PDF Metadata Extraction via the use of special PDF Templates that extract full text, fields, data from charts, graphs, or table; Support for the Adobe PDF file format, including electronic signatures, automated PDF rendering, electronic forms support, scalable vector graphics extraction, PDF metadata extraction, and desktop integration; Technology-neutral Format (TNF) file conversion based on the AnIML (XML) schema and the ASTM E13.15 standard for long-term archival of analytical data; Secure Access for Everyone (SAFE) authentication based on PKI trust infrastructure for legally enforceable and regulatory compliant electronic signatures; “Active archival” to permanent media (SAN, IBM Tivoli Storage Manager, EMC Centera, NTFS) and content storage virtualization; Automated records collection via scheduled import, print to PDF, and BPM; Strong compliance capabilities (21 CFR Part 11, Sarbanes-Oxley, SEC, OSHA) that are extended to better manage Microsoft Excel spreadsheet templates; Integrated records retention policies; Unified, n-tier architecture based on a single, web-based user interface and a single repository (with support for centralized database management and federations of file systems); and, Integrated Business Process Management (BPM) functionality for workflow automation. With this rich functionality, Enterprise Content Manager platform capabilities span technology solutions for document management, records management, knowledge management, dynamic report building, records archival, PDF file management, automated records collection, electronic forms processing, and scanning and imaging. Pricing for Enterprise Content Manager starts at $5,500 for a single server, 5-user system. For details, visit http://www.scisw.com.

Scientific Software Accelerates Business Processes with New BPM Solution

Scientific Software, Inc. has announced a next-generation solution for business process management (BPM). Scientific Software Business Process Manager enables organizations to streamline, automate, and optimize mission-critical business processes while enabling seamless collaboration between people, processes and content. Business Process Manager can accelerate processes across all industry applications, including SOP management, regulatory compliance (Sarbanes-Oxley, Basel II, HIPAA, 21 CFR Part 11, OSHA), Six Sigma process improvements, new product introductions, scientific data archiving, engineering change notices, purchase requests, insurance claims processing, and forms processing. Business Process Manager is tightly integrated with the Scientific Software Enterprise Content Manager system out-of-the-box, but is designed as a stand-alone BPM solution and can easily be embedded into 3rd party or custom applications. It is based on industry standards such as the Microsoft .NET framework, XML and web services. For details, visit http://www.scisw.com.

Labtronics Releases LimsLinkExpress to Reduce the Cost of Instrument to LIMS Interfacing

Labtronics Inc. has released LimsLinkExpress, a low cost solution that reduces the time and resources required for implementing an instrument to LIMS interface. LimsLinkExpress provides basic instrument to LIMS interfacing for laboratories that don't require the extensive security features and sophisticated processing capabilities that are included in Labtronics' full LimsLink product. With its streamlined approach to instrument interfacing, LimsLinkExpress can be implemented using Labtronics' special fixed cost, on-line installation services. These web-based services eliminate the cost of on-site visits keeping your project on track and within budget. Most instruments can be interfaced in less than two days. Because LimsLinkExpress is based on the industry standard LimsLink platform all LimsLinkExpress interfaces are fully compatible with the full LimsLink application and can be upgraded to LimsLink at any time, giving laboratories a clear upgrade path to follow as their interfacing requirements change and mature. For details, visit http://www.labtronics.com.

National Instruments Introduces New Analytical Instrument Drivers for LabVIEW

Leading analytical instrument vendors recently teamed up with National Instruments (NI) to offer driver software that easily integrates their instruments with NI LabVIEW for life science lab and research applications. Customers can visit NI's Instrument Driver Network web site to download more than 40 analytical drivers from 19 instrument vendors such as Harvard Apparatus, Sutter Instrument, and CARDIAC. For details, visit http://digital.ni.com/express.nsf/bycode/nn0904a01.

SAP Invests EUR 10 million for Global Support Center in China

SAP AG has opened a new SAP Global Support Center (GSC) in Dalian, China. The GSC China will become the primary hub for delivering services and support to SAP customers in Asia Pacific countries including China, Japan and Korea. The GSC China will also serve SAP customers worldwide as part of SAP's 24/7 service and support network, SAP(R) Active Global Support. The new support center in Dalian will be staffed initially with more than 130 native speakers of Chinese, Japanese, Korean, and English. With an investment of EUR 10 million, the facility has been built with capacity for workforce expansion as the number of serviced customers increases. For details, visit http://www.SAP.com.

GenoLogics Life Science Software Announces a New Chief Executive Officer

GenoLogics, developers of proteomics laboratory information management system ProteusLIMS, has announced the appointment of a new Chief Executive Officer, Michael Ball. Michael brings with him 18 years experience of technology and senior management experience, with a particular emphasis on business development, sales, marketing, operations and customer service in high growth environments. Michael has a sound knowledge of
mergers, acquisitions and strategic partnerships as well as extensive international experience. Previously, Michael has held VP positions at both Creo and Carmanah Technologies. Michael will work closely with company founder James DeGreef, who will move to the position of President. For details, visit http://www.genologics.com.

ARC Research Sees Need to Automate Data Collection Fueling Growth in Fixed vs. Portable RFID Readers

Manufacturers who are subject to RFID mandates must ensure that their consulting and solution providers implement automated product data flow and hands-free data generation through the use of fixed RFID infrastructure versus manual portable equipment. Fixed RFID readers are necessary in order to fulfill RFID's supply chain automation vision and eliminate the incremental labor and material handling costs associated with current slap-and-ship techniques. According to ARC's just-issued report, RFID Systems in the Manufacturing Supply Chain, RFID's lack of reliance on line-of-sight readings enables widespread use of fixed readers, whose shipments are expected to grow at a Compounded Annual Growth Rate (CAGR) of 64.6 percent over the next five years. The total market for RFID Systems used in manufacturing supply chain applications, including tags, readers, and other hardware infrastructure, totaled $65.8 million in 2003 and is forecasted to grow to almost $3.8 billion in 2008. Today's typical RFID compliance tagging scenario involves labor-intensive, end-of-line slap-and-ship operations that are usually performed in a warehouse or distribution center. This approach is costly because of the typical reliance on standalone stations that employ manual handling, exception routing, and, consequently, increased labor requirements. "More ominously, slap-and-ship is not a scalable approach that can be ramped up to production volumes in conjunction with the rapidly escalating time lines embodied in customer mandates. Enabling increased product output is particularly crucial in the ramp-up from pilot to production, since early findings reveal that RFID can have a negative impact on production rates," says ARC Vice President Chantal Polsonetti, the principal author of ARC's RFID Systems in the Manufacturing Supply Chain. RFID readers are part of the infrastructure that enables EPC data to move through the RFID-enabled supply chain. Fixed readers for shipping and receiving dock doors, overheads, and vehicle and forklift mounts should be the choice of manufacturers since they enable the type of automation which results in personnel reductions. Data collection occurs automatically as tagged items, cases, or pallets pass fixed readers mounted on conveyors, dock doors or forklift trucks, with no human intervention required. Hands-free operations through the use of fixed readers and other RFID infrastructure which are part of the factory or distribution center infrastructure will eliminate the incremental labor and material handling costs associated with current slap-and-ship techniques. Consequently, manufacturers should ensure that their RFID consultants, system integrators, and enterprise software providers are partnering with technology providers who provide this type of capability and enable hands-free operation and automated data flow. For details, visit http://www.arcweb.com/res/rfid.

House Mulls Law to Create Mandatory Registry for all Trial Data

House lawmakers, concerned about drugmakers suppressing negative clinical trial data and the FDA’s inability to compel firms to release all drug studies, have vowed to introduce legislation that would establish a mandatory registry for clinical trials of drugs and biologics. The bill, to be introduced by Democratic Reps. Edward Markey of Massachusetts and Henry Waxman of California, would expand on the government’s ClinicalTrials.gov website managed by the National Institutes of Health to ensure the public has access to information on ongoing clinical trials and to results of the studies after they have been completed. Among other things, the bill would require the timely posting of study results that are not published in peer-reviewed medical literature. It also would contain strong enforcement mechanisms, including civil monetary penalties for noncompliance, according to the lawmakers. For details, visit http://www.fda.gov.

Generic Drug Industry May be Headed for Consolidation

Increasing competition in the generic drug market may drive a wave of consolidations among generic drugmakers in the next few years, according to an industry analyst. One likely target is Watson Pharmaceuticals, which has a 12-percent share of the U.S. generic drug market, according to Michael Krensavage, a financial analyst
with Raymond James. Basing his forecast on factors that include acquisition speculation, Krensavage said Israel-based Teva Pharmaceuticals and the Swiss firm Novartis, whose Sandoz unit has a major presence in the U.S. market, are likely suitors for Watson.The trend toward acquisitions may have begun last month when the two largest generic companies continued to make inroads on both sides of the Atlantic when Teva acquired Pfizer’s Italian generic pharmaceutical marketing firm, Dorom, and Sandoz bought Sabex holdings, a leading Canadian generic injectables firm. For details, visit http://www.fda.gov.

PerkinElmer Boosts LIMS Productivity with New Labworks Graphical User Interface

PerkinElmer, Inc., a leading provider of drug discovery, life science research and analytical solutions, has announced a new version of its LABWORKS ES laboratory information management system (LIMS) software based on a completely new interface designed to further simplify operation and improve user productivity. Styled after the familiar Microsoft Outlook graphical interface, the new LABWORKS ES software uses a standard tree structure as well as menus and tool bars for simple navigation and greater ease of use. New and experienced users will save time through fewer clicks to accomplish the same tasks as before. Through the improved, highly intuitive interface, new users will have a sharply reduced learning curve. This is the second update this year to the LABWORKS ES software and is part of PerkinElmer’s new update policy, which brings new functionality to users every three months. Users have the option to update LABWORKS each quarter or can update less frequently. PerkinElmer studies have shown, however, that regular updates contribute to productivity gains and reduce disruptions to workflow as changes are introduced more incrementally during a frequent update cycle. The initial 2004 LABWORKS update focused on significantly improving scheduling, organizing and reporting of critical laboratory data. Among the new capabilities was a Process Scheduler module used to schedule routine sampling and to monitor sample statuses throughout an organization based on time, frequency, sample locations, and type of analysis. Other additions included a sophisticated new query function that makes it easy for users to work with data in both LABWORKS and outside databases. For details, visit http://www.perkinelmer.com.

STARLIMS Corporation Awarded GSA Schedule 70 Contract for LIMS Award Facilitates a Simplified Purchase of LIMS by Federal Customers

STARLIMS Corporation has been awarded a Schedule 70 contract by the U.S. General Services Administration (GSA), the procurement arm of the federal government. GSA Schedule 70 provides federal agencies on a worldwide basis with information technology (IT) and telecommunications hardware, software, and professional services. The Schedule 70 award supports STARLIMS' increasing involvement in large scale government LIMS projects in areas of public health, food and water supply and scientific investigations. Since there is no maximum order limitation under the multiple-award schedule, customers can use Schedule 70 to support large-scale, multi-million dollar LIMS implementations. Federal agencies can obtain information about STARLIMS by searching for Contract Number: GS-35F-0660P. The contract period is for five years, July 9, 2004 - July 9, 2009 with three separate five-year options. STARLIMS licenses and services are offered under the following Special Item Numbers:
* SIN 132-33 - Perpetual STARLIMS Software Licenses
* SIN 132-34 - Maintenance of STARLIMS Software
* SIN 132-50 - STARLIMS Training Courses for Information
* SIN 132-51 - Professional Services
For details, visit http://www.starlims.com.

STARLIMS and Orion Systems International Partner for Public Health

Orion Systems International Inc, a leading provider of clinical workflow and integration technology to the healthcare industry, and STARLIMS Corporation, ae global provider of Laboratory Information Management Systems, (LIMS), have announced a partnership to address the need for rapid and unified exchange of laboratory data between information systems and organizations. STARLIMS will embed Orion's RhapsodyT Integration Engine in their LIMS solution, leveraging Rhapsody's support for HL7 Version 3 W3C messaging schemas for the reporting of surveillance data and the Public Health Information Network (PHIN) message transport required for the secure
transmission of public health data. The use of RhapsodyT will significantly reduce the complexity involved for
public health partners when extracting or populating data from the STARLIMS system. The partnership between Orion and STARLIMS is particularly targeted at providing support for agencies involved in the Centers for Disease Control's nationwide PHIN initiative, which aims to build a standard framework for the consistent exchange of response, health, and disease tracking data between public health partners throughout the United States. For details, visit http://www.starlims.com.

Autoscribe Introduces Software Module for Managing Calibration and Maintenance Routines

Autoscribe has introduced a new software module for managing calibration and maintenance routines that will enable laboratories to keep all instruments in prime working order and to avoid expensive down-time. This is a standalone package or a module for the MATRIX LIMS package, developed by Autoscribe. The same module also provides for keeping a full inventory of all equipment, including warranty details and lists of consumables, along with calibration limits and other performance criteria. The system will assist any laboratory to keep instrumentation in good order and available for use, by alerting managers of when and how equipment needs to be calibrated. Spurious and unreliable results are avoided because equipment is automatically assigned an unavailable status when the calibration or maintenance period is overdue. Costs and equipment down-time can also be tracked, potentially valuable information when considering or negotiating future equipment purchases. For details, visit http://www.autoscribe.co.uk.

Resource Management and Scheduling Focus of Newest Release of QATrax

TraxStar demonstrated the resource management and scheduling capabilities of QATrax 3.3, its newest release, at IEEE's EMC 2004 Symposium in August 2004. QATrax 3.3 offers increased productivity with enhanced visibility over resource schedules. Additional resource views now display scheduled activities for people and equipment side-by-side, mimicking the intuitive display of the traditional whiteboard. Gaps in the schedules are highly visible cues of resource availability. Each user can configure what they see, resource by resource. For details, visit http://www.traxstar.com.

New LIMS Industry Study Confirms Standardization Reduces Total Cost of Ownership

Thermo Electron Corporation has announced findings from a market survey on LIMS (Laboratory Information Management System) standardization and Total Cost of Ownership (TCO), conducted on its behalf by IDC, a Framingham, Massachusetts-based research and consulting firm. The new study identifies and quantifies a number of compelling benefits that can be realized from harmonizing processes and standardizing on a single global LIMS. Entitled "Standardizing on LIMS: TCO and ROI for the Multi-Lab Setting", the study is the first of its kind to investigate the IT and business value of LIMS standardization. A White Paper resulting from the study is available on the company's website. IDC's study is based on in-depth interviews with senior LIMS and IT managers at leading companies, in industries such as pharmaceuticals, chemicals, food and beverage, and oil and gas, that have either standardized or are in the process of standardizing on one LIMS solution. Participating companies, including Thermo LIMS customers, cited the potential for reduced IT personnel, improved reporting and easier access to data as the principle reasons for standardizing on one LIMS. Key findings of the study include:
* Companies reported as much as a 40% reduction in TCO by standardizing on one LIMS.
* Annual benefits of approximately $300,000 per lab were realized from implementing a standardized LIMS.
* On average, companies improved IT efficiency and were able to reduce their IT staff supporting LIMS by 57%.
* User support activities, applications management and validation, time devoted to troubleshooting and data management were typically reduced by as much as 90%. TCO is a business concept model that helps organizations account for all direct and indirect costs incurred throughout the lifecycle of an IT asset, from original acquisition through retirement. For details, visit http://www.thermo.com/informatics.

Thermo Electron Appoints Global Sales Director for Informatics Business

Thermo Electron Corporation has announced the appointment of Bill Summers as the Global Sales Director,
Informatics. In this newly-created role, Summers will be responsible for all commercial aspects of the Informatics business on a worldwide basis, driving sales of Thermo's market leading informatics solutions, including SampleManager and Nautilus LIMS and the Atlas Chromatography Data System. Prior to joining Thermo, Bill Summers spent over nine years with Aspen Technology in a variety of business development roles, most recently as Vice President of Sales for chemicals/pharmaceuticals. He was previously a manager in the mergers & acquisitions group of UOP. Summers graduated with a degree in Chemical Engineering from the University of Connecticut in 1984 and received his MBA from the University of Houston in 1991. For details, visit http://www.thermo.com/informatics.

Scientific Software Announces EZChrom Elite Support for Windows XP Service Pack 2

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 has been tested and validated to operate using Microsoft’s Windows XP Service Pack 2. This ensures that users will be able to take advantage of the many security enhancements provided by this very important update to Widows XP. In August 2004, Microsoft released a significant update to Windows XP, called Windows XP Service Pack 2 (SP2). Windows XP SP2 provides a number of long-requested fixes and enhancements related to network communications, buffer overflow protection, e-mail attachments and Internet Explorer security. However, many software applications are not yet able to operate under SP2. Scientific Software's EZChrom Elite Version 3.1.4 fully supports Windows XP SP2. Existing customers can download the SP2 update for EZChrom Elite from the Scientific Software website. 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.

Agilent Technologies Introduces Pharmaceutical Method Validation Software

Agilent Technologies Inc. has announced the latest version of its software for validating analytical methods according to the regulations of the pharmaceutical industry. The new method validation pack version A.02.01 for Agilent's ChemStation Plus chromatography data system (CDS) provides solution stability calculations for short- and long-term stability studies as defined by the International Conference for Harmonization (ICH). The software further offers major productivity improvements for validation planning, execution and reporting. The method validation pack is a software module that features advanced statistical calculations and result management in a relational database, and integrates seamlessly with the ChemStation Plus CDS. It supports automated method validation from planning to final reporting according to ICH, Pharmacopoeia and FDA guidelines, including 21 CFR Part 11. Version A.02.01 supports stability testing of drugs over the short term (24 to 72 hours) and long term (12 to 24 months) according to ICH Q1A and Q2B guidelines. Stability testing is routinely used to monitor how the quality of pharmaceutical ingredients and products change over time and under different environmental factors, and to develop recommended storage conditions. For details, visit http://www.agilent.com.

Agilent Technologies to Acquire Silicon Genetics, Leading Provider of Life Science Informatics

Agilent Technologies Inc. and Silicon Genetics have announced an agreement for Agilent to acquire Silicon Genetics, a leading provider of software solutions for life science discovery. With the addition of Silicon Genetics' genomics data analysis and management tools to its portfolio, Agilent will become a market leader in life science informatics. The acquisition is subject to closing conditions, and financial details of the agreement were not disclosed. Silicon Genetics, privately held, has been recognized as one of the fastest-growing technology companies in North America with inclusion on the Deloitte Technology FAST 500 and several other industry rankings. Silicon Genetics' customers include more than 600 leading pharmaceutical companies, academic institutions and major research organizations around the world. Based in Redwood City, Calif., Silicon Genetics employs 50 people, most of whom are expected to join Agilent. Together, the staffs of Silicon Genetics and Agilent will form a life science informatics team that will be an incubator for informatics products spanning DNA, RNA, protein and pathway applications. The team will work on developing the products of Silicon Genetics, the Agilent Spectrum Mill proteomics workbench, the Agilent Synapsia informatics workbench and more. For details, visit http://www.agilent.com.

ChemSW Releases New, Configurable Chemical Inventory System for Multinational, Multisite Applications

ChemSW, Inc. has introduced CISPro Global Chemical Inventory System, a new program designed to meet the needs of large companies with many users in multiple facility locations. CISPro Global's software framework allows it to operate in regulated and non-regulated environments, or in a combination of both, for an unlimited number of users. The system has already been installed at Procter and Gamble, where it is being implemented across their multinational, multibusiness R&D environments. CISPro Global incorporates the inventory management functionality of ChemSW's core product line in a new application framework that allows virtually unlimited custom configuration to meet changing and evolving processes and workflows. At the same time, the software framework enables ongoing upgrades and support of the system, regardless of the degree to which the system is user-configured. CISPro Global delivers all the necessary tools to accurately track chemicals and supplies and meet safety and regulatory requirements, including bar code labeling, remote inventory control, document linking and links to MSDSs. The new system allows the tracking of an unlimited number of material classes, including reference standards, with multiple security layers. Materials can easily be designated as GMP or lab use only, and inventories for individual business units can be maintained independently, within a single global database. The system interface can be adjusted based on custom logins, allowing the customer to specify what data each individual can access. For details, visit http://www.chemsw.com.

EarthSoft Announces EQuIS Data Processor Microsoft .Net Certification

EarthSoft has announced certification by Microsoft’s ISV program of the EQuIS Data Processor (EDP), which was tested by Microsoft. EarthSoft continues to work closely with Microsoft, moving from a Microsoft Solutions Provider to a Microsoft Certified Partner in the ISV program. "As a result of this certification, EarthSoft joins a group of ISV’s (Independent Software Vendors) who are committed to meeting the high standards of Microsoft’s integration criteria," says Jigish Avalani, Director of US ISV Team at Microsoft Corp. “Today, Microsoft recognizes EarthSoft for its skills and expertise in providing business efficiencies with Microsoft products and technology.” EDP is the first lab checking program tested and certified by Microsoft. Over 100 labs in the US now have either the EDP or ELDC, making EQuIS EDD checking tools the most widely used in the industry. The new EQuIS Data Processor (EDP) is an application built on the Microsoft .NET Framework, which utilizes modern W3C standards (including XML and XML Schema) for defining and checking EDDs. EDP and the companion format definitions can include custom checking of content, layout, valid values, and relational checks never before possible in a comparable tool. Additionally, EDP Online offers web-enabled data checking tools for automated processing in high volume operations that must check thousands of EDDs every month. For details, visit http://www.earthsoft.com.

Atrium Research Delivers First Industry Report on Emerging Market for Electronic Laboratory Notebooks

Atrium Research & Consulting, a market research organization dedicated to scientific informatics, has announced the release of the first independent industry report on the emerging Electronic Laboratory Notebook (ELN) market. Entitled "Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management", this nearly 200 page report is the culmination of months of in-depth research and analysis on ELN best practices, customer requirements, key suppliers, legal issues, benefits, and industry trends. The ELN market size is analyzed along with growth rates and supplier market shares. Additionally, the use of ELN technology to enable an enterprise knowledge management strategy is investigated. Over 50 charts, tables and figures illustrate key points. Paper laboratory notebooks have been used for hundreds of years. Despite billions of dollars of investment in computer technology and automated instrumentation, the paper notebook has remained as a final repository of experimental data and results. An ELN not only replaces the paper notebook, but also enables collaborative and electronic R&D. It is designed for intellectual property protection, support of patent and drug applications, streamlining operational processes, knowledge management, and compliance with government regulations. ELNs are utilized in drug discovery, food development, packaged goods R&D, medical device design, chemical manufacturing, and for many other applications. The potential market for ELN technology is large - over $1 billion – and sales of vendor solutions are growing over 30% per year. With over 25 ELN suppliers offering a wide range of capabilities and features, prospective users can gain the knowledge and insight they need to make an informed vendor selection. Best practices and details on common needs will help them to streamline requirements and project planning. Informatics suppliers and developers can discover the keys to success in this fast growing market. For details, visit http://www.atriumresearch.com.

Nonlinear Dynamics and Matrix Science Integrate Leading Proteomics Software Products

Nonlinear Dynamics Ltd., a leading provider of bioinformatics solutions, has announced a close technical collaboration with Matrix Science Ltd. Under this agreement, Nonlinear Dynamics’ protein informatics system will be enhanced to provide seamless integration with Matrix Science’s Mascot Server. Produced by Matrix Science, Mascot is a powerful search engine which uses mass spectrometry (MS) data to identify proteins from primary sequence databases. This new collaboration sees the incorporation of a Mascot interface into Nonlinear’s upcoming protein informatics platform, providing an integrated solution for the analysis and identification of proteins through MS.
The protein informatics range follows the researcher’s workflow, including experiment set-up, 2D gel image analysis, data-mining and MS-based protein identification. The central database integrates all data generated during this workflow and provides powerful data-mining tools to identify trends, patterns and outliers. Following this agreement, the system will be enhanced to enable users to link directly to a Mascot server. This will enable users to perform Mass Spectrometry searches employing Matrix Science's proven methods of searching, including peptide mass fingerprinting, and MS/MS ions searches. For details, visit http://www.nonlinear.com.

Labtronics Introduces Analyze XLerator for Excel

Labtronics Inc. has announced the introduction of Analyze XLerator, a new laboratory software package that uses Microsoft Excel as a platform for automating both data collection and the processes that generate laboratory data. Analyze XLerator can automate any analytical procedure that uses RS232 or TCP/IP instruments. Pre-configured Excel templates for ASTM and EPA Standard Methods such as BOD, pH, EC, ISE, AA, TOC, Colorimetry and a number of weighing applications are included with the software. The templates are fully configurable. Users can add additional functionality or create new templates for other test procedures performed in the lab. At run-time, Analyze XLerator automatically opens an Excel template and adds a floating toolbar to the spreadsheet that the analyst uses to start their automated procedure. This familiar working environment allows analysts to readily adapt to this automation technology. For details, visit http://www.labtronics.com.

Labtronics Releases Nexxis ST Solution for Laboratory Sample Tracking

Labtronics has released Nexxis ST, the newest member of the Nexxis LAB suite of products, which provides small to medium sized laboratories with an affordable system for storing and tracking their test results. Nexxis ST can replace paper based systems with a secure automated system that provides users throughout the lab with direct on-line access to sample information. Users can log in their samples, assign tests to the samples and record the sample results in the Nexxis ST database. Samples can be entered singly or as batches. Tests can be arranged in groups to simplify the assigning of tests to samples. Sample results can be entered manually or Nexxis methods can collect data directly from laboratory instruments and automatically populate the result database. In addition to the sample tracking capabilities of Nexxis ST, the Nexxis LAB suite provides automation of laboratory procedures and SOPs and includes modules for Chemical Inventory Management, Calibration Management and Balance Automation. For details, visit http://www.labtronics.com.

Labtronics Releases New Version of LimsLinkCDS

The latest release of LimsLinkCDS, includes new configurable Chromatography Data System interfaces for Millennium 32, Empower, TotalChrom, ChemStation and Galaxie, that significantly reduces the amount of time and resources required to implement and use a CDS/ LIMS interfacing solution. This new generation of LimsLinkCDS interfaces employs the latest technology, embedded interfacing, to give analysts an automated process for sequence creation that they can start with a single mouse click, from within their CDS. New menu items in the CDS give analysts direct access to their LIMS, allowing them to create sample worklists without having to leave the CDS application. The analyst can view and edit the worklists to ensure they are complete and accurate before they are automatically expanded to include standards, check samples and replicates. For details, visit http://www.labtronics.com.

Acsis Launches RFID Quickstart for CPG & Pharma

Acsis Inc. has announced its Quickstart program to give CPG and pharmaceutical companies the components and vertical functionality necessary to implement an RFID system with low risk. According to the company, Quickstart provides low total cost of ownership for compliance and a scalable platform for integration. Two distinct preconfigured solution packages are tailored to help consumer products and pharmaceutical companies meet trading partners’ radio frequency identification (RFID) compliance mandates including Wal-Mart. Each solution includes a fixed-reader station, smart-label printer, light stacks, services and software based on Acsis’ Adaptive Device Integration Platform. The Adaptive Device Integration Platform is an open, Web services-based device integration technology for EPC commissioning management and integration of devices regardless of vendor, including RFID readers, barcode scanners, printers, optical & density sensors, palletizers, programmable logic controllers (PLC’s), weigh scales, and OPC-based production equipment. For details, visit http://www.acsisinc.com.

Bruker BioSpin Announces World's First Actively-Shielded 900 MHz NMR Magnet

Bruker BioSpin Corporation has announced the new 900 US2 magnet, the world's first actively-shielded 900 MHz superconducting magnet for NMR applications. The 900 US2 combines Bruker BioSpin's proprietary UltraShield and UltraStabilized technologies, delivering the highest field strength actively-shielded magnet available today. UltraShield technology reduces the magnetic stray fields by an order of magnitude over non-shielded magnets, allowing a footprint that is one-fourth the size of a conventional, non-shielded 900 MHz magnet. Bruker BioSpin's proven UltraStabilized sub-cooled magnet technology operates the magnet coil at 2o K, providing exceptionally stable performance. The 900 US2 features a compact design that enables it to fit in the same size cryostat as the conventional non-shielded 900 MHz magnet. Bruker BioSpin now offers US2 magnet models at two field strengths - 800 and 900 MHz. Combined with Bruker BioSpin's Avance NMR spectrometer, they are ideal for structural biology applications. For details, visit http://www.bruker-biospin.com.

Bruker Announces New NMR Sample Rail Automates Preparation for Increased Throughput

Bruker BioSpin Corporation has introduced the new SampleRail for NMR. The Sample Rail enables fully automated sample preparation and delivery for 24-hour, hands-off, high-throughput NMR operation. The system interfaces with a liquid handling robot, which prepares the samples in NMR tubes and then transports them on a rail system to the magnet. The liquid handler is synchronized with the NMR experiments for just-in-time sample preparation, ideal for unstable samples requiring analysis immediately after preparation. The SampleRail increases the utility of NMR in various high-throughput applications such as metabonomics, SAR (structure activity relations) by NMR, protein-ligand binding detection and other drug discovery methods. The SampleRail is compatible with all Bruker BioSpin Avance NMR spectrometers, and is controlled by Bruker's SampleTrack laboratory information management system software. For details, visit http://www.bruker-biospin.com.

Bruker Introduces New NMR Accessory that Automatically Tunes CryoProbe

Bruker BioSpin Corporation has announced an Automatic Tuning and Matching (ATM) accessory for their family of CryoProbe products. Available for all new and future CryoProbes, this accessory provides precise, sample-to-sample adjustments, for higher sensitivity and performance. Ideal for automated, high-throughput NMR applications, the unique ATM accessory automatically tunes and matches the probe, ensuring unattended system optimization for each individual sample. Probes with the ATM can be used with all Bruker BioSpin Avance NMR spectrometers. For details, visit http://www.bruker-biospin.com.

FDA Considers Guidance on Pharmacogenomic Combination Products

As the FDA prepares to issue a final guidance document on submitting pharmacogenomic data, the agency is in the early stages of developing a new guidance on how a genetic testing device could be co-developed with a drug or biologic to create a new combination product. In the foreseeable future, there likely will be genetic tests that influence pharmacologic intervention, Janet Woodcock, the FDA's acting deputy commissioner for operations, said during a pharmacogenomics workshop on the co-development of drug, biological and device products. The problem is that the pharmacologic and testing categories have usually been considered separate entities for regulatory, reimbursement and clinical purposes, she said. The workshop, sponsored by the FDA and the Drug Information Association, discussed ways to close the gap. The new guidance initiative is the FDA's latest move to stay ahead of the curve in the burgeoning field of pharmacogenomics. Last November, the FDA issued a draft guidance urging drugmakers to voluntarily submit pharmacogenomic data when possible. The final guidance on submitting data will be out very soon, Woodcock added. For details, visit http://www.fda.gov.

FDA Issues Guidance for Engaging Biotech Clinical Trial Consultants

The FDA has released a guidance document that instructs clinical trial sponsors on when and how to request that the agency engage an independent consultant to participate in reviewing clinical studies, which serve as the primary basis of efficacy claims. The guidance — part of a commitment the FDA made as an addendum to the Prescription Drug User Fee Amendments of 2002 — is intended to speed the development and review of human drugs. The document also finalizes a draft guidance that was published in May 2003. Comments on the guidance will be accepted until Aug. 19, 2005, and can be submitted electronically to www.fda.gov/dockets/ecomments. Written comments can be sent to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. To view the Federal Register notice about the guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0112-nad0002.pdf. To view the guidance document, titled “Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols,” go to http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0112.gdl00001.pdf.

FDA to Re-open 1996 Draft Guidance on Obesity Drugs

The FDA wants to encourage the pharmaceutical industry to devise drug-based treatments for obesity and near obesity. In a speech earlier this month, FDA acting Commissioner Lester Crawford said there are numerous opportunities for the development of safe and effective obesity drugs, and suggested that re-opening a 1996 draft guidance on weight-control drugs could push that development forward. To that end, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee will re-open the 1996 draft guidance on the development of weight-control drugs for discussion at a meeting Sept. 8. The FDA issued a solicitation for comments on its 1996 draft guidance earlier this year; the final guidance is expected to be issued later this year, Crawford said. For details, visit http://www.fda.gov.