LIMSource Calendar of LIMS, Informatics and Lab Data Automation Conferences and Trade Shows

• LIMS Market to Grow to $366 Million with Huge Upside Potential
• Desert Moon Technologies Finalizes Acquisition of Forensic Technology LabPlus Technologies Operations
• PESC Replaces a Legacy LIMS with StarLIMS
• L.i.M.S. Announces Key Leadership Appointment
• Autoscribe Announces StabilityTracker to Track and Report the Status of Pharmaceutical Stability Testing
• SampleManager IDI 2003 from Thermo Electron Enhances Integration Between LIMS and the Enterprise
• Thermo Electron Extends Relationship with IBM to Enterprise LIMS Business
• Accelerated Technology Laboratories will Exhibit at the Eastern Analytical Symposium 2003
• Bio-Rad Offers Free, Downloadable Chemistry Drawing, Publishing, and Spectroscopy Applications for Academia
• Bio-Rad’s KnowItAll 3.0 Offers Enhanced Features for ADME/Tox & MS
• SAP Ships Solution for Master Data Management
• Novo Nordisk IT to Become Certified Service Provider for NuGenesis Technologies Products
• Scientific Software Recognized as Top 25 Company Fourth Year in a Row
• Scientific Software Announces Free Software Utility
• Scientific Software Announces Release of CyberLAB KES in Kanji
• ChemSW's New Chemical Inventory System Module Links Unlimited Number of Documents
• CSols and Wavefront Software Announce New Alliance
• LabCon Delivers New Wireless Interface Connector Solution for Interfacing RS 232 Instruments
• Labtronics' NEXXIS Integrates RS232 Instruments with NuGenesis SDMS
• Labtronics B.V. Expands in Europe
• SQassim Cement Company and ABB Sign Contract for PL-1 Upgrade Project
• GAO Recommends Better Tracking of Minorities in Pediatric Trials
• Thermo Offers New Generation of ActiveApps for Spectral Data Processing
• Thermo Electron Publishes New Brochure on eRecordManager Data Archival Solution
• Autoscribe Releases Matrix CRS - Compound Registration Systems
• Autoscribe Announces Configurable Approach to Managing Employee Training Needs
• Algorithme Pharma Purchases InnaPhase Corporation's Watson LIMS in Canada
• ABB and Nicklas & Partner Join Together to Provide Collaborative Production Management Solutions
• Bio-Rad Announces New Software Technology for In-Silico ADME/Tox Consensus Modeling
• Bio-Rad's KnowItAll Informatics System 2.2 Offers Enhanced Features for NMR, MS, and 3D Structure Drawing
• JEOL USA and ACD/Labs Introduce Automated Structure Elucidation for NMR
• Agilent Technologies to Integrate its HPLC and ChemStation Solutions with Advanced Chemistry Development's AutoChrom and ChromGenius Software
• Agilent Technologies Reports Third-Quarter 2003 Results; Company on Track to Achieve Profitability in Fourth Quarter
• Labtronics Announces Software Upgrade for Technicon AAII and Alpkem RFA Instruments
• Caliper Technologies Acquires Zymark Corporation
• Oracle Introduces Several New Products
• SAP Expands mySAP Customer Relationship Management (mySAP CRM)
• SAP Supports WS-I Basic Profile 1.0
• FDA Applies Risk-Based Approach to Preapproval Inspections
• FDA's cGMP Initiative Aims to Boost Safety, Efficiency
• FDA Releases Part 11 Guidance, More Revisions May Come
• FDA, GPhA Launch ANDA Review Cycle Initiative

LIMS Market to Grow to $366 Million with Huge Upside Potential

The worldwide market for Laboratory Information Management Systems (LIMS) is expected to grow at a Compounded Annual Growth Rate (CAGR) of 4.8 percent over the next five years. The market for these commercial-off-the-shelf (COTS) applications is projected at $290.3 million in 2003 and is forecasted to be $366 million in 2008, according to a new ARC Advisory Group study. Manufacturers of all sizes across industry boundaries are recognizing that home grown systems may not be cost effective. “The perception that commercial LIMS solutions require extensive customization is outdated. Manufacturers are displaying an increased willingness to implement moderately customized, out-of-the-box solutions to decrease their LIMS Total Cost of Ownership (TCO),” according to Senior Analyst Paula Hollywood, the principal author of ARC’s “Laboratory Information Management Systems (LIMS) Worldwide Outlook.” This study projection is for the commercial LIMS hardware, software, and services market. When home grown LIMS solutions are included, ARC estimates the potential for this market to be between $550 to $750 million dollars; i.e., two to three times current forecasts. A huge upside opportunity is the conversion of these custom solutions — with their inherent high total cost of ownership to out-of-the-box solutions. Recognizing the difficulty convincing users to ditch their home grown systems for packaged software, these numbers are not part of the forecast. But, if someone can tap into this area, this market has great upside potential. Additional information on this market study can be found at http://www.arcweb.com/res/lims.

Desert Moon Technologies Finalizes Acquisition of Forensic Technology LabPlus Technologies Operations

DMT-LabPlus, Inc. (DMT) and Desert Moon Canada Holdings, Inc.Technologies Company, each a subsidiary of Desert Moon Technologies, Inc. a life-sciences,environmental, and health an information management solutions firm, and Forensic Technology WAI, Inc. (FTI), a worldwide leader in forensics LIMS, ballistic information systems, and evidence management systems, have announced that DMTC has acquired the LabPlus Technologies worldwide LIMS software business from FTI. As a result of this acquisition, the worldwide LabPlus Technologies software business will become a division of DMCH DMT with headquarters in Phoenix, Arizona, USA. Canadian offices will remain in Montreal, Quebec and will be responsible for the LIMS software business product evolution, development and North American customer support. The European offices will be relocated, and the support team will remain within Dublin, Ireland. Ireland and will be responsible for providing professional services and customer support to the European and Middle Eastern customer base. DMCH DMT will retain the LabPlus product brand and all customers and partners but will change the company name to DMT-LabPlus, Inc. Announcements for expansion plans within key US markets are expected in the coming weeks. “As more companies begin to embrace the importance of and organizational value gained from enterprise-wide laboratory information solutions, we want to be positioned as the visionary responding to the industry’s changing business needs. Acquiring LabPlus Technologies allows us to leverage our depth and expertise with laboratory analytical support, information intelligence and reporting with laboratory workflow automation and project management”, said Ron Hardin, President and CEO of DMT. “This gives our customers one more reason to choose DMT as their software provider of choice for complete laboratory solutions and moves us closer to our strategic goal of being the preferred full life-cycle solution from discovery through manufacturing. Our integrated approach to gathering, managing, analyzing and sharing information uniquely positions us in the market place and is a clear distinction between us and our competition. We will continue to build cost-effective solutions and seek out technology alliances that minimize business service interruption during integration as well as reduce the cost of ownership. Most important, however, is that we instill confidence and demonstrate value for the existing LabPlus customer base during the transition period. We want to ensure our new customers that in joining the DMT team they will see no interruption to their existing support services, and that they will benefit greatly from forthcoming releases to the product,” said Mr. Hardin. For details, visit http://www.dmteks.com.

PESC Replaces a Legacy LIMS with StarLIMS

Pacific Environmental Science Centre (PESC) has replaced their legacy LIMS with a StarLIMS solution. With multi-functionality required, covering 105 applications, and with 12 functional areas of the laboratory and around 500,000 tests conducted per year, Richard Stubb, Head of Scientific Support at the Pacific Environmental
Science Centre (PESC) describes the migration of 25 years of database programming within 117 days in a PDF available from the L.i.M.S. Ltd web site at http://www.starlims.com/PESC_DataSheet.pdf.

L.i.M.S. Announces Key Leadership Appointment

L.I.M.S. (USA) Inc. has announced the appointment of Jeff Ferguson, as its new Chief Operating Officer. In Jeff's new position he will direct the company's product development, general management of sales, marketing, professional services, and operations. Jeff brings the company over 15 years of industry expertise combining operational know-how and leadership. For details, visit http://www.starlims.com/KLA.htm.

Autoscribe Announces StabilityTracker to Track and Report the Status of Pharmaceutical Stability Testing

Autoscribe has announced the availability of a program to assist stability groups track and report the progress of FDA mandated trials. Recently Autoscribe introduced Matrix Stability 2.0, the latest version of their powerful stability data management system, which can be supplied as a stand-alone product or as an integrated module of Matrix Plus LIMS. This new release contains comprehensive functionality to develop, approve, execute and record all aspects of a stability study from protocol definition to result reporting. Autoscribe has developed StabilityTracker in response requests from companies that already have a validated LIMS, which supports their QC testing but that has limited functionality for their stability group. This new stand-alone product supplements but does not replace the existing LIMS. It records all details concerning a study and the multiple lots that are part of the study, including formulation and packaging information. StabilityTracker prompts when pulls are due and displays which tests must be carried. It records and reports when the pulls have been made and when tests are completed. It also records who carried out each activity. It is a much more secure and compliant way of recording this information than discrete Excel spreadsheets. In addition, StabilityTracker contains a complete audit trail and access to all functions and data is tightly controlled. It is developed by Autoscribe in an ISO 9002 certified process using modern lifecycle techniques. Full requirements, design and testing documentation is available; audits are welcomed.For details, visit http://www.autoscribe.co.uk.

SampleManager IDI 2003 from Thermo Electron Enhances Integration Between LIMS and the Enterprise

Thermo Electron Corporation has released SampleManager IDI 2003, the latest generation of software integrating Thermo’s SampleManager LIMS and SAP AG’s R/3 Enterprise, the leading Enterprise Resource Planning (ERP) system. Combining Thermo’s flagship LIMS with SAP AG’s R/3 Enterprise gives customers an enhanced ability to provide consistent quality-related information to the entire enterprise. To leverage the full benefits of modern ERP solutions, organizations require automated access to all aspects of their business, including the process laboratory. Organizations interfacing LIMS with an ERP system can expedite the data flow between the laboratory and manufacturing, streamline data handling, and integrate data collection and reports. SampleManager IDI, the first LIMS interface to be certified by SAP AG, was developed to address the needs of large-scale production facilities where integration with ERP systems is a business requirement. SampleManager IDI 2003 enables SAP customers to fully utilize new functionality in R/3 Enterprise Quality Management (QM) module, while benefiting from the use of a specialist, functionally rich ‘enterprise-centric’ LIMS product within the laboratory. A simple point-and-click interface allows creation of data through SampleManager or R/3 Enterprise, and the ability to easily map critical business needs into the LIMS database. Graphical table-driven SAP objects and user-driven mapping procedures ensure easy access to accurate information in the LIMS, in a flexible, easily understood format. SAP customers upgrading to a new version or customizing their R/3 Enterprise deployment can update the table-driven SAP objects in SampleManager IDI in a matter of minutes. For details, visit http://www.thermolabsystems.com.

Thermo Electron Extends Relationship with IBM to Enterprise LIMS Business

Thermo Electron Corporation hasannounced that it has expanded its relationship with IBM to pursue co-operative business opportunities in the global LIMS marketplace. Thermo and IBM will work together to create solutions that leverage Thermo’s LIMS expertise with IBM eServer system architecture. An intensive cycle of system testing was recently performed on Thermo’s Nautilus and SampleManager LIMS running on an IBM eServer xSeries 235. Over 19,000 individual tests were performed using a combination of automated and manual scripts between April and June 2003. Thermo reports that the processing power and capacity of the IBM server, hosting the latest versions of both LIMS servers and databases, provided a smooth and highly efficient testing result. IBM hardware is now an integral part of Thermo’s LIMS testing environment, providing increased assurance of the resilience and quality of the Thermo/IBM integrated solution. With an installed base of over 1,100 systems and around 45,000 daily users worldwide, Thermo’s SampleManager LIMS is one of the most established and industrially robust LIMS on the market. The new collaboration builds on an extensive relationship between Thermo and IBM to deliver joint solutions in such areas as data archiving, using Thermo's eRecordManager and IBM Tivoli Storage Manager, and processing proteomic data using Thermo's SEQUEST Cluster software and IBM's eServer 1350 Linux Cluster. For details, visit http://www.thermolabsystems.com.

Accelerated Technology Laboratories will Exhibit at the Eastern Analytical Symposium 2003

Accelerated Technology Laboratories, Inc. (ATL), a premier supplier of LIMS, will exhibit new features in Sample Master Pro XP and ScreenIT Pro LIMS at the Eastern Analytical Symposium, EAS 2003. The annual conference is scheduled for November 17-20, 2003 in Somerset, New Jersey. Sample Master Pro XP LIMS has a new look and feel patterned after Microsoft’s XP products. New features include: Time Tracking and Customer Relationship Management modules, new EDD formats, integrated e-mailing, expanded capability for instrument integration and the ability to include GPS coordinates and multiple locations for a sampling site, with a graphical interface. ScreenIT Pro LIMS is a user configurable LIMS that is ideal for raw materials and manufacturing laboratories. New features include: enhanced Workload, Production and Backlog Reports, Certificates of Analysis, SPC Charts and multiple level specifications with visual quality alerts and e-mail notification. In addition, ATL, Inc. will be presenting three technical papers at the Eastern Analytical Symposium. For details, visit http://www.atlab.com or http://www.eas.org.

Bio-Rad Offers Free, Downloadable Chemistry Drawing, Publishing, and Spectroscopy Applications for Academia

Bio-Rad Laboratories, Inc. has announced the release of the KnowItAll Informatics System, Academic Edition, a free, downloadable, fully-functional software package for chemical structure drawing, publishing, and spectroscopic analyses. The KnowItAll Academic Edition, available at http://academic.knowitall.com, enables users to draw structures in 2D and 3D, perform IR and Raman functional group analysis, process IR, NMR, and Raman spectra, access the renowned Sadtler spectroscopy handbooks, and generate high-quality laboratory reports. This software is offered exclusively to the academic community as a part of Bio-Rad’s continued commitment to promote learning and research initiatives in academia, providing the latest and most advanced software technology and databases for inquiry-based learning in organic and analytical chemistry. The software and database tools in the KnowItAll Academic Edition can be used by students, teachers, and researchers at any level. They work well in the organic chemistry curriculum to teach students fundamentals of structure & bonding and spectroscopy as well as in the analytical chemistry curriculum to teach advanced spectroscopy and spectrometry techniques. The KnowItAll Academic Edition includes free on-line training movies to teach professors and students how to use and get the most out of the software. For details, visit http://www.informatics.bio-rad.com.

Bio-Rad’s KnowItAll 3.0 Offers Enhanced Features for ADME/Tox & MS

Bio-Rad Laboratories, Inc. has announced the release of the KnowItAll Informatics System version 3.0, a major upgrade to the industry's leading software & database solutions for spectroscopy, cheminformatics, and ADME/Tox prediction. Highlights and additions in the new release include a new ADME/Tox Consensus Modeling Environment to optimize the combined results of multiple in silico ADME/Tox models; the world’s first ADME/Tox Consensus Modeling Environment through the use of a new application called ValidateIt that enables the user to train multiple continuous variable models against a set of chemical structures with known values; new Blood Brain Barrier, Plasma-Protein Binding, Mutagenicity, Water Solubility, Log P and Log D models; and a new MS Documentation tool to create a fragmentation line and display the masses of two fragments. For details, visit http://www.informatics.bio-rad.com.

SAP Ships Solution for Master Data Management

SAP Master Data Management (SAP MDM) enables companies to harmonize data across diverse applications and IT landscapes, solving the common problems generated by similar but different customer, product, or vendor information stored across multiple systems. SAP MDM, the latest product of the SAP NetWeaver technology platform, enables companies to manage master data in heterogeneous environments, across business units and the extended enterprise. The product extends and combines key capabilities of SAP NetWeaver into an overall solution for maintaining master data across a heterogeneous set of systems and data sources. As such, it leverages SAP Exchange Infrastructure, SAP Business Intelligence, SAP Knowledge Management, and SAP Enterprise Portal. SAP MDM can be deployed on an evolutionary basis to minimize disruptions to the daily flow of business; can be quickly implemented without altering the existing system landscape; and is flexible to adapt to established business processes and organizational structures.For details, visit http://www.SAP.com.

Novo Nordisk IT to Become Certified Service Provider for NuGenesis Technologies Products

NuGenesis Technologies Corporation, a market leader in scientific data management, and Novo Nordisk IT, a leading pharmaceutical IT consultant and developer in Europe, have announced that Novo Nordisk IT will become a Certified Service Provider for the NuGenesis Scientific Data Management System (SDMS) within the Nordic territories. When the certification process is complete, Novo Nordisk IT consultants will provide complete NuGenesis SDMS project management services including system design, implementation, integration, validation and training. Certification is expected to be complete by the end of 2003. NuGenesis Technologies will continue to offer expert consulting in the Nordic region directly but customers now have a choice of local service representation. For details, visit http://www.novonordisk-it.com or http://www.nugenesis.com.

Scientific Software Recognized as Top 25 Company Fourth Year in a Row

Scientific Software, Inc. has been recognized for the fourth year in a row as one of the Top 25 East Bay software companies by the East Bay Business Times. Scientific Software, Inc. is a world leader in the development, sale and support of software systems to the scientific community. With over 55,000 worldwide installations, the company's EZChrom Elite Chromatography Data System is used in a wide range of markets such as pharmaceutical, environmental, chemical, and food analysis. The company's CyberLAB Knowledge Engineering System is used by leading pharmaceutical and biotechnology companies providing an enterprise-wide solution for information collaboration, data management, regulatory compliance and knowledge engineering. For details, visit http://www.scisw.com.

Scientific Software Announces Free Software Utility

Scientific Software, Inc., a provider of software solutions to the scientific community, has released a new software utility that is available to all interested parties at no charge. The AIA FileViewer is a software utility that provides a graphic application to all AIA (Analytical Instrument Association) chromatography data files. This stand-alone application lets users view AIA files (net CDF files) directly, without having to read the file into a proprietary Chromatography Data System. Once opened by the AIA FileViewer, users can perform additional graphic operations to overlay multiple traces, scale, and render the AIA file into a format suitable for cut/paste operations into Microsoft applications. The AIA FileViewer can be downloaded directly by accessing the Scientific Software web site at http://www.scisw.com.

Scientific Software Announces Release of CyberLAB KES in Kanji

Scientific Software, Inc. has released its CyberLAB Knowledge Engineering System in Kanji. The new release will allow users in Japan to take full advantage of CyberLAB features in their native language. The CyberLAB Knowledge Engineering System is a secure, web-based system designed to capture and warehouse all the electronic records across the enterprise in one scalable architecture. Users can create laboratory reports and search, retrieve, data mine, and archive any type of an electronic record such as instrumentation raw data, reports, spreadsheets, documents, presentations and image files. CyberLAB assists organizations to become compliant with FDA regulations when required. Built using standard web technology, CyberLAB is expandable from a single user system to global multi-site implementations enabling global research collaboration and data sharing. For details, visit http://www.scisw.com.

ChemSW's New Chemical Inventory System Module Links Unlimited Number of Documents

ChemSW, Inc. has announced a new Internal Document Storage Module for its CISPro CIS Chemical Inventory System. This new feature saves time and eliminates paper trail steps by linking all documents that relate to a particular chemical container in the inventory tracking system. Critical documents include Certificates of Analysis and MSDS, as well as any testing results. "In a traditional system, numerous paper documents are generated around a particular chemical lot," explains Brian Stafford, President of ChemSW. "It's impossible to ensure that these documents stay with a chemical container as it moves throughout a facility. The result is that information is not available when it's needed. This new module keeps all necessary information in the inventory tracking system, at the user's fingertips." The new software module is available for any CIS Pro Chemical Inventory System, from desktop to enterprise and web-enabled versions. ChemSW's CIS Pro was developed specifically for the management and tracking of laboratory chemicals in regulated environments. ChemSW is a leading provider of chemical and biochemical inventory management systems, MSDS systems and other chemistry laboratory software and services. For details, visit http://www.chemsw.com.

CSols and Wavefront Software Announce New Alliance

CSols and Wavefront Software have announced that they are partnering to market and sell products and services encompassing CSols Links for LIMS. This new alliance benefits analytical laboratories by providing advanced solutions that streamline data acquisition and management, and enable integration of networked laboratory data systems which includes chromatography data systems (CDS), instruments and LIMS. Instrument-CDS-LIMS integration enables improved regulatory compliance and productivity in the drug discovery, development and manufacturing process. Links for LIMS software provides a seamless, bi-directional interface between networked data systems and any LIMS by using plug-in drivers for all major commercial LIMS. This allows users of networked data systems to integrate their laboratory instruments and chromatography data with their enterprises’ LIMS in accordance with common regulatory standards such as GLP, GMP or the US Food and Drug Administration’s ruling on electronic records and signatures (21 CFR Part 11). Work lists can be uploaded from the LIMS to the CDS. The software can automatically build sequences and report results to LIMS, and can also automate most manual data manipulation and review activities. The software is scaleable from a single instrument to the largest enterprise systems. CSols’ Links for LIMS can also integrate other (non-CDS) instruments with LIMS. For details, visit http://www.wavefrontsoftware.com or http://www.csols.com.

LabCon Delivers New Wireless Interface Connector Solution for Interfacing RS 232 Instruments

During recent years, instrument interfacing has been concentrated on instruments such as like ICPs, CDS and flow analyzers which produce large amounts of data. The return on investment for interfacing is often calculated based on an increase of quality and time savings on retyping of results. As complex instruments do produce more results, more retyping is involved. RS 232 instruments suffer from the high fixed cost of interfacing. The fact that almost all "simple" instruments require an individual PC, eating expensive bench space is the next reason for the lack of interfacing these type of instruments. Labcon Engineering's Wireless Interface Connector (WIC) allows the laboratory to connect their serial instruments to a low cost computer for an affordable price. Distance might be as far as 100 meters. Labcon's WIC allows laboratories to take their computers out of the fume cupboard, wetlab or dusty environment and place them in a more clean area. For details, visit http://www.lab-eng.com.

Labtronics' NEXXIS Integrates RS232 Instruments with NuGenesis SDMS

NEXXIS, from Labtronics Inc, provides a powerful solution for NuGenesis SDMS users who want to include data from RS232 and TCP/IP instruments in their data archiving system. NEXXIS not only collects data it also controls instruments, records the analyst's observations, comments and descriptions and creates reports that can be sent directly to NuGenesis SDMS. NEXXIS can also control workflow on these instruments and ensure that each step of an SOP is carried out correctly. Interactive user screens can be customized to address SOP requirements such as instrument calibration, analysts' qualifications and suitability of the equipment. Each step of the analysis can be clearly defined and controlled. NEXXIS reports can include raw instrument data, calculated data, data previously stored in NuGenesis SDMS, or manually entered information. Results are automatically and filelessly reported directly to NuGenesis SDMS in virtually any format including PDF, Word, Excel or HTML. The combination of NuGenesis SDMS and NEXXIS creates a robust data management and archival system for RS232 and TCP/IP based instruments. For details, visit http://www.labtronics.com.

Labtronics B.V. Expands in Europe

Labtronics Inc. has announced that their European office, Labtronics B.V, is expanding and moving to larger premises in Gouda, The Netherlands. Established in April of 2000, Labtronics B.V. has grown rapidly, providing and implementing Labtronics’ entire range of instrument interfacing solutions throughout Europe. The move allows Labtronics B.V. to provide improved support and training facilities for their growing customer base. As of September 11, 2003, Labtronics B.V. can be reached at Hanzeweg 10, 2803 MC Gouda, The Netherlands. For details, visit http://www.labtronics.com.

SQassim Cement Company and ABB Sign Contract for PL-1 Upgrade Project

ABB,a global power and technology group, has announced that Qassim Cement Company (QCC) located in Buraydah, Kingdom of Saudi Arabia and ABB Contracting Co. Ltd, Saudi Arabia, signed a contract for change of Power Supply to the plant and upgrade of Electrical and DCS (Distributed Control system) to Production Line No. 1. The contract was signed in the boardroom of QCC in Buraydah on 12th August 2003. The contract is to change the power supply to the Cement Production Line No. 1 (PL1) from QCC owned and operated, aged 50 Hz diesel power station to the 60 Hz public grid system of Saudi Electricity Company (SEC) and upgrade of the existing PL-1 Electrical & Control System. The scope of work on a turnkey basis includes provision for SEC power supply to all QCC Production Lines and upgrade of PL-1 Electrical & Control System to continuously operate at 60Hz frequency by installing 33kV Central Switchgears, Static Frequency Converter as well as state of the art technology incorporating Variable Speed Drives and IndustrialIT Control System. For details, visit http://www.abb.com.

GAO Recommends Better Tracking of Minorities in Pediatric Trials

Drugmakers could face the loss of six months of additional marketing exclusivity for pediatric indications if they don’t identify children enrolled in clinical trials by using racial and ethnic definitions laid out in an agency draft guidance earlier this year. The U.S. General Accounting Office (GAO) cited that potential consequence in a report recommending improvements to the FDA’s ability to monitor minority inclusion in pediatric trials. GAO found that in trials conducted for 23 drugs, which later were granted additional marketing exclusivity, 14 percent of the pediatric participants were not identified by race or ethnicity. The aim of such identification is to track drug effectiveness and adverse events that might differ across racial and ethnic groups. In comments on the draft version of the GAO report, the FDA said it recently had begun telling trial sponsors to categorize pediatric patients by race and ethnicity. The FDA suggested in a draft guidance, released in January, that drugmakers use suggested categories when collecting race and ethnicity data in trials. But drugmakers commenting on the draft guidance have criticized the categories as U.S.-centric and inappropriate for international research trials. For details, visit http://www.fda.gov.

Thermo Offers New Generation of ActiveApps for Spectral Data Processing

Thermo Electron Corporation has announced a new series of add-on processing software applications, called ActiveApps, for its leading spectral data processing package, GRAMS/AI. Thermo’s ActiveApps extend the capabilities of GRAMS/AI to allow faster, more powerful processing and unrivalled flexibility. Based upon Microsoft's latest ActiveX technology, ActiveApps allow spectroscopists to perform advanced processing techniques, such as the transferal of data files between applications, a variety of multi-file operations, advanced quantitative analysis and for the prediction of spectral data files. Each of the ActiveApps offers features to enhance the user experience and improve user productivity. New client interfaces and a high level of configurability mean that users are now able to set up their own menus and toolbar buttons in each of the ActiveApps, thereby customizing the interface to suit the way each user works. For details, visit http://www.thermolabsystems.com.

Thermo Electron Publishes New Brochure on eRecordManager Data Archival Solution

Thermo Electron Corporation has announced the availability of a new brochure focused on its laboratory informatics solution, eRecordManager. The eight-page brochure provides readers with a comprehensive overview of the system’s functionality for data storage, searching and retrieval of instrument data, reports and documents, together with an outline of its underlying technology. The system was developed for deployment in data-intensive laboratories in industries such as pharmaceuticals, chemical/petrochemicals, and food and beverage. Launched in 2002, Thermo’s eRecordManager helps customers to capture, store and index large volumes of laboratory data and associated information, while also converting the content of these records for storage as GAML (Generalized Analytical Markup Language) files based on XML (eXtensible Mark-up Language) format. The brochure, which is illustrated by a series of screen captures, is available free-of-charge worldwide to organizations that are assessing their long-term analytical data archival and knowledge management requirements. For details, visit http://www.thermolabsystems.com.

Autoscribe Releases Matrix CRS - Compound Registration Systems

Autoscribehas released a suite of inventory programmes that range from simple single workstation systems to global enterprise solutions. Matrix CRS will allow the registration of all compounds with allocation of a unique identity and the tracking of different batches and samples of a compound that may be stored in different locations. Sample and container history can be maintained and bar codes are fully supported. Matrix CRS also handles requests for compounds and maintains the inventory levels as stock is removed and/or replenished. The system can be interfaced to instruments such as balances for automatic update of inventories and a plate handling facility can be added to the system. Audit trailing, system security, version controlling of reference data and electronic signatures are all part of the system. Matrix CRS is the latest addition to the Matrix family of LIMS. For details, visit http://www.autoscribe.co.uk.

Autoscribe Announces Configurable Approach to Managing Employee Training Needs

Many functionally comprehensive software applications are perceived as too complex when not all of the functionality available is initially required. This can increase demands on both training and ongoing support. Equally, adopting a more basic solution can often cause escalating costs later, when upgrading an application or migrating data. Autoscribe have developed an application environment that aims to overcome many of these difficulties. By allowing customers to tailor the user interface of Autoscribe applications, the user's experience can be accurately matched to their current requirements. By using a set of configuration tools the customer can easily add (or remove) functionality by enabling or disabling parts of the user interface. The separation of the user interface from the data and business logic also allows different application clients to use both Windows and Web forms at the same time. Any changes made to the user interface by use of the configuration tools are reflected in both the Windows and Web forms simultaneously. Training Records Management is the first application area to be featured in asequence of new Autoscribe applications to use this development strategy. For details, visit http://www.autoscribe.co.uk.

Algorithme Pharma Purchases InnaPhase Corporation's Watson LIMS in Canada

InnaPhase Corporation has announced that Algorithme Pharma has signed an agreement to purchase Watson LIMS licenses and services for their research and development center based in Montreal, Quebec, Canada. Watson LIMS, a solution within the Pharma LIMS Suite, is specifically designed to support DMPK/Bioanalytical studies in drug development while ensuring regulatory compliance with the FDA's 21 CFR Part 11 guidance on electronic records and signatures. Watson has an established track record of accelerating bioanalysis, sample management and regulatory compliance in pharmaceutical drug development. "Algorithme is committed to using the latest, most innovative technologies within our laboratories in order to better serve our clients," said Troy Bradley, Bioanalytical Director for Algorithme Pharma. "Watson LIMS allows us to provide our customers the opportunity to bring their products and services into the market quickly and efficiently while strictly respecting their deadlines and budgets." "18 of the top 20 Pharmaceutical organizations worldwide are using one or more of InnaPhase's solutions throughout their organizations everyday," said Jo Webber, Ph.D., President and CEO of InnaPhase Corporation. "Implementing Watson will allow Algorithme Pharma to quickly realize the benefits of using the same technology as their customer base while maintaining a competitive edge over other Contract Research Organizations worldwide." Algorithme Pharma is a full-service Contract Research Organization specializing in studies performed on healthy human volunteers. Their main activity sectors are bioavailability and bioequivalence studies along with Phase I trials. For details, visit http://www.innaphase.com.

ABB and Nicklas & Partner Join Together to Provide Collaborative Production Management Solutions

ABB, a leading power and automation technology group, and Nicklas & Partner, Inc (N&P), a premier provider of service and support, engineering and application software and hardware design, have announced a partnership. ABB and N&P are partnering to better serve the North American cement industry with ABBís CPM solution portfolio, enhanced with strong regional professional services. Rauli Hantikainen, Head of ABB Industrial IT Solutions for Cement and Minerals Industries of ABB Switzerland Ltd, said the partnership is an important step in implementing ABBís strategy of providing comprehensive and truly integrated CPM solutions for North American customers. N&P have offices in Alpharetta, GA and Houston, TX, USA, as well as Turgi, Switzerland, and the parent company's head office in Rˆmerberg, Germany. For details, visit http://www.np-e.com or http://www.abb.com.

Bio-Rad Announces New Software Technology for In-Silico ADME/Tox Consensus Modeling

Bio-Rad Laboratories, Inc., a multinational manufacturer and distributor of life science research products and clinical diagnostics, has announced that their Informatics Division has introduced a new ADME/Tox Consensus Modeling Environment for use in in silico ADME/Tox screening. The new technology has been integrated into the Company's KnowItAll Informatics System, used for ADME/Tox prediction, spectroscopy data management, and cheminformatics. The new Consensus Modeling Environment is a software technology that optimizes the combined results of multiple in silico ADME/Tox models. The Consensus Modeling Environment has the capacity for greater accuracy than any of the individual models. Initially, the Consensus Modeling Environment will be applied to two types of discrete prediction models˜log P (octanol/water partition coefficient) and water solubility˜and one type of classification model˜mutagenicity. Bio-Rad Informatics has entered into agreements with developers of these technologies to deploy multiple models in the Consensus Modeling Environment. Bio-Rad eventually plans to extend this technology into other predictive models of interest to ADME/Tox investigators. For details, visit http://www.bio-rad.com.

Bio-Rad's KnowItAll Informatics System 2.2 Offers Enhanced Features for NMR, MS, and 3D Structure Drawing

Bio-Rad Laboratories, Inc. Informatics Division has announced the release of the KnowItAll Informatics System version 2.2, a major upgrade to this leading software & database solution for spectroscopy, cheminformatics, and ADME/Tox evaluation. Highlights and additions in the new release(s) include ProcessIt NMR to import and process NMR spectra; ProcessIt MS to import and process mass spectra and hyphenated techniques; and, SymApps, a software program that converts 2-D chemical structure drawings to 3-D, and calculates, displays, and animates the symmetry for a molecule. KnowItAll‚s ADME/Tox Edition log P Prediction offers a neural network method in addition to atomic and fragment for improved accuracy. Bio-Rad's Informatics Division specializes in state-of-the-art software and database solutions for the pharmaceutical, biotech, and chemical industries. For details, visit http://www.bio-rad.com.

JEOL USA and ACD/Labs Introduce Automated Structure Elucidation for NMR

JEOL USA, Inc. and Advanced Chemistry Development, Inc. (ACD/Labs) have announce the integration of JEOL’s Delta NMR and ACD/Structure Elucidator software packages, resulting in the only complete system to combine data collection and structure elucidation for automatically determining molecular structures. NMR structure determination of small molecules is one of the most important tools available to the synthetic chemist. NMR spectrometers automate data collection, processing, and presentation, but until now, the actual structure determination has been left to the chemist or an offline structure elucidation software package. By directly coupling reduced NMR spectrometer output from JEOL’s Delta software to ACD/Structure Elucidator, the time spent on NMR structure determination is now reduced from several days to hours or minutes, and the chemist is provided with a range of possible structures for a compound that might otherwise be overlooked. ACD/Structure Elucidator has been built on the combined strength of ACD/Labs’ NMR prediction and spectral data interpretation software. Through a unique set of algorithms, ACD/Structure Elucidator enables scientists to determine the chemical structure of unknown compounds using data acquired from their NMR spectrometer or a combination of analytical devices. Delta software is the only NMR software to combine spectrometer control and data management into a single robust application and allow concurrent processing of multiple sets and simple, seamless operation. Featured with JEOL’s newest generation of high-resolution NMR spectrometers, the ECA and ECX series, Delta unifies NMR data acquisition, processing, visualization, and output. For greater flexibility, Delta operates in both Windows and Linux environments. For details, visit http://www.jeol.com.

Agilent Technologies to Integrate its HPLC and ChemStation Solutions with Advanced Chemistry Development's AutoChrom and ChromGenius Software

Agilent Technologies Inc. and Advanced Chemistry Development Inc. (ACD/Labs) have announced an agreement to develop and market the integration of ACD/Labs AutoChrom and ChromGenius software with the Agilent ChemStation software and 1100 Series HPLC systems. The agreement is expected to benefit analytical laboratories in a wide range of industries by providing a faster and more productive way to develop analysis methods for high-throughput applications. ACD/Labs' forthcoming AutoChrom will be a fully automated version of ACD/Labs Method Development Suite, a complete package of ACD/Labs tools for databasing, sharing, processing, and optimizing chromatographic applications, as well as for developing new separation methods based on chemical structures and retained chromatographic knowledge. The first release of ACD/Labs AutoChrom will only be compatible with Agilent ChemStation. This agreement also provides ChemStation users with the ability to push task lists from ACD/Labs ChromGenius to ChemStation. ACD/Labs ChromGenius is a generic method selection tool for high-throughput chromatography that determines appropriate separation methods based on analyte structure and pre-experimental calculations. ACD/Labs software currently supports Agilent's electronic formats for liquid chromatography (LC) and mass spectrometry (MS) data, enabling scientists to import data seamlessly from Agilent ChemStation into ACD/Labs ChromManager or Method Development Suite. Both ACD/Labs products come equipped with the ACD/Labs Chromatography Applications Database, which comprises over 4,800 applications, including those developed on Agilent columns. Users can retrieve suitable separation methods for an analyte by conducting structure similarity and substructure searches on existing Agilent methods or methods imported from ChemStation.Agilent ChemStation is a family of networked data systems that provides modular software components for instrument control, data acquisition and data management, with the flexibility to meet both a lab's present and future requirements. The ChemStation base software handles applications such as LC, LC/MS, gas chromatography, capillary electrophoresis, and capillary electrophoresis/mass spectrometry, and can be extended with add-on software modules for data organization and storage, remote control and monitoring, compliance with FDA 21 CFR Part 11, and validation of analytical methods. For details, visit http://www.acdlabs.com or http://www.agilent.com.

Agilent Technologies Reports Third-Quarter 2003 Results; Company on Track to Achieve Profitability in Fourth Quarter

Agilent Technologies Inc. reported orders of $1.47 billion and revenue of $1.50 billion for the fiscal third quarter ended July 31, 2003. During the quarter, the company recognized a $1.4 billion non-cash charge required under Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes," and reported a GAAP net loss of $1.56 billion, or $3.28 per share. Excluding that charge, the company would have reported a loss from operations of $110 million, or $0.23 per share, which compares to a GAAP loss of $223 million, or $0.48 per share, one year ago. Also excluding $99 million of net restructuring charges and intangibles amortization, Agilent reported a net loss for the third quarter of $11 million, or $0.02 per share, versus a loss on a comparable basis of $0.31 per share one year ago. "We are encouraged by our third-quarter operating results," said Ned Barnholt, Agilent chairman, president and chief executive officer. "Orders and revenues came in at expectations, with earnings from operations near the top end of expectations. We are confident that we'll meet our commitment to achieve an operating breakeven cost structure of $1.45 billion and return to profitability in the fourth quarter of this year." Agilent saw a continued rebound this quarter in semiconductor equipment orders, which reached their highest level in three years. Activity in the company's other segments remained roughly flat compared to the prior year. "We made good progress in continuing to reduce our structural costs," Barnholt said. "These costs were reduced by nearly $100 million during the quarter, while worldwide headcount fell by an additional 2,400 during the last three months." Continued progress was also reflected on the balance sheet. The company generated $38 million cash from working capital during the quarter despite sequentially higher revenues. Capital spending, at $62 million, remained below depreciation expense of $77 million. Net cash consumption was only $103 million despite $121 million of cash restructuring payments. The company ended the quarter with over $1.4 billion in cash and equivalents. Looking ahead, Barnholt said, "We are seeing more evidence of a sustainable upturn in semiconductor capital equipment, and in the underlying semiconductor markets." Overall, the company anticipates a normal seasonal increase during the fiscal fourth quarter, with revenues in the range of $1.50 billion to $1.60 billion. Earnings before restructuring and amortization charges are expected to be in a range of an operating breakeven to $0.10 per share. "Our fourth-quarter priority remains firmly focused on achieving a $1.45 billion operating breakeven cost structure, which will lay the foundation for sustained profitability in 2004," Barnholt said. For details, visit http://www.agilent.com.

Labtronics Announces Software Upgrade for Technicon AAII and Alpkem RFA Instruments

Labtronics Inc has announced the release of an all new version of NAP, their data collection and analysis software for Technicon AAII and Alpkem RFA instruments. NAP 4.0 is a full 32 bit application for the Windows 2000 and Windows XP Professional platforms that provides a complete data system for continuous flow and flow injection analyzers. The new version features an all new hardware configuration that uses USB technology to maintain a high-speed connection between the instrument and the PC, without having to install any components inside the PC. Simply plug in and start processing. This not only simplifies setup it also provides users with the option of running NAP on a laptop or notebook PC. NAP 4.0 also provides a new direct connection with MicroSoft Excel. NAP can now automatically launch Excel, open a worksheet using a pre-defined template and fill the spreadsheet with the run results. The full processing power of Excel can then be used to further process the data. For details, visit http://www.labtronics.com.

Caliper Technologies Acquires Zymark Corporation

Caliper Technologies Corp.has acquired Zymark Corporation, a privately-held provider of laboratory automation, liquid handling and robotics solutions to the life sciences, biotechnology and pharmaceutical industries. The combined company will offer a state-of-the-art, comprehensive portfolio of laboratory automation products with a global commercial infrastructure to provide customers with highly innovative solutions for accelerating drug discovery and development in the life sciences, pharmaceutical and biotechnology industries. As a result of the acquisition, Zymark has become a wholly-owned subsidiary of Caliper and will continue to sell products under its own name. Under the final terms of the deal, Caliper has purchased Zymark for approximately $57 million and 3.15 million shares of Caliper common stock. The agreement also provides for a potential additional earn-out stock component of up to 1.575 million shares of Caliper stock if specified targets for sales of Zymark products are met in 2003 and 2004. For details, visit http://www.calipertech.com or http://www.zymark.com.

Oracle Introduces Several New Products

Oracle Corporation has introduced the Oracle Database 10g, a new software designed to help customers and partners achieve the highest levels of efficiency from their Information Technology (IT) investments, including hardware, software and, most importantly, labor. Oracle Database 10g relieves IT professionals from time-consuming, repetitive administrative work, enabling them to focus more on solving business problems. Oracle has also announced Oracle Application Server 10g and Oracle Enterprise Manager 10g. Together, they comprise Oracle Grid Computing, one of the first integrated grid infrastructure software products on the market. Oracle Enterprise Manager 10g introduces automated management software that provides a complete view of a company's computing infrastructure. System administrators can enforce policies, manage service levels, and rebalance existing computing resources and applications as business requirements change. For details, visit http://www.oracle.com.

SAP Expands mySAP Customer Relationship Management (mySAP CRM)

SAP has outlined its new and enhanced CRM analytics offering as part of the latest version of mySAP Customer
Relationship Management (mySAP CRM) announced in June. New capabilities in mySAP CRM include real-time analytics to leverage customer insight during each customer interaction; marketing optimization to boost response rates; sales, marketing and service business planning to closely measure performance against strategic targets; and out-of-the-box analytics scenarios. By enabling deep integration with multiple sources and applications across the enterprise, organizations can now better measure and predict customer actions by transforming raw information into business strategies for optimizing the most profitable customer relationships. The new analytics capabilities in mySAP CRM enable companies to extract more business value from their wealth of transactional data to better understand customers and the products they want, at what price, and under what conditions. For details, visit http://www.sap.com.

SAP Supports WS-I Basic Profile 1.0

SAP has announced its support for the first release of the WS-I BasicP rofile 1.0 (BP 1.0), a set of implementation guidelines for companies to utilize a set of core Web services specifications to develop interoperable Web services. The Web Services Interoperability Organization (WS-I) brings the work of multiple standards organizations (such as W3C and OASIS) together for the purpose of providing clarity and guidance around Web services interoperability. As a founding WS-I Board member, SAP actively participated in the development of the BP 1.0 and will support the new guidelines throughout their implementation and industry adoption. The SAP NetWeaver technology platform, which drives lower cost of ownership across heterogeneous IT landscapes, corresponds to the BP 1.0 and allows SAP customers to develop, deploy, and integrate enterprise applications in alignment with the new implementation guidelines. Through SAP's support of the BP 1.0, customers can operate directly with the new implementation guidelines, rather than dealing with the individual Web services specifications, such as SOAP (Simple Object Access Protocol), WSDL (Web Services Description Language) and UDDI (Universal Description, Discovery and Integration). For details, visit http://www.sap.com.

FDA Applies Risk-Based Approach to Preapproval Inspections

Aiming to reduce the number of preapproval inspections (PAI) and leverage resources for higher-risk inspections, the FDA has announced changes to its inspection program to give field officers more flexibility in determining whether a PAI is necessary. According to Center for Drug Evaluation and Research (CDER), the strategy of assigning PAIs now includes two general categories: those that will regularly prompt an inspection request from CDER, and those where the district office may choose to perform an inspection. CDER deleted categories mandating inspections for narrow therapeutic range drugs and for generic versions of the top 200 prescription drugs. The revised inspection strategy -- incorporated into the Preapproval Inspections/ Investigations section of the Compliance Program Guidance Manual -- provides district field officers with "greater flexibility in determining if a preapproval inspection is necessary based on the most current knowledge and [current good manufacturing practice] status of a firm," the agency said in a statement. Under the changes, regular inspections will be carried out in nine specific categories, including new molecular entities, priority new drug applications, and for firms that have not been inspected in the past two years. Outside of the nine areas, the district office may determine on its own if a preapproval inspection is warranted. For details, visit http:///www.fda.gov.

FDA's cGMP Initiative Aims to Boost Safety, Efficiency

The FDA has announced the formation of a special inspection team, changes in its preapproval inspection program, and the release of four draft guidances and a final guidance on various manufacturing issues as part of a continuing effort to improve current good manufacturing practices (cGMPs). The agency hopes these steps will help make pharmaceutical manufacturing "more efficient and safer," FDA Commissioner Mark McClellan said. The guidances are intended to help the pharma industry and the agency "focus their efforts where they are most beneficial, on critical and risky areas," he said. The five guidances, published in today's Federal Register, were:
- A draft guidance establishing a dispute resolution process for science and technical issues related to cGMPs;
- A draft guidance setting guidelines for using comparability protocols to implement changes in manufacturing processes after obtaining marketing approval for protein-based human and veterinary drugs and biological products;
- A draft guidance establishing a regulatory framework to encourage voluntary implementation of new manufacturing and quality assurance technologies;
- A draft guidance updating recommendations on aseptic processing for sterile drug products; and
- A final guidance outlining the FDA's enforcement of 21 CFR Part 11, dealing with electronic records and signatures.
The guidances and other actions are part of a two-year agency initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," launched in August 2002. For details, visit http:///www.fda.gov.

FDA Releases Part 11 Guidance, More Revisions May Come

The FDA yesterday released the final guidance on 21 CFR Part 11, the regulation dealing with electronic records and signatures, promising to re-examine the underlying regulation and initiate rulemaking in coming months to revise provisions of Part 11. While promising to narrow Part 11's scope and selectively enforce its requirements as the agency reviews the regulation, the FDA stressed that Part 11 remains in effect and its enforcement discretion applies only to points outlined in the guidance. In addition, manufacturers must adhere to all predicate rule requirements, whether or not their systems are ultimately subject to Part 11. The document was released as part of the broader current good manufacturing practices (cGMP) risk-based initiative. To purchase full FDAnews coverage of the Part 11 guidance and other stories relating to the cGMP initiative in Drug Industry Daily go to http://www.fdanews.com/pub/did. To view the final guidance, "Part 11, Electronic Records; Electronic Signatures - Scope and Application," published in the Federal Register, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/5667fnl.pdf.

FDA, GPhA Launch ANDA Review Cycle Initiative

The FDA's Office of Generic Drugs (OGD) and the Generic Pharmaceutical Association (GPhA) have launched a collaborative initiative to help speed generic drug approvals by reining in the number of review cycles. Project First Review Cycle aims to foster dialogue between OGD and generic drugmakers about correcting mistakes in abbreviated new drug applications (ANDAs) that now result in multiple review cycles. Meetings with OGD experts will be held every two or three months, and be open to all GPhA members. The first will be held Sept. 24 in the Washington, D.C., area, according to GPhA. In recent years, 93 percent of ANDAs were not approved on the first review, while 66 percent were not approved after the second cycle. Each review cycle means months of delay and millions of dollars in additional development costs, FDA Commissioner Mark McClellan said. For details, visit http:///www.fda.gov.

What's New - September to October 2003 The following is a wrap-up of news of interest during the months of September to October 2003

What's New - September to October 2003
The following is a wrap-up of news of interest during the months of September to October 2003