LIMSource News: What's New Right Now

• Thermo Evolves Darwin Further for Pharmaceutical Manufacturing R&D and QA/QC Offers Solution for Effective Migration
• Autoscribe to Exhibit Neptune LIMS at WWEM 2006
• Autoscribe Announces New Pathology Management Information System
• NNIT and LabVantage Establish Partnership for LIMS in the Central European Market
• QSI's WinLIMS Can Self-Install
• QSI Announces New WinLIMS Instrument Validation Module
• South Carolina Selects Sample Master Pro LIMS
• GraphLogic to Build Custom LIMS for Genetic Services for Sequenom
• GraphLogic Installs Customized LIMS Solution for 454 Life Sciences
• Labtronics Releases NEXXIS Sample Tracker Version 3.0
• Labtronics Releases Latest Version of the NEXXIS Chremical Inventory Manager
• Thermo Delivers Enhancements to GRAMS Spectroscopy Software
• Bristol University to Deploy ACD/2D NMR Processor Site-Wide for Advanced Processing and Data Analysis
• New ACD/ChemSketch Freeware
• ACD/Labs’ Collaborating with GlaxoSmithKline to Provide New and Enhanced Prediction Algorithms for Their Scientists
• Thermo’s New Environmental and Food Safety Productivity Solutions Enable Quick and Cost-Effective GC/MS Method Compliance
• Thermo Introduces Comprehensive GC/MS Data Review and Reporting Packages for Environmental, Food Safety, Toxicology and Forensic Laboratories
• PerkinElmer Launches Clarus 600 Gas Chromatograph/Mass Spectrometers
• PerkinElmer Announces Partnership with Ion Signature Technology to Enhance Evaluation of Complex GC/MS Samples
• Cerno Bioscience Paper Demonstrates Automated and Parameter-Free Peak Integration for LC/MS/MS Quantitation
• Bruker Daltonics Introduces Next-Generation Horizontal Top-of-the-Line MALDI-TOF/TOF Mass
Spectrometer
• Bruker Daltonics Introduces High Performance Compact Vertical MALDI-TOF/TOF Mass Spectrometer
• Waters Corporation to Integrate Ultra Performance Liquid Chromatography into Applied Biosystems/MDS SCIEX
• Waters Corporation Acquires Thermometric AB
• Thermo Wins Omega Award for Service Excellence for Second Consecutive Year
• QISoft Strengthens Development Team
• David Phillips Joins BioAnalyte to Build on Success in LC/MS Software Industry
• ClinPhone Strengthens Team Post-IPO
• ClinPhone Poll Identifies Key Challenges Facing Drug Accountability
• ABB Enters into a New Cement Market
• Holcim’s Lägerdorf Plant Improves Performance with ABB’s Precalciner Control Solution
• ABB Wins Major Control System Contract from Jura Cement
• Savi Networks to Deploy Cargo Security and Tracking Network at Virginia Port Authority Terminals
• IU Study: More Internet Users may be Taking ‘Phishing’ Bait Than Thought
• Medical School Scientist to Lead IU’s Bioinformatics Program
• USDA Selects Denver for New Information Technology Site
• Study Highlights Need for Comparative Drug Reviews
• FDA Publishes Guidance Agenda, Seeks Comments
• FDA Withdraws Guidances Due to Format Changes
• FDA Issues Guidance on Efficient Drug Manufacturing
• Manufacturing Inefficiency Costs Industry $50 Billion Annually, Study Finds
• Senate Hold Remains as Von Eschenbach Nomination Passes Commmittee
• John E. Niederhuber Appointed as Director of the National Cancer Institute
• Senate Democrats Move to Postpone Drug Safety Bill
• FDA, MIT to Collaborate on Drug Safety

GenoLogics Targets Translational Medicine, Cancer Research and Other Areas with Partnership Strategy of End-to-End Solutions

GenoLogics Life Sciences Software Inc. (GenoLogics), a leading developer of lab and scientific data management software solutions, is developing a sophisticated network of key partners, to create end-to-end lab and scientific data management solutions, for various proteomics and genomics applications such as cancer research, biomarker discovery, and translational medicine. Company leaders are actively selecting and pursuing partners with best-in-class, complementary products to provide robust end-to-end solutions to GenoLogics customers. GenoLogics has built an open, user configurable platform that acts as the central nervous system for laboratory automation and operations. It integrates specialized software tools, multiple lab instruments, analysis packages, and new technologies to offer researchers a seamlessly integrated lab and data management solution that is flexible and will adapt to meet their future needs. GenoLogics' specialized solutions for proteomics and genomics research, Proteus and Geneus, are both built on this core platform. On the open source software ( OSS ) partnering front, GenoLogics supports and integrates the Trans Proteomics Pipeline (TPP) and the Computational Portal Analysis System (CPAS). These are among the company's first OSS integration initiatives, and GenoLogics product managers are pursuing other opportunities to provide additional high-value OSS integrations to their customers. For details, visit http://www.genologics.com.

Thermo Evolves Darwin Further for Pharmaceutical Manufacturing R&D and QA/QC Offers Solution for Effective Migration

Thermo Electron Corporation, world leader in analytical instrumentation and informatics, has introduced significant updates to Darwin LIMS, its commercial-off-the-shelf (COTS) laboratory information management system (LIMS) designed specifically for pharmaceutical manufacturing R&D and QA/QC. Darwin version 1.1 features extensive interfacing capabilities to provide tight integration with SAP for rapid batch disposition and release and streamlined workflow, plus new historical data trending and charting functionality. The embedded charting and trending for product stability testing allows for real-time data review and rapid reporting. Darwin 1.1 has also been optimized to operate on the Oracle 10g platform. By incorporating SAP and additional systems interfacing capabilities, as well as batch and product management capabilities, customers are better prepared to integrate Darwin into their global enterprise landscape. "Since its launch in December 2005, Darwin has enjoyed a tremendously positive reaction,” said Dave Champagne, vice president and general manager of Thermo’s informatics business, citing honorable mentions by the Pittcon Editor’s Award and Instrument Business Outlook. “Our goal with Darwin has been to deliver as much domain-specific out-of-the-box functionality to our customers as possible. Version 1.1 addresses some critical needs and clearly positions Darwin as the definitive solution for the pharmaceutical industry. As a COTS solution, Darwin lowers the cost, risk and time associated with implementation, training, validation, maintenance and upgrades of traditional LIMS.” Thermo is able to assist customers with migration to Darwin 1.1 using Migration Agent, a combination of professional services and software that reduces risk and overcomes business challenges when migrating. Migration Agent employs services personnel for project management and implementation, as well as an extract, transform and load (ETL) tool that has been configured specifically for Darwin 1.1. For details, visit http://www.thermo.com/informatics.

Autoscribe to Exhibit Neptune LIMS at WWEM 2006

Autoscribe will exhibit its Matrix Gemini Neptune LIMS solution for the Water and WasteWater Industry at WWEM 2006. WWEM is a specialist event for companies who provide products and services for the Water, Wastewater and Environmental Monitoring community. Autoscribe will also be presenting a workshop entitled: "How Implementing a LIMS Improves Business and Laboratory, Efficiency, Compliance and Productivity" at WWEM on November 1st in Room 5 from 13:30 – 14:00. Neptune has been developed with inputs from several large metropolitan water districts and contains the deep functionality and reports needed for this application. Neptune’ is built using powerful and easy to use OneTIme configuration tools that are part of Matrix Gemini. There is no custom code to support and there are no special scripts to write. Screens developed using the configuration tools for desktop clients are immediately available over the web without any programming or scripting. Neptune delivers most of the functionality required by a water treatment laboratory out of the box. However, as each laboratory has some different requirements, these are satisfied by changes to the configuration files rather than custom code. Every Matrix system and hence, each Neptune system has the same source code, all differences in appearance, terminology, workflow, tests and reports are contained in the configuration files. For details, visit http://www.autoscribe.co.uk.

Autoscribe Announces New Pathology Management Information System

Autoscribe has announced the Matrix Gemini fully configurable Commercial Off-The-Shelf (COTS) Pathology Management Information System that is designed for all laboratories. Matrix Gemini delivers an identical user experience no matter whether a LAN, WAN or the Web is used. As soon as any screen is designed using the unique Matrix Gemini OneTime Configuration Tools, it is immediately available via the company's network or over the web. For details, visit http://www.autoscribe.co.uk.

NNIT and LabVantage Establish Partnership for LIMS in the Central European Market

NNIT A/S and LabVantage Solutions, Inc. have established a partnership to bring industry and implementation expertise together with a state of the art laboratory information management suite. The partnership between LabVantage and NNIT covers life sciences organizations in Germany, Austria, and German-speaking regions of Switzerland and Luxembourg. LIMS support vital business processes in the life sciences industry, from research and development to formulations and manufacturing. By working together, NNIT and LabVantage can provide customers with LIMS solutions that are cost-effectively configured and validated to the individual business needs. LIMS is a vital part of NNIT’s services. Philip Skou, Vice President of NNIT Switzerland, explains,
"After a decade of working with a broad range of LIMS for many customers, we’re seeing the LIMS
market change. Customers want a LIMS package from a company dedicated to software development,
that invests in leading functionality and uses a modern thin-client architecture. Research-based companies are moving away from local, disconnected LIMS installations towards integrated, enterprise-wide LIMS. That’s what LabVantage’s Sapphire LIMS provides." NNIT has significant experience with LabVantage’s Sapphire and enterprise implementations in the pharmaceutical industry. This includes multiple time zones, multilingual support, and integration to ERP, MES and Scientific Data Management Systems (SDMS). With over 30 LIMS consultants, NNIT has provided customers with LIMS consulting, project management, change management, integration, validation, installation and operational support services. In addition to LabVantage’s Sapphire, NNIT is experienced with complementary products, such as Labtronic’s LimsLink for instrument integration and
Business Objects for advanced reporting. According to Jim Aurelio, LabVantage’s President & CEO, "NNIT is a perfect match for providing the central European market with the combination of leading software and services, and for supporting our rapid expansion in the global LIMS market."For details, visit http://www.labvantage.com or http://www.nnit.com.

QSI's WinLIMS Can Self-Install

According to Quality Systems International (QSI), their latest WinLIMS software release includes innovative new tools that handle installation, configuration and testing with no need for supplier visits. "We believe that the latest version of WinLIMS sets a new benchmark for the LIMS industry" explained QSI's Clive Collier "In addition to its self-install functions, WinLIMS includes tutorials and training aids that will get users up and running without the usual huge commitment of resources." The system will self-install both server and client software. If it finds that no SQL database engine exists, it automatically installs Microsoft SQL Server 2005 Express Edition, creates the necessary WinLIMS databases and configures connectivity, so there is no need to purchase a separate database package. Tutorials covering all aspects of set-up and configuration use an internal test database to protect user data, and contain advice on how to optimise the system for individual user requirements. Key aspects are condensed into easy-to-understand information sheets, so operators can quickly find the instructions they need without having to search through the very extensive user manuals. This software release also has a new "look and feel" with the emphasis on simplicity, making screens and data requirements easier to understand. "You can't do all this unless you have complete confidence in the integrity and completeness of your basic LIMS offering", said Collier. "We even offer WinLIMS on a monthly rental basis." For details, visit http://www.lims-software.co.uk.

QSI Announces New WinLIMS Instrument Validation Module

According to QSI, the new Instrument Validation Module included in the latest WinLIMS software release is the most comprehensive tool currently available for ensuring the quality of analytical data provided by the instruments connected to a LIMS. Most LIMS can indicate when events like instrument calibration or routine maintenance become due. Rather than treating each instrument as an entity, it can be defined as an assembly of components, each with its own criteria for triggering an event. These criteria can be different for each component - they could be based on operating hours, the number of samples run, the result of a QC sample, or a physical parameter. This ensures that the instrument is only taken out of service when absolutely necessary. For example, the lamp in an HPLC detector might need to be changed after a certain number of hours, whereas the column's performance could be dependent on the number of samples run. Having initiated the appropriate action, the system can then create a test sample to validate the instrument's return to normal service. Also included in this release are new tools that handle installation, configuration and system testing without the need for supplier visits, and extensive training aids and user tutorials. For details, visit http://www.lims-software.co.uk.

South Carolina Selects Sample Master Pro LIMS

The South Carolina Department of Agriculture has selected Sample Master Pro LIMS, from Accelerated Technology Laboratories (ATL), as its new laboratory data management solution. The South Carolina Department of Agriculture maintains a laboratory for testing selected products in order to protect consumers from unsafe, ineffective, or fraudulent goods. The department staffs a food, feed, seed, petroleum and residue laboratory. It performs chemical, biological, and physical, qualitative and quantitative analyses. The laboratory required a configurable LIMS based on technology that would provide complete traceability of samples and versatility in reporting and viewing of data. It desired features such as: user-based security, bar-coding, flexibility of ad-hoc querying and reporting and the ability to interface with laboratory equipment. In addition, it needed a LIMS that was easy to learn and that would provide remote users with secure, real-time Internet access to sample status, results and reports. After evaluating various LIMS systems, the South Carolina Department of Agriculture concluded that ATL's Sample Master Pro LIMS was their LIMS choice. For details, visit http://www.atlab.com.

GraphLogic to Build Custom LIMS for Genetic Services for Sequenom

GraphLogic Inc. has been selected by Sequenom, Inc. to create a custom laboratory information management system (LIMS). The LIMS will provide core workflow as part of Sequenom's commercial genetic analysis services. It will contain complete sample tracking, project management, and inventory control functionality, in addition to reagent tracking and assay setup. GraphLogic Inc provides a development platform and customization services, creating complex applications in less time than it takes to implement off-the-shelf software. For details, visit http://www.graphlogic.com.

GraphLogic Installs Customized LIMS Solution for 454 Life Sciences

GraphLogic has completed installation of a customized sequencing LIMS for the 454 Life Sciences Sequencing Center in Branford, CT. 454 is using GraphLogic's integrated modules to manage customer projects that were sequenced with the Genome Sequencer 20 System. The LIMS provides a mechanism for sample tracking through all production operations including storage and inventory, sample movement through sequencing workflow and the capture of production metrics with full reporting capabilities. For details, visit http://www.graphlogic.com.

Labtronics Releases NEXXIS Sample Tracker Version 3.0

Labtronics has announced the release of NEXXIS Sample Tracker (ST) version 3.0. NEXXIS ST provides small to medium sized laboratories with an affordable system for storing and tracking their laboratory test results. With the latest release, authorized users can now utilize the NEXXIS Web client thus eliminating the installation of any client software. As a result, the system can now be accessed via any PC with Internet Explorer within an organization. NEXXIS ST is built on the NEXXIS Application Development Platform, which uniquely combines a powerful Application Development Tool for developing laboratory solutions with a scalable Laboratory Platform to deploy, manage and execute the applications. For details, visit http://www.labtronics.com/nexxisst.htm.

Labtronics Releases Latest Version of the NEXXIS Chremical Inventory Manager

Labtronics has announced the release of NEXXIS Chemical Inventory Manager (CIM) version 2.1. With the latest version, NEXXIS CIM sees improved system performance and enhanced scalability for the enterprise environment. Additionally, CIM now includes integration methods allowing it to seamlessly interact with customer specific applications in addition to standard NEXXIS application modules like qELN, the Balance Data System, Sample Tracker and the Calibration Manager. NEXXIS CIM is built on the NEXXIS Application Development Platform, which uniquely combines a powerful Application Development Tool for developing laboratory solutions with a scalable Laboratory Platform to deploy, manage and execute the applications. For details, visit http://www.labtronics.com/nexxiscim.htm.

Thermo Delivers Enhancements to GRAMS Spectroscopy Software

Thermo Electron Corporation, a leading provider of analytical instruments and laboratory informatics solutions, has introduced GRAMS 8.0, a comprehensive update of the company’s leading multi-vendor spectroscopy software solution. GRAMS is relied on by spectroscopists worldwide for visualizing, processing and managing data from FT-IR, NIR, Raman, UV-Vis, Fluorescence, NMR and hyphenated instruments manufactured by multiple vendors. It interfaces with more than 150 instruments, including Thermo’s leading spectroscopy and chromatography products. GRAMS use of open standards has made it the platform of choice for customers and third parties working in both regulated and unregulated environments. Version 8 enhances GRAMS’ workgroup and enterprise connectivity via a full client/server update to Spectral DB, and features the all-new Web-enabled Envision viewing and reporting tool. Spectral DB’s newly developed integration with Oracle and SQL Server provides an analytical data management system that is scalable from individual users to entire organizations. Capable of storing analytical data and chemical metadata, the new Spectral DB transforms an organization’s ability to organize, search and share its scientific information. GRAMS Envision introduces Microsoft .Net technology to the GRAMS suite, and allows scientists to find, view, manipulate and report analytical data stored in many of the most popular formats. Using XML-enhanced ‘Smart Convert’ technology, Envision adds support for more than 20 new data formats. This allows scientists to work with ‘live’ spectral data on their desktops rather that relying on static snapshots or purchasing multiple workstation licenses from several vendors. For more information on GRAMS 8, including download of a free demonstration, visit http://www.thermo.com/grams. For more information on open standards visit http://www.gaml.org.

Bristol University to Deploy ACD/2D NMR Processor Site-Wide for Advanced Processing and Data Analysis

Advanced Chemistry Development, Inc. (ACD/Labs) has announced that Bristol University has purchased a site license for 2D NMR Processor which provides all students, faculty, and staff at the University with unlimited access to the software. ACD/2D NMR Processor will be used by Bristol University to reduce the bottlenecks in their NMR instrument rooms by providing all students and staff with offline desktop processing of NMR data. A CD/2D NMR Processor supports all major NMR formats and provides capabilities for desktop processing, analyzing, and interpretation for all 1D and 2D NMR experiments. ACD/2D NMR Processor will be used by Bristol University to reduce the bottlenecks in their NMR instrument rooms by providing all students and staff with offline desktop processing of NMR data. In addition, the advanced flexibility of this product enables it to be used as an effective teaching tool as structures can be attached to peaks and correlations in experimental spectra, an invaluable tool for teaching spectral interpretation in the classroom. Dr. Craig Butts, Ph.D, Director of the NMR Facility in the School of Chemistry at Bristol University, adds, "The world-class research and teaching conducted in the School of Chemistry at Bristol demands access to the highest quality NMR data. We are in the process of upgrading both our hardware and data processing facilities. Following in-house testing of a number of options, we found that the ACD/Labs software provides us with a robust and versatile platform, enabling students to maximise the quality and accuracy of experiments and reports. The opportunity to work with the industry standard software while undertaking academic research, or as part of their undergraduate degree, is a key advantage to our students. ACD/Labs were also able to offer us a competitively priced and flexible site license that meets the range of access requirements of both the students and staff members at Bristol." For details, visit http://www.acdlabs.com.

New ACD/ChemSketch Freeware

Advanced Chemistry Development, Inc., (ACD/Labs) has announced the latest version of ACD/ChemSketch Freeware, a comprehensive chemical drawing package. Among many other features, this product offers tautomer recognition, 2D structure cleaning, 3D optimization and viewing, and drawing of polymers, organometallics, and Markush structures. With the added InChI chemical nomenclature protocol compatibility, and access to PubChem, ACD/ChemSketch can be used to search online chemical databases directly from the software interface according to structure or substructure searches. Academic institutes and personal users will be able to access the version 10 freeware version before the commercial version 10.0, is released in November 2006. ACD/ChemSketch version 10 freeware contains many important advances and updates. But while ACD/Labs freeware remains as substantial and functional as ever, the commercial version offers even more advanced and unique features, including a searchable dictionary of over 155,000 chemical trivial names with structures, the ability to view and search SDfiles of chemical structures in a new SDF viewing interface component in ChemSketch, and a chemical search engine for locating embedded structures in Microsoft Word, Microsoft PowerPoint, Adobe PDF, and many other file types. A full comparison of the freeware versus commercial version of ACD/ChemSketch can be found at http://www.acdlabs.com/download/chemsk_freeware_vs_commercial.html.

ACD/Labs’ Collaborating with GlaxoSmithKline to Provide New and Enhanced Prediction Algorithms for Their Scientists

Advanced Chemistry Development, Inc. (ACD/Labs) has announced that it will be collaborating with GlaxoSmithKline (GSK) to focus on the creation of a specially adapted algorithm for predicting solubility in aqueous DMSO solution as well as related enhancements to ACD/Labs’ pKa and aqueous solubility prediction algorithms. Complementing the collaboration, GSK’s recent purchase of ACD/Solubility DB, following their previous purchase of ACD/Labs’ logD, logP, and pKa predictors, now provides the full range of ACD/Labs’ physicochemical predictors to GSK scientists worldwide. The deployment provides GSK scientists with access to ACD/Labs’ predictors through their corporate intranet. In response to the request by GSK to anticipate specific characteristics of compounds relating to their workflow, ACD/Labs is working on new customized algorithms for the prediction of solubility in aqueous DMSO solution. The algorithms will be derived from tens of thousands of experimentally determined data points provided by GSK, likely one of the largest such data sets measured under uniform and controlled experimental conditions. In addition, the collaboration is also focused on the facilitation of training the pKa algorithm for the out-of-the-box solution, using ACD/Labs’ Accuracy Extender module and GSK’s own experimental measurements. The outcome of this work in particular will provide augmented automation and speed of introducing new pKa data into ACD/pKa DB. ACD/Labs’ customers will benefit from features being developed for pKa Accuracy Extender that have been influenced by discussions with scientists at GSK. For details, visit http://www.acdlabs.com.

Thermo’s New Environmental and Food Safety Productivity Solutions Enable Quick and Cost-Effective GC/MS Method Compliance

Thermo Electron Corporation, world leader in analytical instrumentation, has announced new Environmental and Food Safety Productivity Solutions designed to accelerate traditional method validation processes. These productivity kits include stocks of relevant pre-diluted standards and other quality control requirements, and can be customized to offer the necessary tools for specific regulated and non-regulated methods guaranteeing full compliance. Developed for use with Thermo’s DSQ II single quadrupole GC/MS, these new tools provide immediate productivity gains. Designed to address the needs of scientists analyzing compounds in GC/MS in routine environmental and food safety environments, the productivity kits help users achieve complete instrument and method validation within only a few days rather than weeks with remarkable cost savings of 90% compared to traditional techniques. They enable laboratories to easily adopt the latest in technology, quickly train new employees, and rapidly document new instrumentation. When purchasing a new GC/MS system, operators in routine laboratories often need to go through a complicated and time-consuming method development process. Thermo’s Productivity Solutions significantly reduce the amount of time required for method development and validation, making transition from an old GC/MS system to a new one as seamless as possible. Thermo’s DSQ II single quadrupole GC/MS employs next-generation curved optics to eliminate performance-robbing neutral noise, thus improving detection, quantitation and spectral performance. The DSQ II is equipped with Thermo’s new DuraBrite source to offer enhanced robustness and sensitivity while also increasing productivity. For details, visit For details, visit http://www.thermo.com/informatics.

Thermo Introduces Comprehensive GC/MS Data Review and Reporting Packages for Environmental, Food Safety, Toxicology and Forensic Laboratories

Thermo Electron Corporation, a world leader in analytical instrumentation, has developed two new versions of its reporting software packages, EnviroLab Forms 2.0 and ToxLab Forms 2.0. Designed to work with Thermo’s suite of GC/MS instruments, including the new DSQ II system, these exciting new software packages offer scientists workflow-oriented approaches to GC/MS analyses. Both packages were developed to allow users to move step-by-step through environmental, food safety, toxicology or forensic analyses, increasing confidence and productivity. Thermo’s novel software solutions provide a logical pathway for the analyst to proceed from sample to result. Every aspect of sample data flow, from method creation and quality control management to batch generation and through data review and reporting, is accessed within the program. Data integrity is also built in to EnviroLab Forms 2.0 and ToxLab Forms 2.0, ensuring accurate and secure results. Thermo’s new EnviroLab Forms 2.0 software adds a powerful productivity engine to Xcalibur software, which comes standard with Thermo’s benchtop GC/MS systems. EnviroLab Forms 2.0 incorporates specific enhancements for environmental and food safety methodologies to provide a comprehensive system encompassing data acquisition, processing, review and reduction, and reporting. Both the new and experienced user will find tools to automatically generate complete data sets, while also providing the ability to perform sophisticated data review and reporting when necessary. A broad selection of industry-compliant reports allows the environmental GC/MS user to easily report sample results. Designed for toxicology and forensic laboratories, Thermo’s new ToxLab Forms 2.0 software offers numerous reporting options, including basic sample confirmation reports and calibration reports. Reports can be generated in real time, through batch reprocessing, or on a sample-by-sample basis. Integrated data review allows users to evaluate quantitative results, spectral data, and peak integrations on a sample-to-sample and compound-to-compound basis. If needed, reprocessing single samples or entire batches is accomplished through a simple click of a button. Both EnviroLab Forms 2.0 and ToxLab Forms 2.0 simplify data review and QC management by flagging out of range values for follow-up. Comprehensive batch summary reports offer batch-at-a-glance data reviewing. Smart Reporting ensures that any changes affecting integration and quantification are made real-time and propagate throughout the batch. Both programs facilitate integration of Thermo’s GC/MS systems with laboratory information management systems (LIMS), and both software packages support paperless operation through generation of electronic reports. For details, visit http://www.thermo.com/gc.

PerkinElmer Launches Clarus 600 Gas Chromatograph/Mass Spectrometers

PerkinElmer Inc, a global leader in Health Sciences and Photonics, has introduced the Clarus 600 Gas Chromatograph/Mass Spectrometers (GC/MS) with best-in-class oven performance, delivering the fastest combined heat-up and cool-down rates for a conventional GC. It also provides state-of-the-art electronics, enhanced software and a choice of three different pumps to meet the diverse performance demands and budget requirements of a range of laboratories. The Clarus 600 MS, combined with the new Clarus 600 GC powered by the best-in-class oven, is designed for a variety of laboratory requirements to ensure increased throughput and improved detection limits and to provide significant return on investment. Hardware improvements include best-in-class oven performance with state-of-the-art electronics, providing fast scanning and increased productivity, multiple pumping options to meet every lab’s needs, a compact footprint to maximize laboratory bench space, the PreVent suite of column flow controls for increased uptime and productivity, and industry-leading sensitivity for both electron ionization (EI) and chemical ionization (CI). The new PerkinElmer TurboMass 5.3 GC/MS software assures method compliance and increased laboratory productivity with expanded resources for the updated electronics and pumping options. This software also includes the latest tools for evaluation with flexible reporting capabilities for a variety of industries. More than 70 standard report templates and many other significant software tools are built in such as SIFI (simultaneous collection of Selected Ion and Full Ion scanning). TurboMass software uses a sample-centric architecture requiring only two clicks to view the mass spectrum or other information collected on a sample, and advanced noise-reduction algorithms as well as other tools for complex analyses. For details, visit http://www.perkinelmer.com/Clarus600GCMS.

PerkinElmer Announces Partnership with Ion Signature Technology to Enhance Evaluation of Complex GC/MS Samples

PerkinElmer, Inc, a global leader in Health Sciences and Photonics, has announced a new partnership with Ion Signature Technology, Inc. (IST). Users of the new PerkinElmer Clarus 600 GC/MS now have the option to incorporate Ion Signature Quantitative Deconvolution Software customized for the Clarus family during data processing for fast and accurate data review and evaluation. "The Clarus GC/MS and Ion Signature Quantitative Deconvolution software work in concert to enable users to rapidly quantify target compounds and identify unknowns in complex GC/MS samples,” said Jonathan Rennert, vice president and general manager, Analytical Sciences, for PerkinElmer’s Life and Analytical Sciences division. “This partnership supports our overall goal to provide solutions that help advance the pace and precision of scientists’ research and testing.”
The recently launched family of Clarus 600 GC/MS systems delivers high performance and increased sample throughput. For many laboratories, adding the Ion Signature option further enhances the Clarus system’s ability to deliver faster results on unknowns. “It provides a tool for laboratories to more efficiently identify target compounds present in even difficult and complex samples,” Rennert said. “By combining this powerful deconvolution capability with the fastest analytical cycle time capabilities delivered by the Clarus 600 GC/MS, customers can significantly increase their analysis and identification of organic compounds. Consequently, it is anticipated that scientists will reap an even greater return on their GC/MS investment.” The Ion Signature FileConvert software package, designed specifically for use with the PerkinElmer Clarus GC/MS series, is the most powerful deconvolution tool in the marketplace. It addresses the needs of the full spectrum of GC/MS users, including environmental contract, forensics, food and beverage, flavor and fragrance, petrochemical and chemical quality-control (QC) laboratories. In these market segments, users face unique co-eluting challenges when multiple components or contaminants overlap at the results stage, which make the clear interpretation of data difficult. To avoid such challenges, the PerkinElmer TurboMass GC/MS software first performs the data acquisition. The IST deconvolution software then comes into play to simplify the complex compounds before the data processing stage to ensure accurate identification. For detials, visit http://www.perkinelmer.com/Clarus600GCMS.

Cerno Bioscience Paper Demonstrates Automated and Parameter-Free Peak Integration for LC/MS/MS Quantitation

A new paper from Cerno Bioscience and XenoBiotic Laboratories, is now available called ‘Automated and Parameter-Free Peak Integration for LC/MS/MS Quantitation’. The paper demonstrates how Cerno’s award winning MassWorks, an easy-to-use post acquisition software package that utilizes the company’s patented MSIntegrity technology to dramatically improve mass spectral measurements, standardizes peak shapes, improves signal-to-noise, deconvolutes overlapped peaks, improves quantitative accuracy and precision, as well as providing automated and parameter-free LC/MS/MS quantitation through a single operation. Although LC/MS/MS quantitation using multiple reaction monitoring is highly selective, peaks with the same ion transition do occasionally overlap due to the interference from endogenous peak or inadequate separation for chiral compounds. In addition, low limits of quantitation are always desirable for the quantitation support for clinical trials. As opposed to hardware approaches, the paper reports novel post acquisition data processing methodologies with a unique calibration algorithm to improve the selectivity and lower quantitation limits when using MassWorks. The methodologies involved extracting four chiral compounds from human plasma and urine. LC/MS/MS analysis of the compounds was performed on an AB/SCIEX API-4000 tandem mass spectrometer employing turbo-ion spray ionization in the positive ion mode along with multiple reaction monitoring (MRM). The data processing technology of MassWorks, MSIntegrity, was used for all the peak integration and quantitation calculation. With no need to set up any peak integration parameters, the integration procedure began by first establishing a peak shape calibration from one chromatogram from within the same run before applying the calibration to the other chromatograms. The peaks in the calibrated chromatograms were integrated accurately without the usual set of empirical parameters, achieving truly automated peak integration. For details and a copy of the paper, visit http://www.cernobioscience.com/resources.

Bruker Daltonics Introduces Next-Generation Horizontal Top-of-the-Line MALDI-TOF/TOF Mass
Spectrometer

Bruker Daltonics has announced its next-generation horizontal top-of-the-line ultraflex III smartbeam MALDI-TOF/TOF mass spectrometer. The new ultraflex III combines various innovative features and further pushes the TOF/TOF performance envelope for applications like LC-MALDI and MALDI molecular imaging, where highest
sensitivity and speed are required. An even further improved smartbeam laser with computer-controlled settings of the laser focus size from 10 um to 80 um makes the new ultraflex III an ideal choice for MALDI molecular imaging. Absorbing tissue areas can now be scanned with a very small laser focus and adjustable repetition rates from 1 Hz to 200 Hz, providing maximum sensitivity. The ultraflex III boosts sensitivity even further and increases acquisition speed by a factor of three for LC-MALDI workflows, in comparison to the previous ultraflex II system. The all-purpose WARP-LC workflow software supports intelligent, result-dependent LC-MALDI acquisition, protein sequence validation, PTM screening and accurate quantitative proteomics for all label chemistries, to ensure outstanding top-of-the-line ultraflex III TOF/TOF performance. For details, visit http://www.bruker-biosciences.com.

Bruker Daltonics Introduces High Performance Compact Vertical MALDI-TOF/TOF Mass Spectrometer

Bruker Daltonics has announced its new autoflex III smartbeam vertical MALDI-TOF or TOF/TOF mass spectrometer. Mass resolution and accuracy, sensitivity, analytical versatility and reliability have all been further enhanced in the new autoflex III smartbeam instruments for optimum performance in expression proteomics, quantitative proteomics, as well as in peptide/protein biomarker discovery, identification and validation. Based on Bruker Daltonics' unique and proprietary smartbeam laser technology, the novel autoflex III series is particularly well suited for MALDI molecular imaging applications in in-vitro imaging of peptide and protein biomarker distributions in tissue sections, e.g. in tumor regions. The smartbeam laser allows variable repetition rates from 1 Hz up to 200 Hz, with a computer-controlled, adjustable laser focus size and unrivalled spatial resolution. In addition to a four-fold sensitivity increase compared to the previous autoflex II, the latest autoflex III offers major advances in mass resolution over a broad mass range, using panoramic PAN technology, the same technology used in Bruker Daltonics' top-of-the-line ultraflex TOF/TOF series. Mass spectra with the simultaneous highest resolution over an extended mass range greatly increase success rates in protein database identifications, without the need to optimize instrument parameters. With Bruker Daltonics' well-established LIFT TOF/TOF ion optics and unique smartbeam technology for unprecedented analytical versatility in sample types, matrices, etc., the high-performance autoflex III and ultimate-performance ultraflex III are the preferred MALDI systems for quantitative expression proteomics, top-down proteomics, intact protein analysis, LC-MALDI workflows and clinical proteomics. The new autoflex III is fully integrated into Bruker Daltonics solution packages such as ClinProt for biomarker discovery, MALDI Molecular Imager for biomarker distribution in tissue section, its Proteineer line (the 2D gel-based proteomics suite), and Proteineer LC line (the LC-based proteomics suite). For details, visit http://www.bruker-biosciences.com.

Waters Corporation to Integrate Ultra Performance Liquid Chromatography into Applied Biosystems/MDS SCIEX

Waters Corporation has announced that it will work with Applied Biosystems/MDS SCIEX to develop Waters ACQUITY UPLC System software controls for use with Applied Biosystems/MDS SCIEX's Analyst software. Greater operational integration and connectivity of the two instrument platforms translates into a higher-level of efficiency and productivity for scientists using both a Waters ACQUITY Ultra Performance LC System connected to a mass spectrometer from Applied Biosystems/MDS SCIEX. The decision to cooperate between Waters and Applied Biosystems/MDS SCIEX engineers to develop the software controls is being driven by scientists in
the mass spectrometry community combining ultra performance liquid chromatography (UPLC) with MS. UPLC has proven to produce narrower and sharper peaks versus HPLC, higher signal-to-noise ratios, and shorter run times, all of which contribute to enhanced mass spectrometer performance bringing laboratories new levels of efficiency. Waters ACQUITY UPLC system is a first of its kind LC system designed to take full advantage of the potential of novel sub two-micron particles to give scientists chromatographic run times that are up to 9X shorter than today's fastest HPLC systems, up to 2X better peak capacity or resolution, 3X better routine sensitivity, and, generally speaking, more information from a single run than anything today's HPLC systems can provide. For deetails, visit http://www.waters.com or http://www.appliedbiosystems.com.

Waters Corporation Acquires Thermometric AB

Waters Corporation has announced the acquisition of all the outstanding capital stock of privately held Thermometric AB (Jarfalla, Sweden), a manufacturer of high-performance microcalorimeters, for approximately $2.5 million. Waters plans to merge the acquired business into its TA Instruments Inc. (New Castle, DE) operation. Thermometric has annual sales of approximately $4 million and this transaction is expected to be neutral to Waters 2006 earnings. Commenting on the acquisition, Terry Kelly, President of TA Instruments said, "The technologies and products from Thermometric are complementary to our leading position in thermal analysis and will allow us to expand our business into new applications, especially in life science research." Waters Corporation holds worldwide leading positions in three complementary analytical technologies - liquid chromatography, mass spectrometry and thermal analysis. These markets account for approximately $5 billion of the overall $20 - $25 billion analytical instrument market. Thermometric AB operated as a privately held company in Jarfalla, Sweden. Their flagship product, the TAM III, is a modular calorimeter that employs proprietary technology to deliver unparalleled calorimetric sensitivity and temperature stability. It is routinely used to characterize materials, and their interactions, in the fields of pharmaceuticals, life and materials sciences. For details, visit http://www.waters.com.

Thermo Wins Omega Award for Service Excellence for Second Consecutive Year

Thermo Electron Corporation, world leader in analytical instrumentation, was recently awarded the NorthFace ScoreBoard Award, for a second consecutive year, in recognition for providing Excellence in Customer Service to its customers. The award presented to Thermo included two categories: Installation Service Representative and Field Service Engineer. The award program, now in its fifth year, rewards organizations that consistently exceed customer expectations and who offer exemplary service to their customers. Omega Management Group, an independent quality auditing firm, judged more than 200 projects from over 50 companies based in the U.S. and abroad in 2005. Each of the award recipients qualified by measuring their customer satisfaction levels at least twice during the year in such categories as technical support, field service, sales process, account management and training. The award recipients are those who, based on survey responses from their own customer base, achieved a 4.0 or above out of a possible 5.0 score in any category measured. With a history spanning 50 years, Thermo offers a broad array of products and services that are backed by one of the largest and most knowledgeable service organizations in the instrument industry. Although the portfolio is extremely diverse, Thermo’s engineers continue to remain specialized in specific products, and are required to prove their expertise by passing strict certification levels for each product they intend to support. This stringent certification program provides a progressive training channel for engineers to demonstrate and prove skill standards through structured classroom instruction, practical laboratory experience, and on-site mentoring. Recognition of Thermo’s service has been due largely to the highly knowledgeable team of 1,200-plus certified Thermo engineers who serve more than 125 countries, and who are dedicated to helping customers improve productivity, quality and profitability. For details, visit http://www.thermo.com/service.

QISoft Strengthens Development Team

QISoft has appointed Dixie Elsasser to the position of Programmer within the Software Development Team based at the Savannah office in the USA. Prior to joining QISoft, Dixie was IT Manager at Operational Support & Services Inc whom she joined after graduating Summa Cum Laude from Troy State University with a B.S. in Computer Science. Following the successful completion of an induction programme, Dixie has commenced work on the development of a new version of QIS, a market leading Process and Product information application from QISoft. QISoft, through its comprehensive suite of MES applications, is at the forefront in delivering solutions to many of the world’s leading companies, providing up to the second information throughout whole manufacturing cycle. For details, visit http://www.qisoft.com.

David Phillips Joins BioAnalyte to Build on Success in LC/MS Software Industry

BioAnalyte Inc., an emerging leader in bioinformatics software, has announced that David Phillips has joined the company as Marketing Manager. David comes to BioAnalyte with more than a decade of marketing, sales, and consulting experience in the software industry. He will assist the company in building a leadership position in delivering high performance mass spectrometry and liquid chomatography analysis solutions to labs worldwide. David was formerly marketing manager at a life sciences software company focused on the clinical research market. David has a BA from St. Lawrence University and a Master of International Management from Thunderbird, The American Graduate School of International Management. He has lived and worked in N. America, Europe, Asia, and Australia. He currently resides in Portland, ME. For details, visit http://www.bioanalyte.com.

ClinPhone Strengthens Team Post-IPO

ClinPhone plc has appointed Dawn Sugden as its new Head of Legal and Company Secretary, following the company’s recent IPO on the London Stock Exchange. Dawn will be based at the company’s corporate head office in Nottingham, UK. In her new role, Dawn is responsible for managing ClinPhone’s full legal team, and acts as company secretary to the Company board. She will report directly to ClinPhone’s CEO, Steve Kent. ClinPhone currently employs more than 600 staff worldwide, managing projects in more than 100,000 clinical trials sites. Dawn Sugden brings extensive experience to ClinPhone, having previously held the position of company secretary and general counsel for the South Bank Board Limited, a registered charity and publicly funded arts organization which manages the Royal Festival Hall. In her role with South Bank Board Limited, Dawn played a key role in the financing and procurement of a £110 million construction project for the refurbishment and enhancement of the Royal Festival Hall and its environs. Prior to that role, Dawn was company secretary and legal advisor at WorkPlace Technologies from 1995 until the sale of the business in 1999. For details, visit http://www.clinphone.com.

ClinPhone Poll Identifies Key Challenges Facing Drug Accountability

Achieving comprehensive drug accountability documentation to ensure regulatory compliance is a major issue facing clinical trial sponsors. This is the main finding of a recent poll conducted by ClinPhone, a global leader in clinical technology solutions. The opinion poll of 250 industry participants was conducted as part of ClinPhone’s recent webinar series, ‘Drug Accountability: Full Visibility through Electronic Management’. The webinar series demonstrated how ClinPhone’s newly-launched drug accountability solution can overcome such problems by enabling sponsors to centrally manage the entire drug accountability process. ClinPhone drug accountability allows clients to demonstrate effective compliance with regulatory requirements by providing a full chain of custody for every medication unit, from dispatch to dispensing to destruction. The results of ClinPhone’s poll highlight that the industry is increasingly focusing on the problem of maintaining accurate drug accountability management within a clinical trial. During the webinar, 28% of respondents identified that ensuring the provision of appropriate documentation meet regulatory requirements as the biggest issue facing them, and a further 26% pointed to the difficulties in consolidating site records, depot records and destruction certification. These results identify a need for a better, faster and more efficient way to manage what is currently a very manual and labor-intensive activity. The findings clearly reinforce the significant benefits that can be gained by using an electronic solution to centrally manage the entire drug accountability process. ClinPhone drug accountability is a natural and logical extension of ClinPhone’s market-leading trial supply management services. Fully integrated with the company’s Interactive Voice Response (IVR) and Interactive Web Response (IWR) services, it facilitates centralized management of the entire clinical supply chain from distribution to destruction. The real-time access to accurate, quality data allows sponsors to gain complete visibility of the status of every used and unused pack associated with the study. ClinPhone’s new solution helps sponsors minimize paper-based operations and enjoy the benefits of a simplified and streamlined workflow. For details, visit http://www.clinphone.com.

ABB Enters into a New Cement Market

ABB, a leading power and automation technology group, has won an order worth more than ten million US$ from Karcement JSC. Karcement has commenced work to rehabilitate its production line No. 6 of the Aktau plant and awarded the electrical restoration project to ABB in April 2006. The project, ABB’s first large cement plant project in a CIS country, will be completed by spring 2007. The plant is then expected to produce an additional one million tons of cement per year. ABB’s scope of supply comprises complete electrification and power distribution, process control (800xA), gas analysers and process instrumentation, including kiln shell scanner. Furthermore ABB delivers the complete infrastructure package including telephone, intercom, lighting, cables and installation material. Also supervision of erection and commissioning is part of the supply. ABB was able to guarantee a very short delivery time, which means that no more than ten months will pass between signing of the contract and the kiln firing. Karcement’s Aktau plant is located 180 km to the south of Astana, the capital of Kazakhstan. With a total area of about 130 hectares, its most important raw materials, limestone and clay, are extracted from two quarries nearby. Kazakhstan is presently experiencing an economic boom, with very high growth rates and a very active construction sector. Deposits of the Aktau cement plant are sufficient to meet the Company’s current production needs in excess of 100 years. For details, visit http://www.abb.com/cement.

Holcim’s Lägerdorf Plant Improves Performance with ABB’s Precalciner Control Solution

ABB,a leading power and automation technology group, has installed a new Model based Precalciner Temperature (PCT) control solution at the Holcim Lägerdorf plant in Germany. PCT was installed on the calciner at the Lägerdorf plant in July 2006 to increase alternative fuels utilization, get closer to the clinker quality targets and reduce the risk of process disruption. The technologies used are Model Predictive Control (MPC) and Mixed Logical Dynamical Systems (MLD). Holcim selected their Lägerdorf plant to have ABB’s PCT solution installed because this plant uses a large number of alternative fuel materials that have a high variability of calorific value and are difficult to transport and dose. Further, material samples are often not representative and temperature measurements alone do not allow identification of which component generated a change in the fuel mix properties. ABB’s PCT has successfully overcome these problems by applying a MPC+MLD scheme that includes unique combination of adaptive first principle mathematical models. The controller detects the gap between what is measured and what is expected, to derive appropriate corrective actions. In order to mitigate disturbances in the process conditions the system takes into account factors like material transport delays, the system’s thermal inertia, flame conditions, combustion air supply, etc. Additionally, accurate modeling of the calcination reaction as a function of the precalciner temperature, plays a central role in the scheme. Peculiarities associated with the transport system have also been considered. For details, visit http://www.abb.com/cement.

ABB Wins Major Control System Contract from Jura Cement

ABB, a leading power and automation technology group, has won an order worth more than two million Swiss Francs for the replacement of a complete control system at Jura Cement’s cement production line No. 5. This major order complements several other follow-up orders which ABB has been awarded since it supplied Jura Cement with complete electrical equipment in 1985. A full range of cement specific applications from ABB Switzerland are now installed at the plant in Wildegg. The contract was signed in August 2006. By the summertime of 2008 the most modern process control systems and control room of any Swiss cement plant are scheduled to go in operation. The existing control units of the subsystems will be integrated into the new level one control system in the most efficient way. ABB’s scope of supply includes a client-server based Industrial IT Control System 800xA with ten operator stations and three engineering workstations. The system’s sixteen AC800M controllers will handle more than 10’000 process signals across the complete production plant. In addition, ABB will supply complete IO-Hardware, erection supervision, as well as commissioning of the plant in close collaboration with the customer. ABB will create the new control concept and will develop the standard software as well as the cement specific software. The advanced software modules were a key factor in selection of the system for its flexibility and handling of plant specific parameters. Jura Cement operates two cement plants in Switzerland. With a capacity of 950 000 tons per year the company is the second largest cement producer in Switzerland. For details, visit http://www.abb.com/cement.

Savi Networks to Deploy Cargo Security and Tracking Network at Virginia Port Authority Terminals

Savi Networks is installing Radio Frequency Identification-based (RFID) technology information services at Virginia Port Authority terminals to further enhance the security and efficiency of cargo container shipments. Under an agreement signed August 22 with the VPA, Savi Networks will deploy a system compatible with international standards (ISO18000-7) at Norfolk International Terminal, Newport News Marine Terminal and Portsmouth Marine Terminal. The network automatically tracks the location and security status of RFID-tagged containers. SaviTrak, the company's web-based managed information service, also will be utilized to deliver real-time information collected by the network infrastructure. Savi Networks, a joint venture between Savi Technology, a Lockheed Martin company, and Hutchison Port Holdings, has similar agreements with a number of major port authorities and terminal operators worldwide who are participating in the development of the company’s global information network. The SaviTrak information service is integrated with an open technology platform that receives and processes real-time data feeds from standards-based RFID technologies as well as other Automatic Identification and Data Collection (AIDC) technologies, such as barcodes, EPC-compliant passive and Global Positioning Systems (GPS) used to track ships and trucks transporting ocean containers. For details, visit http://www.savinetworks.com.

IU Study: More Internet Users may be Taking ‘Phishing’ Bait Than Thought

A higher-than-expected percentage of Internet users are likely to fall victim to scam artists masquerading as trusted service providers, report researchers at the Indiana University School of Informatics. Designing Ethical Phishing Experiments: A Study of eBay Query Features simulated “phishing” tactics used to elicit online information from eBay customers. The online auction giant was selected because of its popularity among millions of users – and because it is one of the most popular targets of phishing scams. Phishers send e-mail to Internet users, spoofing legitimate and well-known enterprises such as eBay, financial institutions and even government agencies in an attempt to dupe people into surrendering private information. Users are asked to click on a link where they are taken to a site appearing to be legitimate. Once there, they are asked to correct or update personal information such as bank, credit card and Social Security accounts numbers. Surveys by the Gartner Group report that about 3 percent of adult Americans are successfully targeted by phishing attacks each year, an amount that might be conservative given that many are reluctant to report they have been victimized, or may even be unaware of it. Other surveys may result in overestimates of the risks because of misunderstanding of what constitutes identity theft. In contrast, experiments such as the one conducted by IU researchers Markus Jakobsson and Jacob Ratkiewicz, have the advantage of reporting actual numbers. Their study, one of the first of its kind, reveals that phishers may be netting responses from as much as 14 percent of the targeted populations per attack, as opposed to 3 percent per year. “Our goal was to determine the success rates of different types of phishing attacks, not only the types used today, but those that don’t yet occur in the wild, too,” said Jakobsson, associate professor of Informatics. Jakobsson also is an associate director of the IU Center for Applied Cybersecurity Research, which studies and develops countermeasures to Internet fraud. Ratkiewicz and Jakobsson devised simulated attacks where users received an e-mail appearing to be legitimate and providing a link to eBay. If recipients clicked on the link they were in fact sent to the eBay site, but the researchers received a message letting them know the recipient had logged in. The researchers specifically designed the study so that all they received was notification that a login occurred, not the login information (such as the recipient’s eBay password) itself – unlike a real phishing attack, which is designed to harvest passwords and other personal information. The study was approved in advance by the IU-Bloomington Human Subjects Committee, which is responsible for reviewing and approving research activities involving human subjects and data collection. The experiment was unusual in that it did not involve debriefing of subjects, given that this step was judged to be the one and only aspect of the experiment that could potentially pose harm to subjects, who might be embarrassed over having been “phished” or wrongly conclude that sensitive information had been harvested by the researchers. “We wanted to proceed ethically and yet obtain accurate results,” said Ratkiewicz, a computer science doctoral student. One experiment they devised was to launch a spear phishing attack in which a phisher sends a “personalized” message to a user who might actually welcome or expect the message. In this approach, the phisher gleans personal information readily available over the Internet and incorporates it in the attack, potentially making the attack more believable. The researchers used three types of approach statements: “Hi can you ship packages with insurance for an extra fee? Thanks”… “HI CAN YOU DO OVERNIGHT SHIPPING? THANKS!” … and “Hi, how soon after payment do you ship? Thanks!” In a large portion of the messages, the user’s eBay username was included in the message to make it appear more similar to those eBay itself would send. “We think spear phishing attacks will become more prevalent as phishers are more able to harvest publicly available information to personalize each attack,” Ratkiewicz said. “And there’s good reason to believe that this kind of attack will be more dangerous than what we’re seeing today.” The results of the IU researchers’ latest phishing study were shared with eBay officials. Jakobsson was the author of a 2004 report which detailed worst-case phishing scenarios and attacks and possible ways to prevent them. It was cited positively by various information technology leaders, including eBay officials. To read Designing Ethical Phishing Experiments: A Study of eBay Query Features, go to http://www.informatics.indiana.edu/markus/papers/ethical_phishing-jakobsson_ratkiewicz_06.pdf. Users of eBay should forward any message they think is fraudulent to spoof@ebay.com. For more information about anti-phishing research activities at IU, go to http://www.indiana.edu/~phishing.

Medical School Scientist to Lead IU’s Bioinformatics Program

An internationally renowned bioinformatics expert at the Indiana University School of Medicine will share his expertise and leadership with the IU School of Informatics. A. Keith Dunker, professor of biochemistry and of molecular biology, has been appointed director of the School of Informatics’ Bioinformatics Program at the Bloomington and IU-Purdue University Indianapolis campuses. He also will continue as director of the Center for Computational Biology and Bioinformatics at the School of Medicine. Bioinformatics is the application of computer technology and information sciences in biomedical research. This discipline enables scientists to gather and analyze huge volumes of data, information critical in life sciences and genetic research. Bioinformatics allows scientists to more rapidly develop therapeutic drugs and effective treatments for disease. Bioinformatics plays a major role in IU’s Life Sciences Strategic Plan, which includes the development of bioinformatics and chemical informatics as major areas of strength in the School of Informatics. Certainly, the School of Medicine – the second largest medical school in the nation – has the leading role in advancing IU’s overall life sciences goals. Dunker, who was recruited to IU in 2003 from Washington State University, focuses his research in the relationship between the lack of protein folding and function. For more than a century it was accepted that protein function follows directly from fixed 3-D structure (virtually all of the work in the biotechnology and pharmaceutical industries rests on this assumption) and so the non-folding proteins were mostly ignored. Analyzing these proteins with bioinformatics is leading to a major change in understanding protein structure and function. Signaling, regulation and control are now realized to often-involved regions of proteins, or even whole proteins that must be unstructured and flexible to carry out their functions. Bioinformatics is one of six cornerstone scientific programs of the medical school-centered Indiana Genomics Initiative, established in 2000 by a $105 million gift from the Lilly Endowment, which followed three years later with a $50 million grant. In 2004, IU Bloomington received a $53 million grant from the Endowment to expand and intensify basic research at the cellular level. The Indiana Metabolomics and Cytomics Initiative, better known as METACyt, significantly complements life sciences research currently under way at the School of Medicine. Dunker replaces Gary Wiggins, adjunct professor, who was serving as interim director of the Bioinformatics Program. Wiggins will continue leading the School’s Chemical Informatics Program. For details, visit http://www.indiana.edu.

USDA Selects Denver for New Information Technology Site

The U.S. Department of Agriculture has announced that the Denver Financial Center has been selected as the new primary information technology site for the USDA National Finance Center (NFC). The NFC headquarters will remain in New Orleans, La. NFC, one of the largest employers in New Orleans, is a federal center of excellence for payroll and human resource functions, serving several federal agencies. With more than 1,300 employees, NFC provides support services to approximately 585,000 federal civilian employees. The center of excellence concept is designed to provide economies of scale and reduce costs. The economy of scale of the NFC has saved between $30 and $100 per employee per year as additional federal agencies have contracted with the center. In a prior continuity of operations review the management of NFC recommended moving the primary information technologies center from the local area due to the periodic risk of hurricanes. The administration and the Congress agreed with the recommendation and appropriated funding for the new location. While the project team was completing the site requirements for the primary data center, NFC was evacuated due to an ensuing hurricane. Hurricane Katrina required the relocation of staff. The data center was moved to a short-term disaster recovery center. Damage assessment from Katrina to NFC reconfirmed the need for a long-term primary computer center outside of the hurricane-prone area. The Denver site was selected from four currently or soon to be vacant federal data centers. The final selection was between Albuquerque, NM and Denver, CO. Factors that influenced the selection included cost, infrastructure, and employable technical talent. For details, visit http://www.usda.gov.

Study Highlights Need for Comparative Drug Reviews

The fact that the newest generation of antipsychotic drugs used to treat schizophrenia is no more effective than earlier, less expensive treatments illustrates the need for a national dialogue about comparative effectiveness between drug classes, an academic says. A study funded by the UK's National Health Service, and published in the October edition of the American Medical Association's Archives of General Psychiatry, found that second-generation antipsychotics (SGA) are no more effective in improving schizophrenics' quality of life than their older counterparts and therefore do not justify their higher costs. "The results of this pragmatic randomized trial refute the hypothesis that the use of SGAs is superior to the use of" first-generation antipsychotics, the study concluded. But Eli Lilly, the maker of Zyprexa and Symbyax, two of the drugs featured in the trial, downplayed the study's results. "We differ with the assumption made by the researchers of this study that all [second-generation drugs] work the same," a Lilly spokeswoman said. "We know that based on real-world evidence and multiple other studies that these drugs do differ in terms of efficacy and side effects." Zyprexa was the 16th highest selling drug in the U.S. in 2005, based on retail sales. Antipsychotics are one of the fastest growing categories of drugs, with the Social Security Administration disability benefits for these treatments growing by 35 percent between 1994 and 2003. As of 2005, 90 percent of patients with schizophrenia received SGAs at a cost of $10 billion annually, according to a commentary that accompanied the study. Robert Rosenheck, a professor at Yale University's Department of Psychiatry and the author of the commentary, says these newer drugs cost as much as 100 times more than earlier antipsychotics, without much difference in efficacy. But this study should not lead to wholesale policy changes, Rosenheck said. "These unexpected empirical findings should not lead to a precipitous turn away from policies that support open formularies for psychotropic drugs." Instead, there should be a broad public dialogue on this issue before such a drastic step is taken, he said. "Polarizing decisions are best delayed until thoughtful public deliberation gives a chance for comprehensive review, consensus building and shared understanding." For details, visit http://www.ama-assn.org.

FDA Publishes Guidance Agenda, Seeks Comments

The FDA has published its annual guidance document agenda and is seeking public comments on possible topics for future guidance development and revisions to existing documents. The Aug. 31 Federal Register notice includes planned guidances for all of the agency's offices, along with contact information for each document. The list represents possible new topics or revisions to existing documents that the agency is considering. But the FDA said it is not bound by this list of topics or required to issue any guidance on this list. The notice is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/oc0689.pdf.

FDA Withdraws Guidances Due to Format Changes

The FDA is withdrawing three electronic new drug application (NDA) and abbreviated new drug application (ANDA) guidances because the agency wants companies to adhere to a single format for submissions. In a notice published in the Sept. 29 Federal Register, the FDA announced it is withdrawing the following guidances: "Providing Submissions in Electronic Format — NDAs;" "Providing Regulatory Submissions in Electronic Format — ANDAs;" and "Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs." The agency is withdrawing these guidances because it is changing the format it requires for these documents from portable document files (PDF) to extensible markup language (XML). Previously, submissions could be in either format, which presented problems for both industry and the agency, the agency said. "A result of having this variety of choices is confusion and frustration for industry, who are not receiving consistent recommendations about how to submit marketing applications," the agency said. "It is also confusing and frustrating for our review staff. In addition, our willingness to receive applications in a variety of different forms has forced the agency to maintain expensive and duplicative processes and systems for receiving and archiving these various application types." The notice is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/99d-0054-nwl0001.pdf.

FDA Issues Guidance on Efficient Drug Manufacturing

The FDA is seeking to help the pharma industry adopt modern quality management system principles so that companies can produce drugs more efficiently, lower costs and prevent shortages through a new guidance released Sept. 29. The document is meant to "foster innovation and continuous improvements in pharmaceutical manufacturing," the agency said. The guidance, titled "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations," brings up to date the agency's thinking on advances in the quality and manufacturing sciences since the current good manufacturing practice (cGMP) regulations were issued in 1978. The document describes the key elements of a robust quality systems model and shows how it can be used to achieve compliance with the cGMP regulations. It is part of the agency's Critical Path Initiative, which seeks to modernize the development of new drugs. Issues the agency's "quality systems working group" identified in August 2002 to be addressed in the guidance include: The rising number of pharmaceutical products; The increasing role of medicines in healthcare; The declining frequency of FDA manufacturing inspections due to lack of resources; The FDA's increasing experience with and ability to learn from various approaches to product quality regulation; Advances in the pharmaceutical sciences and manufacturing technologies; The increasing application of biotechnology to drug discovery and manufacturing; Advances in the science and management of quality; and The globalization of the pharmaceutical industry. The guidance reflects the FDA's risk- and science-based approach and its push for integrated quality systems and international cooperation, while keeping protection of public health at the top of the agenda. For details, visit http://www.fda.gov.

Manufacturing Inefficiency Costs Industry $50 Billion Annually, Study Finds

The pharmaceutical industry is wasting more than $50 billion each year through inadequate IT and misplaced decisionmaking, according to an academic study. The Pharmaceutical Manufacturing Research Project, a joint venture by Georgetown University and Washington University in St. Louis business schools, collected data from 42 manufacturing facilities owned by 19 companies to determine factors that affected industry performance. The "Final Benchmarking Report" assessed performance in terms of manufacturing times, frequency of deviations from manufacturing standards, reasons for deviations, manufacturing yield and rates of improvement for those metrics. The study determined that improvements in manufacturing processes could save industry more than $50 billion in manufacturing costs, which the researchers believe could result in lower drug prices and more money for R&D. The report received no industry or government funding. The researchers found that five factors affect manufacturing performance: IT; decisionmaking; outsourcing; process analytical technology (PAT); and size and range of manufacturing. But IT and who's in charge of decisionmaking played the most important roles in how efficient and effective a company's manufacturing was, one of the authors, Georgetown professor Jeffrey Macher, said. The point of the report was to take an objective view of these issues in order to help industry improve its manufacturing, he added. As drugs become more complex, manufacturing will be more complicated and the need for efficient manufacturing will become more important. A more extensive use of IT to electronically and automatically report, track and resolve deviations, track people and centrally store data "corresponds to higher levels of performance" and will help companies to more quickly diagnose problems as well, the report said. In addition, better manufacturing performance results when lower-level employees, rather than department heads, make decisions. For details, visit http://www.olin.wustl.edu/cres/research.cfm.

Senate Hold Remains as Von Eschenbach Nomination Passes Commmittee

The Bush administration's nomination of Andrew von Eschenbach to be the next FDA commissioner is still facing a hold on the Senate floor even as the nomination passed out of committee Sept. 20 by a voice vote.
Von Eschenbach has not taken the steps to protect the public's health that should be expected from a permanent commissioner, Sen. Jim DeMint (R-S.C.) said in a statement explaining his hold on the nominee. DeMint is calling on the agency to suspend sales of the contraceptive RU-486, pending an investigation into safety concerns. "I believe a qualified FDA nominee would publicly discourage the use of RU-486 and take immediate steps to suspend the drug until a full investigation can be completed," DeMint said. "Dr. von Eschenbach has now been the acting FDA commissioner for a year, yet he has done nothing to publicly discourage the use of this deadly drug." Von Eschenbach is also facing a hold from Sen. David Vitter (R-La.), who wants the agency to allow some form of drug importation. Vitter's office did not respond to a request for comment. But von Eschenbach has a powerful ally in Senate Health, Education, Labor and Pensions Committee Chairman Mike Enzi (R-Wyo.), who shepherded the nomination through his committee. The senator will work with Senate leadership to get the hold removed, an Enzi spokesman said. Enzi commented in a statement that von Eschenbach has the "qualifications to head up the agency and bring about reforms necessary to restore consumer confidence in our nation's food and drug watchdog agency." The nominee is also under pressure from frequent FDA critic Sen. Chuck Grassley (R-Iowa), who wrote the agency Sept. 20 urging it to improve its handling of drug safety risks and increase the transparency in the preapproval process. "I am writing this letter to encourage you to establish and implement a resuscitation plan to restore the FDA's credibility in the mind of its own employees and the American public," Grassley said. "An agency that hemorrhages whistleblowers is an agency needing critical care." For details, visit http://www.fda.gov.

John E. Niederhuber Appointed as Director of the National Cancer Institute

Dr. John E. Niederhuber has been appointed as Director of the National Cancer Institute. Niederhuber takes the place of the nominee to run the FDA, Andrew von Eschenbach, who left the NCI to pursue the FDA commissioner's slot, but his nomination has been stalled by controversy over the agency's handling of the Plan B contraceptive. Niederhuber is a nationally recognized surgical oncologist with special clinical emphasis on gastrointestinal, hepatobiliary, and breast cancer. His pioneering work in hepatic artery infusion chemotherapy and implantable vascular access devices were major contributions to cancer care. He brings a long career of medical and administrative expertise to this position. Having served as a surgeon, laboratory and clinical researcher, cancer center director, and leader of several national cancer organizations, as well as in key senior positions at the National Cancer Institute, he has a unique perspective of the complexities of the cancer field from which to approach this new challenge. His experience will be vitally important in our efforts to further reduce cancer incidence and mortality.For details, visit http://www.cancer.gov.

Senate Democrats Move to Postpone Drug Safety Bill

Democrats on the Health, Education, Labor and Pensions (HELP) Committee are urging Chairman Mike Enzi (R-Wyo.) to delay the markup of his drug safety bill until there has been a hearing on the bill and time to consider the recommendations in a recent report by the Institute of Medicine (IOM). The National Academies' IOM report, which reviewed the FDA's drug safety practices, is an important tool in understanding problems with the regulatory system and how to address those problems, Sen. Chris Dodd (D-Conn.) and other Democrats on the HELP Committee wrote in a letter to Enzi. This new information, along with the lack of any hearings to consider Enzi's bill, the "Enhancing Drug Safety and Innovation Act," gives the lawmakers pause. "We believe it would be a mistake to move drug safety legislation through the HELP Committee before Congress and the public have an opportunity to consider [the report's] findings," the Sept. 26 letter said. "Too much is at stake to rush legislation that has not had a single hearing through the HELP Committee." IOM's Sept. 22 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," blasted the agency's handling of drug safety issues and recommended legislative action to fix these failings. The report recommended that Congress give the FDA the authority to require whatever postmarketing risk assessment and risk management programs are needed to monitor and ensure the safe use of drug products. Meanwhile, Enzi and cosponsor Sen. Edward Kennedy (D-Mass.) have used the report to herald the need for the bill. The report "adds new urgency for Congress to act on reform legislation to give the [FDA] better tools to protect and promote the public health," the senators said in a Sept. 22 statement. Their bill would require the FDA to approve drugs and biologics, as well as new indications for these products, under a risk evaluation and mitigation strategy, a mechanism to acquire and adapt to new safety information about a drug. For details, visit http://www.iom.edu.

FDA, MIT to Collaborate on Drug Safety

The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases as part of a broad agency initiative to improve its postapproval monitoring of drugs, a high-ranking FDA official said. The FDA and MIT's Center for Biomedical Innovation (CBI) will work to supplement the agency's current safety data with automated healthcare databases that will allow the FDA to undertake real-time drug safety monitoring. Doing so will help address shortfalls in the current system,said Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs. "We need to improve the information we rely upon, and our tools and resources for gathering that information in a timely and reliable way," he added. The FDA has been under pressure to make changes to its drug review program, facing growing criticism for its handling of Vioxx and other drugs, with critics arguing that the FDA review process is too slow and incomplete to catch potential problems. MIT will use advanced computerized methods to automate the process of recognizing unusual patterns of infectious disease. Doing so would allow the agency to more quickly identify problems with drugs used to treat these diseases, allowing for an accelerated response. These tools will be similar to those public health departments and the Centers for Disease Control and Prevention use to fight bioterrorism and pandemic influenza. But these changes require more than planning. "All of this is going to require significant new investments in time and resources aimed at improving FDA's IT backbone, which has grown outdated over the years," Gottlieb said. "It will also require continued support by Congress." The proposal got the support of several activists. "This has potential," William Vaughan, senior policy analyst for Consumers Union, said. The agency will need more money to pay for these projects, perhaps through the next round of Prescription Drug User Fee Act (PDUFA) negotiations. PDUFA expires Oct. 1, 2007. The move is beneficial, Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, said. These databases are helpful because they "allow more early warning signs to be seen — and seen earlier." However, Sidney Wolfe, director of Public Citizen's Health Research Group, rejects the proposal. The agency has long developed detailed databases to track side effects, but rarely acts on that information, he said. "Analysis without action is really a fraud." Also, this move seems to override the Office of Drug Safety, which usually takes on such responsibilities. Contracting out this work is "an insult" to that office, he added. For details, visit http://www.fda.gov.

What's New : September - October 2006 The following is a wrap-up of news of interest during the months of September to October 2006

What's New : September - October 2006
The following is a wrap-up of news of interest during the months of September to October 2006