LIMSource News: What's New Right Now

• Thermo Electron and Fisher Scientific to Combine in Industry-Transforming Transaction
• Teamwork Award Presented to STARLIMS for On-Time, On-Budget Implementation of LIMS Solution for DCLS
• Thermo Re-Engineers Industry Leading LIMS for More Power and Greater Ease-of-Use
• New LabPAS/CT V 2.5, Complete P1 Trial Workflow System with PDA, to be Unveiled at DIA Annual Meeting
• Latest Release of LabSoft LIMS v8.06 Provides Expanded Reporting and Security Features
• GenoLogics’ Flagship Proteomics Solution Now Includes Automated Informatics and Supports the ISB’s Trans Proteomic Pipeline
• Leading Chinese Pharmaceutical Research Service Company Selects Watson LIMS
• GenoLogics and Bioinformatics Solutions Collaborate to Integrate Their Proteomics Data Management and Data Visualization Software
• Industry Accolades for STARLIMS V10
• Top Marks for QSI in LIMS Survey
• Fred Hutchinson Cancer Research Center Deploys GenoLogics’ Proteomics Purposed Software Solution to Accelerate Their Cancer Biomarker Discovery
• STARLIMS Academy to Provide Technical Training for Employees, Customers and Partners
• Thermo Enables Greater Flexibility for ADMET Studies with Galileo LIMS v 3.2
• GenoLogics Partners with GeneBio to Enhance Proteomics Lab and Data Management Capabilities for Life Science Researchers
• LabWare Advances Informatics Fellowship at IUPUI
• STARLIMS Named Preferred LIMS Provider for Six Genetics Laboratories of UK’s National Health Service
• University of Dundee FingerPrints Proteomics Facility selects GenoLogics’ Proteus to Improve Operational Lab Management and Customer Service
• BioTech Business Expected to Reach $5 Billion by 2010 in India
• Waters Debuts New Class of Mass Spectrometry Technology
• Chenomx Inc. Releases Version 4.5 of Metabolomics Software Suite
• Bruker Daltonics' New ClinProTools 2.1 and flexImaging 2.0 Software Now Permit Integrated Statistical and
Image Analysis of Tissue Samples
• Green Mountain Logic Expands Management Team
• Teranode Awarded Patent that Enables Adaptive Workflow
• Teranode Continues to Build Customer Momentum with New Customer Wins and Existing Site Expansions
• Mettler Toledo Releases Berger SFC for Agilent ChemStation
• IU Scientists Devise Means to Test for Phony Technical Papers
• AcquiData, Inc. Releases Testream/CS v 6.6
• ESA Biosciences Integrates the Coulochem III System with ABI/MDS Sciex Analyst Software, Coupling Mass Spectrometry and Coulometric Electrochemistry
• Chenomx and Umetrics Partner to Provide an Enhanced Metabolomics Analysis Platform
• Bruker Daltonics Introduces Novel WARP-LC 1.1 Software for LC/MS/MS Based Quantitative Proteomics
• Otsuka Chooses ClinPhone's Innovative Integration Solution
• ESA Detectors Now Directly Connect with Agilent ChemStation Drivers Through Standard USB Interface
• SYSTECH International Releases TIPS 7.0 Operating System
• ACD/Labs and Elsevier MDL to Integrate Informatics Solutions
• Colombian Logistics and Security Firm Deploys RFID-based Information Solution from Savi Technology to Continously Monitor Cargo Shipments
• Savi Technology Releases New RFID Sensor Tags to Track and Monitor the Condition of Global Shipments
• New Savi Knowlege Center Delivers State-of-the-art RFID Training On-site or Online
• Protedyne Introduces Radius Robotic System
• Roch Kelly Joins Protedyne Corporation as Chief Operating Officer
• Drug Safety Amendment Defeated on House Floor
• FDA Appeal May Expand Generic Drug Market
• FDA Moving Toward New cGMP Approach, Greater Use of International Standards
• Several Guidances Withdrawn as Inconsistent with New GMP Initiative

Thermo Electron and Fisher Scientific to Combine in Industry-Transforming Transaction

Thermo Electron Corporation and Fisher Scientific International Inc. have announced that the boards of directors of both companies have unanimously approved a definitive agreement to combine the two companies in a tax-free, stock-for-stock exchange. The transforming merger will create the leading provider of laboratory products and services in the high-growth life, laboratory and health sciences industry. The new company will be named Thermo Fisher Scientific Inc. and is expected to have 2007 revenues of more than $9 billion. Thermo and Fisher have complementary technology leadership in instrumentation, life science consumables, software and services. By combining these capabilities, the company will be uniquely positioned to provide integrated, end-to-end technical solutions. Thermo Fisher Scientific will have an industry leading global sales and service organization with nearly 7,500 professionals serving its customers worldwide. Under the terms of the agreement, Fisher shareholders will receive 2.00 shares of Thermo common stock for each share of Fisher common stock they own. Based on Thermo's closing price of $39.45 per share on May 5, 2006, this represents a value of $78.90 per Fisher share, or an aggregate equity value of $10.6 billion, not including net debt of $2.2 billion. Upon completion of the transaction, Thermo's shareholders would own approximately 39 percent of the combined company, and Fisher shareholders would own approximately 61 percent. The transaction will be treated as a reverse merger with Thermo as the acquirer. Marijn E. Dekkers, president and chief executive officer of Thermo, will become president and chief executive officer of the combined company, and Paul M. Meister, vice chairman of the board for Fisher, will become chairman of the board of the combined company. Following the close of the transaction, Paul M. Montrone, chairman and chief executive officer of Fisher, will be stepping aside in support of the new management team. He will be concentrating on launching new business opportunities and will remain an adviser to the company. Jim P. Manzi, chairman of the board of Thermo, will serve on the board of directors of the combined company. Thermo Fisher Scientific's board of directors will be comprised of eight members, with five nominated by Thermo and three nominated by Fisher. For details, visit http://www.thermo.com.

Teamwork Award Presented to STARLIMS for On-Time, On-Budget Implementation of LIMS Solution for DCLS

STARLIMS Corporation has received a “Teamwork Award” from the Division of Consolidated Laboratory Services (DCLS) of the Commonwealth of Virginia. The award was presented in recognition of DCLS’s successful implementation of a STARLIMS LIMS. DCLS is one of the largest public health laboratory networks in the United States with a staff of nearly 250 scientists that provide support to over 26 state agencies including the Departments of Health, Agriculture and Consumer Services, and Environmental Quality. “I am very proud of the accomplishments of the DCLS LIMS Solution Implementation Team and pleased that they have received this well-deserved recognition. DCLS and its customers will no doubt benefit from the implementation of this comprehensive LIMS application.” said Wanda Andrews, Assistant Bureau Director for Analytical Services at DCLS. Ms. Andrews overseas a wide range of lab services including environmental and drinking water testing, microbiology, clinical, food, feed/fertilizer, and newborn screening. DCLS is part of the Department of General Services of the Commonwealth of Virginia. DCLS offers a wide variety of analytical services to support state, federal, and local agencies—including public health screening, microbiology testing, environmental monitoring and commercial and agricultural testing. In addition, DCLS also provides emergency laboratory support for local, state and federal agencies responding to criminal acts or events that threaten health, agriculture, and the environment. For details, visit http://www.starlims.com.

Thermo Re-Engineers Industry Leading LIMS for More Power and Greater Ease-of-Use

Thermo Electron Corporation has announced the commercial availability of SampleManager LIMS 9.0, an updated version of its flagship LIMS for global enterprises. SampleManager 9.0 is built on the Microsoft .NET platform, incorporates a Service Oriented Architecture, features an all-new, thoroughly modern user interface and introduces enhanced functionality. "We are extremely excited and proud to introduce the enhancements made to SampleManager 9.0," said Dave Champagne, vice president and general manager of Thermo's Informatics business. "With this one update, we have embraced open industry-standard tools, made SampleManager easier than ever to use, and provided a more agile solution that responds to our customers' changing business and information technology needs." In addition to the changes made to 9.0, Thermo announced that it will leverage its 20 years of experience working with customers in the process industries to build industry- and application-specific functionality into SampleManager's core to reduce customization for industrial labs. Purpose-built functionality and workflows will be offered as standard to increase efficiencies and productivity in industries long-served by SampleManager - petrochemical, chemical, and mining, among others. This commercial-off-the-shelf (COTS) approach significantly reduces the risks and costs associated with customized implementations, maintenance and upgrades, and, for regulated industries, the cost of validating the system. To download a presentation on SampleManager 9.0, visit www.brainshark.com/thermo/samplemanager.

New LabPAS/CT V 2.5, Complete P1 Trial Workflow System with PDA, to be Unveiled at DIA Annual Meeting

Green Mountain Logic will unveil its new LabPAS/CT Version 2.5 software that targets the critical quality and resource needs of Phase I clinical research at the DIA Annual Meeting in Philadelphia, June 18-21. Version 2.5 deploys PDAs on clinic floors to scan patient and collection vessel barcodes, eliminating the potential for errors. It provides real time electronic data entry for collection times, comments, dosing, vital signs and adverse events. LabPAS/CT 2.5 also allows integration with document management systems and with biometric systems for positive subject ID. "The PDA, which sends data to a central database, empowers study staff to scan subject and sample, enter data, etc. right at the subject, providing an unprecedented level of accountability,” said John Rosenblum, CEO of Green Mountain Logic, developer of LabPAS/CT. “The new features in 2.5 were designed to enhance the unique ability of LabPAS/CT to readily adapt to individual study environments and changing protocols, rather than burdening CROs with the need to adapt to the software.” LabPAS/CT uses a web interface and intuitive navigation and is the most scalable, configurable and customizable workflow and sample management solution on the market today. Through the innovative use of barcode scanning it eliminates errors, tracks samples, increases throughput, and supports compliance. In addition, sample collection and dosing are scheduled and tracked according to trial protocols. LabPAS/CT supports compliance with FDA 21 CFR Part 11, GCP and GLP, and also empowers study managers to rapidly alter workflow and schedules as protocols change, by simply dragging and dropping items on their computer screen. It was developed under Green Mountain Logic’s design control process, audited and approved by multiple, nationally-recognized pharmaceutical clients. GML is in compliance with FDA guidance for the development of high-risk software systems and for development of Class 2 Medical Devices. For details, visit http://www.labpas.com.

Latest Release of LabSoft LIMS v8.06 Provides Expanded Reporting and Security Features

Computing Solutions, Inc (CSI) has announced the release of LabSoft LIMS v8.06 with expanded reporting and security features. LabSoft LIMS’ Query Independent Reporting feature utilizes the Query tool as a method to organize, secure, and execute independent Crystal Reports. The addition of multiple connection styles in LabSoft LIMS v8.06 allows Query executed Crystal Reports to retrieve data from LabSoft LIMS or another database. Query Independent Reporting is out-of-the-box functionality that utilizes LabSoft LIMS’ seamless interface with Business Objects Crystal Reports. The enhanced login security options in LabSoft LIMS v8.06 provide greater support of our customers’ regulatory compliance. The security options are configured per system allowing each organization to address their requirements. For details, visit http://www.LabSoftLIMS.com.

GenoLogics’ Flagship Proteomics Solution Now Includes Automated Informatics and Supports the ISB’s Trans Proteomic Pipeline

GenoLogics Life Sciences Software Inc., a leading developer of software solutions for biomarker discovery and proteomics research, has announced key new enhancements to its Proteus software solution. GenoLogics’ Proteus solution now includes Automated Informatics, a technology framework that enables powerful bioinformatics pipelining and analytics automation. This new Automated Informatics framework empowers proteomics researchers to fully automate their analysis pipelines after mass spectrometry integration; convert the data to open data formats, integrate to multiple search engines, and validate, quantify and analyze data generated by applications downstream of the mass spectrometer. Proteus enhancements also include: the integration with the Institute for Systems Biology’s Trans Proteomic Pipeline (TPP), automating and synchronizing the data hand-off between the LIMS and the TPP bioinformatics pipeline, and facilitating a continuous exchange of data between the TPP modules and Proteus; the ability to handle electronic sample sheets, which are editable by end users, can be exported for clinical systems and sample bio-repositories and can integrate imported data with existing projects and experiments; and, the continued development of the software based on open data standards, encouraging the use of Proteus as a central hub to tie together lab information and data management with third-party commercial and open-source software. Through its relationship with the Institute for Systems Biology, GenoLogics brings significant added value to the ISB’s Trans Proteomic Pipeline (TPP) by automating the bioinformatics pipelining workflow which is enabled by its new Automated Informatics framework. For details, visit http://www.genologics.com.

Leading Chinese Pharmaceutical Research Service Company Selects Watson LIMS

Thermo Electron Corporation, the leading provider of analytical instruments and informatics solutions, has announced that WuXi PharmaTech Co., Ltd., the leader in the pharmaceutical R&D services industry in China, has selected Watson LIMS to meet the specific data management requirements of its bioanalytical facilities.
Shanghai-based WuXi PharmaTech serves 19 of the top 20 pharmaceutical companies and 8 of the top 10 biopharmaceutical companies in the world, helping them to shorten the cycle and lower the cost of drug research and development. WuXi provides discovery and development services, from lead identification to pre-clinical, at its state-of-the-art facilities. "This agreement to deploy Watson LIMS catapults our bioanalytical service group to the globally accepted quality level," said Dr. Ge Li, chaiman and CEO of WuXi PharmaTech. "Using Thermo LIMS will significantly accelerate our analysis and laboratory turn-around, reduce costs associated with sample management, and increase workflow efficiency. As an integrated solution, it will substantially enable our laboratory services group to bring high quality services to our clients." Watson is the industry leading laboratory information management system (LIMS) for bioanalytical labs. As a purpose-built, commercial-off-the-shelf solution, Watson promotes compliance with Good Laboratory Practices (GLP) regulations and 21 CFR Part 11 guidance from the U.S. Food and Drug Administration (FDA). Watson is relied on by 18 of the top 20 global pharmaceutical organizations, and is widely used in leading biotechnology and contract research organizations worldwide. Watson is part of Thermo's pharmaceutical suite of informatics solutions. Thermo's purpose-built solutions include Nautilus LIMS for research and development, particularly in biotechnology; Galileo LIMS for in vitro ADME/Tox research; Watson for bioanalysis; an Darwin LIMS for pharmaceutical manufacturing R&D and quality control. Thermo also provides the Enterprise Pharmacology (EP) Series and Kinetica as dedicated DMPK analysis tools, GRAMS/AI for spectral data processing, and Atlas CDS, selected a top chromatography data system in 2005. For details, visit http://www.thermo.com/informatics.

GenoLogics and Bioinformatics Solutions Collaborate to Integrate Their Proteomics Data Management and Data Visualization Software

GenoLogics Life Sciences Software Inc., a leading provider of lab and data management solutions for proteomic and systems biology research, and Bioinformatics Solutions Inc. (BSI), a leader in developing de novo sequencing and protein identification software, have announced the two companies are collaborating to provide an integrated solution for proteomics researchers. GenoLogics and BSI are partnering to integrate GenoLogics’ Proteus lab and data management solution, with BSI’s PEAKS software for peptide sequencing and protein identification from tandem mass spectrometry (MS/MS) data. Customers with both solutions in their lab environment will use Proteus to generate and manage the data from their MS, and PEAKS to automatically submit spectra data, with the results captured by Proteus for simplified collaboration and visualization. "The integration of PEAKS with Proteus improves the overall value of the solution we can provide to our customers, simplifying lab workflow and accelerating results generation,” commented James DeGreef, Founder and VP Product Management for GenoLogics.“Lab researchers can now take advantage of our workflow and data management solution to quickly retrieve and manage MS sample information, and use PEAKS to obtain the complete sequence for each peptide under investigation, enabling high-throughput analysis. This integration is a good example of the value GenoLogics’ open software platform brings to life science researchers and systems biology discovery.” For details, visit http://visit www.genologics.com or http://www.bioinformaticssolutions.com.

Industry Accolades for STARLIMS V10

STARLIMS Corporation, a leading global provider of LIMS, has announced that its entirely web-based STARLIMS Version 10 has received two important industry honors. Introduced at PITTCON 2006 in March, STARLIMS V10 was singled out for an Honorary Mention in the PITTCON 2006 Editors’ Award, and as a “Pick of PITTCON” by Scientific Computing World magazine. Beginning about ten years ago, a group of editors from various laboratory publications established the PITTCON Editors’ Awards to honor products that in their opinions are “the most innovative of the year’s introductions.” During the PITTCON 2006 show, editors of leading industry publications awarded an honorary mention to STARLIMS Version 10. In addition, out of the hundreds of new products introduced at PITTCON this year, the editors of Scientific Computing World selected just three “Picks of PITTCON” — including STARLIMS Version 10. The citation for STARLIMS states: “STARLIMS Version 10 is an entirely web-based off-the-shelf LIMS that works equally well in Internet and Intranet environments. The new version offers enterprise-wide interoperability, no client-side software installations and a short learning curve. At the same time, it provides the advantages typically associated with client/server applications: predictable response times and a full-featured GUI for a rich user experience. The first programmable XML-based solution of its kind, STARLIMS integrates all lab disciplines into a single fully configurable LIMS platform. Disparate business processes are consolidated into a single, compliant platform with comprehensive reporting, surveillance and networking capabilities. The result is vastly enhanced data management and sharing – within the laboratory and across the enterprise.” For details, visit http://www.starlims.com.

Top Marks for QSI in LIMS Survey

Quality Systems International (QSI), a LIMS and Quality Management Software supplier, has been highly rated by users in the 2005 LIMS Watch report. With the highest scores of all LIMS companies in the key areas of support, responsiveness and customer awareness, QSI also achieved the highest average score overall. The report is produced jointly by TrendWatch and Scientific Computing Magazine, and is based on an
international user survey conducted by Forrester Research, an independent research organisation. Particularly notable were users' views of customer support. Asked if they were satisfied with the level of support received, only QSI's customers exceeded a 90% positive response. Over 40% of QSI users expect a response to an e-mail support query in under an hour - more than twice the rating of the nearest competitor. QSI was the only company to achieve a straight 100% approval rating in any category - when users were asked about the level of
product knowledge displayed by support personnel. For details, visit http://www.lims-software.co.uk.

Fred Hutchinson Cancer Research Center Deploys GenoLogics’ Proteomics Purposed Software Solution to Accelerate Their Cancer Biomarker Discovery

GenoLogics Life Sciences Software Inc. has announced that Fred Hutchinson Cancer Research Center chose Proteus, GenoLogics’ proteomics purposed lab and data management solution, to use in its cancer biomarker discovery research in early detection of ovarian cancer. GenoLogics worked with the Hutchinson Center to integrate Proteus with the Center’s recently released Computational Proteomics Analysis System (CPAS) data repository. Proteus will be used in the lab of Dr. Martin McIntosh, associate member of the Public Health Sciences Division at the Hutchinson Center and principal investigator of the Center’s Computational Proteomics Laboratory (CPL). The CPL develops and uses computational approaches for protein and proteomics research. "We were looking for a scientific data management solution based on open standards that could help us share and disseminate data with other leading cancer centers around the world in an eXperiment ARchive format (XAR),” McIntosh commented. “GenoLogics’ Proteus met these requirements.” Proteus is the only data management solution that can export a complete proteomics experiment XAR data file, based on the FuGE (Functional Genomics Experiment) object model with proteomics extensions, and import the file into the lab’s open source Computational Proteomics and Analysis System (CPAS) data repository. CPAS is used to manage the CPL containing over 75 million putative MS2 peptides, growing at 1 million per week. The National Cancer Institute and the Listwin Family Foundation funded the development of CPAS. Several cancer research institutes nationally and internationally have joined with the Hutchinson Center to form an International Cancer Biomarker Consortium (ICBC) with a goal to improve discovery methods and identify biomarkers. For details, visit http://www.genologics.com.

STARLIMS Academy to Provide Technical Training for Employees, Customers and Partners

STARLIMS Corporation, a leading global vendor of LIMS, has established STARLIMS Academy, an international technical training program designed for STARLIMS employees, users and partners. Jeff Ferguson, COO of STARLIMS, explained that, “STARLIMS Academy was created to support our rapidly growing customer base, while also facilitating the establishment of new partnerships. The aim is to ensure the consistency and excellence of all consultancy and implementation work, enabling our customers to maximize and protect the long-term benefits of their STARLIMS investments. STARLIMS customers will be fully confident, knowing that all work done by certified STARLIMS professionals will meet the required standards.” To head STARLIMS Academy, STARLIMS hired Dr. Simon Wood, a leading authority in laboratory informatics. Dr. Wood’s experience includes creating the LIMS industry’s largest consultancy, implementation and support team. Dr. Wood has over 15 years experience in the implementation of business-critical IT systems in the area of laboratory informatics, as well as extensive experience in LIMS implementation, support and training at both the technical and management level. In his position as Global Services Manager of Thermo LabSystems, he was responsible for creating the industry’s largest global LIMS implementation organization, employing 100 people. For details, visit http://www.starlims.com.

Thermo Enables Greater Flexibility for ADMET Studies with Galileo LIMS v 3.2

Thermo Electron Corporation has announced enhancements to its Galileo LIMS, providing greater flexibility for high throughput ADMET experiments that facilitate lead optimization in drug discovery. Galileo is a LIMS designed specifically to support in vitro ADMET experiments, allowing users to design, calculate and report data from metabolic stability, drug-drug interaction, protein binding, permeability and enzyme kinetics studies. Version 3.2 now gives users greater control over the assays performed with user-definable study types and customizable calculations. In addition to user-definable study types to increase flexibility, Galileo now offers user-configurable decision trees that allow the user to define scenarios under which flagged results require further review. Questionable data is quickly reviewed with a new ability to filter data sets and to flag data based on comments entered during analytical data review. Templating of design and output parameters, as well as result flagging, eliminates manual actions, saving time and reducing errors for users. For details, visit http://www.thermo.com/informatics.

GenoLogics Partners with GeneBio to Enhance Proteomics Lab and Data Management Capabilities for Life Science Researchers

GenoLogics Life Sciences Software Inc., a leading provider of lab and data management software solutions for proteomics and systems biology research, and Geneva Bioinformatics (GeneBio) SA, producer of world-class proteomics software, have announced a collaboration that will provide life science researchers a broader solution for managing and analyzing proteomics data by integrating GeneBio’s Phenyx, a proteomics MS data analysis platform with GenoLogics’ Proteus, a lab and data management software solution. Under the terms of the agreement, GeneBio’s Phenyx, a software platform for the identification and characterization of proteins and peptides from mass spectrometry data will be capable of seamless data integration with GenoLogics’ Proteus, the industry’s most advanced solution for proteomics purposed lab and scientific data management and analysis. "We are extremely pleased to be partnering with GenoLogics to provide life science researchers with this valuable integration,” commented Nasri Nahas, CEO of GeneBio. “Phenyx has had a remarkable response from the life science sector since its inception. The next step in the evolution of Phenyx is to increase its availability to potential customers through integration with broader solutions; in this manner, Phenyx can be utilized both as a standalone product and as an integral part of a more comprehensive environment. A lab information and data management system is a logical environment for such an integration, and Proteus is an excellent solution with which to have Phenyx associated. Our collaboration will benefit both new and existing customers alike by giving them the combined expertise of our two companies." This integration enables users to experience an optimized protein search and identification managed from a centralized data management platform and user interface, making the experience more efficient and by extension providing customers with more of what they want in a total lab and data management environment. For details, visit http://www.genebio.com or http://www.genologics.com.

LabWare Advances Informatics Fellowship at IUPUI

A grant from LabWare Inc. will make it possible for more graduate students to further their education and research at the Indiana University School of Informatics. The LabWare Fellowship for Innovation in Laboratory Informatics will aid students enrolled in the Laboratory Informatics Graduate Program at the school’s Indiana University-Purdue University Indianapolis campus. Future recipients of the fellowship will receive a one-time award of $30,000. It is expected the recipient of the 2006-07 award will be selected this summer for the 2006-07 academic year. Swati Lakhanpal was named the first recipient of the LabWare fellowship for the current year. The chemical engineer is expected to complete her studies this August. “This latest LabWare gift enables the School of Informatics to help deserving students pursue vital research involving the practical application of information technology to laboratory sciences and research at the bench level,” says Douglas Perry, associate dean for graduate studies and research and director of the Laboratory Informatics Graduate Program. The program, the first of its kind in the nation, is designed for students with undergraduate degrees in laboratory-based sciences who seek advanced training in laboratory informatics to pursue careers in the agricultural, biomedical, chemical, food, petroleum and pharmaceutical industries. “Tomorrow’s leaders in this field benefit from programs like the one at the Indiana University School of Informatics, which is open to cooperative relationships with industry, resulting in professionals who are ready for the real world,” says LabWare President Vance Kershner. The Wilmington, Del.-based LabWare is a software products company focused exclusively on configurable LIMS. It’s not the first time the school and LabWare have worked together. Nearly two years ago, the two institutions established an active training center at the IUPUI campus, where professionals from around the country are trained to use LIMS. Also, the company provides its experts for training and support and internship opportunities to IU laboratory informatics graduate students. For details, visit http://www.labware.com or http://www.informatics.indiana.edu.

STARLIMS Named Preferred LIMS Provider for Six Genetics Laboratories of UK’s National Health Service

STARLIMS Corporation, a leading global vendor of LIMS, has been selected as the preferred LIMS provider for six Genetics Laboratories within the United Kingdom’s National Health Service. "The decision to purchase STARLIMS was the result of more than a year of evaluations and investigations by several NHS genetics laboratories across the UK. Although genetics has yet to be directly addressed by the National Plan for IT, it was important that we ensured any system purchase met the requirements for interoperability that NPFIT defines. Although STARLIMS was up against stiff competition from other major vendors, the final decision was made unanimously by six laboratories with several more shadowing the tender process with intentions to utilise the evaluation work undertaken,” said Noel Hannan, IT & Technologies Implementation & Project Manager at the West Midlands Regional Genetics Laboratory, Birmingham Women’s Health Care NHS Trust. STARLIMS is designed to facilitate collaboration within the lab, between several laboratories, and between labs and other agencies—for more efficient inter-lab assistance, surge capacity response, and disaster recovery. STARLIMS provides comprehensive public health reporting, surveillance and networking capabilities compatible with international standards, such as HL7 messaging, LOINC and SNOMED. An entirely web-based system with zero client-side installation and a particularly short learning curve, it is rapidly deployed throughout the organization. "Genetics is a rapidly developing specialty. Systems must be capable of revision and extension without the need for complete replacement,” added Noel Hannan, noting the enormous expense and inconvenience of regularly replacing outdated laboratory information management systems. “STARLIMS’s unique multi-tier architecture is a distinct advantage, since it will allow us to change databases and upgrade to new versions while keeping our business rules intact. Also, STARLIMS unique and technologically advanced approach to interfacing means that the users will receive an infinitely configurable browser-based experience which can either emulate current methods of working to speed the transition process; or a toolbox of innovative controls to provide appropriate levels of information granularity.” For details, visit http://www.starlims.com.

University of Dundee FingerPrints Proteomics Facility selects GenoLogics’ Proteus to Improve Operational Lab Management and Customer Service

GenoLogics Life Sciences Software Inc. has announced the University of Dundee FingerPrints Proteomics Facility in Scotland has selected Proteus as its laboratory information and scientific data management system. The FingerPrints Proteomics Facility, based in the School of Life Sciences , provides state of the art proteomics and mass spectrometry capability to both academic and industrial researchers. Facility Manager Douglas Lamont stated, "We're very excited with the prospect of using the Proteus system to improve the services we offer to our wide range of internal and external customers in the UK and beyond. The Proteus web interface will allow us to easily make available a wide range of data files and reports to registered users worldwide at any time. By actively managing all experimental data files in a single location we will be able to store data more securely and allow access to the data and results in a more timely and efficient manner.” FingerPrints is particularly interested in using the Proteus configurable workflow and instrument automation features to offer a range of new services including phosphorylation site mapping. Lamont added, “It was necessary for us to streamline our operation in the areas of sample submission, data analysis and reporting so that we could increase our sample throughput and also be in a position to offer a number of new services. We have now expanded our services to include commercial phosphorylation site mapping and Proteus will enable us to automate our project and sample management, integrate data from any instrument or software and easily generate reports to provide faster service to our customers. The bottom line for us will be better operational management and customer satisfaction." For details, visit http://www.dundee.ac.uk or http://www.genologics.com.

BioTech Business Expected to Reach $5 Billion by 2010 in India

The biotechnology industry in India is growing at an exponential rate and is expected to touch business worth over $5 billion by 2010 and generate over a million jobs in agriculture and pharmaceutical and allied sectors, according to Biocon India Chairperson and Managing Director Kiran Mazumdar Shaw. For details, visit http://www.Checkbiotech.org.

Waters Debuts New Class of Mass Spectrometry Technology

Waters Corporation has introduced a first-of-its-kind mass spectrometry technology that differentiates sample ions by mass, size and shape. The Waters Synapt High Definition MS (HDMS) System is designed for researchers working at the limits of conventional mass spectrometry (MS) and who need to further characterize and define complex samples. The Synapt HDMS system employs new ion-mobility technology and software to enable the analysis of sample ions differentiated by size and shape, as well as molecular mass. This additional dimension of separations fidelity leads to improved specificity and sample definition, meaning scientists can extract more information about their samples including the detection of previously undetected constituents. A key feature of this new system is the patented Waters Triwave technology, a unique methodology for combining highly-efficient, ion-mobility based measurement and separations with high-sensitivity performance, accurate mass quadrupole time-of-flight mass spectrometry. Operational control and data acquisition and processing are performed through Waters MassLynx Software. Shipments of the new mass spectrometer are expected to begin in the second half of 2006. For details, visit http://www.waters.com/HDMS.

Chenomx Inc. Releases Version 4.5 of Metabolomics Software Suite

Chenomx Inc. has released Chenomx NMR Suite 4.5, a set of integrated software applications for performing NMR-based metabolomics. By closely integrating tools for creating and manipulating metabolic profiles, Chenomx NMR Suite allows users to identify and quantify metabolites in complex NMR spectra with unparalleled speed and accuracy. Chenomx NMR Suite can import data acquired with Varian or Bruker spectrometers, or data from any JCAMP-DX data source. Chenomx Profiler, part of Chenomx NMR Suite, allows users to rapidly identify and quantify metabolites of interest using Chenomx compound libraries representing over 250 metabolites. Chenomx Signature Builder, also part of Chenomx NMR Suite, allows users to add their own compounds to a custom compound library, making it easy to identify and quantify any metabolite of interest. New in 4.5 is tight integration with state-of-the-art Umetrics statistical analysis tools, allowing users to easily move data analyzed with Chenomx NMR Suite into a rich statistical analysis environment. Adoption of Chenomx NMR Suite in both industrial and academic settings has been swift; Chenomx counts many leading pharmaceutical companies as clients, as well as academic and non-profit institutions from around the world. For details, visit http://www.chenomx.com/products.

Bruker Daltonics' New ClinProTools 2.1 and flexImaging 2.0 Software Now Permit Integrated Statistical and
Image Analysis of Tissue Samples

Bruker Daltonics has announced its new ClinProTools 2.1 and flexImaging 2.0 software versions. Together, these integrated software packages allow biologists and clinical researchers to merge statistical analysis on MALDI-TOF profiling spectra with molecular images of tissue distributions of peptide and protein biomarkers. This unique analysis capability is now available on the Company's novel MALDI Molecular Imager. ClinProTools is Bruker Daltonics' state-of-the art bioinformatics solution for biomarker panel analysis, biofluid profiling, multivariate data analysis of large sample cohorts, classical statistics and sample classification. ClinProTools 2.1 now includes many additional features for data analysis and visualization: the new proprietary Supervised Neural Network algorithm allows a third independent multiclass, multivariate analysis approach, complementing the company's existing Support Vector Machine and Modified Genetic Algorithm. Furthermore, it supports univariate peak statistics and a proprietary QuickClassifier algorithm. In addition to these supervised approaches, ClinProTools 2.1 also includes Principle Component Analysis (PCA) for unsupervised data analysis. For details, visit http://www.bruker-biosciences.com.

Green Mountain Logic Expands Management Team

Patricia Sears has joined Green Mountain Logic as Marketing Director. Sears, with 25 years of marketing experience, previously led an award winning advertising agency serving the pharmaceutical and health care industries. In addition, Michelle LaJoice has joined Green Mountain Logic as sales manager. LaJoice, with a BS in Business Administration from Champlain College, previously worked in sales for Health Enhancement Services and Advanced Biomedical Consulting. Green Mountain Logic's LabPAS/CT is a workflow and sample management solution designed specifically for Phase I research. Located in Vermont, the company provides life science companies with automated workflow solutions that enhance drug development. For details, visit http://www.labpas.com.

Teranode Awarded Patent that Enables Adaptive Workflow

Teranode Corporation, a leading innovator of scientific data and workflow management software for the Life Sciences industry, has announced that the U.S. Patent and Trademark Office (PTO) has issued the company U.S. Patent No. 7,010,760 B2 for a key element of TERANODE XDA. The patent protects the method and apparatus for TERANODE XDA's match rules, a feature for integrating datasets and metadata in dynamic workflow. By automating critical data integration, the match rules enable scientists to quickly and reliably understand the provenance and relationships of data within projects. Traditional informatics solutions depend on static, predefined schemas and workflows which are brittle and often break down when scientists need to make changes to the design of an experiment. TERANODE XDA accommodates change through an adaptive schema and workflow capability without requiring error-prone, manual data management procedures or expensive reprogramming. "TERANODE XDA is the first product to integrate process metadata, schema metadata, and instrument data as part of a workflow," said Larry Arnstein, CTO of Teranode. "The match rules technology provides new flexibility in laboratory operations, while providing unrivaled data integration. Once captured, TERANODE XDA leverages semantic web standards to unlock the true potential of the data by enabling analysis, reporting, and search across projects and disciplines." TERANODE XDA is a powerful informatics platform that leverages existing IT infrastructure to manage scientific data and workflow. TERANODE XDA allows scientists to automate workflow, manage the lifecycle of scientific data, and unify disparate data across laboratories, improving the speed and quality of R&D projects. For details, visit http://www.teranode.com.

Teranode Continues to Build Customer Momentum with New Customer Wins and Existing Site Expansions

Teranode Corporation, a leading innovator of scientific data and workflow management software for the Life Sciences industry, has announced it continues to build customer momentum with the addition of a top five global pharmaceutical company, as well as Tethys Bioscience and Calibrant Biosystems, among others. Teranode also announced that several existing customers, including AstraZeneca, Nastech, NIH Chemical Genomics Center, Pfizer, and St. Jude Children's Research Hospital, have all expanded its use of the company's technology. TERANODE XDA, a scientific data and workflow management platform, unifies and reports data across an increasingly diverse set of laboratories. The unnamed world-leading top five pharmaceutical company selected Teranode's award-winning platform, TERANODE XDA, to handle lifecycle management of samples and associated data within its pathway research group. Tethys Bioscience chose TERANODE XDA as a flexible way to handle inventory management, and assay design, along with optimizing the accessibility and analysis of data while minimizing the cost of informatics. Calibrant Biosystems selected TERANODE XDA as their solution of choice for proteomics data and workflow management in support of quantitative protein biomarker profiling associated with cancer and other human disease. "Our challenge is to provide scientists the flexibility to change experiments in the laboratory, while ensuring the ability to integrate the results across the project team," said Paul Rudnick, director of bioinformatics for Calibrant Biosystems. "TERANODE XDA provided a comprehensive, adaptive platform for automating workflow, managing data, and unifying reporting." For details, visit http://www.teranode.com.

Mettler Toledo Releases Berger SFC for Agilent ChemStation

Mettler Toledo has released the Berger SFC for Agilent ChemStation, which allows for full integration with the Agilent 1100 and 1200 series LC and LC-MS. Benefits of the new system include: Reduces the overall cost of entry into Supercritical Fluid Chromatography (SFC); Extends LC and LC-MS instrument lifetime; Provides a complimentary technique to both LC and LC-MS; Expands the range of compounds that can be accurately quantified; Enhances flexibility to allow users a wide range of options and configurations; and, Reduces the learning curve for Agilent ChemStation users. For details, visit http://us.mt.com/mt/filters/apf.jsp.

IU Scientists Devise Means to Test for Phony Technical Papers

Authors of bogus technical articles beware: A team of researchers at the Indiana University School of Informatics is designing a tool to distinguish between fake and real papers. It’s called the Inauthentic Paper Detector – one of the first of its kind anywhere – and it uses compression to determine whether technical texts are generated by machine whose intent is to deceive, or by humans. “This is a potential problem since no existing systems, the Web for example, can or do discriminate between content that is meaningful or bogus,” says assistant professor Mehmet Dalkilic, a data mining expert. “We believe that there are subtle, short- and long-range word or even word string repetitions that exist in human texts, but not in many classes of computer-generated texts that can be used to discriminate based on meaning.” The IPD system is based on a combination of compression algorithms, computing tools that reduce the size of data to save space or speed transmission time. To begin their study, the team identified two kinds of texts they would analyze: Authentic text (or document) is a collection of several hundreds or thousands of syntactically correct sentences such that the text as a whole is meaningful. Inauthentic text (or document) is a collection of several hundreds of thousands of syntactically correct sentences that as a whole have no meaning. The IU researchers’ work is documented in their very authentic paper, Using Compression to Identify Classes of Inauthentic Texts, which they presented at the Society for Industrial and Applied Mathematics Conference on Data Mining, April 20-22, in Bethesda, Md. The informatics study largely was inspired by a prank pulled by three Massachusetts Institute of Technology students, who in 2004 developed a computer program that churned out randomly generated fake computer science language, essentially a four-page compilation of gibberish. They submitted it as a research paper to an international conference on computer science and informatics – and it was accepted without review. Radivojac, whose research expertise is machine learning, says the IPD easily detected numerous inauthentic technical papers tested, including the MIT students’ spurious submission. “We hypothesized we could build a reliable and fast model that recognizes fake papers automatically,” says Radivojac. “We combined these with machine-learning methods to build a predictor of these kinds of papers.” In general, identifying meaning in a technical document is difficult, Dalkilic says. “We don’t claim we have found a way to distinguish between meaning and nonsense, but we do emphasize that there are many nontrivial classes of inauthentic documents that can be easily distinguished based on compression algorithms.” To see how the Inauthentic Paper Detector works, visit
http://montana.informatics.indiana.edu/fsi/about.html.

AcquiData, Inc. Releases Testream/CS v 6.6

AcquiData, Inc. is proud to announce the release of Testream/CS v 6.6. Version 6.6 offers a brand new reporting program, ReportWriter. Written in .NET this powerful tool offers a ‘drag and drop’ user interface making it easy for customers to integrate spreadsheets, Word documents, graphs and charts into attractive reports, ready for electronic or print distribution. The scheduling module in ReportWriter also permits the automatic production of reports on a daily/weekly/monthly basis. Additional enhancements include direct data entry into the real-time web page reports, increased sample ID storage capacity in the data acquisition program, and significantly enhanced out of tolerance alarm options for superior production support. For details, visit http://www.acquidata.com.

ESA Biosciences Integrates the Coulochem III System with ABI/MDS Sciex Analyst Software, Coupling Mass Spectrometry and Coulometric Electrochemistry

ESA Biosciences, Inc., a subsidiary of Magellan Biosciences, Inc., has announced the Coulochem III Analyst Driver – Version 1.0, which enables the Coulochem III electrochemical (EC) system to be used as an integrated device for diverse applications within Applied Biosystems/MDS SCIEX’s Analyst 1.4.1 LC/MS software. Analyst software enables users to control Applied Biosystems/MDS SCIEX’s mass spectrometers (MS) and other HPLC devices. ESA’s Coulochem III system, with a variety of EC cells, can be combined with LC-MS in multiple configurations. When used as reaction devices in series with MS, they are useful for studies in oxidative metabolism, degradation and reactive species formation. This combination is of particular value in drug discovery and development. The system may also be used in parallel with MS for complementary detection, providing an added degree of sensitivity and selectivity. This combination is useful for many applications including the field of metabolomics. Once installed, the Coulochem III plug-in driver acts as a companion software application in the Available Devices list within Analyst software. This allows control of the Coulochem III detector within a regulated environment using electronic records and the associated features in Analyst software. The new driver results in seamless instrument control and processing of MS and EC data, all while maintaining the utility of the Analyst software. For details, visit http://www.esainc.com.

Chenomx and Umetrics Partner to Provide an Enhanced Metabolomics Analysis Platform

Chenomx, Inc., a leading provider of software and compound libraries used to identify and quantify metabolites in NMR spectra, and Umetrics AB, a worldwide leader in multivariate analysis and modeling software, have announced a partnership to provide a comprehensive metabolomics solution to researchers worldwide. The partnership combines Chenomx’s powerful and easy-to-use metabolic profiling software with Umetrics’ proven multivariate analysis software, providing researchers with a turn-key solution for discovering biologically
relevant patterns in NMR spectra. "Metabolomics researchers are faced with two key challenges,” explains Jack
Newton, Director of Product Development for Chenomx. “First, they must analyze large NMR data sets, potentially consisting of thousands of NMR spectra, to find meaningful patterns in their data. Translating these patterns into biologically relevant information in the form of metabolite identification and quantification is the second key challenge. These two processes are tightly coupled, and the decision to partner with Umetrics to make the process as intuitive and as effortless as possible for the end-user was a natural one.” Jan Wahlström, European CEO and Sales Manager, adds “This partnership is great news for scientists working in metabonomics and metabolomics as it provides them with a seamless interface between data collection and data analysis, allowing them to get on with the science.” For details, visit http://www.chenomx.com.

Bruker Daltonics Introduces Novel WARP-LC 1.1 Software for LC/MS/MS Based Quantitative Proteomics

Bruker Daltonics has announced its novel WARP-LC 1.1 software suite for quantitative proteomics using isotope labeling. WARP-LC is the first comprehensive solution for quantitative LC-MS/MS protein analysis. All current industry-standard label chemistries are fully supported (ICPL, SILAC, iTRAQ, ICAT, and (18)O/(16)O-C-terminus labeling) and WARP-LC is open to other customized labelling technologies. Full support for multiplexed quantification (e.g., ICPL= triplex, iTRAQ or SILAC 4plex) is provided, irrespective whether isobaric or non-isobaric labels are used. Median-based statistics provide highest data quality with automatic outlier detection and validation of quantitative results. WARP-LC is the single proteomics quantification platform for all Bruker Daltonics mass spectrometers: Flex-series MALDI TOF/TOFs, HCT-series ion traps, micrOTOF-Q and APEX-Q FTMS series. In addition, WARP-LC enables advanced data LC/MS visualization with SurveyViewer
and ProteinBrowser functionality and extensive data validation and reporting tools. For details, visit http://www.bruker-biosciences.com.

Otsuka Chooses ClinPhone's Innovative Integration Solution

ClinPhone, a global leader in clinical technology solutions, has announced that its Clinical Trial Management
Software (CTMS) Integration solution has successfully supported 12 projects for Otsuka Maryland Research Institute, Inc. (Otsuka). ClinPhone's CTMS Integration enables separate clinical systems to work together synergistically, helping pharmaceutical sponsors to improve and streamline the entire clinical trial process.
Traditionally, tracking and evaluating the progress of ongoing clinical trials is a very time-consuming and labor-intensive activity, requiring sponsor personnel to manually input, gather, and evaluate individual study information from separate repositories. In contrast, ClinPhone's CTMS Integration facilitates real-time data exchange between its Interactive Voice and Web Response (IVR and IWR) systems and Otsuka's CTMS. It allows automated integration of vital study data including patient enrollment, dispensation, withdrawal and drug shipment milestones. ClinPhone's integration solution has yielded several important benefits. It has helped Otsuka save valuable time and resources in the day-to-day study management by eliminating the need for re-keying data and discrepancy resolution. Consequently, Otsuka has enjoyed the benefits of simplified, streamlined workflows. Most importantly, the ability to aggregate accurate data in a timely manner means that management decisions are based on the best information available. For details, visit http://www.clinphone.com.

ESA Detectors Now Directly Connect with Agilent ChemStation Drivers Through Standard USB Interface

ESA Biosciences, Inc., a subsidiary of Magellan Biosciences, Inc., has announced that its Corona CAD and Coulochem III HPLC detectors can now be interfaced to the Agilent ChemStation through a standard USB interface. This new interface allows for control and direct digital data acquisition of ESA’s most popular HPLC detectors in the ChemStation environment. ESA and Agilent customers worldwide will benefit through the lower cost and increased simplicity of integration. Establishing this first available, fully integrated, ChemStation driver set was the result of a close collaborative effort between ESA and Agilent. As the largest installed base of any chromatography software application, the Agilent ChemStation upgrade package (Revision B.02.01) was scheduled for release in March. According to Agilent, the new user interface will significantly improve productivity and ease integration of important specialty HPLC detectors. The ChemStation B.02.01 will also be available in localized versions in Japanese and Chinese. For details, visit http://www.esainc.com.

SYSTECH International Releases TIPS 7.0 Operating System

SYSTECH International, a leading provider of Packaging Performance Management solutions for manufacturing operations, today announced the release of its TIPS System Software version 7.0 on the Microsoft Windows XP Embedded Platform. Powerful and highly scalable, TIPS System Software provides maximum performance for mission-critical applications and facilitates a real-time global view of the packaging line. Its standards-based architecture is designed to work seamlessly with other systems and equipment and allows users to leverage existing technology investments. Acording to Robert DeJean, SYSTECH's President and CEO,"The new operating system offers performance and memory management optimization without changing the look and feel of previous systems. Customers will benefit from its enhanced bar code grading and case content capabilities, as well as simplified maintenance procedures. Future releases will support SYSTECH's next generation vision and line automation functionality." TIPS 7.0 is part of SYSTECH International's comprehensive suite of inspection, packaging line automation and information management solutions. For details, visit http://www.systech-tips.com.

ACD/Labs and Elsevier MDL to Integrate Informatics Solutions

Advanced Chemistry Development, Inc., (ACD/Labs) has joined a growing community of informatics companies working with Elsevier MDL to offer scientists better integrated informatics solutions for managing pharmaceutical, biotechnology, and other life sciences research. ACD/Labs, a longtime collaborator with Elsevier MDL, joins the rapidly expanding MDL Isentris Alliance as a preferred partner and will provide connections between its products and the new-generation MDL Isentris platform. Antony Williams, VP and Chief Science Officer for ACD/Labs, said: “ACD/Labs recognizes that members of the scientific community rely on a variety of informatics tools and technologies to meet specialized needs. For many years we have worked with Elsevier MDL to provide integration between our powerful predictive tools and analytical data management solutions and MDL ISIS technology. Now we can extend that legacy of cooperation and offer integrated solutions for researchers using the new MDL Isentris platform." "By making it easier for scientists to conduct research—accessing the data they need using applications that work together—the informatics companies in the MDL Isentris Alliance are offering R&D organizations a path to improved productivity,” said Elsevier MDL Senior Vice President Vikki Rehn, Framework Development. “As major pharmaceutical companies adopt the new-generation MDL Isentris platform, they benefit immediately from collaboration that permits rapid integration of specialty applications into comprehensive research information systems. For years, our partnership with ACD/Labs has brought important value to mutual customers. By joining the Isentris Alliance, ACD/Labs increases the value to researchers using Isentris.” ACD/Labs joins a group of leading software and consulting companies from around the world (including Spotfire, Tripos, InfoChem, InforSense, Klee, Aston, DeltaSoft, and Symyx) working with Elsevier MDL to create informatics solutions that combine MDL Isentris technology and specialized vendors’ offerings. MDL Isentris is an open technology, tiered informatics platform for integrating data, workflow applications, and business processes. Initial integration between ACD/Labs and Elsevier MDL will focus on ACD/Name software and the Isentris-based MDL Draw chemical representation tool and MDL Notebook application. The integration will be extended later to enable researchers to simplify everyday chemistry-related tasks, including accessing chemical property calculators and name/structure converters. For details, visit http://www.elsevier.com or http://www.acdlabs.com.

Colombian Logistics and Security Firm Deploys RFID-based Information Solution from Savi Technology to Continously Monitor Cargo Shipments

To enhance visibility, management and security of Colombian container shipments, Emprevi Ltda. is deploying Savi Technology's SmartChain Transportation Security Solution (TSS), which leverages real-time information from active Radio Frequency Identification (RFID) technologies. By providing Emprevi with value-added services for its customers, Savi TSS will help Emprevi to generate new business opportunities and enable its customers to cut costs, improve inventory management, decrease safety stock, and reduce the potential for drug trafficking and smuggling, theft, loss, or terrorist intrusions. Emprevi Ltda. (Empresa de Prevencion y Vigilancia Ltda.) is a Colombia-based provider of logistics and security services for importers and exporters, including major U.S.-based public companies in the pharmaceutical and healthcare, consumer product goods, food and beverage, transportation and logistics services industries. Emprevi plans to integrate Savi TSS into a new Emprevi service offering called, Global Trade Control, which will provide its clients with continuous online monitoring of cargo containers and their contents, and rapid detection and deterrence of potential security breaches. Beyond tracking container movements within Colombia, Emprevi plans to extend end-to-end visibility of these shipments by linking their service with SaviTrak, the global information service provided by Savi Networks. SaviTrak provides real-time, information services on the location, security and integrity of containerized cargo shipments as they move throughout a global network of RFID-enabled ports and inter-linked supply chain checkpoints. The Savi Regional Cargo Visibility and Security Network, powered by Savi TSS, will provide Emprevi's customers in Colombia with real-time information of RFID-tagged containers that are transported by truck or rail to and from Distribution Centers in Cali and the Port of Buenaventura, which handles a large portion of Colombia's foreign trade volume. Plans call for extending Savi TSS through Emprevi's Global Trade Control offering to additional clients and facilities in Colombia. For details, visit http://www.savi.com.

Savi Technology Releases New RFID Sensor Tags to Track and Monitor the Condition of Global Shipments

Savi Technology, a leading provider of RFID-based supply chain solutions, has announced the release of two innovative sensor tags that reduce spoilage and damage by monitoring the temperature and humidity of military and commercial shipments, including aircraft engines, ammunition, medical supplies, food stuffs, and other perishables vulnerable to environmental conditions as they move through the supply chain. The Savi ST-673 and ST-674 are active RFID tags that provide visibility to assets and shipments as they move through the supply chain. In addition, the tags periodically record the environmental status data to an event log in the Savi SensorTag's memory. If the collected data rises or falls outside the acceptable condition range, the Savi SensorTag sends a real-time alarm to a fixed or mobile RF reader, and notification of the temperature or humidity change is escalated via a web application, cell phone or email, allowing the problem to be addressed immediately before spoilage or damage occurs. The complete environmental event logs can be uploaded to handheld readers or to fixed readers at stationary sites such as yards and warehouses in the supply chain. This enables users to identify the time and location of unacceptable environmental conditions, or to confirm that acceptable ranges, and therefore shipment quality, are maintained throughout the journey. By alerting users to problematic environmental conditions when goods are moving through the supply chain, these new active RFID products reduce losses due to spoilage or damage. The active tags are based on ISO 18000-7 standards operating at 433.92 MHz, which has proven to be the most effective RFID frequency for bending around metal objects such as metal containers. For details, visit http://www.savi.com.

New Savi Knowlege Center Delivers State-of-the-art RFID Training On-site or Online

Leveraging more than 16 years of proven, real-world expertise, the Savi Knowledge Center recently opened its doors as a new showcase facility providing on-site and online instruction on how best to deploy Savi Technology's portfolio of successful Radio Frequency Identification (RFID) supply chain solutions. Savi Technology already has trained for more than 1,000 customers and partners, and participants now have the advantage of learning about RFID and Savi's widening range of real-time solutions for defense and commercial organizations in an upgraded, world-class learning environment designed for hands-on, skills-based instruction. Located at the company's global headquarters in Sunnyvale, California, the Savi Knowledge Center also provides courses at a satellite site in Herndon, VA. Highly credentialed trainers provide instruction on RFID solutions through a dozen classroom courses ranging from "Introduction to RFID" and "Field Service Engineering" to"Savi SmartStart Solution" and "Savi Consignment Management Solution." Most recent participants in Savi Knowledge Center courses have included customers and partners from a wide range of organizations, including major international shippers, systems integrators, port and terminal operators, logistics service providers, and military services. Courses typically last 2-5 days, depending on the breadth and depth of material to be covered. For details, visit http://www.savi.com.

Protedyne Introduces Radius Robotic System

Protedyne Corporation, a leading lab automation provider, has unveiled its new Radius robotic system, a sophisticated benchtop automation platform designed with a radial arm to provide a high level of flexibility. Radius is built using the principles of industrial design, ensuring rugged reliability, superior speed, and unmatched precision. Radius can easily and quickly accommodate a variety of applications in diagnostic testing as well as biotech and pharmaceutical research. Designed to be compact, Radius is driven by a patent-pending inverted SCARA robot to allow for the most useable work space on deck. This robot can also reach outside its frame, offering greater device integration options. While modest in size, Radius retains the essential components of robust industrial automation and utilizes the company’s exclusive interchangeable SmartTools. The robot can automatically pick up the correct tool on the fly, without user intervention. "Coming from an industrial automation background, I’ve championed the advances labs can make by applying the methodologies used in industrial design,” said Peter Massaro, Chief Technology Officer of Protedyne. “Currently, most laboratory automation is about 10 years behind other industries that employ automation for improved efficiency, reliability, process control, and integrity of results. With our BioCube System, Protedyne took the lead in marrying laboratory automation requirements and industrial design. To bring it one step further, we wanted to build a benchtop automation system for labs with lower throughput requirements as well as space and budget constraints. Radius accomplishes that. With its smaller footprint and lower cost, all laboratories can now benefit from true industrial automation,” continued Massaro. For details, visit http://www.protedyne.com.

Roch Kelly Joins Protedyne Corporation as Chief Operating Officer

Protedyne Corporation, a leading laboratory automation provider, has announced that Roch Kelly has joined the company’s management team as Chief Operating Officer. Mr. Kelly will head the Company’s Manufacturing, Purchasing, Customer Care, and Human Resources departments. Mr. Kelly has over 20 years of experience in life sciences leadership. Most recently, he was Vice President of Clinical Operations, North America and Worldwide Business Operations for PAREXEL International in Waltham, MA. PAREXEL is a provider of full clinical trial support services to the pharmaceutical, biotech and medical device industries. At PAREXEL, Mr. Kelly was responsible for over 400 employees and led the worldwide proposal development and contract management organization. He also developed and implemented worldwide, cross-divisional business strategies and tactics. Prior to that he was Executive Director of Manufacturing Operations at Chiron Diagnostics where he led two manufacturing sites (Medfield, MA and Sudbury, UK) with responsibility for production, manufacturing engineering, materials management, MRP systems, facilities, regulatory compliance and customer support. He holds a BS in Finance from Miami University, and a MBA from Syracuse University. For details, visit http://www.protedyne.com.

Drug Safety Amendment Defeated on House Floor

A controversial amendment to a House appropriations bill giving the FDA new authority to require postmarket studies was stripped from the legislation, while another divisive provision eliminating conflict-of-interest waivers for advisory boards lives on. Rep. Rosa DeLauro's (D-Conn.) provision giving the agency authority to require postmarket studies was stricken as improperly legislating through the appropriations process, a move that is prohibited under House rules. The amendment, which was added to the fiscal 2007 Agriculture, Rural Development, FDA and Related Agencies Appropriations bill, was meant to address growing concerns over the agency's drug review program. It was removed from the bill when the presiding officer of the House ruled in favor of a point of order raised against it. The agency has faced 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. Incidents like Merck's withdrawl of Vioxx make such additional authority necessary, DeLauro said in a statement following the point of order. She also pointed out that both the Government Accountability Office and many consumer groups have advocated for the FDA to have this authority. However, another proposal that the FDA itself has opposed is moving forward. Rep. Maurice Hinchey's (D-N.Y.) amendment prohibiting the FDA from granting waivers allowing doctors or scientists with conflicts of interest to serve on FDA advisory panels had not been stricken from the appropriations bill as of press time and will apparently not face opposition from the White House. While the FDA has argued that such a proposal would undermine the effectiveness of the agency's advisory committee system, the White House did not oppose the amendment in its May 23 Statement of Administration Policy (SAP) on the bill. The SAP is a document in which the administration gives its view on pending legislation, including provisions it will oppose. For details, visit http://www.fda.gov.

FDA Appeal May Expand Generic Drug Market

The FDA is pushing to expand the generic drug market by challenging a recent court decision providing two generic manufacturers with 180 days of market exclusivity for their version of the cholesterol-lowering drug Zocor, court filings show. The agency filed a motion May 25 seeking expedited review of a federal district court’s decision that Ivax Pharmaceutical Industries and Ranbaxy Laboratories have six months’ exclusivity for a generic version of Merck’s Zocor (simvastatin), arguing that providing exclusivity would hinder the broader generic market. Zocor is due to go off patent June 23. If Ivax and Ranbaxy prevail, other generic manufacturers will not be able to produce versions of Zocor until Dec. 23. The FDA filed its original appeal May 24. "The sooner the court resolves the issue presented — assuming the court does so in FDA’s favor — the sooner full generic competition can begin and the sooner the public can reap the benefit of full competition,” the May 25 filing with the U.S. District Court for the District of Columbia says. The agency also argues that greater certainty in how its statutory authority over drug patents applies helps the pharmaceutical industry “whose business plans depend on how the statutory provisions at issue are interpreted.” The issue in Ranbaxy Laboratories, et al. and Ivax Pharmaceuticals v. Leavitt is whether the FDA can delist a patent after a generic drug applicant has filed a new drug application, but before patent litigation begins. Doing so would deny the applicant the 180-day period of marketing exclusivity that the first generic applicant usually enjoys. Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) the agency can grant generic market exclusivity to the first manufacturer to file a certification that its product will not infringe a brand manufacturer’s patent. The period of exclusivity is meant to be an incentive for generic companies to file the application even though doing so will open them up to a patent infringement suit. For details, visit http://www.fda.gov.

FDA Moving Toward New cGMP Approach, Greater Use of International Standards

The FDA's decision to withdraw seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative is a sign that the agency is serious about updating its approach to cGMP and taking a more global view of regulations, industry sources say. The agency withdrew several Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research guidances because of inconsistencies with its Pharmaceutical Current Good Manufacturing Practices for the 21st Century initiative. In the meantime, the FDA is recommending that the drug industry use International Conference on Harmonisation (ICH) documents as a guide to manufacturing practices. The move is being lauded by industry sources that say the agency's previous manufacturing standards had focused too little on risk-based decisionmaking. The agency's approach to GMP had been "overly prescriptive," representing "overkill in a check-the-box mentality," Janeen Skutnik, Pfizer's director of compendia affairs and regulatory monitoring, told FDAnews. The agency's suggestion for industry to use ICH documents is also another sign that the FDA is moving toward a global approach to regulation, Skutnik said. But companies will face short-term compliance problems through the agency's actions, Gordon Richman, vice president of strategic compliance and general counsel of the consulting firm EduQuest, said. Industry faces a learning curve for two reasons, Richman said. First, the move from a quality assurance approach to the FDA's new quality systems approach is an "evolutionary step" in risk management, requiring significant infrastructure changes for companies. For example, the FDA now expects company management to be more involved in ensuring proper manufacturing practices. Industry needs to change their infrastructure to ensure this greater involvement, Richman said. Some companies are "mistakenly sitting back" waiting for amendments to the cGMP regulations before taking steps to comply with the initiative, he said. For details, visit http://www.fda.gov.

Several Guidances Withdrawn as Inconsistent with New GMP Initiative

The FDA, in a notice published in the Federal Register, announced its plans to withdraw and revise seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative.
The agency announced its Pharmaceutical Current Good Manufacturing Practices for the 21st Century on Aug. 21, 2002. The initiative is meant to "enhance the cGMP, to focus our resources and regulatory attention on those aspects of manufacturing that pose the greatest risk to the quality of the product, to ensure that our work does not impede innovation in manufacturing, and to promote consistency in our regulatory approach," the agency says. The FDA is continuing to review its guidance and will withdraw and revise other guidance documents that are inconsistent with the initiative, the notice adds. The agency is also planning new guidances to support its initiative. The notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/cd062.pdf.

What's New - May to June The following is a wrap-up of news of interest during the months of May to June 2006

What's New - May to June
The following is a wrap-up of news of interest during the months of May to June 2006