LIMSource News: What's New Right Now

• UK Biobank Implements Nautilus LIMS by Thermo Electron Tracking Data from One of Largest Medical Research Studies Ever
• QSI's Win-LIMS Rental Solution Provides Low Cost LIMS
• Autoscribe's Training Manager Actively Manages Training Records
• ATL Announces Seamless Integration of Sample Master Pro LIMS with the Discharge Monitoring Report Creator
• LabPas CT Adds Formulary Accountability, Recruitment, Clinical Lab & EDC for Phase 1 Studies
• QATrax Releases Auto-Scheduling Release 4.0
• Bio-Rad Releases Version 7.5 of its KnowItAll Informatics System
• National Instruments Announces the 20th Anniversary Edition of LabVIEW, LabView 8.20
• Scientists Satisfied but Loyal Customers Remain Elusive for Many Suppliers
• Atrium Research Publishes Results of Annual ELN Survey
• Recent Survey Addresses Biosafety and Security in Asia
• Labtronics and JusticeTrax Partner
• Labtronics Releases Web Version of NEXXIS
• Labtronics' Pipette Tracker and Collect XL Connect Multi-Channel Weighing System
• Thermo Unveils Novel Environmental Solutions Package to Enable Reliable and Accurate Drinking Water Analyses
• Thermo Announces Its New Single Quadrupole GC/MS System to Accelerate Productivity in the Workplace
• Thermo Introduces the LTQ FT Ultra Hybrid FTICR, the Most Powerful New Mass Spectrometer on the Market
• High Throughput Screening of Counterfeit Drugs Described in New Paper on Novel Mass Spectrometry Techniques
• Cerno Bioscience Paper Demonstrates Accurate Mass Measurements from Product Ions on Unit Mass Resolution Mass Spectrometers
• ClinPhone Launches Ground-Breaking Drug Accountability Solution For Clinical Trials
• ABB Supports Startup of New Cosevco Cement Plant
• Protedyne Announces Ability to Integrate the LightCycler 480 System for Real-Time PCR Assays in Life Science Research
• Intelli Innovations Unveils Barcode Producer 4.0 For Mac OS X
• Embarcadero Systems Set to Integrate Savi Networks' Information Systems at U.S. Port Terminal Operations
• Savi Technology's RFID-Based Portable Deployment Kit Shines in M2M's Gold "Value Chain" Award Bestowed on the U.S. Marine Corps
• FDA Rejects Drug Safety Bill's Risk Management Plan Provision
• Senators Enzi and Kennedy Introduce Drug Safety Bill
• CBER Issues Final Electronic Submission Guidance
• Survey of Scientists Depicts a Struggling FDA
• Thermo Announces New Additions to Proteomics Product Suite
• Cerno Bioscience Granted US Patent for its MS Calibration and Data Analysis Software, MassWorks
• Beckman Coulter Adopts ARTEL Technology for Field Service
• ClinPhone Announces Successful Completion of IPO
• Savi Networks Partners with Georgia's Maritime Logistics Innovation Center
• Lawmakers Working Toward Compromise on Biotech Funding Dispute
• Waters Corporation Enters Into Collaborations with Chinese Partners Raising the Bar for Food Safety and Environmental Standards in China
• Autoscribe Features Easy to Implement Sample Tracking System
• Siemens Signs Contract with Finnish Defense Forces for a Highly Secure Voice and Data Network
• Accelerated Technology Laboratories Announces ISO 9001:2000 Certification for the Fifth Consecutive Year
• DCSS Announces the Formation of Lab Answer to Provide World-Class Laboratory Informatics Solutions
• GenoLogics Announces Geneus, a Solution for Cross-Science Systems Biology Research
• Labtronics and Agilent Technologies Join Forces to Provide Complete Laboratory Integration Solution to Agilent Customers
• Palakal Tapped to Lead Informatics Grad, Research Programs at IUPUI
• SGS Group Expands Use of Labtronics' LimsLink to Improve Lab Productivity and Ensure Data Quality
• ABB in Partnership with Nesher Israel Cement Enterprises Ltd
• Savi Technology Recognized a a Top Information Technology Provider by Computerworld
• Advancements to Freeware ACD/Column Selector Help Take the Guess Work Out of Column Selection
• New, Advanced Version 3.0 Software Increase Capabilities for ESA’s CoulArray’ Detector
• Bruker BioSciences Shareholders Approve Acquisition of Bruker Optics
• ARTEL Announces New Appointments to Support LDQA Service Suite
• TeGenero Files for Bankruptcy After Catastrophic Clinical Trial
• FDA Enforcement Numbers Show an Agency Stretched Too Thin
• Approval Pathway for Biologics Unlikely Until 2008
• Gottleib Speech Signals Sea Change in FDA Drug Safety Strategy

UK Biobank Implements Nautilus LIMS by Thermo Electron Tracking Data from One of Largest Medical Research Studies Ever

Thermo Electron Corporation, the leading provider of analytical instrumentation and laboratory information management systems (LIMS), has implemented its Nautilus LIMS at the UK Biobank to track, store, manage and report on the biological data of 500,000 people as part of one of the largest medical research projects ever conducted. UK Biobank is a long-term national project to build the world’s most detailed information resource for medical researchers. It will follow the health of 500,000 volunteers aged 40-69 in the UK for up to 30 years. Following consent, each participant will be asked to donate a blood and urine sample, have some standard measurements (such as blood pressure) and complete a confidential lifestyle questionnaire. Over the next 20 to 30 years, UK Biobank will allow fully approved researchers to use these resources to study the progression of illnesses such as cancer, heart disease, diabetes and Alzheimer’s disease. From this they hope to develop new and better ways of preventing, diagnosing and treating such problems. Data and samples will only be used for ethically and scientifically approved research. "Thermo’s experience serving the health sciences and pharmaceutical industries combined with the flexibility and adaptability of Nautilus made Nautilus the obvious choice for the data management of this massive project,” said Hemal Rajani, LIMS manager for UK Biobank. “The Biobank is expected to grow from one clinic to 15 by the end of 2007, with all sites feeding biological samples that will be entered into and tracked by the LIMS. Several decision-makers on the LIMS selection team had previous experience with Nautilus and feel confident it’s the best tool for this project.” The UK Biobank participates in a LIMS user group with two other biobank organizations using Nautilus – the Hunt Biobank in Norway and the Singapore Tissue Network. Rajani said the three organizations are doing similar work, using the many of the same tools and are collaborating on methods involving Nautilus. Though Nautilus offers flexibility in workflows required by R&D organizations, the UK Biobank has configured the LIMS to follow certain and fixed workflows so all samples follow the same protocols for testing and storage. The collected data will be made available to researchers studying the impact of genetics, lifestyle and environment on health. To appropriately archive the vast amount of data generated by the UK Biobank study, Nautilus is part of an automated system that receives samples, fractions them into appropriate vessels for testing, analysis and storage, and then tracks and stores all data relative to the sample. The LIMS will be used to provide daily updates and management reports. For details, visit http://www.thermo.com/informatics.

QSI's Win-LIMS Rental Solution Provides Low Cost LIMS

A Software Rental scheme from Quality Systems International (QSI) provides a new and unique way for clients to enjoy the benefits of LIMS without depleting their cash reserves. QSI Software Subscription Contracts, launched in December 2005, brought full functionality WinLIMS to users for a typical outlay of around £400 a month. This new scheme has been introduced for customers not wishing to commit to the fixed term of a Subscription Contract. Said QSI's Clive Collier: "IT solutions like WinLIMS bring real quality improvement benefits - less errors, time savings and improved efficiency - to any small laboratory or manufacturing business. QSI Software Rental provides a minimal risk route to achieving that competitive edge. We've included installation programmes, tutorials and training aids to virtually eliminate set-up costs, but because clients can cancel the rental at a month's notice, we know we will still have to maintain the highest levels of service and support! This scheme gives customers a unique opportunity to prove the benefits of LIMS to their business without the usual significant commitment of resources." Rental agreements can be converted to a Subscription Contract or full purchase at any time. For details, visit http://www.lims-software.co.uk.

Autoscribe's Training Manager Actively Manages Training Records

Autoscribe's Training Manager solution uses a protocol driven system and can be accessed directly or via the web to actively manage training records. Training Manager is part of a suite of software products developed using Microsoft.net technology. Training Manager is a fully configurable, ‘out of the box’ (COTS) ISO9000 protocol driven 'active' approach to the management of your employees' training records. The Training Records Management system notifies users, supervisors and the appropriate management team of the current status of employees training records, requirements, courses attended or to be attended, course / course vendor evaluations and comments etc. Automated reports can be sent by email to all users and can be viewed or printed out on demand. The system can be implemented on client/server and / or web browser or over Citrix. Regulatory authorities can conduct audits of company sites and quality systems. Additionally training record management is part of all regulatory requirements eg GLP, GMP, GxP, Gamp, Galp, FDA, Food and Drug Regulatory Authorities, Healthcare, Clinical, EU, EPA etc. For details, visit http://www.autoscribe.co.uk.

ATL Announces Seamless Integration of Sample Master Pro LIMS with the Discharge Monitoring Report Creator

Accelerated Technology Laboratories, Inc. (ATL) has announced seamless integration of Sample Master Pro Laboratory Information Management System (LIMS) with a Discharge Monitoring Report (DMR) Creator. DMR forms are for reporting monitoring results required by the National Pollutant Discharge Elimination System (NPDES)/State Disposal System (SDS) permit for a wastewater treatment system. ATL’s DMR Creator allows users to rapidly generate the NPDES DMR form from data that is already stored in the LIMS and exported from Sample Master Pro LIMS. The ATL reporting package includes functions to collect and collate all data associated with the NPDES permit number into a final report format that is ready to send via automated reporting. These reports can also be converted to Adobe PDF and can also be sent out electronically. The Sample Master Pro LIMS task manager allows clients to configure automatic time based reporting of validated samples based on user defined criteria. These reports can also be scheduled for automatic printing, e-mailing or faxing in common formats such as RTF, PDF, .xls. The DMR package can easily be created in a few mouse clicks, saving significant amounts of time. The DMR reporting package provides several functions that include; minimum, maximum, average concentration and loading. Additional information contained in the report includes parameter, MDL, permit information, location, monitoring period and facility. Clients can also configure DMR report templates that will store the required reporting parameters and calculation logic that is required to generate the DMR results. The DMR report template will drive the system to generate DMR’s that meet regulatory submission requirements. DMR calculation results can be viewed and refined as necessary before generating the final DMR for submission. Customers that utilize Sample Master Pro LIMS Result Point can post these reports on the Internet in PDF format so that they are available for download 24 hours and day and seven days a week. For details, visit http://www.atlab.com.

LabPas CT Adds Formulary Accountability, Recruitment, Clinical Lab & EDC for Phase 1 Studies

LabPas CT has announced the addition of formulary accountability, recruitment, clinical lab and EDC components to make it one of the most comprehensive software solution for the management of Phase 1 clinical studies. "The expanded functionality of LabPas CT is the result of input from our Phase 1 CRO customers. We've responded to their desire to automate and integrate every component of their studies to assure the highest level of quality," said John Rosenblum, CEO of Green Mountain Logic, developers of LabPas CT. LabPas CT deploys PDAs on clinic floors to scan patient and collection vessel barcodes/RFIDs, 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 is also unique in its ability to adapt to individual study environments and changing protocols, rather than burdening CROs with the need to adapt to the software. For details, visit http://www.labpas.com.

QATrax Releases Auto-Scheduling Release 4.0

The latest releases of QATrax Global and Enterprise Editions with Auto-Scheduling provide exponential improvements in the workflow automation of assigning and scheduling test lab resources, thereby dramatically improving test laboratory operating efficiency. Benefits include heightened visibility of projects, tests and schedules across the organization, resulting in faster time-to-market for new products. The Global Edition of QATrax 4.0 provides these and other benefits for a single laboratory, accessible from any location worldwide, while the Enterprise Edition provides the similar benefits for a group of laboratories, including those with projects spanning multiple sites. Auto-Scheduling and ReScheduling is a core functionality offered by QATrax. QATrax integrates this functionality into the test request and testing process, rewarding management, engineers and technicians with real-time visibility, central to efficient test lab management and effective testing. Decisions made from the vantage of real-time visibility reduce uncertainty in the product testing cycle, which, in turn, results in fewer delays in getting product to market. QATrax is specifically designed for the test lab environment and can track project plans from inception to production. QATrax understands work requests, equipment or devices under test, test methods and test sequences and is designed to support quality standards including ISO 17025. For details, visit http://www.traxstar.com.

Bio-Rad Releases Version 7.5 of its KnowItAll Informatics System

Bio-Rad Laboratories, Inc., a multinational manufacturer and distributor of life science research products and clinical diagnostics, has announced the release of version 7.5 of its award-winning KnowItAll Informatics System. The new release offers enhancements to many of the applications featured in prior versions of the KnowItAll platform and features a new edition of the software, the KnowItAll Informatics System - Metabolomics Edition for metabolomics research. KnowItAll Informatics System - Metabolomics Edition integrates Infometrix' Pirouette chemometrics technology with Bio-Rad's award-winning KnowItAll platform, databases and NMR (Nuclear Magnetic Resonance) tools. It is the first end-to-end metabolomics research platform, providing spectral analysis and chemometrics tools in addition to links to metabolic pathways for metabolite/biomarker identification. The integration of these technologies allows researchers performing metabolic profiling studies to manage and analyze data easily in their search for relevant biomarkers. This capability is useful for distinguishing normal versus abnormal biological systems, response to drug treatment, and toxicological evaluation in disease treatments. For details, visit http://www.informatics.bio-rad.com.

National Instruments Announces the 20th Anniversary Edition of LabVIEW, LabView 8.20

National Instruments, a global leader in virtual instrumentation, has announced NI LabVIEW 8.20, the 20th anniversary edition of the LabVIEW graphical system design platform for test, control and embedded system development. The LabVIEW anniversary edition introduces powerful new features including general compatibility with The MathWorks, Inc. MATLAB software, new FPGA-based custom hardware design wizards for building industrial controllers and updates to the NI Modulation Toolkit for LabVIEW so engineers can develop models to simulate communications systems and evaluate parameter and design decisions. For details, visit http://www.ni.com/labview.

Scientists Satisfied but Loyal Customers Remain Elusive for Many Suppliers

According to the findings of a recent survey of satisfaction and loyalty among over 1,700 life scientists, most leading life science suppliers enjoy customer satisfaction ratings of 70% or higher. New England Biolabs, Sigma-Aldrich and Invitrogen boast the most satisfied customers. Satisfaction, however, does not immediately translate to enduring loyalty and a new report from BioInformatics, LLC reveals points of strength and vulnerability for 24 companies across the entire purchasing cycle. Companies such as Fisher Scientific, Qiagen, and Promega excel in key areas of corporate performance such as the perceptions of ease-of-use, easy ordering procedures and excellent post-sale support. The importance of 18 key customer "touchpoints" from pre-purchase considerations, through the actual purchase, and on to post-purchase support, were examined in terms of their individual importance and the best and worst performing brands in each category. "High rankings in specific touchpoints can be offset by sub-par performance in other areas. The market's leaders understand that their brands embody everything that shapes a customer's experience with their company. If it is a positive and meaningful experience, customers develop an emotional attachment that makes it difficult for them to switch to another brand," stated Dr. Tamara Zemlo, Director of Syndicated Research and Analysis. On average, the scientists surveyed simultaneously use the products and services of 10 life science brands, indicating that no single supplier can meet all of their research needs. In this highly competitive environment, suppliers must deliver a branded customer experience in order to drive consistent revenue growth. The report also takes a closer look at the interaction of satisfaction, retention, and loyalty through the Customer Experience Index -- a measure of the level of commitment a customer has to a particular brand. In this section of the report, manufacturers of capital equipment such as Applied Biosystems, Bio-Rad Laboratories and Perkin-Elmer are notable for their high levels of overall customer satisfaction and retention despite the challenges of communicating the value of their complex instruments during every phase of the purchasing cycle. Providing a superlative customer experience is about managing the details. This report provides suppliers with access to the details that matter when scientists consider purchasing products from one brand over another. Using this information, suppliers can enhance the processes and procedures in place to reflect the optimal point-of-contact mix. For a copy of the report, visit http://www.gene2drug.com/reports.

Atrium Research Publishes Results of Annual ELN Survey

Atrium Research, an independent market research organization dedicated to scientific informatics, has announced the availability of the 2006 Electronic Laboratory Notebook Survey. This study contains the results and analysis of Atrium Research’s annual survey of information technology and scientific decision-makers in the life sciences, chemical, academic, government and food markets. Comprehensive data and analysis are reported on 150 questions answered by 466 professionals from nineteen countries regarding the emerging market for Electronic Laboratory Notebook (ELN) technology. This 158 page report highlights user and prospect user opinions on data management challenges, purchase interest and intent, motivations, project goals, funding, integration needs, and supplier brand perception. The market for ELN is exploding with over thirty suppliers offering commercial solutions. One of the fastest growing informatics markets with a growth rate of over 30% per year, ELN has the potential to radically improve the effectiveness of laboratory operations. ELN not only replaces traditional paper notebooks which have been used for centuries to record experiments, data and conclusions, but also enables new approaches to data and information integration. An ELN can create virtual teams of scientists who freely share their knowledge and experiences - decreasing the time to discover and develop new molecular entities. "We forecast double-digit growth for ELN over the next four years" said Michael H Elliott, founder and CEO of Atrium Research. “Our study shows strong interest in the technology to eliminate a major barrier in the vision of the electronic laboratory. As was the case with LIMS in the early 1980’s, the life sciences are leading ELN adoption and deployment.” For details, visit http://www.atriumresearch.com.

Recent Survey Addresses Biosafety and Security in Asia

A report recently released by Sandia National Laboratories shows that researchers in 16 Asian countries often use insufficient biosafety practices. Biosafety Level (BSL) 2 practices are often employed for research involving BSL 3 agents. Nearly two-thirds of respondents investigating Japanese encephalitis, avian influenza, and severe acute respiratory syndrome (SARS) - which are all BSL 3 agents - perform their research under BSL 2 specifications. This report was produced under contract by BioInformatics, LLC, an Arlington, VA-based research and consulting firm, and is now publicly available on the Sandia Web site. BioInformatics used its cutting-edge research expertise to create this report on Asian biosafety and biosecurity research practices in support of Sandia National Laboratories' Biological Weapons Nonproliferation Department. "This research is simply an extension of the types of analyses we perform regularly for a variety of clients in the life science industry -- all of whom are interested in obtaining insights into the minds of life scientists," observed Dr. Tamara Zemlo, Director of Syndicated Research and Analysis. "Understanding the current practices and future needs of life scientists can be important for a variety of reasons -- from benchmarking technological innovation to evaluating the commercial potential of new product lines to assessing potential bioterror risks at home and abroad." For this report, BioInformatics surveyed 300 scientists to assess the current practices employed in studying infectious agents by laboratories located in 16 Asian countries -- segmented by the level of biotechnological sophistication. BioInformatics also performed an in-depth review of the tools and technologies supporting biodefense research, which is available in their 2004 report, "Market Opportunities in Biodefense Research." This report provides a thorough analysis of the commercial opportunities in this fast-growing and well-funded market. The full report on Asian biosecurity is available at http://www.biosecuritycodes.org/docs/Asia%20summary%20SAND%20report%20final.pdf.

Labtronics and JusticeTrax Partner

Labtronics and JusticeTrax have announced that Labtronics LimsLink will now be recommended as the instrument interfacing tool to be utilized to interface instrumentation to their LIMS product, LIMS-plus. JusticeTrax is the provider of LIMS designed for forensic laboratories of all sizes. JusticeTrax has partnered with industry leading organizations, allowing the integration of best-in-class components into total criminal justice solutions. LimsLink's industry leading technology complements this strategy, offering the industries most recognized and used instrument interfacing tool. For details, visit http://www.justicetrax.com or http://www.labtronics.com.

Labtronics Releases Web Version of NEXXIS

Labtronics has released NEXXIS version 3. This release is highlighted by a fully functional web client that requires no software to be loaded onto workstations. Using Microsoft Internet Explorer, users can access and process all of their laboratory procedures. NEXXIS is an Application Development Platform that reduces the time and cost required to develop and implement secured, web-based laboratory data management solutions. NEXXIS combines a powerful Application Development Tool for creating laboratory solutions with a scalable Laboratory Platform to deploy, manage and execute these applications. There is now a single software platform that integrates users with information, instruments and systems at the precise point that it is most required - during analysis. For details, visit http://www.labtronics.com.

Labtronics' Pipette Tracker and Collect XL Connect Multi-Channel Weighing System

A new interface is now available from Labtronics to connect with a multi-channel pipette calibration balance system used for pipette calibrations with the Pipette Tracker and Pipette Tracker Pro through the Collect XL software. Labtronics' Collect XL software is able connect multiple RS232 interfaces directly to the same Excel sheet simultaneously. A special Excel template was created for this application to re-organize the readings to what Pipette Tracker expects. Within Pipette Tracker, the calibration that was run on the multi-channel balance system can be started like normal. By using a new interface from Pipette Tracker's run-time calibration window to Excel, the re-organized weight readings are stored within the Collect XL Excel method template and transferred directly to the calibration window, which applies the appropriate environmental Z-factor, tolerance limits and method Pass/Fail criteria to each weight reading as they are transferred in. For details, visit http://www.labtronics.com.

Thermo Unveils Novel Environmental Solutions Package to Enable Reliable and Accurate Drinking Water Analyses

Thermo Electron Corporation, world leader in analytical instrumentation, has announced the launch of its new environmental water monitoring package, EQuan. Designed for reliable and accurate analysis of water samples, this comprehensive package has been specifically developed to monitor trace levels of pesticides, hormones, antibiotics, pharmaceuticals and veterinary products in drinking water. EQuan significantly reduces sample analysis time as it allows samples to be directly injected and enriched followed by immediate LC-MS/MS analysis. Limits of Detection (LODs) are considerably improved compared to conventional injection techniques (up to 100 times) with detection limits of 10ppt (parts per trillion) easily achieved. Achieving low LODs of pesticides, antibiotics and veterinary residues in drinking water is of paramount importance in order to monitor the regulatory levels as stated by US, Japanese, and European Environmental and Water directives. These substances pose a significant health threat and therefore, need to be accurately detected. Traditionally, LC-MS/MS has been used by the environmental industry for the identification and quantification of these residues. However, this methodology typically requires extensive offline sample preparation, which can be particularly time consuming and expensive. The unique capabilities of EQuan for online sample preparation and clean up of environmental samples result in improved sensitivity and precision as well as unmatched throughput. The new environmental solutions package also features Quantitation-Enhanced Data-Dependent MS/MS (QED-MS/MS) functionality to achieve precise quantification with simultaneous structural confirmation using an in-built MS/MS library. In addition, the unique enhanced resolution (H-SRM) capabilities of the TSQ Quantum add to the specificity of samples and can help to significantly improve Limits of Quantification (LOQs). EQuan consists of a TSQ Quantum series mass spectrometer, two Surveyor HPLC pumps with a pre-concentration column, an analytical column, a CTC autosampler and an EQuan kit consisting of columns and HPLC accessories. EQuan can use any of Thermo’s TSQ Quantum series instruments depending on the specific application, including the TSQ Quantum Access, TSQ Quantum Discovery MAX, and TSQ Quantum Ultra. For details, visit http://www.thermo.com/ms.

Thermo Announces Its New Single Quadrupole GC/MS System to Accelerate Productivity in the Workplace

Thermo Electron Corporation, a world leader in analytical instrumentation, has introduced the latest product innovation for laboratory GC/MS – the DSQ II. Based on the proven reliability and performance platform of Thermo’s DSQ and PolarisQ GC/MS systems, the DSQ II incorporates the new DynaMax XR ion detection system and the DuraBrite ion source. The DynaMax XR detection system allows for linear quantitation across six orders of magnitude and higher, increasing the effective analysis range of the instrument while decreasing sample preparation requirements. The DuraBrite ion source features enhanced source designs to increase robustness with heavy matrix samples. An optional new closed electron ionization (CEI) ion volume further enhances performance with environmental samples. Using a curved pre-filter and the DuraBrite source, the DSQ II significantly reduces neutral noise, providing enhanced sensitivity, even at low femtogram levels. This innovative instrument offers increased sensitivity, extended linear range, and advanced fast scanning for lower levels of detection. With continued product enhancements in ion source and detector technologies, the new DSQ II is ideal for routine GC/MS analysis across a wide range of applications including environmental, food safety, forensic chemistry and toxicology. Three pump configurations provide expanded capabilities and flexibility for a variety of applications: a 70 Liters per second (L/sec) turbomolecular pump for electron ionization/mass spectrometry applications, a 250 L/sec turbomolecular pump for the addition of chemical ionization or solids probes, and a 200/200 split flow pump for ultimate performance with differential pumping. Upgrades to vacuum interlock, chemical ionization, solids probes and pulsed positive ion/negative ion chemical ionization (PPINICI) are also available. The DSQ II has the industry’s fastest scanning capability by a single quadrupole system with scan speeds greater than 11,000 amu/sec. The DSQ II comes standard with advanced mixed scan mode capabilities for sequential selected ion monitoring (SIM) and full scan analysis. This feature offers the enhanced sensitivity of SIM with the added confidence of full-scan fingerprints. Powerful Xcalibur software provides complete control of the GC/MS system, while application-specific software such as EnviroLab Forms 2.0, ToxLab Forms 2.0, and ToxLab 2.0 provide processing, data control and work flow functions for today’s busy laboratories. For details, visit http://www.thermo.com.

Thermo Introduces the LTQ FT Ultra Hybrid FTICR, the Most Powerful New Mass Spectrometer on the Market

Thermo Electron Corporation, world leader in analytical instrumentation, has announced the launch of its next generation hybrid FTICR mass spectrometer, the LTQ FT Ultra. This new instrument analyzes complex matrices and large molecules with independent sub ppm mass accuracy, ultra high resolution in excess of 750,000 and improved detection circuitry. The LTQ FT Ultra is equipped with a novel ICR cell design, the Ultra Cell, which improves sensitivity and widens the dynamic range to exceed 4000, all on an LC timescale. It is suited for top-down and bottom-up proteomics as well as metabolomics. Thermo’s new LTQ FT Ultra is the ideal analytical solution for monitoring complex mixtures such as Dissolved Organic Matters (DOM), polymers and crude oil samples as well as for the unambiguous identification of unknown analytes with on-line LC-MS/MS at any concentration. This hybrid FTICR mass spectrometer provides attomole sensitivity for identification of low abundance peptides on a routine basis. The linear excitation characteristics of the Ultra Cell allow larger cyclotron radii, which dramatically reduce space charge effects. These performance gains are achieved without the costs and difficulties associated with a higher field magnet. The LTQ FT Ultra is the successor of Thermo’s Finnigan LTQ FT high performance hybrid mass spectrometer, which was introduced in 2003. For details, visit http://www.thermo.com/ms.

High Throughput Screening of Counterfeit Drugs Described in New Paper on Novel Mass Spectrometry Techniques

In order to chemically fingerprint counterfeit anti-malarial drugs, Prof. Facundo Fernandez's bioanalytical chemistry lab at Georgia Tech conducts experiments using novel mass spectrometry techniques. A newly-published paper, authored by Fernandez, et al., describes the use of ambient mass spectrometry ion sources for open air, high throughput screening of both counterfeit and genuine anti-malarial tablets. Characterization of Solid Counterfeit Drug Samples by Desorption Electrospray Ionization and Direct-analysis-in-real-time Coupled to Time-of flight Mass Spectrometry was published in ChemMedChem 2006, 1, 702-705. The paper addresses a widespread public health problem, counterfeiting of an effective but costly anti-malarial drug, artesunate. Until now, there have been no satisfactory techniques for rapidly screening large quantities of pills, or for rapidly identifying the components in counterfeit drugs. Among several techniques described in the paper, Fernandez used a direct analysis, exact-mass time-of-flight mass spectrometer (the JEOL AccuTOF-DART) to identify unknown components in counterfeit artesunate tablets. The counterfeit drug tablets were rapidly found to contain a surprising variety of compounds ranging from acetaminophen to antibiotics and antihistamines to older antimalarial drugs that are no longer effective. None of these components are effective against malaria, but may provide temporary relief and false confidence that may prevent the victim from obtaining effective treatment until the disease has progressed to a serious condition. Interestingly, several counterfeit drug tablets were found to contain trace amounts of genuine artesunate. The levels of artesunate in these tablets was well below the effective dose, but may have been added to confuse field tests for counterfeit drugs. DART is a patented, unique ion source offered by JEOL USA for its AccuTOF time-of-flight mass spectrometers to enable direct detection of chemicals on surfaces, in liquids, and in gases without altering the sample state. DART is unique in that samples are analyzed in open air, using no radioactive components, solvent sprays, exposed high voltage, or vacuum. For details, visit http://www.jeolusa.com.

Cerno Bioscience Paper Demonstrates Accurate Mass Measurements from Product Ions on Unit Mass Resolution Mass Spectrometers

A new paper from Cerno Bioscience and Wyeth Pharmaceuticals, called ‘Accurate Mass Measurements of Product Ions for Metabolite Identification on Unit Mass Resolution Mass Spectrometers’, demonstrates that high mass accuracy can be achieved on conventional triple quadrupole mass spectrometers of unit mass resolution running in MS/MS mode. This is achieved using Cerno’s award winning MS calibration and data analysis software, MassWorks, an easy-to-use post acquisition software package that utilizes Cerno’s patented MSIntegrity technology, to dramatically improve mass spectral measurements. The level of accuracy required for metabolite identification can normally only be performed on high resolution mass spectrometers, but the results of this research prove that MassWorks can achieve mass measurements of product ions with 5 ppm accuracy on a unit mass resolution instrument. The method was demonstrated for a set of small-molecule pharmaceuticals from an ABI/Sciex 4000 Q Trap by infusion as well as by LC/MS/MS measurements of rat liver microsomal incubation of verapamil on an ABI/Sciex 3200 Q Trap. All the mass spectral data were collected in profile mode and processed using MassWorks software. For the infusion, a few or a single known fragment ion(s) from the MS/MS spectra were selected as calibration standards in order to internally calibrate the spectra. Other fragment ions in the spectra were tested for mass accuracy resulting in mass errors of less then a few mDa in most cases. The LC/MS/MS fragment ions were generated on-the-fly by information dependent scans. Accurate mass measurements of about 5 mDa for demethylated verapamil and its fragments were achieved by applying an external calibration generated by the known fragments of the parent drug verapamil. Interestingly, the research also found that mass spectrometry calibration, including both mass and peak shape, is critical for high mass accuracy and that internal calibration aids the achievement of the highest possible mass accuracy. Peak saturation is a key factor causing poor mass accuracy in a quadrupole system. For details, visit http://www.cernobioscience.com.

ClinPhone Launches Ground-Breaking Drug Accountability Solution For Clinical Trials

ClinPhone, a global leader in clinical technology solutions, has announced the launch of ClinPhone drug accountability, a complete web-based electronic solution to enable central management of the entire clinical supply chain. ClinPhone has introduced its drug accountability solution following extensive research which identified the clinical trial industry’s need to improve the current drug accountability management process. For clinical trials, the regulations require that all investigational materials are properly accounted for and reconciled from start to finish. ClinPhone’s solution helps pharmaceutical sponsors effectively comply with the requirements and demonstrate a full chain of custody for every medication unit from dispatch to dispensation and destruction. ClinPhone drug accountability allows sponsors to create and maintain electronic documentation for the whole drug accountability process by seamlessly capturing and integrating data from site, monitor and distribution depot users. It facilitates management and tracking of each unit of clinical supplies including receipt at distribution depots and investigative sites, dispensing to patients, return of medication packs from patients, return of used medication packs to distribution depots and final destruction of supplies. Its intuitive and user-friendly features include electronic dispensing and returns logs, downloadable data for off-line use by study monitors and real-time reporting. ClinPhone drug accountability is a 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) solutions, 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. The solution helps minimize paper-based operations, thereby removing the need to consolidate and reconcile data from numerous sources. Utilizing ClinPhone drug accountability, sponsors and users can enjoy the benefits of a simplified and streamlined workflow for managing the entire drug accountability, reconciliation, returns and destruction processes. For details, visit http://www.clinphone.com.

ABB Supports Startup of New Cosevco Cement Plant

ABB, a leading power and automation technology group, has announced that the Song Gianh cement plant, Cosevco’s (Midland Construction Corporation) new 1.4 million tpa facility in Vietnam, has been successfully put into operation. Completion of the project was one of the fastest in Vietnam in recent years. The contract was signed in September 2002 and came into effect only two months later. The plant began producing cement in June 2006. This rapid schedule was made possible due to the excellent cooperation between all involved parties. The Song Gianh cement plant is now producing with the newest technology amidst the strong demand of a growing cement market. The perspectives of this cement plant in the middle of Vietnam are extremely good. The near six square kilometer plant area includes high quality limestone mountains and a river port. ABB delivered the complete electrical and automation equipment, engineering, design, training, supervision and commissioning for the total cement plant. The ABB scope of supply included power distribution, DriveIT medium and low voltage motors and drives, OperateIT control systems and OptimizeIT optimization systems as well as communication and instrumentation systems. Deliveries for the infrastructure comprised cables, lighting, earthing and lightning protection and the fire detection system. The deliveries were initiated at the end of 2003, according to the contract schedule. The Song Gianh cement plant is based at Cuong Trung A and Cuong Trung B villages in Tien Hoa, a commune located in the central Vietnamese Quang Binh province. For details, visit http://www.abb.com/cement.

Protedyne Announces Ability to Integrate the LightCycler 480 System for Real-Time PCR Assays in Life Science Research

Protedyne Corporation, a leading designer of industrial automation, has integrated their new Radius bench top robotic system with Roche Diagnostics’ LightCycler 480 Real-Time PCR System to create an automated high-throughput solution for real-time PCR assays. The robust and flexible Radius system is an ideal match for the versatile LightCycler 480 instrument and provides the speed and reproducibility needed for these assays. Protedyne’s Radius is a new bench top robotic system using the principles of industrial automation to offer the highest levels of flexibility, reproducibility, and process control for today’s busy laboratories. Its unique radial design and vertical construction provide maximum functionality that can access areas of the bench top beyond its own footprint for simple and cost-effective device integration. The Radius system uses Protedyne’s software that easily adapts to multiple protocols – and SmartTools, easily interchangeable tools with built-in microprocessors that store tool calibration information and track performance data. For details, visit http://www.protedyne.com.

Intelli Innovations Unveils Barcode Producer 4.0 For Mac OS X

Intelli Innovations, Inc. has unveiled Barcode Producer 4.0, its next-generation barcode creation software suite for Mac OS X. The new release offers major new functionality covering 100% of the company's top 10 feature requests, including GS1-128 coupon barcodes, ISBN dual numbering, background grids, Bar Width Reduction
(BWR), dynamic height adjustment, and on-screen dimensional indicators. Barcode Producer 4.0 represents the biggest upgrade in the product's history, bringing comprehensive support for the latest standards in barcode generation coming this January 2007 (including 13-digit only ISBN barcodes). Version 4 sports a new barcode rendering engine with options for vector EPS, Adobe PDF, and bitmap TIFF output, rigorously tested using ISO industry standard barcode verification equipment. For details or to download a free demo, visit http://www.intellisw.com/barcodeproducer.

Embarcadero Systems Set to Integrate Savi Networks' Information Systems at U.S. Port Terminal Operations

Embarcadero Systems Corporation (ESC), which supplies technology support for over 30 percent of cargo containers moving throughout U.S. West Coast ports, recently formed a strategic services partnership with Savi Networks to implement Radio Frequency Identification (RFID)-based systems at port terminal facilities throughout the United States. Savi Networks provides information services called SaviTrak, which leverages standards-based RFID and other Automatic Identification and Data Collection (AIDC) technologies at ports worldwide to further improve the efficiency, effectiveness and security of global supply chains. The agreement calls for ESC to implement solutions at port terminal facilities that are part of the growing global partner community of Savi Networks, which is majority-owned by Lockheed Martin Corporation. ESC also will provide systems integration of automated data collection points with SaviTrak information services and other supply chain management systems used in port environments. ESC will implement solutions at ports where Savi Networks has partnership agreements with major terminal operators. For details, visit http://www.savinetworks.com.

Savi Technology's RFID-Based Portable Deployment Kit Shines in M2M's Gold "Value Chain" Award Bestowed on the U.S. Marine Corps

The U.S. Marine Corps Systems Command was recently honored with a Gold Value Chain Award (Supply Chain Management category) by M2M magazine for its rapid deployment of the Portable Deployment Kit (PDK), a highly mobile “solution in-a-case” leveraging RFID, satellite and other wireless technologies to help soldiers automatically track military supplies in remote field operations. The PDK was developed by Savi Technology, a provider of active Radio Frequency Identification (RFID)-based supply chain solutions, in conjunction with industry partners and the DoD’s Product Manager, Joint-Automatic Identification Technologies. Savi Technology, a Lockheed Martin Company, led the design and development of the suitcase-sized PDK, which is a breakthrough “mobile chokepoint solution” that integrates several Automatic Identification and Data Collection (AIDC) technologies, including bar codes, 2D bar codes, active RFID and GPS location with satellite communications – all in a single carrying case. In addition to the military, the PDK can be used by other government and commercial applications where there are requirements to track supplies in near real-time and there is no fixed reader infrastructure, such as public disaster and hunger relief organizations and commercial logistics operations in the oil and gas, chemical and construction industries. For details, visit http://www.savi.com.

FDA Rejects Drug Safety Bill's Risk Management Plan Provision

The long-awaited effort to overhaul the nation's drug safety efforts faces FDA opposition as agency officials reject a recent legislative proposal to improve risk management plans as "unrealistic." But at least one congressional source dismissed the criticism. The "Enhancing Drug Safety and Innovation Act," drafted by Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.), is meant to improve the FDA's oversight of drugs once they are on the market and imposes on the industry new safety planning requirements before launching a drug. It also establishes a national clinical trial registry. The 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 (REMS), a mechanism to acquire and adapt to new safety information about a drug. Every risk plan would include 15-day, quarterly and annual adverse event reports, FDA-approved labeling and a pharmacovigilance statement that explains and justifies whether standard adverse event reporting is adequate, or if more studies and clinical trials are needed. But one FDA official, who asked not to be named, is rejecting this proposal. The REMS program unnecessarily slows the drug review process, removes agency discretion to tailor risk management reviews for individual drugs and places unreasonable deadlines and financial burdens on the agency, the source said. These concerns are shared by a number of other FDA officials, the source added. "The timelines for achieving goals under the legislation are unrealistic, and the resources that it would require would add significant new burdens and financial strains on FDA," the source said. "It's a very bureaucratic solution to a very practical problem." But these comments are merely "pot shots from faceless, nameless FDA talking heads," Enzi spokesman Craig Orfield said. "A 'very bureaucratic response'? Frankly, this criticism is the textbook bureaucratic response of the year." For details, visit http://www.fda.gov.

Senators Enzi and Kennedy Introduce Drug Safety Bill

Months of negotiations have come to an end as the top Republican and Democrat on the Senate Health, Education, Labor and Pensions (HELP) Committee finally introduced their comprehensive overhaul of the nation's drug safety efforts. The "Enhancing Drug Safety and Innovation Act," drafted by Chairman Mike Enzi (R-Wyo.) and ranking member Edward Kennedy (D-Mass.), improves the FDA's oversight of drugs once they are on the market and imposes on the industry new safety planning requirements before launching a drug, the lawmakers said. "The FDA needs better authorities and more resources to monitor and manage drug safety after drug approval," Kennedy said, "and this bill gives FDA both." Enzi said the bill would "raise the bar to ensure that drug safety is not an afterthought, but an integral part of the process from the very beginning. It requires drugmakers to engage in better safety planning before a drug is approved for release to the public, and will improve both the understanding of and response to risks that arise after a drug is on the market." The bill would also tighten conflict-of-interest rules for FDA advisory committee members and establish a public-private partnership to improve drug development and evaluation and advance the FDA's Critical Path Initiative. The FDA has been under pressure to make changes to its drug review program, especially its habit of granting conflict-of-interest waivers to advisory board members. It 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. Introduction of the Enzi-Kennedy bill did little to calm the agency's critics, however. Sidney Wolfe, director of Public Citizen's Health Research Group, immediately denounced the bill for not repealing the user fees drugmakers pay to the FDA when they submit a new drug application and for not including a provision removing the Office of Drug Safety from CDER and making it independent. For details, visit http://www.fda.gov.

CBER Issues Final Electronic Submission Guidance

The FDA's Center for Biologics Evaluation and Research (CBER) has issued a guidance on how manufacturers of biologic products should submit their lot release protocols in electronic format to CBER's Product Release Branch. CBER may require manufacturers to submit samples of any lot of any licensed biologic product for review and testing, together with the protocols showing the results of applicable tests. The agency is recommending that these submissions be made in electronic format, such as floppy disk or CD-ROM. Each CD-ROM or disk should include a cover letter in PDF format with a description of the submission, a statement that the submission is virus-free and regulatory and technical point of contact information. Identification information for each lot release protocol should be in a separate PDF file. Lot release information for each lot should be saved in a separate file, which the agency recommends be named under the old DOS standard that limits the filename to eight characters with an extension of up to three-characters. The first four characters of the filename should be the year, followed by a four-digit sequential submission number for that year, with a two- or three- character extension designating the type of the submission, such as ".P0" (zero) for a submission under the original protocol. Finally, the agency recommends the use of functional bookmarks to help with navigation within the PDF file. For details, visit http://www.fda.gov/cber.

Survey of Scientists Depicts a Struggling FDA

The FDA is in disarray, beset by political and industry influences and hampered by insufficient funding to protect public health, a study of agency scientists concludes. This study, released July 20 by the Union of Concerned Scientists (UCS), is just the beginning, as the group will soon seek out former FDA officials to get their recommendations for changes with an eye toward the Prescription Drug User Fee Act negotiations as the vehicle for reform. UCS surveyed nearly 1,000 FDA scientists to determine their views of how independent and candid agency researchers are allowed to be in assessing the health and efficacy of drugs and devices. According to the study, "Voices of Scientists at FDA: Protecting Public Health Depends on Independent Science," FDA staff see an agency that is in decline. The study, which is the latest is a flurry of attacks on the agency, finds that 47 percent of respondents believe the agency is less effective than it was five years ago. Half of the staffers surveyed, including consumer safety officers, chemists and other specialists, also believed that the FDA was heading in the wrong direction. At least one-third of the 997 respondents believed that their work was interfered with by outside political and industry influences, that retaliation for their views hampered scientific candor and that the FDA is failing to protect human health, the study said. The report also noted that morale at the agency is increasingly poor. However, many times an equal or greater number of respondents reported that they were independent and were not worried about being candid with their findings. For instance, 67 percent of the scientists said that they had never been asked explicitly to provide incomplete, inaccurate or misleading data, and 60 percent said they never faced implicit pressure to do so. Furthermore, 77 percent said that the FDA's scientific documents and reports rely on the best available science. The FDA rejected the report, calling it "highly unscientific," and based on "leading questions and innuendo. FDA would expect more rigor to support more far-reaching allegations and conclusions," the agency said in a release. The FDA also criticized the scientists who cooperated with the survey for going outside normal channels to "try and impose their views through the media. This is unfortunate because it undermines the scientific decisionmaking process and devalues the many contributions made by other FDA staff who do work within the established framework."
The report is available at http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html.

Thermo Announces New Additions to Proteomics Product Suite

Thermo Electron Corporation has announced an array of new products for its industry-leading Proteomics application suite. These include the LTQ XL linear ion trap and LTQ FT Ultra mass spectrometers along with comprehensive software packages such as MALDI Tissue Imaging, SIEVE, BioWorks 3.3, and ProSightPC. Thermo's new LTQ XL linear ion trap features Pulsed Q Dissociation (PQD), rapid positive/negative switching capabilities and High Resolution Isolation (HRI) scanning capabilities. This strengthens the proven protein detection and characterization capabilities of the LTQ platform. The LTQ XL has the added benefit of an Electron Transfer Dissociation (ETD) option, taking advantage of the huge ion storage capacity and fast cycle time of Thermo’s linear ion trap. Ken Miller, proteomics marketing manager for Thermo, stated, "The ability to use CID (collision induced dissociation), PQD, and ETD interchangeably enables the LTQ XL to address the advanced application needs of proteomics researchers. Additionally, Thermo’s optional vMALDI ion source and Orbitrap or FT detectors make the LTQ XL the universal proteomics platform of choice.” Further extending the proteomics suite, the new LTQ FT Ultra includes a patented ICR cell, which delivers approximately five times more sensitivity and offers a wider dynamic range and ultra-high resolution, all on an LC timescale. The new ICR cell design, together with improvements in detection, allows for routine attomole sensitivity and a dynamic range in excess of 4000 while achieving sub-ppm mass accuracy. Thermo also unveils several advanced software packages including SIEVE, BioWorks 3.3, Tissue Imaging and ProSightPC. SIEVE is a label-free differential expression analysis software for biomarker discovery, offering an automated workflow to compare LC/MS analyses from large sample populations. It is a highly accurate tool for analyzing data from biomarker discovery experiments. BioWorks 3.3 software brings an important quantitative dimension to proteomic analysis, providing tools for automated analysis of iTRAQ labeled samples, as well as SILAC and metabolic labeling experiments. Additionally, the software allows for easy interoperability with Mascot from Matrix Science, UK. Users will be able to launch searches on their Mascot server from BioWorks 3.3 and compare SEQUEST and Mascot search results. Tissue Imaging software adds a vital new capability for determining the spatial distribution of small molecules or peptide compounds of interest. This powerful technique is now available for the Finnigan LTQ XL with the vMALDI source option. ProSightPC is a first-ever automated top-down protein analysis software. Using all combinations of CID, ECD and IRMPD data from the LTQ FT Ultra, the software is able to completely identify and characterize intact protein iso forms. For details, visit http://www.thermo.com.

Cerno Bioscience Granted US Patent for its MS Calibration and Data Analysis Software, MassWorks

Cerno Bioscience has announced that its MS calibration and data analysis software, MassWorks, has been granted United States Patent No. 6,983,213. Cerno’s patent covers a fundamentally new approach to calibrating mass spectrometry (MS) data. MassWorks is an easy-to-use post acquisition software package that utilizes Cerno’s patented MSIntegrity technology to dramatically improve data readings, achieving high mass accuracy even on conventional mass spectrometers of unit mass resolution.The software is a first-of-its-kind comprehensive approach to calibrating various types of mass spectrometry systems to enable highly accurate mass spectral analysis, including high mass accuracy, best possible quantitative precision and accuracy, and high fidelity molecular identification. MassWorks has been developed for biotech, environmental and pharmaceutical applications, and enables analysts to obtain up to 100X improvement in mass accuracy in a fast and versatile MS software application package. The patent demonstrates Cerno’s authority on understanding the exact isotope masses and abundances of any known calibration compound to generate, for the first time in the development of mass spectrometry, a comprehensive MS calibration equation, which corrects not only the peak mass positions, but also the peak shapes. This enables unit mass resolution instruments to routinely obtain mass accuracies of up to 5ppm, making it possible to perform accurate compound identification through elemental composition searches, a capability usually only available on more expensive systems. MassWorks recently won the PITTCON 2006 Editors’ Choice Bronze Award following its show debut at the Pittsburgh Conference of Analytical Chemistry and Applied Spectroscopy in March 2006. This prestigious accolade is given to the best new product introduction for its contribution to the advancement of science, as judged by a panel of editors attending the show. MassWorks utilizes Cerno’s DirectRead technology to read most instrument data formats directly, eliminating the need for importing or exporting MS data to the clipboard or utilizing intermediate exchange formats. This saves time, reduces transcription errors, simplifies file management, and saves substantial disk space. As DirectRead doesn’t alter the original data, it assists compliance with common regulatory requirements such as GLP and 21 CFR Part 11. For details, visit http://www.cernobioscience.com.

Beckman Coulter Adopts ARTEL Technology for Field Service

ARTEL has announced that Beckman Coulter, a leading manufacturer of biomedical testing instrumentation, has adopted the ARTEL MVS (Multichannel Verification System) to verify the accuracy and precision of its automated liquid handling systems used in pharmaceutical and clinical laboratories. As part of Beckman Coulter’s Field Service Operational Qualification Program, an option available to the company’s Biomek customers, the MVS provides solid documentation about system performance, helping laboratories meet compliance and regulatory requirements. Because Biomeks quickly generate data used in critical assays and due to increasing regulatory pressure governing process controls, Beckman Coulter wanted a more convenient method to measure instrument performance. Upgrading its Field Service Operational Qualification Program technology with the MVS, a rapid and traceable system, allows Beckman Coulter to easily meet customer demands for documented validation. "ARTEL’s MVS allows us to rapidly assess the performance of our instruments in the field and provide documented, traceable data,” notes Lisa Knapp, Technical Services Manager for Beckman Coulter. “This is especially important for some of our customers operating in regulated environments who need third-party validation of instrumentation and processes.” The MVS is based on proprietary Ratiometric Photometry, which measures light absorption by two specially formulated dyes in order to verify volume, making it especially effective at low volumes. This ability to measure microliter volumes was paramount to Beckman Coulter’s selection of the MVS, especially as the company’s products advanced to handle smaller and smaller liquid quantities to meet market demands. Additionally, the MVS can perform calibration very quickly, and can be applied to Beckman Coulter’s full portfolio of Biomek Liquid Handlers, ranging from one to 384 channels. For details, visit http://www.artel-usa.com.

ClinPhone Announces Successful Completion of IPO

ClinPhone plc, a leading specialist supplier of technology solutions to the clinical trials industry, has announced the successful completion of its Initial Public Offering on the London Stock Exchange. The Offering raised a total of £56.3 million, net of expenses, from the sale of new and existing Shares to institutional investors at a price of 148p per share. At the Offering price, the Company will have a market capitalisation of £94.1 million on listing. Investec Bank (UK) Limited has acted as sole sponsor, financial adviser and underwriter to the Offering. The Offering comprised a total of 40.7 million ordinary shares, consisting of 13.75 million new Shares and the sale of 26.9 million existing Shares by certain selling shareholders. The Company has raised proceeds of £18.1 million from the Offering which will primarily be used to reduce bank borrowings and pay for the costs relating to the flotation. The number of Shares in issue at listing will be 63,553,569 million. Directors and senior managers holding 6,418,854 Shares in aggregate representing 10.1 per cent of the issued share capital on admission are subject to lock-ups of 12 months following admission to listing. Certain other existing shareholders holding 13,743,100 Shares in aggregate representing 21.6 per cent of the issued share capital upon admission are subject to lock-ups of six months following admission to listing. Admission to the Official List of the Financial Services Authority and commencement of dealings on the London Stock Exchange’s main market took place on Friday, 23 June 2006 under the ticker symbol CNP. For detials, visit http://www.clinphone.com.

Savi Networks Partners with Georgia's Maritime Logistics Innovation Center

Savi Networks, a provider of Radio Frequency Identification (RFID)-based information services to monitor cargo container shipments, and the Maritime Logistics Innovation Center (MLIC) have announces an agreement to help Georgia's industries and logistics providers enhance their competitiveness in the global marketplace. Savi Networks initially will provide SaviTrak, the company's real-time information service, to terminal facilities at Georgia’s ports. The agreement delivers a number of direct benefits, including the ability of terminal operators and their customers to obtain real-time information on RFID-tagged containers at other ports worldwide connected to Savi Networks, which is majority-owned by the Lockheed Martin Company. Participating port and terminal operators in Georgia will be able to provide customers greater levels of efficiency, real-time visibility and conditions of containerized cargo. In addition, MLIC will leverage Savi’s solutions for research and development efforts throughout Georgia's industries and to enhance the state’s role as a center of global commerce. The RFID-based infrastructure utilized by Savi Networks automatically reads and transmits data on RFID-tagged containers and has been installed at major ports worldwide. With this announcement, the Georgia Ports Authority (GPA) joins U.S.-based terminals operated by the Trans Pacific Container Service Corp. (TraPac) and Marine Terminals Corporation (MTC) as well as internationally based terminal operators with SaviTrak agreements. Ports and terminal operators benefit from SaviTrak, which is offered via an open technology platform that accommodates multiple and interoperable Automatic Identification and Data Collection (AIDC) technologies, such as barcodes, EPC-compliant passive and active RFID technologies, and Global Positioning Systems (GPS) used to track ships and trucks transporting ocean containers. For details, visit http://www.savinetworks.com.

Lawmakers Working Toward Compromise on Biotech Funding Dispute

More venture capital-backed biotech firms could become eligible for federal research funding under a compromise being worked out by Senate Republicans. Sen. Olympia Snowe (R-Maine), the chairwoman of the Small Business and Entrepreneurship Committee, will be working with other Republican lawmakers and the Biotechnology Information Organization (BIO) to decide how to allow biotech firms with venture capital backing to receive federal funds reserved for small businesses. At issue is R&D funding awarded under the Small Business Administration's Small Business Innovation Research Program (SBIR), which accounts for approximately $2 billion in grants annually. Companies with more than 49 percent ownership by venture capitalists are currently not eligible for SBIR funds. Biotech companies and lawmakers such as Sen. Kit Bond (R-Mo.) argue that these funds are essential to these companies' competitiveness in the marketplace. Snowe will work to modify Bond's bill S.1263, which amends the Small Business Act (SBA), to make companies with majority venture capital ownership eligible for the funds. "Hopefully we'll find that middle ground" between allowing more firms with venture capital ownership and making eligibility so broad that the companies that currently do not qualify as small businesses become eligible for the SBIR funds, Snowe said after a July 12 hearing on the bill. The lawmaker wants to determine how to define an "investor" for the purposes of SBIR and decide whether companies supported by individual or multiple venture capitalists should be allowed to receive these funds. Snowe is hoping to address the issue in her committee by the end of July, with an eye toward reauthorization of the SBA by Oct. 1. Not receiving these funds would be "a major setback," for the biotech industry, Bond said during the hearing. The biotech industry "is like no other in the world" because of the time and money necessary to get products to market, he added, necessitating supplemental funding. But critics, including the Small Business Technology Council, argue that these funds are better spent on companies that lack the financial backing of venture capitalists. Modifying the definition of a small business is "a slippery slope" that would push legitimately small businesses out of the running for these funds, Gene Watson, program manager of the Wyoming SBIR/STTR (small business technology transfer) Initiative, said. However, BIO believes that the program "makes us competitive," Lauren Choi, BIO's director of policy, capital formation and emerging companies, said. It is "critical" that SBIR amendments are included in the SBA reauthorization, she said. For details, visit http://www.fda.gov.

Waters Corporation Enters Into Collaborations with Chinese Partners Raising the Bar for Food Safety and Environmental Standards in China

Waters Corporation has formally announced collaborations with the China Municipal Center for Disease Prevention and Control (China CDC), Beijing Municipal Center for Disease Prevention and Control (BJCDC) and The Research Center for Eco-Environmental Sciences (RCEES) of the Chinese Academy of Sciences to provide technology and expertise for food safety analysis and environmental regulatory compliance. Waters Corporation is one of the world's leading scientific analytical instrument companies in liquid chromatography (UPLC), mass spectrometry (MS) and laboratory informatics all of which are essential enabling technologies for the analytical laboratory. These joint collaborations with China's premier food safety and environmental centers signifies a strong vote of confidence in Waters and its commitment to address China's rapidly increasing food safety and environmental challenges. The announcement and ceremony solidified the partnerships aimed at bringing out the best in each organization in meeting increasingly stringent food safety and environmental standards in China. Waters is excited about having the opportunity to provide a range of robust technologies and expertise to complement the Chinese food safety and environmental agencies in ensuring that international standards are not only met, but exceeded," explains Art Caputo, President of Waters Division. "We embrace the groundbreaking research being conducted by our Chinese partners and their feedback will, in turn, allow us to better our products and services. It is a synergistic partnership." "The collaboration we are currently engaged in with Waters helps us to develop advanced applications and solutions to problems unique to China's development," Dr. Wu Yongning, Director of Chemical Contamination Control at China CDC. Director of Beijing CDC, Mr. Liu Ze Jun affirms, "Indeed, our partnership with Waters has already produced very rewarding results. We look forward to intensifying our relationship with Waters." One of Waters' cutting-edge innovations, ACQUITY Ultra Performance LC (UPLC), a breakthrough in separation science pioneered by Waters, eliminates significant time and cost per sample from the analytical process while improving the quality of results. The collaboration with the various food safety and environmental agencies and their rapid adoption to embrace the latest technology and application solutions, reinforces China's commitment to improve and comply with international standards. As one of the state guardians in ensuring strict food safety standards for the public, "such collaboration is timely and crucial", states Zheng Minghui, Professor and Associate Director, State Key Laboratory of Environmental Chemistry and Ecotoxicology for RCEES. "We are confident that this partnership with Waters will complement China's on-going commitment in food safety and environmental standards, especially in the area of analytical method development in toxicology." Since 1983, Waters China has supported some of Asia's largest laboratories including those in Shanghai and Beijing. For details, visit http://www.waters.com.

Autoscribe Features Easy to Implement Sample Tracking System

Autoscribe's SampleTracker lowers the barrier for sample tracking by offering a competitively priced, low cost starting point that allows all laboratories to gain the experience and benefits of a LIMS implementation. Sample Tracker allows users to track samples and the progress of work and is suitable for many applications in a wide variety of industries. SampleTracker may be used in both highly regulated and unregulated industries and provides exactly the same user experience no matter how users access the application; rich client on a LAN, thin client on a WAN, or via the Web using a standard browser. Unique OneTime Configuration tools automatically create a unified Sample Tracking configuration for both desktop and web use. Once a screen has been built using the unique OneTime Configuration Tools, it is immediately available on the network or via the Web. For details, visit http://www.autoscribe.co.uk.

Siemens Signs Contract with Finnish Defense Forces for a Highly Secure Voice and Data Network

Siemens and Juniper Networks have announced that the Finnish Defense Forces have selected the two companies to deploy a next-generation backbone network that will integrate the data transmission and communication systems for reconnaissance, surveillance and military command. Siemens Osakeyhtiö will be responsible for the delivery of the Juniper Networks M-series routers, plus Redcell network and service configuration suite of products from Dorado Software and related maintenance. The Juniper Networks routers enable the creation of new IP-based services and prevent malicious attacks from compromising data security. At the same time, the transmission network will offer the flexibility to rapidly respond to the demands imposed by potential crises and network outages. The deployment by Siemens will include Juniper Networks M-series routers, which will serve as the backbone of the network. For network and MPLS service configuration management, Siemens will supply the Redcell software from Dorado Software. Additionally, the multi-year contract provides for training, maintenance and spare parts supply. Siemens will deliver Juniper Networks M320 and M10i routers to the Defense Forces. Juniper Networks M-series multiservice edge routers combine best-in-class IP/MPLS capabilities with unmatched reliability, performance and service flexibility. Delivering rich CoS features in combination with the simultaneous support of existing and emerging Layer 2 and Layer 3 services, the M-series offers a long-term, strategic investment for any network operator looking to benefit from the increased reliability, efficiency and flexibility of a multi-service IP/MPLS network With the new Redcell system, the Defence Forces will get an advanced network and service configuration management system that permits, among other things, secure VPN management of the MPLS network. Redcell also offers a strategic investment as it is designed for a multi-vendor environment and can be used for controlling other network components as well as the M-Series. Similarly, the network management software will offer redundancy. For details, visit http://www.siemens.com/communications.

Accelerated Technology Laboratories Announces ISO 9001:2000 Certification for the Fifth Consecutive Year

Accelerated Technology Laboratories, Inc. (ATL), a leading supplier of LIMS, has announced its fifth year of successful Registration to ISO 9001:2000. ATL was originally certified in April 2001. Mr. Steve Rayburn, Director of Training and Validation, recognizes the continuous efforts of ATL, Inc.’s employees and partners, while pointing out the many on-going benefits of ISO Registration for the company and its clients: "We have worked hard towards creating an effective Quality Management System that helps us achieve greater market share, productivity and achieving our ISO registration. My appreciation goes to ATL, Inc.’s employees for their perseverance and commitment to ATL’s quality management program. Our customers demand and deserve high quality laboratory data management solutions. We are continually striving to exceed our client's expectations with our LIMS, training, support and in our laboratory automation, project management and consulting services.” ATL, Inc.’s system was audited and registered by SGS International Certification Services, Inc. SGS Group is one of the largest verification, testing and certification organization in the world. For details, visit http://www.atlab.com.

DCSS Announces the Formation of Lab Answer to Provide World-Class Laboratory Informatics Solutions

Digital Consulting & Software Services, Inc. (DCSS) has announced the formation of a new company, LabAnswer LLC. LabAnswer is the consolidation of all the laboratory informatics services of DCSS into a subsidiary. The formation of a subsidiary will facilitate the refinement of business processes to better address the needs of laboratory niche clients, employees and partners. The DCSS Board of Directors and management team decided that the name change would be a better reflection of the laboratory services offered by this focused consultancy. One of the largest independent Laboratory Informatics consulting providers in North America, LabAnswer can scale and deliver enterprise informatics projects and solutions, including single site implementations, global deployments and complete informatics outsourcing. LabAnswer provides laboratory informatics services including outsourcing, deployment, installation, integration, migration, support and validation For deatils, visit http://www.labanswer.com.

GenoLogics Announces Geneus, a Solution for Cross-Science Systems Biology Research

GenoLogics Life Sciences Software Inc. (GenoLogics), a leading developer of lab and management software solutions for proteomics biomarker discovery and research, has announced a data and workflow management solution for Genomics researchers. Geneus will be based on an open, configurable, integrating platform, and purposed for genomics and systems biology researchers. Geneus facilitates the collection, organization, management, and analysis of genomics information, providing researchers with unparalleled opportunity to focus on their science challenges rather than their workflow and data management challenges. GenoLogics developed Geneus in response to customer demand for a reliable laboratory and data management solution for genomics. GenoLogics’ Geneus and Proteus products combined with an open, integrating, data management technology platform for systems biology, will enable researchers at pharmaceutical companies, biotechnology companies, and academic institutions, to implement a laboratory and data management solution for systems biology and discovery, across multiple sciences, labs, and facilities. Geneus features include: End-to-end data management for gene expression and genotyping processes; Seamless integration with genomics software and instrumentation, allowing automated and accurate data capture; A technology platform based on an open integrating, automated, and adaptive workflow model; An open platform providing access to data for cross-application discovery and collaboration between researchers; Highly flexible and configurable workflow to easily manage all data from various sources; Streamlined sample submission, reporting, and billing; Extensive capabilities for quality control enforcement in the lab; and, a Web interface. Geneus will be scaleable and suitable for both high-throughput labs and low-throughput labs, and will be priced accordingly. In addition, this product will support genomics research workflows by providing support for gene expression and genotyping from industry leading genomics workflow vendors including Affymetrix, Illumina and Applied Biosystems. An early access version of Geneus will be ready for install by the end of 2006. General availability and full release is planned for early 2007. Pricing for this product is not fixed and will be quoted based on many factors such as number of labs, users, instrument integration points, automated data capture points, and professional services. For details visit http://www.genologics.com.

Labtronics and Agilent Technologies Join Forces to Provide Complete Laboratory Integration Solution to Agilent Customers

Labtronics Inc., a leader in providing innovative laboratory data integration and management solutions, and Agilent Technologies Inc., a premier measurement company, have signed a distribution agreement that authorizes Agilent to distribute Labtronics’ LimsLink and LimsLink CDS integration solutions to Agilent customers. The agreement allows Agilent to directly provide their customers with solutions to integrate their Agilent technologies with any other laboratory systems. After careful consideration Agilent determined that Labtronics offered the most complete and flexible solution available thus providing Agilent customers with the highest return on their investment in integration. "Agilent is one of the premier laboratory instrumentation and informatics companies in the world and we are proud that they chose Labtronics as the best integration solution for their customers," said Robert Pavlis, President of Labtronics. For details, visit http://www.labtronics.com.

Palakal Tapped to Lead Informatics Grad, Research Programs at IUPUI

Mathew J. Palakal has been appointed associate dean for Graduate Studies and Research at the Indiana University School of Informatics at IU-Purdue University Indianapolis. Palakal, a professor of informatics and of computer and information science, assumed his new position July 1. He also will continue to head the Informatics Research Institute. Palakal replaces Douglas G. Perry, who becomes dean of the newly established College of Informatics at Northern Kentucky University, Highland Heights, Ky. In his new duties as associate dean, Palakal will oversee the informatics graduate programs and research activities at the school’s IUPUI campus. Among those programs are bioinformatics, chemical informatics, laboratory informatics, human-computer interaction design, media arts and science, and the recently launched doctoral degree program in informatics. "Students and faculty will benefit greatly from Dr. Palakal’s talents, insights and energy as he assumes his new role,” said Darrell L. Bailey, executive associate dean. “At the same time, we will miss Doug Perry and the vision he has provided to develop and build our graduate programs. Both of these men’s contributions to the school have been far-reaching.” Palakal has been a key player in Project CLIOH (Cultural Digital Library Indexing Our Heritage), a collaboration between the IUPUI School of Informatics, IU Library system, the Mathers Museum in Bloomington, and the Indiana State Museum. CLIOH develops technologies to collect, archive and disseminate library and museum-compliant information for the world’s endangered cultural treasures. His work also has benefited the local cultural scene. Palakal was instrumental in the development of ArtXplore, the personal digital assistance/wireless technology created by the IRI for the Indianapolis Museum of Art. His other research interests include intelligent information management systems and bioinformatics. He is widely published in professional and trade journals. Palakal, the former chair of the Department of Computer and Information Science in the School of Science at IUPUI, has received several teaching awards and honors since his initial academic appointment in 1988 as an assistant professor. The new associate dean earned his doctorate in computer science at Concordia University, Montreal, Canada, in 1987. He also received his master’s and bachelor’s degrees in computer science from the same institution. For details, visit http://www.informatics.iupui.edu.

SGS Group Expands Use of Labtronics' LimsLink to Improve Lab Productivity and Ensure Data Quality

Labtronics Inc. has announced that SGS Group has chosen LimsLink to be the standard integration technology for their North American Mineral Group laboratories and will be rolling the technology out to several sites across North America. SGS Group is a leading inspection, verification, testing and certification company. SGS North America Mineral Group has been successfully utilizing LimsLink at six of their sites in the United States and Canada for almost two years. During that time, these laboratories have been able to eliminate the time analysts used to spend manually entering results from their laboratory instruments. This timesaving allows them to run more samples, thus improving the productivity of their laboratories. They are also able to review, approve and perform calculations on the data before committing the results to their LIMS, which has improved the quality of the data. The success of their existing LimsLink implementations has prompted them to start implementing the integration solution at their other locations across North America. Another factor in their decision was that Labtronics had trained SGS personnel on how to develop and implement instrument integrations on their own. This internal competence allows them to expand their use of the solution to their other laboratories without needing to engage any outside services. SGS has also been impressed with the adaptability of LimsLink. One of their laboratories using LimsLink changed from their current LIMS to a new LIMS. This meant that all of the instrument results now needed to be sent to this new LIMS. Typically, this would mean having to re-write all of the existing integrations; however, LimsLink's ability to work with any LIMS allowed them to move their integrations to the new LIMS, without having to re-write any of their existing LimsLink methods.For details, visit http://www.labtronics.com.

ABB in Partnership with Nesher Israel Cement Enterprises Ltd

ABB, a leading power and automation technology group, has announced its continued success with the OptimizeIT Expert Optimizer system for Nesher Israel Cement Enterprises Ltd. The Expert Optimizer (EO) system was implemented on two kilns, three raw mills and two coal mills in order to leverage company assets and increase profitability. The Ramla plant is located mid-way between Tel Aviv and Jerusalem. The plant produces around 15,000 tonnes of cement clinker per day. Since June 2000, EO has been controlling the two precalciner kilns at Ramla, Israel. During that time over 23 million tonnes of clinker have been produced when under EO control. EO has been on control for over 95% of available time. "The very high run times on EO control have allowed us to control complex kiln and milling systems, plus handling of alternative fuels with varying calorific values, chlorine and water content” said Dan Rafaely, the engineer responsible for this project. “The stable operation under these conditions have led to better quality control, plus fuel and refractory savings”. This project shows that ABB’s Expert Optimizer continues to produce value for customers. It demonstrates and reinforces Expert Optimizer as a proven but innovative product, which can boost plant productivity and profit while ensuring satisfaction of the process and environmental constraints. For details, visit http://www.abb.com.

Savi Technology Recognized a a Top Information Technology Provider by Computerworld

Savi Technology, a provider of active Radio Frequency Identification (RFID)-based supply chain solutions, was recently named one of the top five information technology providers in the “Business Related Services” category of this year’s Computerworld Honors Program. Savi Technology’s innovative EchoPoint technology and SmartChain Software Suite were nominated by Morgan Stanley, a global financial services firm and market leader in securities, investment management and credit services. Savi Technology, a Lockheed Martin company, provides solutions for the management, security and condition of commercial and military supply chain assets, shipments and consignments. In case studies presented to the judges, Savi’s solutions have proven to help the U.S. Department of Defense and international defense forces reduce excess supplies, improve fill order rates and enhance war fighter confidence. Examples also showed that Savi Trak, the real-time information service provided by Savi Networks, has helped improve the visibility, operational efficiency and security of international commercial cargo shipments. "For the 18th consecutive year, the Computerworld Honors Program has identified the most innovative organizations and people who use technology to promote positive, social, economic and educational changes,” said Bob Carrigan, chairman of the Computerworld Honors Program Chairmen’s Committee and president, IDGH Communications. Savi’s EchoPoint is a highly configurable technology system using multiple frequencies for spot-level and wide-area locating of assets, and includes Savi’s active, data-rich RFID tags, readers and signposts. Savi’s SmartChain software products include supply chain applications and enterprise software, which enables users to leverage real-time information from Savi’s own active RFID EchoPoint products as well as other Automatic Identification and Data Collection devices, ranging from bar codes, sensors, passive RFID and GPS location systems. Each year, the Computerworld Chairmen’s Committee, a group of 100 Chairmen/CEOs of global technology companies, nominates individuals and organizations worldwide whose visionary application of information technology promotes positive social and economic progress. Nominations are evaluated by an independent board of CIO-level judges. More than 400 nominations were submitted from 23 countries. Savi Technology has been the recipient of numerous awards in recent years, including from market analyst firms such as the ARC Advisory Group and Frost and Sullivan, organizations such as the World Economic Forum, and magazines such as World Trade, Inbound Logistics, Red Herring, and others. For details, visit http://www.savi.com .

Advancements to Freeware ACD/Column Selector Help Take the Guess Work Out of Column Selection

Advanced Chemistry Development, Inc. (ACD/Labs) has announced the latest update to ACD/Column Selector, a freeware reversed-phase HPLC column selection tool. The latest upgrade increases the number of columns available for selection from 153 to 187, which will allow chromatographers to compare and contrast the latest columns, and help take the guesswork out of column selection. ACD/Column Selector was created through a collaboration with Mel Euerby and Patrik Petersson of AstraZeneca. The freeware application was developed from over 3000 experiments characterizing the most commonly-used reversed-phase columns. Patrik Petersson, PhD, Associate Principal Scientist at AstraZeneca, states, “ACD/Column Selector allows chromatographers to scientifically compare the most popular columns according to certain parameters (ligand density, hydrophobic selectivity, shape selectivity, hydrogen bonding capacity, total ion-exchange capacity, and acidic ion-exchange capacity). Users may identify equivalent columns (“backup columns”) as well as columns with widely differing characteristics to fully exploit selectivity differences in method development.” ACD/Column Selector is a free ChemBasic application that runs within freeware ACD/ChemSketch. For details, visit http://www.acdlabs.com/columnselector.

New, Advanced Version 3.0 Software Increase Capabilities for ESA’s CoulArray’ Detector

ESA Biosciences, Inc., a subsidiary of Magellan Biosciences, Inc., has announced the new CoulArray’ Application Software – Version 3.0 for more effective operation of ESA’s highly sensitive and selective CoulArray HPLC electrochemical array detector. The new, streamlined software features single window interface operating controls and enables the CoulArray detector to effectively handle ballistic (< 5 min) gradient conditions when higher throughput LC assays require many samples to be processed in a short period of time.
In addition, the Version 3.0 software enables full CFR21 Part II compliance permitting the CoulArray detector to operate in regulated drug development laboratories. The enhanced ESA software comes with complete security features, audit trails, electronic signatures and data traceability. Its easy-to-use wizards, PDF report generation capabilities and compatibility with Windows 2000/XP operating systems make Version 3.0 the latest and most advanced software package for CoulArray users. ESA’s CoulArray Detector is the state-of-the-art electrochemical detection system for sophisticated clinical, life science and pharmaceutical applications and is widely used as the endpoint for many assays. The Version 3.0 software enables the CoulArray to be used more effectively and efficiently in a wide range of fields, especially in pharmaceutical discovery and development. For details, visit http://www.esainc.com.

Bruker BioSciences Shareholders Approve Acquisition of Bruker Optics

Bruker BioSciences Corporation has announced that its shareholders have approved the acquisition of molecular spectroscopy company Bruker Optics Inc. for $135 million, to be paid approximately 59% in cash and 41% in BRKR stock. The acquisition agreement had previously received unanimous approval by a Special Committee of independent directors of the Board of Directors of Bruker BioSciences, as well as by all independent directors, with the non-independent BRKR directors recusing themselves from the Board vote. The agreement had also been unanimously approved previously by the Board of Bruker Optics. At the Annual Meeting all proposals were approved with overwhelming majorities by the Bruker BioSciences stockholders. In particular, the proposal requesting approval of stockholders for the acquisition of Bruker Optics was approved by a majority of greater than 99% of the BRKR shareholders not affiliated with the controlling shareholders of BRKR who voted at the Annual Meeting For details, visit http://www.bruker-biosciences.com.

ARTEL Announces New Appointments to Support LDQA Service Suite

ARTEL, a technology leader and expert in liquid delivery measurement and quality assurance, has announced the appointment of Robert Pineau to National Accounts Manager and the hire of Trena Penney as Marketing Representative. Both will be supporting ARTEL’s pharmaceutical and biotechnology customers. These personnel moves were designed to enhance the firm’s ability to meet the demand for its new LDQA (Liquid Delivery Quality Assurance) service suite, including Automated Liquid Delivery Equipment Qualification and Optimization, Manual Pipetting Training and Certification, SOP Review and Development Support, and Regulatory Compliance Guidance. "In their new roles, Bob and Trena will be instrumental in helping ARTEL meet the growing demand for liquid delivery process support and maintain our high level of customer service,” notes Kirby Pilcher, President, ARTEL. Mr. Pilcher continues, “Bob and Trena are superb technologists and have proven their skills in effectively communicating with customers in laboratory settings. They are spearheading our corporate objective of getting closer to and understanding the processes and needs of customers.” Mr. Pineau previously held the position of Senior Marketing Representative at ARTEL and works closely with ARTEL’s largest pharmaceutical and biotechnology customers. He has more than 20 years of experience serving the biopharm market. Ms. Penney, who holds a BS in Microbiology from the University of Maine, joins ARTEL from Maine Biotechnology Services, where she performed research and quality testing in the laboratory and developed solutions to meet customer needs. For details, visit http://www.artel-usa.com.

TeGenero Files for Bankruptcy After Catastrophic Clinical Trial

TeGenero, the German pharmaceutical startup whose UK-based clinical trial for its immune-boosting drug TGN1412 caused severe adverse reactions in six healthy male volunteers, filed for bankruptcy protection in a court in Wurzburg, Germany, on July 4. "The unforeseeable adverse reactions caused by TGN1412 in the TGN1412-HV Phase I trial have made it impossible to attract the investment necessary for the company to continue operations," the firm said in a statement. The six affected participants fell ill on March 13, within hours of taking the investigational drug at the trial site at Northwick Park hospital in London. According to media reports, one of the trial participants, a trainee plumber named Ryan Wilson, is still confined to a wheelchair after suffering heart, liver and kidney failure, as well as pneumonia and septicemia. TeGenero said that investigations conducted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Germany's Paul-Ehrlich-Institut "have identified no deficiencies" in the preclinical testing of the drug, and that the adverse events "were completely unforeseeable." According to an April 6 statement from the German agency, "Low dosages of the trial medicine did not cause any adverse effects in the primates tested. Higher dosages caused only mild transient reactions. A very low dose, 1/160 of that used without adverse effects on monkeys, was used on humans." The MHRA said that the trial "was run according to the agreed protocol, and the correct dose of the product was given to the patients." However, other reports indicated that the drug caused swollen glands in some of the test monkeys. One volunteer who received a placebo said the informed consent document was hard to read and he was pressured to sign it within 10 to 15 minutes. The trial was conducted by the contract research organization Parexel, which cited the MHRA report on the trial in disclaiming responsibility. "Although there were certain discrepancies identified in the MHRA report, there were no issues that contributed to the adverse reactions experienced by the volunteers, despite the fact that this was a highly challenging situation," Herman Scholtz, head of Parexel International Clinical Pharmacology, said in a May 25 statement. TeGenero said the trial participants' claims for compensation will continue to be handled by the firm's insurers. "TeGenero has been supporting the official investigations as well as developing laboratory tests of its own to try to establish what happened in the trial," the company said. "TeGenero will continue to make its expertise available for the purposes of such investigations to the fullest possible extent." For details, visit http://www.fda.gov.

FDA Enforcement Numbers Show an Agency Stretched Too Thin

The FDA's own enforcement reports show it to be an agency under increasing pressure to do more with less — the number of warning letters is dropping even as recalls skyrocket, sources say. The FDA required 5,338 recalls last year, according to enforcement numbers obtained by FDAnews. The recalls represent an 11-year high and represent a significant increase from the 4,670 issued in 2004, FDA documents show. The recall numbers are available at: http://www.fda.gov/ora/about/enf_story/ch10/Recalls.pdf. Meanwhile, the number of Form 483 warning letters is continuing to drop, with the agency issuing 535 in 2005 as compared with 725 the previous year. The warning letter data is available at: http://www.fda.gov/ora/about/enf_story/ch10/10yrWL.pdf. These numbers illustrate an agency that is allowing more mistakes to reach the market, requiring an ever greater number of recalls, Gordon Richman, vice president of strategic compliance and general counsel of the consulting firm EduQuest. The numbers also are a sign of rising quality system or manufacturing errors in industry, which allow flawed products to get into the market, he said. This data "doesn't paint a very encouraging picture" as to where the agency's enforcement efforts are headed, Richman added. But both he and a consumer activist who assessed these numbers stressed that the FDA was not to blame — Congress is. "This is not the agency's fault, it is Congress' fault in not adequately funding the agency," the consumer advocate, who asked not to be named, added. Specifically, Congress and the president's budgets are not keeping up with the rate of inflation and the increased responsibilities the FDA must address, Richman and the source said. The agency needs more investigators and an updated information technology system, including databases, that helps to better track problems in medical product development, the consumer advocate added. For details, visit http://www.fda.gov.

Approval Pathway for Biologics Unlikely Until 2008

Any legislative fix to the current FDA approval process for follow-on biologics is likely at least two years away because of other legislative priorities and the need for lawmakers to get up to speed on this issue, a Senate staffer says. "I would look to 2008" for legislative proposals amending the Food, Drug and Cosmetic Act (FDCA) to ease approval of follow-on biologics, said the staffer, who asked not to be named. While lawmakers such as Senate Health, Education, Labor and Pensions Chairman Mike Enzi (R-Wyo.), ranking member Sen. Edward Kennedy (D-Mass.) and Sen. Orrin Hatch (R-Utah) support a change, there are a number of obstacles. First, lawmakers are still formulating their positions on the issue, the source said. There are technical, scientific, legal and regulatory questions that need to be answered first, including when and how these products should be approved. "You don't build a house without a foundation," the source said. "Right now we don't have a foundation." To develop this knowledge, lawmakers will need to have hearings, briefings and formal discussions with stakeholders. "We have to start an educational process," the source said, which could begin as soon as the fall. Beyond the need to better acclimate themselves with the issue, other constraints will prevent legislative action before 2008, the source added. A bill in 2006 is unlikely because it is getting too close to the midterm elections for a new bill to make it through the legislative process. "I will say there will be no action this year," the source said. Next year is also not realistic because of other competing legislative priorities. In 2007 Congress will have to reauthorize both the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act. These bills are two of the top healthcare priorities for Congress, the source said. "They are absolutely must-do items. That's going to drive the schedule" next year. For details, visit http://www.fda.gov.

Gottleib Speech Signals Sea Change in FDA Drug Safety Strategy

A senior FDA official's speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA's thinking on drug safety. Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs, announced in a June 12 speech before the American Medical Association that risk management plans (RMPs), while important in some instances, may be too prevalent. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he added. "I worry about the future," Gottlieb said. Instead, the agency should look to a more collaborative approach, placing more responsibility on the medical community's shoulders to ensure that medicines are used correctly, Gottlieb said. "I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations," he added. This announcement shows that the agency has realized that there is a better way to enhance drug safety than requiring RMPs, Peter Pitts, director of the Center for Medicines in the Public Interest and a former FDA associate commissioner for external relations, told FDAnews. This speech is a "very clear signal to people within the agency" that a change is necessary, he added. Drug safety "cannot be viewed as a punitive measure." Up to now the agency has used RMPs to show that they are doing something about drug safety, but these plans are an empty measure of success, he said. Gottlieb's speech shows the agency is ready to stop "hiding behind" RMPs and take a better approach, Pitts added. Because doctors have the final say over their patients' use of drugs, they must be more involved in the drug safety process. It is "crucial" for the collaboration that Gottlieb spoke about to take place, he said. This speech may have been timed to coincide with ongoing Prescription Drug User Fee Act (PDUFA) negotiations and a growing call in Congress for a new FDA office to handle drug safety, Pitts said. PDUFA is a vehicle for the agency to receive much of its funding, but that funding is tied to the FDA meeting specific performance goals. The speech may be a signal to Congress that the amount of RMPs the agency requires should not be used a performance measure, Pitts said. For details, visit http://www.fda.gov.

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

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