LIMSource News: What's New Right Now

• LabVantage Unveils SAPPHIRE R5

• QSI Launches WinLims Rental Customization Service

• Autoscribe Announces Matrix Track-IT for Sample Tracking Needs

• GenoLogics Releases Geneus 4.0 with Enabling NextGen Sequencing Capabilities

• FreeLIMS Announces New Labmatica LIMS

• Thermo Fisher Scientific Announces New Chromatography Software for Chemical, Environmental and Academic Markets

• Thermo Fisher Scientific is Presented with Two Frost & Sullivan Best Practices Awards for Market Leadership and Competitive Strategy Leadership in Informatics

• GenoLogics Releases Proteus 4.0, Enabling More Complex Workflows and Enhanced Analytics

• Thermo Fisher Scientific Announces HUNT Biobank's Selection of Thermo Scientific Nautilus LIMS for One of the Largest Population-Based Health Studies

• Waters Unveils Advances in Mass Spectrometry and Separations Science

• Thermo Fisher Scientific Partners with NextDocs to Offer Comprehensive Enterprise Document Management and Workflow Solutions for the Laboratory

• AlphaMetrix to Represent SciGene

• LabVantage Announces a Record Turnout for Its 2008 Annual User Conference

• Labtronics and Molecular Devices Connect on LIMS Interfacing

• Chemical Manufacturer Finds Right Formula with DEACOM ERP Software

• Laboratory Network Selects LimsLink as Their Single Interfacing Solution

• Bruker Daltonics Introduces Novel LC/GC Time-of-Flight Mass Spectrometer micrOTOF II for LC/MS and GC/MS on One System

• Bruker Daltonics Introduces maXis, a Revolutionary New Ultra-High Resolution TOF Mass Spectrometer at ASMS Conference

• FDA Gets Initial Approval of $2.1 Billion for Fiscal 2009

• Revisions to New cGMP Rule Going Through FDA Clearance

• FDA Releases Draft Guidance on Submitting Case Study Reports

• Administration’s Request for Additional FDA Funding Draws Criticism

• WHO Assembly Adopts Plan to Revise Patent Barriers

• Joint FDA-EMEA Inspections Program Outlined

• FDA Says SPL Program Will Not Delay Approvals

• FDA to Address Problem of Similar Drug Names With Pilot Program

• FDA Details Outside Partnerships in Sentinel Initiative

LabVantage Unveils SAPPHIRE R5

LabVantage Solutions, Inc. has announced the commercial availability of the SAPPHIRE Release 5 Laboratory Information Management Suite (LIMS). SAPPHIRE is an industry-leading zero footprint and configurable off-the-shelf (COTS) LIMS that consolidates functionality typically found in multiple laboratory systems. SAPPHIRE R5 builds upon 20+ years of laboratory information management know-how and almost a decade of thin-client computing experience to deliver an enterprise LIMS platform that redefines and optimizes the way leading laboratories conduct business. By leveraging configurable, modular driven solutions, rather than custom developed software or services, SAPPHIRE R5 can tailor point specific or enterprise wide solutions to address each organization’s unique needs. SAPPHIRE R5 continues to set the standard for laboratory information management by offering a broad spectrum of functionality that is fully configurable out-of-the-box and that can be deployed at any point in time, depending on an organization’s business requirements. Features include: Ubiquitous Global Deployment; Enhanced User Experience; Expanded Functionality; Comprehensive Reporting and Analytics-Driven Decision Support; and, Multi-Optional Application Server and Standards-Based Services. For details, visit http://www.labvantage.com.

QSI Launches WinLims Rental Customization Service

Quality Systems International (QSI) is launching a Rental Customization Service that will enable WinLims Rental customers to have a cost-effective way of tailoring the company’s WinLims ‘out of the box’ solution to meet their specific information management requirements. The new service allows QSI’s WinLims Rental customers to specify any custom requirement and receive a cost from QSI for the custom code. The customised coding service is then paid for on a monthly basis over a 12 month period. "We believe the Rental Customization Service will make the WinLims Rental package even more attractive and affordable. Customers will now be able to conserve their capital and pay for the customised solution out of their income revenues. And a further benefit is that the whole package is tax deductable,” said QSI’s UK managing director Clive Collier. “The new service addresses the needs of many organizations that believe there may be some functionality they might require at sometime in the future, which is not in the WinLims ‘out of the box’ product. Now they have a future-proof solution that they can afford.” QSI’s WinLims Rental provides an innovative approach to owning a LIMS solution. WinLims Rental allows an organization to use a full LIMS for a low monthly fee, with a low up-front cost. WinLims Rental is identical to QSI’s full WinLims system, and comes bundled with an installation program and tutorials to get users up and running as quickly and easily as possible. The rental agreements can be converted to a subscription contract or full purchase at any time, keeping an organization’s options open.. For details, visit http://www.qsiuk.com.

Autoscribe Announces Matrix Track-IT for Sample Tracking Needs

Autoscribe has announced a software solution for tracking, compliance, recording and reporting needs called Matrix Track-IT.The Matrix Track-IT system is a single, flexible, software product that allows the exact same program and code to be fully and compliantly configured to meet the precise needs of different applications without writing any custom code or esoteric scripts. Totally different fields and labels may be created using the uniquely powerful Matrix “OneTime Configuration” tools, so as to support various applications, all using exactly the same source code. Different localizations and languages are also fully supported. Matrix Gemini “OneTime Configuration” tools create a unified screen configuration which is immediately available via a LAN, WAN or web browser without the need for custom programming. This allows Matrix Track-IT to provide an identical user experience whether working on a desktop PC or accessing data remotely via a web browser. Customers can also be allocated secure user names allowing them to track their own work online. Matrix Track-IT has been configured to globally manage the inventory of samples in a large, multi-site development program for a major pharmaceutical company. It provides the current location of all tissues and slides in multiple studies across multiple sites. A complete history and chain of custody for each sample is captured and stored. Prior to using Matrix, it was very difficult to locate any specific sample or slide when required by a scientist or pathologist. Once entered into Matrix, the location and history of each sample is readily available. Data entry is reduced by the use of barcode labels and scanners located throughout the laboratories. The entire system is validated and operates under GLP guidelines. For details, visit http://www.autoscribe.co.uk.

GenoLogics Releases Geneus 4.0 with Enabling NextGen Sequencing Capabilities

GenoLogics, the leading developer of translational research informatics solutions, has announced the new release of its lab and data management system for genomics research, Geneus 4.0, with many new enhancements including the ability to handle NextGen sequencing workflows. "GenoLogics has partnered with Illumina and is now an Illumina Connect member with capabilities to integrate microarray, as well as sequencing-based workflows into their genomics data management system,” said Omoshile Clement, Ph.D., Senior Product Manager of Informatics for Illumina. Illumina Connect is a bioinformatics partnership program that offers customers the ability to extend data analysis beyond Illumina’s BeadStudio platform for advanced downstream analysis. Dr. Clement continued, “We are excited to see GenoLogics taking a proactive approach and integrating their software analysis tools with sequencing platform’s such as Illumina’s Genome Analyzer.” Geneus increases the productivity of genomic research laboratories challenged with managing large amounts of data. The solution is preconfigured to address genomic workflows, including NextGen sequencing, and delivers advanced querying and reporting capabilities along with a secure web interface to facilitate collaboration. "The development of Geneus functionality to effectively manage NextGen sequencing from Illumina, ABI, Roche or other vendors, was a natural path for expanding the capabilities of Geneus,” said GenoLogics’ VP of Products, Sal Sanci. “Purpose built for genomics data management, Geneus provides immediate out-of-the box impact for our clients performing PCR, microarray, genotyping and sequencing workflows.” Geneus is a robust sample tracking and data management system for large research and core laboratories. The solution simplifies end-to-end sample and data management by integrating with instruments and software programs from leading genomics technology providers. Aconfigurable and flexible platform, Geneus is designed to adapt to evolving technologies and changes in lab operations. Labs can create their own workflows and processes without the need to write code. Geneus enables automatic execution of scripts and retrieval of results from bioinformatics pipelines, as well as an adaptive reporting framework to pull meaningful results for analysis. Geneus is part of the GenoLogics Solutions for Research Informatics for discovery labs. Along with its sister-solution, Proteus and a highly configurable common platform, Geneus enables research organizations to conduct systems biology efficiently and effectively. The GenoLogics Research Informatics solution enables data from different science workflows and across multiple labs to be tracked, captured and stored in one secure, central lab and data management system. For details, visit http://www.genologics.com.

FreeLIMS Announces New Labmatica LIMS

FreeLIMS has announced a new version of their LIMS, known as Labmatica LIMS, available for download. The LIMS is now available under a dual license model. This means there are two different products which are based on the same core source code. 1.) Labmatica LIMS (commercial license). 2.) Labmatica FreeLIMS (GNU/GPL). The new version has no datamodel changes compared to the last 0.9.9.6 FreeLIMS version. Therefore users can just replace the client program and it will work as before. In addition, a new feature allows users to add/drop parameters "on the fly" to an existing sample. In addition they have changed their URL to www.labmatica.com. For details, visit http://www.labmatica.com.

Thermo Fisher Scientific Announces New Chromatography Software for Chemical, Environmental and Academic Markets

Thermo Fisher Scientific Inc. has introduced new ChromQuest 5.0 Chromatography Data System (CDS) software. ChromQuest 5.0 software provides a new user interface, data acquisition, data processing and reporting for Thermo Scientific LC and GC instrumentation, including the Accela High Speed LC system and all of the configurations of the versatile TriPlus Autosampler. Designed for multi-user and multi-instrument operations, ChromQuest 5.0 provides features specifically of interest to chemical, environmental and academic laboratories, including multi-level calibrations, graphic method editing, conditional sequence actions and automated LIMS export. The easy-to-use chromatography software provides integrated instrument control for the existing Thermo Scientific LC systems, including the entry level SpectraSYSTEM, the novel Surveyor Plus LC system and the Accela High Speed LC instrument. Additionally, ChromQuest 5.0 provides digital control for all Thermo Scientific LC system components including pump and Photo-Diode Array (PDA) detector. The software also provides integrated instrument control for the complete range of existing Thermo Scientific GC products from the compact and affordable single channel Focus GC, to the advanced and innovative TRACE GC Ultra, automated by the flexible TriPlus autosampler for Liquid, Headspace and SPME sampling techniques. For details, visit http://www.thermo.com/lc or http://www.thermo.com/gc.

Thermo Fisher Scientific is Presented with Two Frost & Sullivan Best Practices Awards for Market Leadership and Competitive Strategy Leadership in Informatics

Thermo Fisher Scientific Inc. has been presented with two 2008 Frost & Sullivan Best Practices awards for Market Leadership and Competitive Strategy Leadership in Informatics. Frost & Sullivan has recognized the company for its significant accomplishments in the development of a portfolio of technologically advanced purpose-built Laboratory Information Management Systems (LIMS) products. According to the recent Frost & Sullivan analysis, Thermo Fisher's North American market share was nearly 12 percentage points greater than its nearest competitor. Thermo Fisher has maintained its market leadership position since 2005, highlighting the company's ability to continue to capture and grow market share in a highly competitive marketplace. The receipt of the 2008 Best Practice Award for Competitive Strategy Leadership, in addition to the award for Market Leadership, is recognition of the company's strength in delivering continuous value to its customer base. "Long the leader in the LIMS market, Thermo Fisher continues to shine as the most recognized brand name for LIMS solutions. With one of the largest portfolios of LIMS products worldwide and an unparalleled reputation for incorporating customer feedback into product updates, Thermo Fisher undisputedly serves as the gold standard for purpose-built LIMS, making Thermo Fisher the ideal recipient of the Market Leadership and Competitive Strategy Leadership Awards in 2008," says Frost & Sullivan. Thermo Fisher's Market Leadership and Competitive Strategy are exemplified by its customer base. In addition to 19 of the top 20 global pharmaceutical companies, Thermo Scientific LIMS are employed by the world's leading companies in the oil & gas, chemicals, environmental, food & beverage, forensics, metals & mining, waste water and many other industries. Given the flexibility of Thermo Scientific LIMS, industry giants, such as BP, Dow, Abbott Labs, Quaker, AstraZeneca and Pfizer Inc. utilize Thermo Scientific LIMS. For details, visit http://www.thermofisher.com or http://www.awards.frost.com.

GenoLogics Releases Proteus 4.0, Enabling More Complex Workflows and Enhanced Analytics

GenoLogics, a leading developer of translational research informatics solutions, has announced the new release and general availability of Proteus 4.0, its lab and scientific data management system for proteomics. "With the latest release, Proteus gains all the strength of a robust multi-science platform while maintaining its unique application features for proteomics research,” says Mike Sanders, Product Manager for Proteus. “As part of our Omix platform, Proteus’ new adaptive reporting framework allows customers to integrate data from different sources and enhance their scientific data analysis. While the new integrations and generic importer formats for search engines helps customers streamline protein identification and relative protein expression analysis, Proteus has many more enhancements in this latest release including improvements to our LC-MALDI workflows to analyze larger volumes of data.” Proteus improves lab efficiency by automating data capture from proteomic experiments and by seamlessly tracking projects, samples and results. It does this with purposed instrument and analytical software integrations and enhancing analysis of contextually relevant protein and peptide comparisons. It also has a web interface for customer and external collaborators to submit samples and for the laboratory to publish results. "One of the enhancements we are looking forward to using with Proteus 4.0 is the integration to ProteinPilot,” says Dr. Bruce Stanley, Scientific Director of the Penn State Milton S. Hershey Medical Center’s Proteomics and Mass Spectrometry Core. “The updated LabLink web interface will allow us to better share quantitative proteomic results with our researchers as we focus on collaborations in translational research.” Proteus can be easily configured for new technologies and workflows, including user-level configurations without programming skills. For the more sophisticated user, it is easy to integrate with in-house systems with a simple framework to send and receive data from any external program. And with an open read-access to the database, plus the reporting tools in the Adaptive Reporting Framework, Proteus is a powerful informatics solution to meet evolving needs. For details, visit http://www.genologics.com.

Thermo Fisher Scientific Announces HUNT Biobank's Selection of Thermo Scientific Nautilus LIMS for One of the Largest Population-Based Health Studies

Thermo Fisher Scientific Inc. has announced that HUNT Biobank has selected its Thermo Scientific Nautilus LIMS to gather, store, manage, track and retrieve the biological data of approximately 100,000 people from Nord-Trøndelag County, Norway, as part of one of the largest population-based health studies ever performed. Initiated to support epidemiological, clinical and preventative medical research, HUNT Biobank studies provide insight into disease status and progression, particularly in relation to quality of life measures such as environment, education and occupation. Spanning almost 25 years, HUNT Biobank now represents an integrated family and personal database. In the selection of Thermo Scientific Nautilus LIMS, HUNT Biobank required a system that would interface with the laboratory's existing robotics, import files from the hospital laboratory and then return results for every participant. Participation from the population has been successful in large part because every participant receives the feedback document reporting their health status, facilitated by Nautilus LIMS. The LIMS was also required to provide clinical follow-up, data handling and quality control following data collection and distribute coded data files to various research groups. Additionally, the LIMS would serve as the means of linking information from the extensive HUNT database to each study participant's personal identity number, as well as to end-point national health registries. Following a thorough market research, HUNT Biobank selected Thermo Scientific Nautilus LIMS for its unmatched flexibility and ease-of-use and the inherent capability of yielding real-time, dependable analyses and reports, in addition to the extensive Nautilus LIMS installed base of biobanking organizations, which would provide a network of shared user experiences. The unique security capability of Nautilus LIMS has allowed HUNT Biobank users to keep regulated data separate from unregulated processes. This has ensured maximum data authenticity, integrity and traceability. Hunt Biobank is now using Nautilus for its most ambitious study, HUNT 3, which is due for completion in June 2008. HUNT 3 incorporates over 130 sub-studies, including status in subjective health, diabetes, lung, cardiovascular, thyroid, muscle and skeletal diseases, mental diseases, prostate complaints, urinary incontinence, female reproductive disorders and gynecological diseases. For details, visit http://www.thermo.com/informatics.

Waters Unveils Advances in Mass Spectrometry and Separations Science

Waters Corporation has unveiled several new mass spectrometry innovations, including the Waters Xevo TQ MS System, an advanced tandem quadrupole mass spectrometer that allows scientists with varying levels of mass spectrometry (MS) expertise to quickly produce the highest quality data with confidence. In addition, Waters is previewing its new UPLC System with nanoTile technology, a new UltraPerformance LC separations platform for both large- and small-molecule applications that will deliver information-rich, high-sensitivity analyses when coupled to Waters SYNAPT High Definition MS/HDMS and SYNAPT MS Systems. Other products announced include the VERIFYE High Definition Proteomics System, the nanoACQUITY UPLC System with 2D Technology, and the Atmospheric Solids Analysis Probe (ASAP). "Mass spectrometry is a vital analytical tool for a wide variety of applications -- pharmaceuticals, biotechnology, food safety, environmental," said Art Caputo, Executive Vice President and President of the Waters Division. "Waters is meeting customers needs by bringing to market technology that allows laboratories to be more efficient and productive and makes high-performance capabilities available to scientists in various disciplines."For details, visit http://www.waters.com/asms.

Thermo Fisher Scientific Partners with NextDocs to Offer Comprehensive Enterprise Document Management and Workflow Solutions for the Laboratory

Thermo Fisher Scientific Inc. has entered into a collaborative agreement with NextDocs Corporation to bundle and sell the NextDocs enterprise document, quality and compliance management solution suite. The offering is a natural extension of Thermo Fisher Scientific's portfolio of LIMS (laboratory information management systems) and CDS (chromatography data systems) products, allowing the company to offer a comprehensive, fully integrated informatics and content management solution to the industry. The NextDocs Document and Compliance Suite will be sold by Thermo Fisher Scientific under the NextDocs brand name and offers users an intuitive 'plug and play' solution for managing data that addresses the growing need for an easy to use, web-based solution that is designed to enable organizations to comply with FDA 21 CFR Part 11, GMP, GLP, GCP and other regulations and industry standards. "There has been a need in the industry that has gone largely unanswered until now, for a secure, cost effective, validated content management solution that incorporates structured data from LIMS, CDS and other enterprise systems along with unstructured information that support laboratory processes, all in a completely validated solution. In the past, solutions have been incomplete, cumbersome and expensive." says Dave Champagne, vice president and general manager, Informatics at Thermo Fisher Scientific. NextDocs product suite is designed to be used in both regulated and unregulated environments to provide organizations with a complete content management and collaboration system for managing documents, records (e.g. training records), SOP's (standard operating procedures), activities and other information critical to the enterprise. Built on the leading Microsoft Office SharePoint 2007 platform, NextDocs Document and Compliance Suite delivers content management tools for regulatory compliance and operational excellence without sacrificing usability and affordability. The Suite provides organizations with the ability to track, approve, and manage data in a secure and centralized repository. NextDocs products require zero desktop installation, allowing for rapid deployment and ROI. A valuable component of the NextDocs Document and Compliance Suite is that it is fully web-based with rich user interfaces that can be securely accessed from any location, and seamlessly integrated with Microsoft Office and other desktop applications to improve productivity. For details, visit http://www.thermo.com/informatics.

AlphaMetrix to Represent SciGene

Alphametrix and SciGene have announced the signing of an exclusive agreement under which Alphametrix will sell the entire line of SciGene products in Germany and Austria. SciGene is dedicated to the development of novel and robust solutions for hybridization and post-hybridization processing of microarrays and FISH samples used in cytogenetics. The Company’s products, including the Little Dipper Microarray Processor, Mai Tai Hybridization System, and NoZone Workstations, are used in combination to automate and control important steps in microarray and FISH sample processing for enhanced assay reliability. "SciGene’s mission is to automate the entire microarray workflow from sample to scanner for the benefit of research and molecular diagnostic laboratories. We have selected Alphametrix as our authorized distributor based on their experience microarray based applications and these target markets products and superior staff of technical sales and support personnel.” said James Stanchfield, Ph.D., President and CEO of SciGene. "With the addition of SciGene products, we now offer a complete microgenomic solutions portfolio with products for sample selection, extraction, labelling, quality control and microarray hybridization analysis," says Udo Schimmel, General Manager of AlphaMetrix.For details, visit http://www.scigene.com.

LabVantage Announces a Record Turnout for Its 2008 Annual User Conference

LabVantage Solutions, Inc. has announced a record number of customer and partner participants at its annual Training & Education Conference held last week at The Venetian Resort Hotel in Las Vegas Nevada. This year's conference promoted the theme - Building on Experience. Sharing the Vision. LabVantage showcased the latest release of the SAPPHIRE R5 Laboratory Information Management Suite, a zero footprint and configurable off-the-shelf (COTS) solution consolidating functionality typically found in multiple laboratory systems. With its combination of functionality, flexibility, and technology, "For our customers, partners, and the LabVantage staff, the annual LabVantage user conference presents a distinctive forum in which to exchange information, experience, and insight," states Jim Aurelio, President & CEO of LabVantage. "This year's conference proved to be especially gratifying for all as we rolled out the latest SAPPHIRE R5 suite, and shared our vision for the laboratory informatics market." SAPPHIRE R5 offers even more functionality on LabVantage's innovative technology platform. This conference enabled customers to view detailed functional demonstrations of this new functionality, as well as, learn about the clear paths to upgrade to the latest release. It also provided practical insights and case studies from customers across multiple industries. For details, visit http://www.labvantage.com.

Labtronics and Molecular Devices Connect on LIMS Interfacing

Labtronics Inc. and Molecular Devices (a division of MDS Analytical Technologies) have announced the development of a new LimsLink template to simplify the connection of SoftMax Pro 5 software with any LIMS package. The LimsLink template allows for secure transfer of microplate assay results from SpectraMax microplate readers to any commercially available LIMS. SoftMax Pro 5 software from Molecular Devices is the industry standard microplate analysis software, offering extensive data capture, analysis, and reduction capabilities for Molecular Devices’ SpectraMax line of absorbance, luminescence, fluorescence, and multi-detection microplate readers. LimsLink is Labtronics’ configurable software for creating instrument-to-LIMS interfaces. LimsLink helps laboratories to eliminate manual data management and ensures the speed, accuracy and security of data recording, by electronically transferring valuable instrument data to LIMS. The new LimsLink template provides pre-configured support for the exchange of information between the two applications by means of the standardized XML structures for plate layouts and data files established for SoftMax Pro software. LimsLink will retrieve sample IDs and concentration information from LIMS, and then automatically populate the plate layout in SoftMax Pro software. At the end of analysis, the user will export the results via XML, which LimsLink will collect and format for reporting back to LIMS. The template method is completely configurable with respect to the LIMS queries as well as LIMS reporting. Tom Curtis, Vice President of Product Innovation at Labtronics, noted, "The new LimsLink template speeds up the process of creating flexible LIMS interfaces that fully address the specific instrument and LIMS configurations that the SoftMax Pro 5 user has in place." Commenting on the Labtronics LimsLink interface, Craig Tin, Product Manager for SoftMax Pro software at MDS Analytical Technologies stated, "Our pharmaceutical and biotechnology customers can more efficiently transfer their microplate assay data to their LIMS package of choice in a secure GLP environment. Our collaboration with Labtronics helps increase productivity of GLP labs standardized on the SpectraMax microplate reader platform". The new LimsLink template is available for LimsLink v4.1 and SoftMax Pro version 5.3. For details, visit http://www.labtronics.com.

Chemical Manufacturer Finds Right Formula with DEACOM ERP Software

Producer of the DEACOM Integrated Accounting and Enterprise Resource Planning (ERP) Software System, Deacom, Inc. has announced that Synalloy Corporation has chosen DEACOM to integrate its specialty chemical manufacturing business in one software system. The selection of the DEACOM System is part of a company-wide initiative to reduce costs associated with productivity, safety, inventory controls, quality, and delivery. Synalloy Corporation, a diverse manufacturer of piping and piping systems and specialty chemicals, has been in business since 1945 and employs over 440 people with operations in South Carolina, Tennessee, and Georgia. The company used a combination of software systems to manage its chemical group, which consists of Blackman Uhler LLC, Organic Pigments LLC, and Manufacturers Chemical LLC. This system setup lacked the centralization needed for viewing information across the entire chemical group, according to Synalloy Information Systems Director Rhonda Harmon. "One of our chemical companies was still running a homegrown system separate from our main ERP system," Harmon says. "And the ERP system we were using was so customized, particularly in the areas of costing and data collection, that it was no longer being supported by our vendor. We were performing many functions outside of our current system that should have been part of our ERP system." The DEACOM ERP System is scheduled to be implemented in October of 2008. Once live, the system will integrate the business processes of Synalloy's chemical group, including lab management and regulatory reporting, accounting, inventory control, purchasing, sales order entry, Customer Relationship Management (CRM), and production in a single database. For details, visit http://www.deacom.net.

Laboratory Network Selects LimsLink as Their Single Interfacing Solution

A leading full-service analytical testing firm with a network of NELAP (National Environmental Laboratory Accreditation Program) certified laboratories across the United States has recently chosen LimsLink from Labtronics Inc. as the single instrument/LIMS interfacing solution for all of their laboratory instruments at all of their laboratory facilities. In addition to creating new interfaces, LimsLink will replace already existing interfaces that had been custom programmed over the years. Eliminating these custom coded interfaces and implementing LimsLink as their standard interfacing solution will reduce the workload for their IT group and reduce the costs related to developing and supporting instrument interfacing throughout their organization. A 3 member implementation team has completed a one week LimsLink training course introducing them to LimsLink’s unique configuration process that uses radio buttons, drop down menus, special processing modules and an exclusive graphic parser to simplify creation of highly sophisticated and highly functional interfaces With that limited amount of training the team is already implementing interfaces for their ICPs, ICPMS, chromatography systems and other lab instruments. Once LimsLink is fully deployed within their organization, the group will have interfaced hundreds of instruments. For details, visit http://www.labtronics.com.

Bruker Daltonics Introduces Novel LC/GC Time-of-Flight Mass Spectrometer micrOTOF II for LC/MS and GC/MS on One System

Bruker Daltonics has announced the new further enhanced micrOTOF II API-TOF mass spectrometer, as well as a novel, optional GC-APCI Interface for a single high-performance platform for LC/MS and GC/MS with unprecedented analyte flexibility. Bruker Daltonics has enhanced its well-known high-resolution API-TOF system, the micrOTOF, even further improving its resolution to greater than 16,500 and its mass accuracy to 1-2 ppm. Even better mass accuracy plus SmartFormula™ makes the micrOTOF II an outstanding instrument in its class, providing the user with high confidence in formula determination and identification, even in complex mixtures. For additional analytical flexibility, the micrOTOF II now can be equipped with a new GC-APCI (atmospheric pressure chemical ionization) interface which allows GC/TOF-MS analysis on the same instrument. This cost-effective combination obviates the need for a dedicated GC/TOF, offering instead outstanding mass accuracy and resolution on a single platform with simple interchange between LC and GC operation in a few minutes without tools. The micrOTOF II the first universal bench-top accurate mass tool for GC and LC chemical analysis. Typical applications for GC/TOF-MS include multiple target screening, identification of unknown peaks in the GC chromatogram and metabolomics studies. The high acquisition speed of 20 Hz spectra-to-disk of the micrOTOF II allows temporal resolution of the sharp peaks which are generated by a GC. All renowned Bruker software tools to deliver real answers from LC/TOF-MS data, such as Smartformula™ for molecular sum formula generation, or TargetAnalysis for screening can be immediately applied to GC/TOF analysis. For details, visit http://www.bruker.com.

Bruker Daltonics Introduces maXis, a Revolutionary New Ultra-High Resolution TOF Mass Spectrometer at ASMS Conference

Bruker Daltonics has announced the maXis, a revolutionary new Electrospray Ultra-High Resolution tandem TOF (UHR-Qq-TOF) mass spectrometer. The novel maXis demonstrates Bruker’s leadership in the design of cutting-edge mass spectrometers to meet future requirements in applications including small molecule identification, metabolomics, quantitative proteomics, as well as biomarker discovery and validation. The maXis is unique in offering simultaneous no-compromise ultra-high resolution of 40,000 – 60,000 FWHM over a broad mass range, MS and MS/MS mass accuracy typically between 600 and 800 ppb, and all at speeds of up to 20 full spectra per second. "Now ultra-high resolution mass spectrometry over broad mass ranges is finally compatible with ultra performance liquid chromatography,” explained Bruker Daltonics Executive Vice President Dr. Ian Sanders. “Our new maXis indeed represents a major step forward in tandem mass spectrometry, offering a no-compromise solution for exceptional accurate mass, ultra-high resolution over a broad mass range and high sensitivity MS and MS/MS analysis at a speed able to take full advantage of modern, fast liquid chromatography or fast capillary electrophoresis separations.” For details, visit http://www.bruker.com.

FDA Gets Initial Approval of $2.1 Billion for Fiscal 2009

The amount includes $282 million more than originally requested by the administration, according to its chairwoman, Rep. Rosa DeLauro (D-Conn.). That increase includes the additional $275 million that HHS Secretary Mike Leavitt requested for the agency last week. "We are indeed eager to fund this request,” DeLauro said in her opening statement at the subcommittee’s markup session. She called the administration’s request for the additional funds an acknowledgment that “the nation’s food and drug safety system is broken.” However, DeLauro criticized the administration for not indicating how it wants the FDA to use the additional funds and promised to hold hearings on the subject. When asked when the hearings would take place, she could not provide a date but said the subcommittee would “move quickly.” "We are trying to look at where the money is being spent,” she added. “Accountability procedures are going to be put in place. The FDA needs to move on what its Science Board said and on what the recalls have taught us. For the first time in a very long time, there has been a recognition of the serious problems that exist. We are building the pieces to put the agency back on track. There has to be a focus on prevention, not just reaction.” DeLauro was referring to a report issued last December by a subcommittee of the FDA’s Science Board, which said that a lack of funding, inadequate workforce, weak scientific base and obsolete IT system are preventing the FDA from carrying out its mission. The budget measure now goes to the House Appropriations Committee for a markup, which was scheduled for next week but has been postponed, according to Kirstin Brost, a spokeswoman for Rep. David Obey (D-Wis.), the committee chairman. The bill has no number until the full committee introduces it in the House, and the Agriculture subcommittee has not made it or its details available as of press time.For details, visit http://www.fda.gov.

Revisions to New cGMP Rule Going Through FDA Clearance

The FDA has modified its proposed current good manufacturing practice (cGMP) rule, which could be published in the next few months, according to an agency director. "There are some revisions to what was in the direct final rule … which is going through clearance in the next several weeks, hopefully,” Richard Friedman, director of the FDA’s Division of Manufacturing and Product Quality, said last week at the International Society for Pharmaceutical Engineering’s (ISPE) 2008 Engineering Regulatory Conference. Friedman emphasized that he could not comment on the exact release date but that he hoped it would be in the next few months. Top agency officials are working with higher-ups in the administration to determine when rules will be published, he said. The FDA issued the regulation late last year as both a proposed and final direct rule. The final rule was withdrawn when the agency received significant adverse comments from industry to changes it made in the cGMP regulations. One such modification would have explicitly required manufacturers to validate aseptic processes. Russell Madsen, former acting president of the Parenteral Drug Association and president of The Williamsburg Group, commented that aseptic processes could not be validated. During the ISPE conference, Friedman said he agreed with some of the adverse comments received and that the modifications will clarify certain aspects of the regulation.For details, visit http://www.fda.gov.

FDA Releases Draft Guidance on Submitting Case Study Reports

Postmarket follow-up individual case study reports must include the original report’s unique identification number to avoid duplication in the FDA’s Adverse Event Reporting System (AERS), the agency says in a new draft guidance. The new draft guidance for electronically submitting postmarket individual case study reports (ICSRs) instructs manufacturers on filing such reports to the AERS. The guidance replaces previous drafts on the topic, including “Providing Regulatory Submissions in Electronic Format — Postmarketing Expedited Safety Reports” issued in 2001 and the ICSR portion of “Providing Regulatory Submissions in Electronic Format — Postmarketing Periodic Adverse Drug Experience Reports” issued in 2003. The new draft, “Providing Regulatory Submissions in Electronic Format — Postmarketing Individual Case Safety Reports,” applies to unapproved drugs; drugs marketed under approved NDAs and ANDAs; biologics and therapeutic vaccines marketed under BLAs; human cells, tissues and cellular products regulated under Public Health Service Act section 361; and nonprescription drugs marketed without an approved application, the FDA says. Vaccines approved for prophylactic use are not covered by the guidance since adverse event reports for those products are submitted to the Vaccine Adverse Events Reporting System. Whole blood or components of whole blood are excluded as well. The draft guidance does not address electronic submissions of descriptive information for periodic reports, which is covered under the Periodic Safety Update Reports section of the “Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” guidance. CDER posted a revision to that guidance on its website. It can be accessed at http://www.fda.gov/cder/guidance/7087rev2.pdf. Comments for the draft, which was published in Thursday’s Federal Register, are due Aug. 11. The draft can be accessed at http://www.fda.gov/cder/guidance/5161dft.pdf.

Administration’s Request for Additional FDA Funding Draws Criticism

The Bush administration’s request for an additional $275 million for the FDA in fiscal 2009 drew criticism from an influential Democratic lawmaker who characterized it as too little, too late. "Though it’s taken an inexcusably long time, I’m glad to see the administration is finally acknowledging that FDA lacks the resources necessary to protect the public health,” Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, said. “Unfortunately, the administration’s proposed funding increase falls $100 million short of the amount FDA’s own advisory board determined is needed to ensure the safety of our food, drugs, cosmetics and medical devices. "My committee has held more than a dozen hearings in the past 17 months on the safety of imported food, drugs and devices. It’s clear that FDA’s infrastructure has not kept up with the global marketplace. The agency is in urgent need of a major overhaul, which is exactly what my forthcoming legislative proposal will accomplish.” HHS Secretary Mike Leavitt announced the administration’s request for the additional funds for the FDA. “We are moving from an intervention strategy — where we stand at the border and try to catch things that are unsafe — to an integrated strategy of prevention with verification,” Leavitt said. “Combined with crucial legislative proposals, this increase will allow FDA to continue to transform its regulatory strategies to meet the challenges of the evolving global marketplace. I urge Congress to act quickly to give FDA the authority and funding it needs to enhance the safety of our food and medical products.” The additional funding includes $100 million for drug, device and biologic safety to help the FDA conduct more aggressive safety surveillance to identify early signs of adverse events linked to medical products and to implement new requirements under the FDA Amendments Act related to clinical trials, pediatric drugs and devices, postmarket study commitments and the labeling and safe use of drugs, according to an HHS statement accompanying Leavitt’s announcement. For details, visit http://www.fda.gov.

WHO Assembly Adopts Plan to Revise Patent Barriers

Representatives attending the World Health Organization’s (WHO) annual World Health Assembly have settled on a provision to encourage developing countries to prevent and penalize anti-competitive practices involving pharmaceutical patents. The provision was part of a resolution aimed at removing intellectual property barriers that could discourage pharmaceutical R&D and access to medicines in the developing world. Several groups have praised the R&D initiative, which stemmed from the WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property on a Global Strategy and Plan of Action. The draft plan calls for “developing possible new mechanisms to promote transfer of and access to key health-related technologies” through examining “the feasibility of voluntary patent pools of upstream and downstream technologies to promote innovation of and access to health products and medical devices.” According to the WHO, 2,704 delegates from 190 countries agreed to explore R&D incentives — including prizes — that are not linked to product prices. Countries also agreed on the importance of creating a global patent database to promote innovation and access to medicines. While there was praise for the assembly’s efforts, nongovernmental organizations were disappointed that the initiative did not resolve such issues as time frames and sustainable sources of funding, according to Knowledge Ecology International, an advocacy group. For details, visit http://www.fda.gov.

Joint FDA-EMEA Inspections Program Outlined

The FDA and the European Medicines Agency (EMEA) will pilot a joint good manufacturing practice (GMP) inspections program under a bilateral agreement. Following a meeting of the Transatlantic Economic Council, the European Commission (EC) characterized the FDA and EMEA’s relationship as a beneficial cooperation. The EC lists new GMP initiatives the two agencies will undertake. The joint inspections program will apply to facilities in both the U.S. and the European Union (EU), the EC said. Joint inspections of active pharmaceutical ingredient (API) facilities in countries outside the U.S. and the EU will be part of the program as well. The agencies will pilot a GMP information exchange covering inspection schedules and results. Information on facilities that have been inspected would be shared so the agencies could get greater inspection coverage and better identify API production sites in countries outside the U.S. and the EU. "The collaboration on inspections should result in more effective use of resources and a higher safety level of product from third countries,” the EC said. For details, visit http://www.fda.gov.

FDA Says SPL Program Will Not Delay Approvals

The FDA is telling pharmaceutical companies in a new guidance that its structured product labeling (SPL) efforts to electronically index the content of prescription drug labels will not add review time to applications although the content might be part of labeling negotiations. "SPL indexing will not affect review times or delay approvals,” the guidance says. “However, indexing considerations may be incorporated in the standard labeling review discussions.” SPL is an extensible markup language data standard for submitting physician labeling electronically and the only one CDER uses to process, review and archive electronic labeling submissions. The agency published the final guidance, “Indexing Structured Product Labeling,” in Monday’s Federal Register. A draft version was released last year in March, 2007. For products regulated by CBER, the content of labeling must be submitted electronically, and the center will soon begin recommending such information be submitted in SPL format, the guidance says. Indexing SPL refers to adding machine-readable tags to labels, enabling healthcare professionals with clinical decision support tools and electronic prescribing systems to rapidly search and sort product information, the guidance says. The tags will not be visible on printed labels. Unlike the draft form of the guidance, the final version says sponsors can suggest indexing terms when they submit an SPL file in regulatory submissions. Both the draft and final guidance recommend firms not change indexing elements associated with existing SPL files. Questions regarding existing SPL files should be submitted via email to spl@fda.hhs.gov. The final guidance can be accessed at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0364-gdl.pdf.

FDA to Address Problem of Similar Drug Names With Pilot Program

Reducing medication errors caused by look-alike and sound-alike proprietary names — through a two-year pilot program it expects to begin in 2009 — is the focus of a draft concept paper the FDA has released in advance of a public meeting scheduled for June 5–6, 2008. The pilot program will be designed to let drug companies volunteer to evaluate proposed proprietary names and submit the data for review to CDER or CBER, as appropriate. Following the passage of the FDA Amendments Act of 2007 last September, the FDA said it would devote some of the money it gets from user fees to address the problem of similar proprietary names, including such factors as unclear label abbreviations, acronyms, dose designations and error-prone label and packaging design. In the pilot program, CDER and CBER will evaluate the safety and promotional implications of submitted drug names. If a name seems prone to cause confusion, the relevant center “will not recommend its approval for use in the market and will request the applicant propose an alternate name for evaluation,” the draft says. “Any preventable risk of error that can be identified prior to drug approval should be addressed.” Product names must be safe and promotionally acceptable, and CDER and CBER will determine whether the company submitting them used adequate reasoning to come up with them. For example, applicants are advised to avoid proprietary names that incorporate or suggest a dosing interval or dosage form since these may change, use common medical abbreviations or coined abbreviations, or include or suggest the composition of the drug product. The June 5–6 meeting will address the pilot program and developments in the science and practice of proprietary name analysis since 2003, when the agency held two public meetings on the subject. Also on the agenda will be the strength of evidence for the agency’s approach to reviewing the names of prescription and nonprescription products and best practices in the absence of a gold standard. The draft concept paper can be viewed at http://www.fda.gov/cder/drug/MedErrors/meeting_names.pdf.

FDA Details Outside Partnerships in Sentinel Initiative

The FDA is detailing its public and private collaborations in a report on the Sentinel initiative, a program designed to improve the agency’s postmarket surveillance of medical products. The program will leverage HHS’ Nationwide Health Information Network (NHIN), which is intended to provide a secure, interoperable infrastructure connecting providers and consumers. It would be built out of state and regional health information exchanges and other networks, the report says. Last September, HHS awarded $22.5 million in contracts to nine health information exchanges to begin trial implementation of the network. The FDA announced Sentinel’s launch in late May when the Center for Medicare & Medicaid Services published a final rule allowing federal and state agencies access to claims data under Medicare Part D. The FDA will start mining the Part D claims database when the regulation takes effect June 27. The external collaborations listed in the Sentinel report are classified under risk identification, risk assessment and risk minimization categories. For example, the FDA’s memorandum of understanding with the NIH on adverse event reporting is listed in the report under risk identification. "The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety” can be accessed at http://www.fda.gov/oc/initiatives/advance/reports/report0508.pdf.

What's New - Right Now The following is a wrap-up of news of interest during the month of June 2008

What's New - Right Now
The following is a wrap-up of news of interest during the month of June 2008