LIMSource News: What's New - March to April 2007

Sapio Sciences Introduces Exemplar LIMS

Sapio Sciences has introduced their Exemplar Laboratory Information Management (LIMS). According to the company, Exemplar LIMS was designed by leading researchers at pharmaceutical and non-profit institutions to set new standards in breadth of functionality, flexibility, and extendibility. Exemplar LIMS allows for complete tracking of sample BioBanks, all data associated with samples (SNP’s, Gene Expression values, etc), analytics results, and all protocol related information in one application. Exemplar LIMS core features include: BioBanking, eLab Notebook, and DataBanking. Analytics tracking will be incorported into a future release. Exemplar LIMS provides n intuitive and easy-to-use Web-based interface as well as complete field level audit tracking and built in reporting of sample history, projects, etc. It is easily extendible with no programming, supports new protocols or data tracking requirements in minutes, provides point and click data dependency where one field can be dependent on another’s value, provides the ability to add unlimited new fields, and more. For details, visit http://www.SapioSciences.com.

PerkinElmer Introduces LABWORKS LIMS 6.0 with New WorkflowArchitect For Greater Ease of Use, Flexibility

PerkinElmer, Inc., a global leader in Health Sciences and Photonics, has introduced LABWORKS LIMS 6.0, a scaleable LIMS that will provide customers with improved flexibility, choice and control of their LIMS. This solution delivers a common architecture for both Web and console/client applications. "The LABWORKS LIMS new release is in response to customers’ needs for a tailored yet simpler and easier-to-use data management and control system that works within their company’s laboratory operations and enterprise,” said Robert Hudson, global director of sales and service for Enterprise Software Solutions. “We’ve leveraged our deep history and expertise in delivering effective LIMS solutions to provide customers with long-term data management solutions that can meet their needs for stability and control while at the same time providing flexibility to adapt to their ever-changing business environments.” A key feature of the improved workflow management system is WorkflowArchitect, a new graphical workflow editor designed to allow the user to easily tailor and test changes to the default LABWORKS workflow. Additional features include the updated LABWORKS Desktop providing an integrated real-time Desktop Messenger system to facilitate real-time communication and system notifications that are important for effective handling of routine and exceptional situations; an integrated Electronic Signature to assist labs in securing faster compliance and approvals; a ClickOnce Subscriber model that improves uniformity and lowers the cost to maintain the system by providing both functionality and ease-of-deployment; and new services for data integration enabling easier sharing of LABWORKS information within the laboratory and the larger enterprise. Hudson noted that LIMS are most effective when the laboratory personnel who provide the content can recognize their own processes and terminology in the system. “While even the best-designed workflows will have points requiring human intervention, the integration of the WorkflowArchitect with both the new Desktop Messenger and Electronic Signature exemplify our understanding of and response to laboratory needs,” Hudson added. LABWORKS LIMS is a valuable tool for applications in the chemical, petrochemical, water and wastewater, agriculture, food and beverage and process control arenas, helping customers automate instrumentation, integrate laboratory processes and provide sample information management and quality control from scheduling through analysis and reporting. For details, visit http://www.perkinelmer.com/labworks.

Acclaim Pharma Research Opens State-of-the-Art Phase I Clinic with Green Mountain Logic's LabPas CT

Acclaim Pharma Research, preparing to open a state-of-the-art 90-bed Phase I clinic in London, Ontario, Canada has selected LabPas CT to fully automate their clinical trials. According to Dr. Aditya Gupta, CEO and founder of Acclaim Pharma Research, “Automating our Phase One trials with LabPas CT positions us on the cutting edge of the clinical trials industry. We offer sponsors reduced trial times, faster data lock and error-free quality.”John Rosenblum, CEO of Green Mountain Logic, which developed LabPas CT, added, “Acclaim is an exciting partner for us. Their commitment to quality and vision for the future is inspiring; and their strategic approach is clearly demonstrated by their newly renovated, fully automated facility." "Our goal was to comprehensively automate our trials. LabPas CT was the only software that thoroughly understood the Phase One environment and provided a fully integrated work flow and data management solution,” said Anna Maria Di Lorenzo, Director of Clinical Operations. “We never even considered doing our trials using paper or spreadsheets.” Acclaim’s new 10,600 square foot facility is located adjacent to the University of Western Ontario, also in London, Ontario. Acclaim Pharma Research’s clinical staff has more than 25 years of pharmaceutical experience in conducting more than 85 Phase II - IV trials and 650 Phase I bioequivalence studies with extensive expertise in pharmacokinetics. Acclaim Pharma Research is a sister company of Mediprobe Research, a Phase II - IV CRO also founded by Dr. Gupta. For details, visit http://www.labpas.com.

Thermo Fisher Scientific Extends Informatics Offering into Colombia Enters Strategic Partnership with IST Internacional

Thermo Fisher Scientific Inc. has established a new partnership with Bogota-based Integrador de Soluciones Technologicas Ltda. (IST Internacional) to open a new sales center for Thermo Scientific informatics solutions in Colombia and central America. The new partnership will support sales activities in Colombia for the complete Thermo Scientific informatics product range, placing a special focus on LIMS and CDS. Dedicated sales experts will target a number of industries which are strong in Colombia, and which Thermo Fisher has long served, including petrochemical, chemical, mining, cement, mineral, metal, environmental, water treatment and pulp and paper. Thermo Scientific informatics solutions have been deployed throughout the Life and Laboratory Science industry of the Latin American and Caribbean region for more than 20 years. Thermo Fisher Scientific provides regional customers with software solutions designed to improve their operations as well as reduce risk and total cost of ownership. The business operates offices in Chile, Mexico, Brazil and Argentina and has an extended network of authorized partners in Peru, Ecuador, Venezuela, Puerto Rico and Colombia. For details, visit http://www.thermo.com/informatics.

Global Pharmaceutical Giant Licenses LabVantage’s Sapphire Biobanking Solution to Support its Biorepository Operations

LabVantage has announced that a global pharmaceutical giant has licensed LabVantage’s Sapphire Biobanking Solution to support its biorepository operations. At the heart of its research and development (R&D) efforts, its biorepositories face the challenge of managing the exponential growth of biomaterials, the expanding geography of storage locations, and the mounting complexity of internal and regulatory compliance restrictions. Its pathology and cell bank groups could no longer be managed through its existing method of Excel spreadsheets and multiple in-house developed solutions. "The company needed an integrated, robust informatics solution specially designed for biorepository management," explained Ron Kasner, Vice President of Corporate Development at LabVantage. "Specifically, it required comprehensive data capture, location management, and compliance capabilities to help them store, locate, and access vital biospecimen information," he added. Sapphire will serve as a core technology infrastructure for their pathology and cell bank groups to track tumors, cell lines, and other derivatives through the quality control process and maintain a biorepository bank for users to search and locate required specimens for various R&D projects. "We are proud that Sapphire will play a vital role in advancing this renowned pharmaceutical giant’s research efforts and accelerating its development of promising new products," said Jim Aurelio, CEO & President of LabVantage, "As the volume and complexity of specimen collections continuously increases around the world, this is a real case study of how pharmaceutical companies can rely on LabVantage to deliver them a tailored biobanking solution, leveraging the best combination of functionality, flexibility, and technology." For details, visit http://www.labvantage.com.

STARLIMS to be Implemented at Singapore Health Sciences Authority

STARLIMS Corporation, a leading global provider of LIMS, has been selected by Singapore Health Sciences Authority (HSA), to be part of Laboratory Integrated Scientific Administration System (LISA)—a complete solution to be supplied by the NCS Group. NCS will integrate a Scientific Data Management System (SDMS) from Agilent Technologies Inc. with the STARLIMS application. The solution provided by NCS will also include the full infrastructure setup for LISA. "We are very pleased to be part of this solution, in which our LIMS will be integrated with Agilent's Cerity SDMS to provide a seamless flow of information within HSA," said Linus Chu, General Manager of STARLIMS Asia Pacific. "The extreme flexibility of our LIMS platform will be instrumental in ensuring smooth integration with a wide variety of instruments and applications already used at HSA. It will also enable smooth integration with the new software to be implemented as part of NCS's solution." "STARLIMS will contribute important functionality to the new solution, notably integrating the different laboratories into a single system, in order to streamline the laboratory operation process for all the laboratories," said Chan Kah Choon, General Manager, Healthcare & Life Sciences at NCS. "Of equal importance, it is a flexible and stable platform, designed for integration with multiple applications, such as Agilent's Cerity SDMS." NCS Group is a leading regional information technology and communications engineering service provider in the Asia Pacific and Middle East regions. NCS provides a holistic range of IT and communications engineering solutions to support its customers' business goals throughout their technology life-cycle. The Singapore Health Sciences Authority (HSA) is the government agency responsible for regulation of health products. HSA is responsible for the quality, safety and efficacy of medicines, medical devices, radiation equipment, blood and blood products, and all health-related products in the country. It runs the national blood banking service and offers consultative services to healthcare institutions. For details, visit http://www.starlims.com.

Thermo Fisher Scientific Expands Biomarker Research Initiatives to Include Clinical Research Applications

Thermo Fisher Scientific Inc. has announced that its Biomarker Research Initiative in Mass Spectrometry (BRIMS) center has expanded its capabilities to involve clinical validation and clinical application assays. The center was initially established to focus on protein biomarker discovery, and subsequently developed an end-to-end mass spectrometry workflow including a complete sample preparation protocol as well as SIEVE, a new software tool which automates label-free, semi-quantitative differential expression of proteins and peptides by comparing LC/MS analyses from large datasets. Thermo Fisher Scientific originally partnered with Massachusetts General Hospital on BRIMS to focus on protein biomarker discovery. The large quantity of well-annotated plasma samples that were available at the hospital were ideally suited for research in biomarker discovery using the Thermo Scientific LTQ FT and LTQ Orbitrap. Moving into the next stage of biomarker verification, the center now uses the Thermo Scientific TSQ Quantum triple-quadrupole platform to develop targeted highly selective reaction monitoring (H-SRM) and multiple reaction monitoring assays for peptides and protein biomarker quantitation. Following the Thermo Fisher acquisition of Cohesive Technologies, BRIMS incorporates the novel Thermo Scientific TurboFlow technology system’s novel approach to sample preparation and separation for MS. The TurboFlow technology minimizes sample preparation, especially for drug discovery, drug development and clinical research applications resulting in a unique LC-MS/MS solution when coupled with the TSQ Quantum triple quadrupole mass spectrometer and FAIMS (High-Field Asymmetric Ion Mobility Mass Spectrometry) technology. The BRIMS center also utilizes Thermo Fisher protein/peptide sample enrichment products, as well as the SILAC Protein Quantitation Kits which, when used in conjunction with Thermo Scientific high resolution mass spectrometers, help facilitate MS analysis of low-abundance proteins. For details, visit http://www.thermo.com/ms.

Waters Corporation and Hitachi High Technologies Corporation to Collaborate on the Development of Chromatography Interface Software for Empower 2 in North America

-Waters Corporation and Hitachi High-Technologies Corporation (HHT), Tokyo, Japan, have announced their intent to develop a software interface for Hitachi's Liquid Chromatograph Instruments 'LaChrom Elite' Control for Waters Chromatographic Data Station Software Empower 2. It is anticipated that HHT will develop and sell an interface for the Waters Empower 2 chromatography data software (CDS) in combination with its own line of liquid chromatography (LC) systems in the North America market. The collaboration will enable scientists to take advantage of the powerful features of both Empower CDS software along with the Hitachi LC systems and
purchase them from the respective companies. For details, visit http://www.waters.com.

Tessella Launches ‘Adaptive Trials Simulation Toolkit’ at Bio-IT World 2007

On April 30 2007, at the Bio-IT World Conference and Expo in Boston MA, Tessella will launch its first ‘Adaptive Trials Simulation Toolkit’ to better equip the pharmaceutical community to carry out adaptive clinical trials. Adaptive clinical trials attempt to increase the efficiency of clinical trials by breaking out of the straightjacket of conventional experimental design. Grant Stephen, CEO of Tessella Inc, stressed: “Running clinical trials is the most expensive and time-consuming phase of drug development, but at the same time their rigor and integrity are paramount for our health and safety.” Tom Parke, Head of Clinical Trial Solutions at Tessella, added: “Developing new ways to run clinical trials is therefore at the cutting edge of optimizing the drug development process; a process that is otherwise sinking into the sand with both increasing costs and a decreasing success rate. To implement adaptive designs requires new statistical frameworks, logistical and organizational support and regulatory approval.” The Tessella ‘Adaptive Trials Simulation Toolkit’ will contain a range of adaptive clinical trial models for simulating different adaptive methods from phase 1 through to phase 3. The first release includes a Bayesian model for phase 2 trials called ‘NDLM dose finder’, and a ‘Seamless Phase 2/3 Simulator’. 'NDLM dose finder' simulates trials run using a Bayesian Model that is updated with response data as the trial runs. A Normal Dynamic Linear Model (NDLM) is fitted to the response data and used to estimate whether any dose will fit the target criteria and which dose it is most likely to be. This allows the model to recommend whether to continue the trial and which doses to favor in randomization. This model is typically more efficient than fixed allocation designs in determining whether there is a dose response and at choosing the right dose range for the next phase. Tessella’s ‘Seamless Phase 2/3 Simulator’ is a key development. At the interim analysis between the two phases, the treatment arms to be retained are selected and the sample size for the next phase calculated. The model allows for the multiple treatment arms by controlling the familywise error rate using the closed testing procedure. In addition, the model uses a combination function to combine data from two phases in the final analysis. As well as saving time between phase 2 and phase 3 this approach allows for a smaller phase 3. For details, visit http://www.tessella.com.

Accelerated Technology Laboratories, Inc. Celebrates Sixth Consecutive Year of ISO 9001:2000 Certification

Accelerated Technology Laboratories, Inc. (ATL) celebrated its sixth year of successful registration to ISO 9001:2000. Originally certified in April 2001, ATL was one of the first LIMS vendors to be certified to the new ISO standard. "ISO registration supports our pursuit of continuous improvement and an on-going commitment to provide our customers assurance of product quality,” said Mr. Steve Rayburn, ATL’s Director of Training and Validation. "Our success in achieving this goal is due to the tremendous dedication and teamwork of our employees. ATL’s Quality Management System is an excellent example of how a committed organization works to achieve excellence in all aspects of its business.” ATL’s Quality Management 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.

Aspectrics Announces Collaboration with Thermo Fisher Scientific

Aspectrics, Inc., the innovator of Encoded Photometric Infrared (EP-IR) analyzers, has entered into an exclusive agreement with Thermo Fisher Scientific to seamlessly integrate Thermo Scientific GRAMS spectroscopy software with Aspectrics’ groundbreaking Encoded Photometric Near Infrared (EP-NIR) process analyzers. Jim Yano, vice president of marketing for Aspectrics comments: “Our collaboration with Thermo Fisher Scientific demonstrates Aspectrics’ commitment to customer satisfaction and development within the global market. With Thermo Fisher Scientific’s rich heritage in spectroscopy software and Aspectrics’ groundbreaking EP-NIR technology, this combination will result in a complete real-time process analyzer solution that will enable our customers to achieve faster and more reliable analyses.” Aspectrics’ EP-NIR analyzers offer a more efficient alternative to traditional NIR systems, with a spectral range extending further than the common 2100nm and achieving a range of 1375-2750nm. The patented Encoder Disk technology provides ultra fast sampling capability (100 Hz) for multi component analysis in a process rugged design to meet the demand for the process monitoring industry. Thermo Scientific GRAMS is a spectroscopy software solution used by industry professionals worldwide for visualizing, processing and managing data from FT-IR, NIR, Raman, UV-Vis, Fluorescence, NMR and hyphenated instruments manufactured by multiple vendors. Aspectrics’ EP-NIR analyzers recently received an ‘honorable mention’ in the Editors’ Award at PITTCON 2007, the largest North American conference and exposition on laboratory science and instrumentation. For details, visit http://www.aspectrics.com.

Thermo Fisher Scientific Introduces QuickQuan 2.0 for Alleviating Bottlenecks in Sample Analysis and Data Review for Drug Discovery and Development

Thermo Fisher Scientific Inc. has introduced QuickQuan 2.0 for automating high-throughput LC-MS/MS assays. Recently showcased at PITTCON 2007, Thermo Scientific QuickQuan 2.0 is designed to alleviate the bottleneck of sample analysis in early drug discovery. QuickQuan delivers rapid LC-MS/MS optimization through an automated on-line infusion mode and valve switching design, allowing precise auto-tuning with high sensitivity and maximizing successful automated quantification of chemically diverse compounds. All analytical information can be stored in Microsoft Access or Oracle databases, which facilitates rapid data exchange across global networks. QuickQuan 2.0 incorporates new features which further extend the capabilities of the software to non-GLP (Good Laboratory Practice) laboratories performing medium to high throughput quantitation assays. The unique Autosampler Infusion feature introduced in this version enables automated compound optimization. When coupled with a CTC HTS or HTC PAL autosampler, the autosampler can be configured for use as an infusion pump, providing more accurate optimization results than traditional techniques at a rate of approximately 70 seconds per compound. Automated optimization of MS/MS parameters enables users to optimize hundreds of compounds without manual intervention. In addition QuickQuan 2.0 has the ability to store results for method generation in a Microsoft Access or Oracle database, removing the need for redundant optimization when reanalyzing samples or transferring instrument methods. When networked with any of the Thermo Scientific TSQ Quantum triple quadrupole mass spectrometers, the system can access this database and perform sample analysis without requiring reoptimization on each individual instrument. In addition, QuickQuan 2.0 is available as a pre-packaged hardware solution that enables column switching without guess work or plumbing. With this solution, users are able to proceed from optimization to sample acquisition without interruptions. QuickQuan 2.0 includes templates for the automated generation of both instrument and processing methods, thereby eliminating the need to create methods manually when studying a large number of compounds. The software also allows users to automatically generate customizable Excel summaries and Xreports, minimizing time required for data processing and review. For details, visit http://www.thermo.com/ms.

Waters Corporation and Symyx Technologies to Collaborate on Research Lab Software Offerings

Waters Corporation and Symyx Technologies, Inc. have announced the integration of Waters NuGenesis Scientific Data Management System (SDMS) with the Symyx Software Electronic Lab Notebook (ELN) product. By making the software products compatible with one another, scientists will find it easier to access, share, use and document scientific information generated by multiple sources. With this new level of integration, scientists using Symyx ELN software to design, document and share experimental information will be able to retrieve directly data and documents stored in the NuGenesis SDMS system, saving considerable time and effort. Laboratories looking to couple NuGenesis SDMS with the Symyx ELN software will get a configurable off-the-shelf software solution with intelligent tools to enhance scientific R&D, project data management productivity, and global collaboration / communication. "To keep up with the mountains of data generated by drug discovery research, leading research firms need solid information management solutions like Symyx Software and Waters NuGenesis," said Patrick Martell, Director of Waters Laboratory Informatics. "The regulatory and competitive environments in which modern pharmaceutical and chemical products are developed demand the highest standards of IP traceability, compliance and efficiency. This new integration of our products helps our customers keep pace with these demands." For details, visit http://www.waters.com.

LABTrack, LLC Introduces LABTrack Pro

LABTrack LLC, developer of the award winning LABTrack Electronic Lab Notebook (ELN) product, has introduced its newest product version – LABTrack Pro. This new version incorporates many new features including native support for both Windows and Macintosh computers and the new Smart-XForms template creation and searching functionality. LABTrack Pro is a thin client application that can be used with both PCs and Mac’s running browsers such as Internet Explorer, FireFox and Safari. According to Richard Stember, CEO of
LABTrack, LLC, “LABTrack’s new cross platform compatibility opens the door for companies with
a varied user base to standardize on a single electronic laboratory notebook.” LABTrack Pro’s new Smart-XForms allows users to easily create and apply fully searchable templates on LABTrack’s lab notebook pages. Created with the built-in word processor, Smart-XForms can contain text, spreadsheets, form elements, rules and calculations. These user defined forms are automatically indexed and the form’s captions and values made available for users to search across notebooks. “In fact”, according to Mr. Stember, “users can create fully
customized and comprehensive applications using Smart-XForms all within the context of their electronic lab notebook”. LABTrack Pro provides a unifying collaborative environment that addresses the document
authoring and sharing needs of virtually all scientists and engineers with an easy to use browser based word processor. Because it is fully scalable up to enterprise level implementations, LABTrack can be deployed by both the smallest and the largest of organizations. Licenses are offered starting at 5 users and going up to 5,000 users. For details, visit http://www.labtrack.com.

WinLIMS Manages Business and Laboratory Information

QSI are now offering their WinLIMS Rental product as a business management tool as well as for the Laboratory. QSI’s Managing Director Clive Collier said “To make sure that WinLIMS Rental would meet customer expectations, we obviously had to create an “out of the box” package whose functionality could handle the vast majority of user requirements without modification or the need for custom code. In developing the package alongside our industrial customers, we have incorporated functionality that goes way beyond just the lab, and provides manufacturers with a whole range of tools with which to manage the wider business. The WinLIMS Rental package contains a set of MRP (Materials Requirement Planning) tools designed to meet the needs of the small to medium manufacturing sector.” All the usual MRP functions – contact management, purchasing and stock control, order processing, invoicing and quotations, raw materials management, bill of materials – are included, but there is other functionality designed specifically for the chemical and allied industries. The WinLIMS Formulations Manager allows the ingredients for a product to be defined and automatically calculates the net cost and gross cost of the product based on the expected yield. The Blending Control module can optimise a blend, not only in terms of product specification variables but also in terms of raw material cost, and can then use the laboratory testing data to perform blending corrections if necessary. The Batch Traceability tool will be invaluable for those needing to establish product traceability in tightly regulated environments. For details, visit http://www.qsiuk.com.

GenoLogics and Proteome Software Partner to Create Proteus-Analytics Lab and Data Management with Protein Identification Validation

GenoLogics, a leading developer of lab and data management software solutions for life sciences research, has announced the launch of Proteus-Analytics, a new proteomics solution bundle. Proteus-Analytics is a tightly integrated solution that combines two best-in-class systems GenoLogics’ Proteus™ lab and data management solution with Proteome Software’s ScaffoldBatch Analysis System for protein identification visualization and validation. GenoLogics and Proteome Software have partnered to offer proteomics researchers a lab and data management solution with unsurpassed integration and protein analysis capabilities. This cooperative effort was aided by GenoLogics’ and Proteome Software’s use of common java technologies, strong customer collaboration philosophies, and commitment to pursuing future product integrations. Proteus-Analytics makes high throughput, high accuracy protein identification manageable, by combining an automated proteomics pipeline with focused peptide automated and manual validation. Proteus, the LIMS and data management component of Proteus-Analytics, is built on a configurable informatics platform. This platform is based on an open architecture which helps facilitate the tight integration to ScaffoldBatch, resulting in a comprehensive end-to-end solution for proteomics research. CEO of Proteome Software, Mark Turner, said, “Proteus-Analytics enables high throughput proteomics labs to achieve confident protein identifications, by uniting the strengths of Proteus and ScaffoldBatch. Proteus’s strength is high throughput proteomics; Scaffold’s is improving the confidence in the proteins found – the result is an end-to-end solution that enables researchers to manage, store, and organize experimental data, and confidently validate protein identifications from tandem mass spectrometer data.” James DeGreef, VP of Product Strategy at GenoLogics, stated, “We are really excited about the interest our current customers have already shown in this new product bundle. Over the next few months we expect many of our current Proteus customers will upgrade to Proteus-Analytics simply because of the obvious benefits this seamless product integration offers them, for a relatively small incremental cost and implementation effort.” For details, visit http://www.genologics.com/products/proteus/proteus_analytics.php.

Thermo Fisher Scientific Deploys SampleManager LIMS at Intertek

Thermo Fisher Scientific Inc. has announced that Intertek, a leading global provider of quality and safety services, has selected SampleManager LIMS as its corporate standard to manage laboratory data in the laboratories of the Intertek Oil Chemical and Agri Division (Caleb Brett). With its global headquarters in Houston, Intertek Oil Chemical and Agri division provides contract testing services to a range of industries from its analytical testing laboratories worldwide. SampleManager LIMS, a Thermo Scientific laboratory information management system (LIMS), was selected to replace an existing commercial system, as well as a home-grown LIMS and manual processes. "Intertek selected SampleManager ultimately because it will benefit our own internal data-sharing and enhance our end-service to our customers. The system offers a majority of the functionality that Intertek requires, with the least amount of customization compared to other solutions we evaluated,” said Darryl Jesionowski, Intertek Oil Chemical and Agri General Manager of Laboratories, Americas, and LIMS project manager. “We look forward to creating one virtual lab with this implementation, using a central server to connect all our Americas laboratories in real-time for access to data, no matter where it is entered.” As the leading provider of commercial laboratory services globally, Intertek handles high volumes of samples requiring rapid turnaround and accurate results for its customers, who range from world’s largest oil companies to local service companies and operate across the commodities sector. A standardized SampleManager deployment integrates the many Intertek Oil Chemical and Agri laboratories in real-time for Intertek users and customers alike to access data. Jesionowski explained that, previously, time and human resources were required to transfer data back and forth between laboratories and customers. “With SampleManager, data will automatically be available,” he said. Additionally, Intertek benefits from SampleManager’s thin-client Web interface, which enables remote users and customers to easily access data. Intertek Oil Chemical and Agri, which piloted SampleManager in one of its larger laboratories, plans to deploy the LIMS across more than 90 percent of its Americas-based laboratories by 2008, and transition out the commercial LIMS now used independently in six laboratories by the end of 2007. Intertek’s long-term strategy is to deploy SampleManager and other Thermo Scientific LIMS and chromatography data and spectroscopy software across Intertek Oil Chemical & Agri locations internationally, according to Jesionowski. For details, visit http://www.thermo.com/informatics.

Thermo Fisher Scientific Introduces New Functionality in Darwin LIMS v 2.0

Thermo Fisher Scientific Inc., aworld leader in serving science, has continued to strengthen the core functionality of its purpose-built laboratory information management system (LIMS) for pharmaceutical manufacturing R&D and QA/QC applications. Thermo Scientific Darwin LIMS provides pharmaceutical users with environmental monitoring and other important features out-of-the-box, lowering the total cost of ownership and significantly reducing deployment risk. "We are excited to show pharmaceutical customers how far Darwin has come since its commercial debut a year ago,” said Dave Champagne, vice president and general manager of informatics for Thermo Fisher. “With the enhancements made in version 2.0, customers can count on Darwin to meet the core requirements of their pharmaceutical manufacturing setting, whether in R&D labs for analytical development or QA/QC laboratories for product quality.” Already offering dissolution, stability management, product and batch management, and system interfacing, Darwin 2.0 adds environmental monitoring to the list of out-of-the-box functionality. These standard requirements of pharmaceutical companies, previously met via customization or implemented as an additional module in a generic LIMS, are now addressed by Darwin as standard functionality requiring minimum configuration. This lowers the cost, risk and time associated with LIMS implementations, validation and upgrades. Environmental monitoring, critical to compliance and quality assurance, includes such functionality as test allocations for monitoring sampling points and frequency of collection. The reporting engine in Darwin has also been dramatically enhanced. Retriever, a web-based data enterprise reporting solution, features dashboard management that enables Darwin users to measure and even forecast key performance indicators in real time. Retriever allows data from any informatics systems, current or legacy, to be directly and securely accessed by the appropriate people within the organization. Also new in Darwin 2.0: support for the creation and management of inspection lots via a tight integration with SAP; enhanced instrument management; a new, advanced formula builder to define complex components limits; support for test allocations; and improvements to the review and approval process that make it easier and faster for users. For details, visit http://www.thermo.com/informatics.

Applied Biosystems Releases New Versions of SQL*LIMS Software and Adds New Functionality

Applied Biosystems has announced new versions and enhancements of its award-winning SQL*LIMS Software at the Pittcon 2007 Conference & Expo. The company released a new 5.1 version of the software that supports Oracle 10gR2 Database, introduced SQL*LIMS, a true plug & play LIMS for pharmaceutical QA/QC, and announced the development of advanced analytics for its SQL*Stability Software. Release of SQL*LIMS v5.1 offers full support for Oracle's 10gR2 database and 10gR2 Application Server. Oracle Database 10g delivers better results by automating administrative tasks, providing industry-leading security and regulatory compliance features, and enabling the highest availability with Real Application Clusters. SQL*LIMS P4 Plug & Play Pharmaceutical Package is a fully functional, fully configured, fully validated LIMS solution that can be deployed almost immediately. Because SQL*LIMS P4 is shipped with industry-standard SQL*LIMS Software and pre-configured with the functionality needed by most pharmaceutical manufacturing operations, virtually no customization is required, which simplifies training, maintenance, and upgrades. The end result: faster deployment, lower cost of implementation, and most importantly, lower total cost of ownership. Exclusively for SQL*Stability, Applied Biosystems and Northwest Analytical (NWA) have introduced a module that provides advanced stability analytics. In addition to complete protocol management, data collection, and inventory tracking, this unique combination will provide the stability manager with a powerful, but user-friendly analytics capability, including regression analysis, calculation of expiry dates, and ANCOVA analysis for pooling multiple studies. Complete stability workflow from within one system speeds response time of stability results, streamlines validation issues, reduces errors, and decreases total IT costs. Multi-site operations will benefit from standardized SOPs and a consistent workflow across multiple stability departments. A full complement of standard Stability Reports are also available through SQL*LIMS. For details, visit http://www.sqllims.com.

LabVantage Sapphire Achieves"Powered by SAP NetWeaver" Status

LabVantage has announced that its LabVantage Sapphire solution has achieved "Powered by SAP NetWeaver" status. The certified integration enables the exchange of information between the mySAP ERP application and LabVantage’s Sapphire Laboratory Information Management Suite (LIMS) using the SAP NetWeaver Exchange Infrastructure (SAP NetWeaver XI) Release 7.0 and LabVantage Sapphire. LabVantage Sapphire Enterprise Connector, a component of LabVantage Sapphire, is a separately installable and configurable application-to-application (A2A) tool that facilitates tailored, bi-directional data flow between LabVantage Sapphire and mySAP ERP. It was developed by LabVantage through a joint information technology (IT) partnership with TCGIvega, expert consultants experienced in SAP solution-based integrations. LabVantage Sapphire can be implemented at various stages of quality and materials control processes within mySAP ERP to realize real-time data updates. "We are extremely excited to introduce to our customers the interface between mySAP and LabVantage Sapphire, which has achieved Powered by SAP NetWeaver qualification," said Jim Aurelio, President and CEO of LabVantage. "As organizations require LIMS and SAP solutions to fulfill their needs, LabVantage Sapphire, integrated with mySAP ERP and Powered by SAP Netweaver, will significantly enhance operational efficiency for our customers through a cohesive information technology infrastructure." A chieving Powered by SAP NetWeaver status verifies the seamless integration between LabVantage Sapphire and mySAP ERP and confirms the existence of product functionality in accordance with SAP's certification procedures. The SAP Integration and Certification Center has certified that LabVantage Sapphire 4 properly integrates with the SAP NetWeaver XI component of the SAP NetWeaver platform to exchange critical data with instances of the mySAP Business Suite family of applications and has demonstrated that LabVantage Sapphire is integrated successfully with the SAP NetWeaver Portal. For details,visit http://www.labvantage.com.

IWW Selects STARLIMS to Meet Stringent German and EU Drinking Water Standards

STARLIMS Corporation has been selected by IWW Water Centre, Muelheim, one of the leading water research institutes in Germany. By implementing the entirely web-based STARLIMS V10 system, IWW will ensure full compliance with stringent water quality regulations, including German, ISO and European standards. "We are committed to providing the highest level of water testing to all our customers, and implementing STARLIMS' state-of-the-art technology helps us guarantee that we will continue doing just that," said Dr. Ulrich Borchers, Manager of the Water Quality Department at IWW. "In addition to providing full traceability of all types of water testing, STARLIMS will enable us to provide more timely and convenient service to our multinational client base."
STARLIMS Outperforms Industry-Specific Systems. The STARLIMS solution was selected over systems expressly developed for water testing. During extensive evaluations, IWW determined that the STARLIMS application would be flexible enough to meet all their specific requirements. At the same time, the STARLIMS application was viewed as more future-proof than competing solutions, since it is entirely based on advanced Internet technologies. As an entirely web-based service, STARLIMS will enable IWW staff to communicate easily even with sites across Germany. STARLIMS' partner in Germany, Axel Semrau GmbH, provides fully localized service, including consulting, implementation and ongoing support. "IWW's selection attests to the compelling advantages of our web-based approach, which is flexible enough to outperform even industry-specific alternatives," said Tamir Gotfried, General Manager of STARLIMS' European operations. "This is the payoff of 20 years of LIMS-only R&D: having amassed a complete set of tools and wizards, we can meet most requirements of most labs straight out of the box. The rest is easily configured using our intuitive web-based application." For details, visit http://www.starlims.com.

Thermo Fisher Scientific Finalizes Informatics Sale to Sinopec, China’s Largest Company

Thermo Fisher Scientific Inc. has announced that Sinopec, the largest company in China and its leading producer and supplier of oil and petrochemical products, signed a contract to standardize on Thermo Scientific laboratory information management systems (LIMS), chromatography data systems (CDS) and desktop spectroscopy software. As the corporate standard at Sinopec, the systems will be used to track, store, manage, report and share data enterprise-wide. The standardization project is focused on saving costs and reducing time-to-market, as well as improving overall product quality through more efficient use of data. After a pilot implementation at its Sinopec Guangzhou Branch, the company decided to implement Thermo Scientific SampleManager LIMS, Atlas CDS and GRAMS enterprise software throughout multiple laboratories in its refinery, chemical and R&D facilities in China. At the Quality Inspection Center in Guangzhou, operators have real-time data monitoring and are alerted to any data variation. When irregularities are spotted, system users can take immediate action to probe for possible causes and make necessary adjustments to ensure product quality. As China’s largest producer and supplier of oil and petrochemical products, and second largest producer of crude oil, Sinopec is an integrated energy and chemical company. The scope of its business mainly covers oil and gas exploration, development, production and marketing; oil refining; production and sales of petrochemicals, chemical fibers, chemical fertilizers and other chemical products; storage and pipeline transportation of crude oil and natural gas; import, export and import/export agency business of crude oil, natural gas, refined oil products, petrochemicals, chemicals and other commodities and technologies; research, development and application of technology and information. For details, visit http://www.thermo.com/informatics.

QSI Adds COSHH Compliance Software to Rental Scheme

QSI (Quality Systems International) have announced a decision to make more of their Quality Assurance software products available by rental. The first of these to be released is RisQ, QSI’s Health and Safety compliance and Risk Assessment package. RisQ was originally developed as an optional module for WinLIMS in response to customer requests, but has now been extended and upgraded to a full functionality stand-alone package. QSI’s Clive Collier commented “RisQ offers faster, more accurate risk assessments, aids compliance with legislation and helps to improve a company’s health and safety record. We believe that small and medium sized businesses are not well served in terms of cost or system capability in this application area, and that’s why we’ve extended the scope of our rental operation – although large organisations can benefit too.” RisQ will appeal particularly to those seeking to comply with COSHH regulations and create comprehensive risk assessments within the working environment. All relevant details of each material – including its CAS and EC reference numbers, physical and chemical properties and of course specific hazard data complete with the appropriate hazard symbols, are held in the system’s database, enabling the production of Materials Safety Data Sheets (MSDS) whenever required. Other data held, such as supplier and delivery records and information on storage and location, enables the total inventory of hazardous materials to be viewed at any time. Using this comprehensive data, RisQ uses functionality consistent with the guidelines of the Royal Society of Chemistry to create detailed Risk Assessments for each material. For details, visit http://www.qsiuk.com.

Pharmaceutical Services Corporation Launches New Informatics Division

Pharmaceutical Services Corporation (PSC), one of the largest validation and quality assurance consulting organizations worldwide, has launched a new Informatics division focused on providing consulting services specific to the selection, implementation, and migration of LIMS and similar mission-critical laboratory software systems. The new Informatics Division is spearheaded by Phil Lofty, PSC’s Vice President, Business Development. “The launch of this new solution-specific division enhances the current services offered by PSC, and is designed to help our clients meet not only their needs today, but also be positioned to meet Informatics challenges downstream,” Lofty explains. “For instance, as regulations and competitive pressures drive changes, we work closely with our clients to ensure that their labs have the information infrastructure to stay current with regulatory requirements while leveraging Best Practices in laboratory systems and processes.” PSC’s new Informatics Division is composed of seasoned industry consultants who have worked in all areas of the drug discovery process and possess extensive backgrounds in management, IT and science. They are experts in the implementation, integration, and validation of leading commercial informatics packages. In addition to extensive expertise in the pharmaceutical and biotech markets, many PSC’s consultants are also knowledgeable in the petrochemical and specialty chemicals industries, enabling them to draw on valuable cross-industry knowledge.
“We can assist our clients to align and optimize all aspects of their laboratory operations, from the CDS on the chemist’s workbench, to the LIMS that manages their lab data, to the ERP that ties the lab to the rest of their organization,” Lofty points out. “Whether an organization requires a complete turn key implementation solution for a global multi-site project or a focused local deployment for a single lab, our services can be scaled to specific needs. For all our clients, our Informatics Services are designed to maximize their process efficiencies, improve their productivity and reduce their total cost of ownership (TCO).” PSC Informatics Services are specifically oriented towards servicing the needs of Research & Development (R&D) laboratories. This includes refining and optimizing all computer and information technology systems within the laboratory. They provide support for all stages of Informatics implementation, from strategy and planning through to implementation and validation. For details, visit http://www.biotech.com.

Core Informatics Partners with ChemAxon to Provide Chemo-Informatics Capabilities Within their Core LIMS Product

Core Informatics has entered into a partnership to provide ChemAxon’s state of the art chemo-informatics capabilities within Core Informatics web-based Laboratory Information Management System: Core LIMS. The partnership maintains Core Informatics as a leading provider of custom LIMS solutions to the pharmaceutical industry. The Core LIMS is a highly configurable LIMS that enables scientists to track any aspect of a drug candidate’s life from sample registration to IND filing. Each installation is customized to reflect the unique needs and requirements of the client offering rich opportunities for integration. The addition of the ChemAxon toolkits brings chemical awareness to the Core LIMS suite and powers chemistry functionalities like; chemical registration, chemical inventory, substructure and similarity searches, SAR table generation and calculated properties. "We are very pleased about the partnership with Chemaxon” said Anthony Uzzo, President of Core Informatics. “There is a rich range of extremely solid chemo-informatics toolkit capability here which translates to a lot of scope for us to implement and evolve customized solutions for our chemistry focused clients." For details, visit http://www.corelims.com.

Labtronics Launches Nexxis iLAB for Real-Time Management of Laboratory Information

With the release of Nexxis iLAB, Labtronics Inc. has introduced a new breed of informatics technology that collects and combines information from laboratory informatics systems, laboratory instruments and analysts and uniquely integrates it into every aspect of a laboratory's daily routine. Nexxis iLAB controls and automates manual procedures in Real-Time, maximizing resource utilization, minimizing management overhead and automatically ensuring adherence to Standard Operating Procedures. Real-Time management of laboratory information means that laboratories can guarantee analysts always follow SOP requirements, that instruments are always calibrated, that chemicals are never used after their expiry date and more. For details, visit http://www.labtronics.com.

eMolecules Announces Integration of ACD/Labs LogP Predictions for Chemical Structures

eMolecules, Inc., the provider of the world’s largest online chemistry database, and Advanced Chemistry Development, Inc. (ACD/Labs), have announced a collaboration that will allow predicted logP data to be displayed in eMolecules freely accessible online database of 5.6 million unique chemical structures. By integrating ACD/Labs’ logP Batch into its state-of-the-art chemical structure search platform eMolecules extends the power and relevance of its high-performance search engine with the ability to preload predicted logP values for small molecule structures. The addition of logP— a measure of a molecule’s lipophilicity—enables more efficient selection and procurement of chemical structures from the eMolecules data set of more than 3.5 million commercially available chemicals. Application of this property spans many industries and areas of research from drug discovery, agrochemicals research, and flavors and fragrances, to monitoring pollutants and their progress through our environment. As such, this physicochemical property is of importance to a broad audience. For details, visit http://www.acdlabs.com.

Labtronics Partners with VALcoa

Labtronics has announced that it has entered into a partnership with VALcoa. With this partnership, mutual clients can benefit from the shared expertise of the organizations in meeting their laboratory informatics needs within regulated environments. An industry leader in laboratory data integration and management solutions, Labtronics offers advanced software and data integration solutions. VALcoa, Inc. offers Validation Services, LIMS Solutions, Information Technology (IT) and Instrumentation, and Manufacturing Services to major pharmaceuticals in the United States, Puerto Rico, Latin America, Canada and Europe. For details, visit http://www.valcoa.com.

ATL Highlights New Features in Sample Master Pro LIMS at Pittcon 2007

Accelerated Technology Laboratories, Inc. (ATL) exhibited new features in Sample Master Pro Laboratory Information Management System (LIMS), Sample Master Result Point, Sample Master Windows PDA Mobile Integration and much more at Pittcon 2007. This year the annual conference was held Feb. 25th – Mar. 2nd at the McCormick PlaceConvention Center in Chicago, IL. For details, visit http://www.atlab.com.

Applied Biosystems Introduces New DNA Technologies that Address Major Challenges Facing Forensic Scientists

Applied Biosystems has announced the first commercial reagent kit for analyzing degraded or limited DNA; a system with new software for automating DNA testing processes to streamline forensic laboratory workflow; and a new software application for expediting the process of laboratory validation. The company said that it expects the AmpFÜPSTR MiniFiler PCR Amplification Kit for degraded DNA, the HID EVOlution System and VALID Software will help the more than 10,000 forensic laboratories around the world maximize the use of DNA in human identification. DNA contained within biological evidence found at a crime scene is a powerful tool for identifying and excluding potential contributors. Similar to fingerprinting, DNA testing can identify and differentiate between individuals. Because DNA can be the ultimate proof of identity, DNA analysis systems have become a significant part of the investigative process. Forensic laboratories use an integrated suite of DNA analysis technologies, instrumentation and human identification analysis software to effectively process DNA collected at crime scenes. Each of these products and technologies are designed to work in unison to strengthen a crime laboratory’s capacity to process reproducible and defensible DNA samples and eliminate sample backlogs. These technologies were developed to enable forensic technicians to more efficiently use DNA in solving crimes, exonerating the wrongly accused and identifying missing persons. "Because DNA can be found virtually everywhere, it has become a great resource in providing information that aids the investigative process, and there are great demands on forensic labs to process samples in a quality, timely manner that meets regulatory requirements,” said Kevin Lothridge, executive director of the National Forensic Science Technology Center (NFSTC). “With tools that expedite and expand the forensic laboratory’s capacity to make positive identification, we can better support law enforcement and public safety professionals in their efforts to prosecute the guilty and exonerate the innocent.” For details, visit http://www.appliedbiosystems.com.

Symyx Technologies Releases New Version of Symyx Software Discovery Notebook

Symyx Technologies, Inc. has announced the release of Symyx Software Discovery Notebook version 4.0. Using the Symyx Discovery Notebook, chemists in pharmaceutical discovery research can plan, record and analyze research, experiments and procedures more efficiently and effectively than with traditional paper lab notebooks.
Discovery Notebook is one of a series of Symyx Software offerings which include electronic lab notebook (ELN) applications tailored to meet the specific needs and protocols of chemists in the discovery, process, analytical, formulations and bioprocess functions. The latest version of Discovery Notebook features an easy-to-use interface for single and parallel experimentation, an advanced software developer kit (SDK), extensive searching and browsing capabilities and a pre-loaded reaction template database containing 30,000 transformations. "This new version of our Discovery Notebook represents the successful integration of several key acquisitions that Symyx has made,” said Paul Nowak, chief operating officer of Symyx Technologies. “This product is uniquely designed to integrate easily into users’ existing systems so they can leverage their current resources, allowing for increased productivity, enabling better data collection and use, and providing more opportunities to make breakthrough discoveries. Our reaction template database ensures that scientists are able to get value right away from Symyx Software, without having to wait one to two years, the typical time it takes before a company’s internal database reaches critical mass.” Discovery Notebook version 4.0 features enhanced searching and browsing capabilities. Utilizing a multi-variable search window the new version includes a powerful search panel that allows scientists to search within sets of prior results and a multi-panel layout eases browsing through experiment data. New usability enhancements include improved scientifically accurate calculator capabilities, drag and drop functionality, icon-based entry for facile data capture and additional experiment property tabs that allow users to capture and configure experiment metadata. Another key new feature of version 4.0 is the inclusion of a software developer kit that allows organizations to create custom forms such as a registration interface. Discovery Notebook 4.0 is based on the Symyx Vault ELN document management platform, also used in other Symyx notebook products. Symyx Vault provides a single, comprehensive platform for ELN documents that can span the entire R&D organization, supporting document browsing and searching, enterprise-level security and auditing, and configurable and highly flexible document workflow. Discovery Notebook version 4.0 is now available for deployment. For details, visit http://www.symyx.com.

Labtronics Releases Latest Version of Nexxis qELN

Labtronics has announced that Version 4.0 of their web-based electronic laboratory notebook has been released. Nexxis qELN is specifically designed to eliminate the paper associated with manual routine procedures in the laboratory. Highlighted in this release are the advanced integration capabilities of ELN with other Nexxis COTS (Custom Off-the-Shelf Solutions) such as Nexxis CIM (Chemical Inventory Manager) and Nexxis CAL (Instrument Calibration Manager). With a zero footprint web client and a scalable, n-tier architecture, Nexxis qELN is an ideal solution for both the individual laboratory and the enterprise. For details, visit http://www.labtronics.com.

Invetech’s Process Engineering Service Improves Laboratory Workflow Efficiency

Invetech, a specialist in instrument development and custom automation, is offering clients a unique process engineering service to improve workflow efficiency in laboratories. The service employs advanced models from the engineering and manufacturing industries, using both automated and non-automated approaches, to identify and eliminate pinch-points and to plan for future changes. Staff in modern laboratories are witnessing increased pressure through growing workloads and time consuming tasks, and scientists have little time to reorganize processes themselves. Invetech employs a team of engineering experts who will integrate with pharmaceutical, clinical and medical laboratory staff to identify causes and analyze problem areas to determine which processes can be changed. The team maps the processes using a state-of-the-art software package and works with laboratory management to determine control strategies. This ensures the changes take place and future additions to laboratory instrumentation can fit seamlessly and efficiently into the new process. Invetech provides advice on workflow issues and will find the best solutions for each individual laboratory. Its aim is to provide a more efficient working environment where scientists are able to apply their skills for maximum effect, improving working conditions for laboratory staff, and increasing throughput and the quality of results. Its specialists will explain which processes will improve through automation, and Invetech can design, manufacture and deliver new bespoke technology to meet this need. Where automation is not viable, the team will employ models from the engineering and manufacturing industries to reduce pinchpoints. For details, visit http://www.invetech.us.

Cerno Bioscience Offers New Online Calibration Tutorial for MassWorks

Cerno Bioscience has announced the availability of a new online tutorial to accompany its groundbreaking MassWorks CLIPS (Calibrated Lineshape Isotope Profile Search) software, a novel method of attaining fast and reliable elemental composition determination (ECD) from single or triple quadrupole mass spectrometers. The tutorial, which can be accessed via www.cernobioscience.com, illustrates how MassWorks CLIPS attains unambiguous elemental composition ID, a capability which has until now been unavailable using mass accuracy alone, and is difficult to achieve even on expensive high resolution systems. The new Cerno Bioscience tutorial describes how, when using classical calibration methods, Mass Spectrometry (MS) data is calibrated for mass position only. This approach leads to substantial errors due to the undefined peak shape, noise, and the empirical basis of conventional centroiding algorithms. Therefore, elemental composition analysis can typically only be carried out using expensive higher resolution systems. The tutorial demonstrates how MassWorks CLIPS uses Cerno Bioscience’s patented approach to MS calibration to accurately locate peaks and suppress noise affecting analysis, enabling users of any single or triple quadrupole mass spectrometers to carry out accurate ECD. MassWorks CLIPS relies not only on mass accuracy but also on a newly developed and uniquely sensitive metric, spectral accuracy, to evaluate formula of very similar exact masses. The new tutorial shows how CLIPS, which was launched at PITTCON 2007, utilizes the accurate mass calibration of MassWorks to obtain up to 5ppm mass accuracy with single and triple quadrupole instruments. Providing an insight into how CLIPS uses mass accuracy and spectral accuracy, the flash tutorial illustrates the unique advantages of MassWorks CLIPS when compared to using mass accuracy alone. For details, visit http://www.cernobioscience.com.

Thermo Fisher Scientific Announces OEM Partnership with Aspectrics GRAMS Spectroscopy Software Sold with EP-NIR Analyzer

Thermo Fisher Scientific Inc. has entered an agreement with Aspectrics, Inc. to include Thermo Scientific GRAMS spectroscopy software in Aspectrics’ new Encoded Photometric Near Infrared (EP-NIR) process analyzer. "We are excited to offer GRAMS’ world-class software as part of our MultiComponent 2750 analyzer,” said Jim Yano, vice president of marketing for Aspectrics. “As the industry standard, GRAMS is well known to our customers, easy to use, and provides superior capabilities, such as chemometrics, that are important for our customers. Combining Thermo Fisher’s rich heritage in spectroscopy software with Aspectrics’ innovative EP-NIR technology will enable our customers to achieve faster and more reliable analyses.” " This agreement demonstrates the strength of GRAMS in the marketplace” said Dave Champagne, vice president and general manager of informatics at Thermo Fisher Scientific. “GRAMS is an open standards platform from which Aspectrics’ clients can control and integrate data from multiple instruments from multiple vendors.” GRAMS is relied on by spectroscopists worldwide for visualizing, processing and managing data from FT-IR, NIR, Raman, UV-Vis, Fluorescence, NMR and hyphenated instruments manufactured by multiple vendors. It interfaces with more than 150 instruments, including leading Thermo Scientific spectroscopy and chromatography products. GRAMS’ use of open standards has made it the platform of choice for customers and third parties working in both regulated and unregulated environments. For details, including download of a free demonstration, visit http://www.thermo.com/grams.

AcquiData Announces Release of Testream/CS 7.0

AcquiData, Inc., a global leader in Product Quality Automation Systems, has announced the release of Testream/CS 7.0. This release brings a wealth of new capabilities including a number of new features added to ReportWriter, AcquiData’s pioneering data reporting tool. Employing an intuitive "Drag and Drop" interface, ReportWriter enables users to easily combine different data elements – spreadsheets, graphs, control charts, Word documents, cpk analyses, text labels, histograms, pictures, etc – into one powerful report. ReportWriter joins with Testream/CS’ Real Time Display Program to offer two ways to access test results: in real time as automatically updating web pages viewable over their company’s intranet, or as print, html or Excel spreadsheets. As a suite of web-based applications that automatically acquire, analyze and report on QA/QC data, Testream/CS stands apart from LIMS or data acquisition products. With instrument interface programs numbering in the hundreds, out of tolerance alarming capabilities and the extensive reporting tools discussed above, Testream/CS can stand alone or easily integrate with other MES, process control or business information systems. For details, visit http://www.acquidata.com.

ABB’s AutoLab and RMP Successfully Installed at Indocement’s Cirebon Plant

ABB Switzerland Ltd has announced the successful commissioning of their new systems at Indocement’s (PT Indocement Tunggal Prakasa Tbk.) Cirebon plant. The total system included the installation of a fully automatic laboratory for two production lines including sampling stations, sample transport, sample preparation, analyzing equipment and an ABB robot. The contract represented a major investment by Indocement and also required the extension of existing equipment and systems and upgrading the control management. As well as the latest version of ABB’s Raw Mix Preparation (RMP) system, installation also included ABB’s Knowledge Manager and Laboratory Information Management System (LIMS). In their retrofit and upgrade project Indocement wanted to retain their investment in as much of their existing systems as possible while at the same time having capacity for expansion. This combination of needs presented various technical challenges, especially in ensuring that existing systems and newly installed equipment would be compatible and able to communicate seamlessly. The source materials at Cirebon have a high variability of chemistry and, for example, the sand and clay are used in a widely varying mix. The newly installed RMP has helped to regulate the quality of the product while throughput has also been increased. The controller performance exceeded expectations and can be seen, for instance, in standard deviations from targets that are clearly lower than the specified levels.
ABB’s skilled team of engineers, amongst whom most notable were Mr Walter Fierz, Mr Manoel Morales and Mr Robert Novianto, used their considerable expertise and enormous wealth of experience to deliver a system that fully met Indocement’s requirements. These specific requirements were for flexible growth at a cost effective rate while providing comprehensive solutions for current and future needs. Mike Mound, Quality Systems Manager for the Minerals Business Unit said “we are pleased and proud that our technological experience in quality information management solutions is helping Indocement to meet their goals and is helping them to achieve a new level of competitive performance”. For details, visit http://www.abb.com/cement.

Symbion Systems, Inc. Announces Partnership with Labtronics, Inc. to Enable Spectroscopic Connectivity for LIMS

Symbion Systems, Inc., a leader in providing analytical instrument control, analysis, and connectivity software, has announced a partnership with Labtronics Inc., an industry leader in laboratory data integration and management solutions. Symbion and Labtronics will cooperate in offering integrated solutions combining the capabilities of Labtronics' LimsLink with those of Symbion's DX, RX, and LX product lines. The combination will provide customers with the advantages of LIMS integration and access to a spectroscopic data system capable of controlling virtually any spectrometer, while processing the large data arrays common to spectroscopy. The Symbion family of products is designed to provide a standard software environment for analytical instrumentation that is both a language and a set of comprehensive, yet easy to use programs, covering all aspects of analysis, connectivity, compliance, and control. Recognizing a range of customer needs for a robust solution to work in conjunction with the Symbion products, enabling LIMS connectivity for the various spectrometers and other analytical instruments, Symbion chose LimsLink, the most widely used and flexible instrument interfacing tool in the industry. With LimsLink, data can be easily collected and reported to LIMS, whether to acquire data from an instrument/instrument data system or to transfer information back and forth between the LIMS, the interface and the instrument. Through their expertise and robust solutions, Symbion and Labtronics will provide a powerful data management and interfacing solution. The combined solutions will improve laboratory workflow and assure compliance with industry regulations such as 21 CFR Part 11. For details, visit http://www.gosymbion.com.

South Carolina Port Partners with SAVI Networks to Provide Cargo Secrity and Tracking Information Network

The South Carolina State Ports Authority (SCSPA) and Savi Networks has announced an agreement to extend the SaviTrak information service to three container terminals at the Port of Charleston to enhance the security and efficiency of in-transit cargo shipments. The installation of SaviTrak’s standards-based Radio Frequency Identification (RFID) infrastructure at the fourth busiest container port on the East and Gulf coasts will automate visibility of RFID-sealed containers and their contents, providing the port and its customers with real-time location and status information, automated alerts, and analytics. SaviTrak will link South Carolina’s Wando Welch, North Charleston and Columbus Street terminals, which account for 2 million container shipments a year, with a global network of trade lanes at partner terminals in Asia, North and South America, and Europe. "With some of the most productive container terminals in the nation, we view SaviTrak as a best-of-breed technology solution that enhances supply chain visibility and security for shippers using the Port of Charleston,” said Bernard S. Groseclose, Jr., president and chief executive officer of the SCSPA. “Linking the information about location, environmental and security status to the physical flow of cargo provides improved supply chain visibility to shippers using our port, while enhancing maritime security." Savi Networks has partnerships with major port and terminal operators to build infrastructure at more than 80 terminals worldwide. The SaviTrak information service is built upon open technologies that process real-time data feeds from RFID devices such as electronic seals (E-Seals) that are based on ISO 18000-7 standards. The SAFE Port Act of 2006 calls for the U.S. Department of Homeland Security to define the voluntary use of container security devices in accordance with international standards, specifically referencing ISO. For details, visit http://www.savinetworks.com.

Cerno Bioscience Launches MassWorks CLIPS for Unprecedented Elemental Composition Determination

Cerno Bioscience has announced the unveiling of MassWorks CLIPS (Calibrated Lineshape Isotope Profile Search), an entirely new way to attain fast and reliable elemental composition determination (ECD) from single or triple quadrupole mass spectrometers. Using Cerno’s pioneering calibration techniques combined with this latest breakthrough, users of any single or triple quadrupole mass spectrometer will be able to attain unambiguous elemental composition ID, a capability previously not possible with accurate mass measurements alone and difficult to achieve even on more expensive high resolution systems. During ECD, CLIPS relies not only on mass accuracy but, more importantly, on a newly developed and uniquely selective metric called Spectral Accuracy when evaluating different formulae of very similar exact masses. In order to use the full isotope fingerprint to unambiguously identify an unknown compound formula, CLIPS utilizes the accurate mass calibration of the award-winning MassWorks. Normally, single and triple quadrupole instruments can only produce indistinct unit mass resolution data, but with MassWorks they can obtain up to 5ppm mass accuracy. This enables a formula search to pare down a small number of formula candidates, a capability usually only available in highly specialized high resolution systems. However, MassWorks not only calibrates the instrument data to accurate mass, it also calibrates the actual instrument lineshape to a known mathematical function. This allows for the accurate calculation of the theoretical isotope profile for each formula candidate using the same lineshape as the calibrated lineshape. The patented CLIPS algorithm then matches each formula candidate to the calibrated mass spectrum with unparalleled differentiating power to provide a unique formula determination via the Spectral Accuracy metric. For users with access to high resolution instruments, CLIPS also provides inexpensive and routine ECD on a day-to-day basis using simple, less expensive equipment. This frees up the high resolution systems and their highly trained operators for more challenging tasks. In addition, CLIPS can significantly reduce labor costs, as ECD can now be performed more routinely by less experienced operators. For details, visit http://www.cernobioscience.com.

Thermo Fisher Scientific to Implement Darwin LIMS at Cell Genesys

Thermo Fisher Scientific, Inc. has announced that Cell Genesys, Inc., a California-based company dedicated to developing and commercializing novel biological therapies for patients with cancer, has selected Thermo Scientific Darwin LIMS v 2.0 to manage its laboratory data. "Cell Genesys selected Darwin as the LIMS to be implemented in our organization for several reasons,” said Charlene Banard, vice president, Quality, at Cell Genesys. “The following factors were instrumental in our decision to select Thermo Fisher over other leading LIMS providers – Darwin’s ability to meet user requirements in an out-of-the-box solution, thus minimizing customization and implementation time; its user interface; Thermo Fisher’s Quality System and coding practices; the company’s longevity and success; and total cost of ownership. The implementation of Darwin LIMS is one of the key activities we are undertaking to better enable our organization to develop and commercialize novel biological therapies for patients with cancer." Darwin LIMS is designed to support, out-of-the-box, the complex testing, workflow and regulatory requirements in pharmaceutical manufacturing R&D and QA/QC environments. Standard functionality includes dissolution, stability testing, environmental monitoring and product and batch management. This ensures compliance with regulations from the US Food and Drug Administration. For details, visit http://www.thermoscientific.com/informatics.

Thermo Fisher Scientific to Develop Next-Generation Laboratory Software Solutions on Microsoft Platform

Thermo Fisher Scientific Inc. has announced that it has established a working relationship with Microsoft aimed at developing next-generation laboratory knowledge management solutions designed to move science forward at an accelerated rate. The products will be built on Microsoft’s technology platform. Thermo Fisher’s laboratory informatics experience, deep industry knowledge and world-class software development expertise – coupled with Microsoft’s scalable, secure and flexible open standards technologies – will allow the development of easy-to-use software tools that increase laboratory productivity with less risk and a superior user experience. "We’re encouraged that Thermo Fisher Scientific will build its next-generation application on Microsoft’s technology platform,” said Paul Mattes, life sciences industry solutions director, Microsoft’s U.S. Healthcare and Life Sciences Group. “Ultimately, this will benefit life sciences customers who will be able to take advantage of Thermo Fisher’s in-depth industry expertise combined with Microsoft’s scalable, secure and easy-to-integrate software platform.” Thermo Fisher has already developed Darwin LIMS, its purpose-built laboratory information management system (LIMS) for pharmaceutical manufacturing R&D and QA/QC, on the Microsoft.NET platform. In addition, SampleManager LIMS, Thermo Fisher’s flagship product for process industries, is now supported on the SQL server, providing customers with a choice of databases. Last month, Thermo Fisher announced that it is more committed than ever to support the open XML standards for data exchange as a member of the Microsoft Bio-IT Alliance. The alliance unites leaders in the pharmaceutical, biotechnology, hardware and software industries to explore new ways of sharing complex biomedical data and collaborate among multidisciplinary teams to ultimately speed the pace of drug discovery and development. The two companies are working together to continue to provide customers with end-to-end solutions for data acquisition storage and analysis. Thermo Fisher is now working on a new Electronic Laboratory Notebook (ELN) solution that will be based on the Microsoft.Net 3.0 Framework. ELNs, as a category, are designed to replace the paper notebooks in which scientists and researchers record extensive notes resulting from their experiments and processes. In addition to collaborating with their colleagues, scientists will use the ELN to access unstructured research and reference information as well as the structured laboratory testing information that resides in LIMS and chromatography data systems (CDS). For details, visit http://www.thermo.com/informatics.

Robert B. Schnabel Selected Dean of IU School of Informatics

Indiana University President Adam W. Herbert has announced that Robert B. Schnabel, an acclaimed computer scientist and researcher, will become the next dean of the IU School of Informatics pending approval by IU trustees. Schnabel is vice provost/associate vice chancellor for Academic and Campus Technology and professor of computer science at the University of Colorado at Boulder. As vice provost, he serves as chief information officer of CU-Boulder, and as the director of the Alliance for Technology, Learning and Society (ATLAS) Institute. "Professor Schnabel has built a national reputation as an academic leader and scientist. He is a strong advocate for the multidisciplinary collaborations that are absolutely vital to the fulfillment of the school's mission. He also has a strong commitment to diversity and has championed programs promoting diversity in IT at all levels. We are both delighted and proud to welcome Professor Schnabel into the IU family," Herbert said. Schnabel succeeds J. Michael Dunn, who will retire June 30. Dunn, who came to IU in 1969 to teach philosophy and rose through the ranks at the College of Arts and Sciences to become its executive associate dean, is credited with building the School of Informatics -- the first of its kind in the nation -- into an internationally recognized education and research center in information technology. When Schnabel becomes dean, he will assume leadership of the university's newest school, which offers academic programs at IU campuses at Bloomington, Indianapolis, South Bend, Southeast (New Albany) and Kokomo. The informatics program also has been approved for IU campuses at Northwest (Gary) and East (Richmond). Established in 2000, the School of Informatics, which includes the Department of Computer Science (Bloomington) and the New Media Program (IUPUI), has 1,500 undergraduate and graduate students, and more than 1,100 alumni. Schnabel has held a number of positions at the University of Colorado prior to his current roles. He was the associate dean for academic affairs, College of Engineering and Applied Science, and chair of the Department of Computer Science. His research and teaching interests include numerical computation, parallel computation, applications to molecular chemistry, and diversifying participation in computing and information technology, both in the areas of education and workforce development. A recipient of numerous teaching and professional awards, Schnabel has led three major campus-wide information technology strategic planning initiatives at the University of Colorado since 1998, leading to many significant administrative and academic innovations on the Boulder campus. As founding director of the ATLAS Institute, he has led the development of a campus-wide program providing multidisciplinary curriculum, research, and outreach programs that integrate information technology with a wide variety of disciplines and people, both inside and outside the university, including the recently opened $31 million ATLAS Building. Through ATLAS, he has been particularly active in programs aimed at broadening the participation of women and under-represented minorities in computing. Schnabel has been principal investigator or co-principal investigator on research projects representing more than $30 million in research funding from the National Science Foundation, the Army Research Office, the Air Force Office of Scientific Research and other organizations. He has served as associate editor or co-editor of five journals and on many professional committees and boards. Currently he serves as editor-in-chief of SIAM Review, the flagship journal of the Society for Industrial and Applied Mathematics. Schnabel is on the board of directors of the Computing Research Association and serves as chair of the Information Technology Deans group of CRA and of the Education Policy Committee of the Association for Computing Machinery. He is co-founder and a member of the executive team of the National Center for Women & Information Technology, and is active in a number of committees and alliances involving minority-serving institutions. Schnabel earned his doctorate and master's degrees in computer science from Cornell University and his undergraduate degree in mathematics from Dartmouth College.For details, visit http://www.informatics.iu.edu.

Industry Veteran Phil Lofty Joins PSC to Launch New LIMS Division

Pharmaceutical Services Corporation (PSC), one of the largest validation and quality assurance consulting organizations worldwide, has appointed Phil Lofty to the position of Vice President, Business Development, based in Pasadena, California. Prior to joining PSC, Lofty managed Quality Assurance, Corporate Computer, and Technical Operations departments for several industry-leading blue-chip companies as well as running his own consulting organization. An experienced QA professional, Lofty has successfully conducted international computer systems consulting services for companies that include Amgen, Allergan, Amylin, Baxter, Biogen-Idec, Johnson & Johnson, and Watson. He has over twenty years of hands-on experience in developing and deploying computer system resources and is skilled in applying technical concepts to improving operations in both FDA regulated and non-regulated environments. He has also managed advanced global technologies while serving the compliance needs of world-class industry clients. "Joining PSC offers a fantastic opportunity to bring a whole new level of service offerings to the pharmaceutical and biotech industries,” Lofty declares. “I am looking forward to developing the areas at PSC that can fully address the challenging issues facing industry, from deploying the latest technology to getting the most out of a company’s mission-critical processes. From Part 11 to MRP/ERP integration, the demands to employ Best Practices tactics just don’t stop.” Lofty will assist the company in developing and launching a new Informatics division focused on providing consulting services specific to the selection, implementation, and migration of Laboratory Information Management Systems (LIMS) and similar mission-critical laboratory software systems. "The launch of this new solution-specific division will really enhance the current services offered by PSC,” states Lofty. “I’ve already selected most of my consulting team – all of whom have years and years of hands-on experience – and I’m really anticipating the division’s launch in early 2007. In fact, the team will offer breadth as well as depth of expertise that goes beyond our core pharmaceutical and biotech markets. Our LIMS consultants have also worked in the petrochemical and specialty chemicals industries and can draw on this valuable cross-industry knowledge for our clients.” For details, visit http://www.biotech.com.

New Freeware Offering Makes ACD/Labs Lipophilicity Predictions Available to All

Advanced Chemistry Development, Inc. (ACD/Labs) has announced the release of a new freeware offering, downloadable from the ACD/Labs website. ACD/LogP, a software tool for predicting the lipophilicity of compounds based on their chemical structure, will now be available as an add-on to the free and commercially-available chemical drawing package, ACD/ChemSketch. LogP, the octanol-water partition coefficient, is a constant which provides a measure of the lipophilic nature of compounds, and is based on the distribution of a particular compound between the two solvents. Water/octanol partitioning is the most commonly used solvent system which provides an approximation of the partitioning of compounds between the lipid membranes of living cells, and cellular and extracellular fluids. "By including logP for free in the ChemSketch interface, we are continuing our tradition of supporting research and education. Chemists who may not otherwise have access to advanced tools can now benefit from them,” said Greg Pearl, PhysChem Product Manager, ACD/Labs. “Freeware is especially valuable to educators and students with limited resources. For example, during a lecture, an educator can interactively demonstrate how subtle changes to a molecule changes it physical properties—much more compelling than discussing a table of numerical results. It also gives students a chance to use the types of tools they will encounter in the workplace.” Current users of ACD/ChemSketch 10.0, freeware and commercial versions, can log on the ACD/Labs website to download the free add-on for ACD/LogP, while new users can register to download the freeware. ACD/ChemSketch is the common interface for the full range of ACD/Labs products, and allows users to easily draw or import chemical structures. ACD/Labs is known throughout the industry for the accuracy and reliability of our physicochemical property prediction software for solubility, pKa, and logD—the lipophilicity of compounds at a specific pH. For details, visit http://www.acdlabs.com.

Labtronics Releases Latest Version of Instrument Calibration Management Software

Labtronics has announced the release of Nexxis CAL (Instrument Calibration Manager) version 4.0. This release includes numerous enhancements, the most significant of which is the system integration capabilities of Nexxis CAL with other Nexxis COTS (Commercial Off-the-Shelf) solutions, such as Nexxis qELN, Labtronics' Electronic Laboratory Notebook. This enhanced integration allows fast and comprehensive integration of Nexxis CAL into the execution of routine procedures in a paperless laboratory environment. This provides a unique bench level assurance that only calibrated instruments can be used for a given test. Nexxis CAL is built on the Nexxis Application Development Platform, which uniquely combines a powerful Application Development Tool for developing laboratory solutions with a scalable web based Laboratory Platform to deploy, manage and execute the applications. For details, visit http://www.labtronics.com.

Labtronics Wins Scientific Computing Product of the Year Awards

Labtronics has been selected for three Scientific Computing, Product of the Year awards. Nexxis qELN was selected as the 'Data Management 2006 Product of the Year'. Nexxis qELN is the first web-based ELN designed specifically for the QC/QA lab. LimsLink CDS was selected as the 'Chromatography 2006 Product of the Year'. As the leader for interfacing CDS to LIMS, LimsLink CDS makes use of 'Embedded Technology' to allow the analyst to connect to LIMS right from within their CDS. Collect was selected as the 'Data Acquisition 2006 Product of the Year'. The new version of Collect provides powerful control options that allow it to interface any RS232/TCP instrument to any Windows program. Its library of close to 500 instruments makes it easy to set up new data collection methods. For details, visit http://www.labtronics.com.

Robert Ellis Joins SciGene Board of Directors

Mr. Robert Ellis was recently elected to the board of directors of SciGene, located in Sunnyvale, California. Mr. Ellis is an industry veteran with over 30 years of experience in developing life science products businesses.
He currently serves as Executive Chairman of Biotrove after having served in the positions of President and CEO. Prior to Biotrove, he was Executive Vice President of Research and Development at Affymetrix. He has also held various executive and senior management positions at Genometrix, Perkin Elmer, Applied Biosystems and Hewlett-Packard. For details, visit http://www.scigene.com.

New Manufacturing Innovation Manager Joins Invetech’s North American Operations Team

Invetech, a specialist in instrument development and custom automation, has announced the appointment of Ian Fitzpatrick as Manager of Manufacturing Innovation in North America. Working with current and prospective clients throughout North America, Ian will lead a team dedicated to exploring how specific client’s manufacturing needs can be achieved. Within this role, Ian is tasked with integrating US nationals into the expanding Invetech team while ensuring Invetech’s work programs are delivered seamlessly. Ian has extensive experience of engineering within the manufacturing industry, and moves from a project management role at Invetech’s Australian office to take up the new position. During his career, he has held various product development and management roles with organizations including Ceramic Fuel Cells Ltd., Established Kadence Engineering Pty Ltd., Nilcra Ceramics Pty Ltd. and ANCA Pty Ltd. For details, visit http://www.invetech.us.

FDA Inspections Down in 2006

Domestic and foreign FDA inspections of biologic and drug manufacturing facilities declined in fiscal 2006, from 4,513 in 2005 to 4,237, according to a recent report from the FDA's Office of Regulatory Affairs. Inspections of facilities regulated by CDER totaled 2,411 in 2006, down 279 from 2005, while inspections for CBER-regulated facilities decreased by 126 to 1,826 for the year, according to the report. In addition, there were 58 Class I recalls in 2006, down from 19 in 2005. There were 45 recalls for CDER-regulated products and 13 for CBER products. Class I recalls are classified as the most important corrections, representing products with a "very serious potential to cause harm, injury or death," according to the FDA. Last Fall, sources said that CDER's decision to perform 45 Class I recalls in 2006 represented a shift in enforcement policy. One such action highlighted in the recent report was Bedford Laboratories' recall of 8,570 vials of preservative-free methotrexate due to an active pharmaceutical ingredient that contained low levels of ethylene glycol. Although the number of Class I recalls spiked last year, the total number of recalls, including Class I, II and III, for both CDER and CBER products declined by 750 to 2,202 for the Oct. 1, 2005, to Sept. 30, 2006, period, the FDA said. The enforcement report said CDER issued 66 warning letters in 2006, while CBER issued 22. The report highlighted several letters to compounding pharmacies. Following the conclusion of fiscal 2006, the agency continued to cite compounding operations, despite a court ruling reducing its authority to regulate compounding pharmacies.
The report can be accessed at http://www.fda.gov/ora/about/enf_story/default.htm.

Von Eschenbach Defends FDA Policies, Proposed Budget

FDA Commissioner Andrew von Eschenbach made his second appearance in two days before Congress to support the agency's proposed 2008 budget, but he also had to defend the agency's handling of Ketek and other controversial topics. Von Eschenbach responded to criticism over user fees, direct-to-consumer (DTC) advertising and conflicts of interest in advisory committees at a House Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee hearing Feb. 28. The agency's proposed budget includes three new user fees that would generate $42.7 million, but Chairwoman Rosa DeLauro (D-Conn.) questioned whether the agency should rely less on user fees and more on appropriations. The proposed budget does not appear to fully fund the FDA's needs, DeLauro said, leaving user fees to make up the difference. User fee critics say the payments allow the industry to have too much influence over the agency. However, the user fees are "compartmentalized" and do not affect the FDA's decisions, von Eschenbach said. He was also challenged on the agency's use of advisory board members with conflicts of interest. Rep. Maurice Hinchey (D-N.Y.) accused the agency of not trying to find people without conflicts of interest, adding that several drugs, including Ketek, would not have been approved if not for the vote of a person with a conflict. The FDA is issuing guidances to improve the advisory committee process and has broadened its access to experts, von Eschenbach said, but Hinchey was not appeased. The approval of Ketek put many people in jeopardy, Hinchey said. At a recent House subcommittee hearing, former FDA employees testified that the agency ignored safety risks to rush the antibiotic to market and that the agency discouraged dissent in the drug review process. In addition, members of the subcommittee at this week's hearing questioned a proposed budget increase that would add 27 staff members to review DTC advertising. Simply adding more staff will not be sufficient to control companies, DeLauro said. The previous day, FDA Commissioner Andrew von Eschenbach defended the agency's budget proposal for 2008 in front of a Senate subcommittee, saying funding increases and new user fees would help accelerate drug approvals and improve product safety reviews. Under the proposed budget, the agency would add three new user fees to generate an expected income of $42.7 million. The user fees would go toward reviewing generic drugs, reinspecting facilities and issuing export certificates, von Eschenbach said during a Senate Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee hearing Feb. 27. Witnesses at a recent House subcommittee hearing criticized the Prescription Drug User Fee Act (PDUFA), saying it gives companies leverage to influence the agency. Von Eschenbach refuted this idea and said the fees only help the agency do its job. "The integrity of the process is not in any way adulterated or impacted" by user fees, von Eschenbach said. Approximately 20 percent of the agency's proposed budget would come from user fees, Deputy Commissioner John Dyer said. This is an increase over past years, but Dyer could not say if the trend would continue. PDUFA expires in September and Congress will have to vote to renew it. FDA officials recently made recommendations for the act's latest installment and held a public meeting to discuss the changes. For details, visit http://www.fda.gov.

FDA Needs Consistent Leadership and Funding, Former Commissioners Say

A lack of consistent leadership and inadequate funding has diminished the FDA's power and credibility, four former agency commissioners said. Congress has let the agency down in denying it reliable, good leadership and appropriate funding, the commissioners said at a Feb. 21 panel discussion at the George Washington University School of Public Health. The turnover of FDA employees during the Bush administration has been "shameful," Frank Young, commissioner from 1984 to '89, said. The Senate confirmed Andrew von Eschenbach as the agency's current commissioner last December after overcoming several holds on his nomination. Von Eschenbach replaced Lester Crawford, who left the agency in September 2005, two months after being confirmed. Crawford pleaded guilty to failing to disclose his ownership of stocks in several firms the FDA regulates. The lack of consistency in commissioners has allowed too much to happen too quickly, which leads to errors within the agency, lessening its credibility, Donald Kennedy, commissioner from 1977 to '79, said. The administration also interferes with the agency by trying to rework science to support policy, Kennedy added. The other commissioners agreed that using scientific evidence as the basis for all FDA decisions was the main way the agency could regain credibility. Congress must also provide the FDA with adequate funding so the agency can rely less on user fees, the former commissioners agreed. The ratio between appropriations and user fees must be rebalanced, Kennedy said. The commissioners did not support abandoning the Prescription Drug User Fee Act, but said Congress has let the agency down by not maintaining its budget and forcing the agency to rely too much on user fees. For details, visit http://www.fda.gov.

McClellan Predicts Biogeneric Bill Approval, Multiple Regulations

A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former Centers for Medicare & Medicaid (CMS) Administrator Mark McClellan, who said he is optimistic that Congress will pass legislation this year easing the entry of follow-on biologics. While McClellan's optimism echoed sentiments expressed by both Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.) at the Generic Pharmaceutical Association's annual conference, he said lawmakers should create a well-founded scientific pathway process prior to passing the bill, S.623, the Access to Life-Saving Medicine Act. "The biologic approval process could involve an array of individual regulations because of the complexities and differences in developing these products and bringing them to market," McClellan said at the conference. Biologics span a wide range of complexities in "protein folding and potential impurities," McClellan pointed out, and if the bill is passed prior to the establishment of a pathway that addresses such areas of manufacturing, regulators will spend an enormous amount of time and drive up agency costs to craft the necessary regulations, McClellan said. The absence of a clear, scientific pathway for approving biogenerics could result in patients experiencing adverse events, he added. The FDA's approval of Sandoz's Omnitrope, the first biogeneric human growth hormone, may be the process on which to model a pathway to approve a relatively simpler biologic, according to McClellan. "The more you can build broad policy acceptance, the greater chance of bringing an approval process to market faster," he said. For details, visit http://www.fda.gov.

FDA Drug Approvals Sluggish in 2007

The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year. The agency approved four NDAs in January and five in February, down from 16 in the first two months of 2006. Further, the FDA has approved only one new molecular entity, down from four in January and February of last year. However, the approval rates were consistent with the agency's average for the first two months of each year between 2002 and 2005. The FDA is likely to implement a stricter review process after criticism from the Institute of Medicine (IOM) spurred the agency to promote its drug safety efforts, analysts from Friedman Billings Ramsey (FBR) said. Following the IOM's report, the FDA issued a series of recommendations emphasizing the need for greater transparency and an increased focus on safety in the drug review process. Despite the more rigorous review process, the rate of overall drug approvals should increase over the next few years, according to FBR. Other companies, such as contract research organizations, will benefit from the FDA's increased drug safety monitoring, FBR said. Congress will likely attach mandatory post-approval monitoring provisions to the Prescription Drug User Fee Act when the bill comes up for reauthorization later this year, the firm added. Contract research organizations are also likely to partner with developers of electronic data capture systems as they become more popular, FBR said. In 2006, the FDA approved 93 NDAs, an increase of 13 from 2005, and 18 new molecular entities. However, the total number of approvals was lower than in 2004. An increased focus on more complex diseases and development technologies could have contributed to the lag in applications and approvals, industry experts said. For details, visit http://www.FDA.gov.

What's New - March to April 2007 The following is a wrap-up of news of interest during the months of March to April 2007

What's New - March to April 2007
The following is a wrap-up of news of interest during the months of March to April 2007