LIMSource News: What's New

• Thermo Fisher Scientific Selected by PRA International to Supply LIMS for State-of-the-Art Bioanalytical Laboratory

• Thermo Fisher Scientific Introduces Darwin LIMS 3.0 with Enhanced Functionality for Pharmaceutical Applications

• STARLIMS Introduces SDMS Functionalities at PITTCON 2008

• Global Healthcare and Medical Products Conglomerate Licenses LabVantage's SAPPHIRE for its QC Laboratories

• Waters Expands Open Architecture Operating Platform with new Automated and Integrated Method SOP Software

• Thermo Fisher Scientific Publishes New Poster from Lab Automation 2008 Purpose-Built LIMS for Life Sciences and High Throughput Screening Laboratories

• NWA Announces NWA eHACCP Solution

• Waters and LabLogic Announce Collaboration

• Siemens Launches Software Solution for Pharmaceutical Applications

• Labtronics' LimsLink CDS Selected for Integration with LIMS at Chinese Manufacturing Facility

• MODA Technology Partners and Northwest Analytical Announce Partnering Agreement

• Bruker Announces Pittcon Editors' Gold and Bronze Awards for Two of its New Breakthrough Products

• Thermo Fisher Scientific Launches New Software Control for the Accela High-speed LC System Featuring Atlas CDS

• Bruker Introduces A Broad Range of New Life Science and Analytical High-Performance Systems and Innovative Solutions at Pittcon 2008

• DEACOM Integrated ERP Software to be Exhibited at American Coatings Show

• ABB Switzerland Ltd Combines its Analyzer and Software Businesses

• Health Canada Publishes Draft Biosimilar Guidance

• FDA Setting Up Shop in China

• FDA Names Janet Woodcock as Permanent CDER Head

• EPA Grilled On Chemical Maker Conflicts

Thermo Fisher Scientific Selected by PRA International to Supply LIMS for State-of-the-Art Bioanalytical Laboratory

Thermo Fisher Scientific Inc. has announced that PRA International, a leading clinical development organization has selected Thermo Scientific Watson LIMS to help manage its state-of-the-art Bioanalytical Laboratory, part of its Early Development Services located in Assen in The Netherlands. PRA International has standardized its laboratory information management systems with Watson LIMS to achieve operational excellence in the management of 150,000 samples per annum The laboratory analyzes samples for studies undertaken for leading pharmaceutical organizations worldwide. Nearly 100 scientists and staff in the Early Development Services laboratory will use Watson LIMS to help service their clients and manage data from state-of-the-art equipment including sixteen LC MS/MS systems. Watson will control the information and data the laboratory processes - from sample receipt through to sample report. Thermo Scientific Watson LIMS will be used to further automate the production of reports for pharmaceutical sponsors who contract with PRA International. The Bioanalytical Laboratory has undertaken more than 2,400 studies, and works in a seamless interface with its pharmaceutical sponsor companies. Since Thermo Scientific Watson LIMS is the LIMS of choice for PRA International's pharmaceutical customers, the decision to standardize on Watson offers a benefit to customers. Peter Ketelaar, vice president of PRA International Bioanalytical Laboratory, explains "The adoption of Thermo Scientific Watson LIMS is part of the site's continuous investment into efficiency and innovation. Investment in a state-of-the-art LIMS reflects our ongoing adoption of best-in-breed solutions and Watson LIMS fits in that category." Mr. Ketelaar says "75% of LIMS in use in our pharmaceutical sponsors' own working laboratories are Thermo Scientific Watson. The data transfer between sponsor and PRA International is seamless within Watson LIMS, since both sides can view the study and data in the same format. As a result, now that we have standardized on Watson LIMS our sponsors view the LIMS as an additional reason to work with PRA International." Watson is a highly specialized, protocol-driven LIMS for drug metabolism and pharmacokinetic (DMPK) studies being utilized in 18 of the top 20 global pharmaceutical companies and leading contract research organizations. PRA selected Watson LIMS not only because of Thermo Fisher's reputation and market leadership, but because of Watson's comprehensive purpose-built functionality and ability to help PRA communicate seamlessly with its sponsors. PRA International works in partnership with pharmaceutical and biotechnology clients, providing outsourced services from protocol development to reporting, providing the expertise needed to obtain regulatory approval and to develop safe and effective drugs. For details, visit http://www.thermo.com/informatics or http://www.prainternational.com.

Thermo Fisher Scientific Introduces Darwin LIMS 3.0 with Enhanced Functionality for Pharmaceutical Applications

Thermo Fisher Scientific Inc. has announced significant functionality enhancements to Darwin LIMS, its purpose-built LIMS designed specifically for pharmaceutical QA/QC. Offering environmental monitoring, dissolution, stability management, product and batch management and system interfacing, Thermo Scientific Darwin 3.0 brings new capabilities to pharmaceutical laboratories. Until now, environmental monitoring and LIMS have typically been disparate systems, requiring users to monitor and aggregate data from multiple environmental locations for product and batch traceability. Thermo Scientific Darwin LIMS fully integrates environmental monitoring data into the batch record. Built-in charting tools allow users to visualize each location independent of the samples. This ensures that any failure is apparent at the batch level and allows the laboratory to quickly determine whether the source of the contamination is in the laboratory or the production environment. This embedded functionality enables laboratory managers to react rapidly to non-conforming product before it reaches the consumer. "By linking this data to the LIMS directly, pharmaceutical companies using Darwin can have greater confidence in the quality of their results and, ultimately, in the quality of the product they bring to the consumer,” said Dave Champagne, vice president and general manager for informatics products, Thermo Fisher Scientific. “We believe no other LIMS vendor can offer the scope, breadth and depth our solution delivers.” The new fully validated Web interface of Darwin 3.0 allows for more efficient reporting and sharing of test data across the laboratory. Built on the Microsoft .NET framework, Thermo Scientific Darwin can be easily extended to meet the specific needs of a customer to include dashboard-ready tools for multi-user and multi-site environments. The interface gives immediate information on resource and instrument utilization, so laboratory managers can maximize productivity by optimizing resources. For details, visit http://www.thermo.com/informatics.

STARLIMS Introduces SDMS Functionalities at PITTCON 2008

STARLIMS Technologies Ltd., a leading provider of LIMS, has introduced a new SDMS module (Scientific Data Management System) at PITTCON 2008. Integrated into the company’s web-based LIMS, this integrated module creates a comprehensive platform to manage scientific and laboratory information—consolidating data and documents from the full gamut of laboratory processes.The company claims that the STARLIMS solution is unique in that it integrates LIMS data and SDMS documents into a single web-based platform. Much of the data created in science-centric organizations is unstructured and not typically managed in a consistent fashion, making it difficult to implement systematic procedures necessary to ensure regulatory and legal compliance. The STARLIMS SDMS module enables organizations to capture, parse, search, manage, share and archive scientific documents. Such documents may include research reports, spreadsheets, product specifications, instrument output files and more. The information extracted from these documents is stored in STARLIMS’s unified platform, and managed with the same control as structured LIMS data has been. In addition, the documents are archived and managed in the same platform as the LIMS data, enabling unified searches and eliminating the inefficiencies of multiple data repositories. "The release of STARLIMS SDMS is a crucial step forward in our vision of unifying laboratory, scientific and enterprise information,” said Itschak Friedman, CEO of STARLIMS. “In addition to its obvious streamlining of laboratory informatics, it stands to make a significant contribution to information sharing—and enterprise-wide collaboration.” What makes the parsing approach of the STARLIMS SDMS unique is its use of artificial intelligence (AI) to automatically extract content from unstructured documents and store it in a structured environment, together with the relevant metadata tags. This process transforms unstructured data into an XML format that is both standardized and highly accessible.STARLIMS SDMS uses the most recent parsing routine to automatically parse information from any document, even an unidentified document. Any inaccuracies are later adjusted with simple drag-and-drop manipulations and the corrections are integrated into the algorithm in an automatic self-correcting mechanism. The result is a highly effective way of processing any type of document: the laborious task of producing parsing scripts becomes trivial; users need not learn complex parsing applications; and processing times are dramatically accelerated. For details, visit http://www.starlims.com.

Global Healthcare and Medical Products Conglomerate Licenses LabVantage's SAPPHIRE for its QC Laboratories

LabVantage Solutions Inc. has announced that a global healthcare company has licensed LabVantage's SAPPHIRE LIMS for its quality control laboratories. The global entity is one of the world's leading, innovative
companies in the healthcare and medical products industry. In connection with its manufacturing operations, the company confronts the difficult task of managing the tremendous volume of tests it conducts per quality sample. The effort to convey the plethora of results for internal reporting and compliance purposes is time consuming and inefficient. Moreover, the amount of reporting paperwork that is generated can fill volumes. In addition, the ability to search that data is complex and requires significant manual effort. All of this has resulted in higher overhead, laboratory bottlenecks, delays in batch release, and a greater risk of inaccuracies. To address these challenges, the company required a laboratory information management solution that could automate its laboratories to remove the bottlenecks that affected production and provide the full traceability it needed for its products. At the same time, it sought a solution that could simplify its reporting and compliance obligations throughout its global enterprise, including easy integration to its SAP Enterprise Resource Planning (ERP) system. The company will couple SAPPHIRE's configurable-off-the-shelf (COTS) functionality for quality management with SAPPHIRE's easy-to-use EVERGREEN™ configuration tool to quickly implement a robust, yet tailored quality management solution and replace its dated legacy systems. LabVantage will also interface SAPPHIRE to a number of instruments and devices, including from Agilent, Waters, Dionex, Beckman, Perkin Elmer, and Mettler. It will also leverage LabVantage's SAPPHIRE ENTERPRISE CONNECTOR, the Powered by SAP NetWeaver certified interface, to easily integrate SAPPHIRE with SAP. For details, visit http://www.labvantage.com.

Waters Expands Open Architecture Operating Platform with new Automated and Integrated Method SOP Software

Waters Corporation has expanded its informatics open architecture operating platform, anchored by the Waters NuGenesis Scientific Data Management System (SDMS), to address predominately manual activities required to perform standard operating procedures (SOPs) for analytical methods or tests. The Waters NuGenesis SDMS Intelligent Procedure Manager is a workflow software package designed to guide a laboratory analysts through routine, comprehensive method SOPs and integrate results with a chromatography data system, such as Waters Empower 2 Chromatography Data Software. "Waters’ laboratory informatics solutions inherently promote an open architecture that invites collaboration among instruments, vendors and departments,” said Phil Kilby, Senior Manager, Informatics Marketing for Waters Division. “As the only laboratory software package able to manage and interrogate scientific data from any source, NuGenesis SDMS is the nerve center of this open informatics platform. Leveraging the well-founded benefits of open architecture, Waters’ platform is designed to allow laboratories to bring instruments and software online compartmentally until full enterprise-level integration is realized" "Supporting a ‘Right the First Time’ philosophy, Waters estimates that using the Intelligent Procedure Manager to automate and integrate method SOPs could potentially reduce cycle times by as much as 50 percent compared to a traditional paper trail, with fewer opportunities for errors,” continued Kilby. The Intelligent Procedure Manager meets the need of today’s manual or paper-driven SOP guidelines that still dominate certain laboratory functions. For example, 1) instrument checks, 2) standards and sample preparation, 3) solvent and mobile phase separation, 4) analyses review, 5) result approval, and 6) final product release are all prone to time inefficiency and data transcription errors because they depend on paper guidelines. From late stage development to final product quality control and lot release, Intelligent Procedure Manager can be equally applied to any lab environment where rigorous adherence to approved test methods and SOPs must be followed, including compliance requirements for cGMP operations. All primary laboratory data and metadata are quickly and easily acquired in electronic form and stored in a secure, 21 CFR Part 11, cGMP-, GLP- compliant database. For details, visit http://www.waters.com.

Thermo Fisher Scientific Publishes New Poster from Lab Automation 2008 Purpose-Built LIMS for Life Sciences and High Throughput Screening Laboratories

Thermo Fisher Scientific Inc. has announced the availability of a new technical poster demonstrating the importance of configurability and flexibility in laboratory information management systems (LIMS) design for life sciences and high throughput screening applications. T he poster was originally presented at the Lab Automation 2008 conference in Palm Springs, CA and is entitled The New Age of Configurability and Flexibility in LIMS Design for Life Sciences and High Throughput Screening. The authors are senior technical and development managers at Thermo Fisher Scientific with decades of experience in pharmaceutical and biotechnology laboratories. They highlight the need for plate handling functionality to be built into the core LIMS solution for high throughput screening (HTS) environments. The poster is ideal reading for life scientists in the biotechnology and drug discovery industries. With the increasing workload in high-throughput laboratories, biotechnology companies require user-friendly LIMS that contain plate handling functionality out-of-the-box, while remaining flexible in how the system can be easily configured and extended to meet their needs. With built-in plate handling functionality utilizing a service oriented architecture in .NET, Thermo Scientific Nautilus LIMS enables organizations to keep pace with changing laboratory techniques, automate processes and manage increasing data volumes. The result is that scientists and organizations are able to give rise to discoveries, make decisions and run tests faster than ever before. Plate handling and automation have become increasingly important in biotechnology organizations where automation and high throughput needs demand that workflows account for the manipulation of samples in a wide variety of plate formats and configurations. These laboratories seek a robust LIMS that can execute and integrate common plate handling operations including replication, splitting, probing, compression, pooling and cherry picking. A plate design utility can greatly simply the administration by enabling variable dimensions, well labeling, common and user-defined fill patterns, specific well configurations and additional attributes and metadata. Adding to the complexity, automated processes generally involve groups of plates. The authors demonstrate how Nautilus LIMS provides the ability to graphically program and emulate dynamic work processes involving groups of plates, organize workflow activity into steps, execute actions on groups of plates at each step in process and dynamically define and assign transition at each step. With trends leaning towards increasing data volumes, high throughput environments require information management systems that allow data from automated workflows and processes to be modeled and integrated easily. To meet this need, these laboratories seek a full-featured LIMS with an inherent configurable utility that allows for communication with other applications and enable effortless integration of instruments and robotic equipment. The system should be able to acquire data from all types of instrumentation, including serial ports and networked instruments while also applying specifications and logic to make dynamic decisions based on collected data. Most biotechnology labs also require the LIMS to integrate older ASCII and CSV file transfers as well as modern XML schemes and service-oriented architectures. The new technical poster is available free-of-charge via
http://www.thermo.com/eThermo/CMA/PDFs/Product/productPDF_4365.pdf.

NWA Announces NWA eHACCP Solution

Northwest Analytical, Inc. (NWA) has introduced its new NWA eHACCP Solution. NWA eHACCP Solution delivers a complete electronic HACCP data collection, compliant data management and secure electronic signature for HACCP document production and management. NWA eHACCP combines process management and improvement with better HACCP compliance. Studies have shown that active process management and continuous process improvement enable successful HACCP safety compliance. NWA has expanded its established plant floor data collection, process management, analytics and improvement system to encompass HACCP compliant data collection, management and reporting to provide a powerful food safety and quality management system. For details, visit http://www.nwasoft.com.

Waters and LabLogic Announce Collaboration

Waters Corporation and LabLogic Systems Ltd. have agreed to collaborate on developing interface software for LabLogic's Laura Radiochromatography System and make it compatible with Waters ACQUITY UltraPerformance LC (UPLC) and Alliance HPLC systems. The collaboration makes the products of both companies more compatible and gives scientists greater efficiency and ease-of-use when employing them in the laboratory. "In working with LabLogic, we are responding to the needs of our ACQUITY UPLC system customers who perform on-line radiochromatographic detection. By working together with LabLogic, we're giving our customers more choices and more ways to be successful," said Bill Foley, Director – Product Marketing, Waters Corporation. Commenting on the collaboration, LabLogic Managing Director Richard Brown said, "Knowing that we are working together gives customers reassurance that the integrity of their product implementation is backed by both LabLogic and Waters, both leaders in their field." The interface software is expected to be available during the third quarter of 2008. For details, visit http://www.lablogic.com or http://www.waters.com.

Siemens Launches Software Solution for Pharmaceutical Applications

Siemens has launched Sipat, a new software solution to support the application of Process Analytical Technology (PAT) in the pharmaceutical industry. Sipat is scalable and modular and allows a controlled quality growth as the PAT initiative expands. The new software solution serves as a common user-friendly interface for all PAT tools and can be fully integrated into the manufacturing and development architectures. The main feature is the ability to interface with an existing manufacturing architecture, allowing full transparency on quality aspects from unit operation level up to ERP, MES and LIMS. With Sipat pharmaceutical companies are now able to gather process understanding, strive for continuous process improvement, develop processes based on ‘quality by design’ principles and to manufacture ‘right-first-time’. Regulatory and financial forces are pitching pharmaceutical manufacturing towards rapid change. Process Analytical Technology (PAT) is an exceptional opportunity for pharmaceutical companies, to improve manufacturing performance, reduce manufacturing costs, reduce time to market and improves supply chains responsiveness. PAT allows to design quality into the process and move to real-time product release. For details, visit http://www.automation.siemens.com/mes/simatic-it/html_76/news/press_releases.htm.

Labtronics' LimsLink CDS Selected for Integration with LIMS at Chinese Manufacturing Facility

Labtronics has announced that an international manufacturer of industrial chemicals has selected LimsLink CDS to manage the transfer of data between ChemStation and SampleManager LIMS at their manufacturing facility in China. The decision to select LimsLink CDS was based largely on the ChemStation configurable interface that simplifies creation of the interface with any LIMS, without requiring programming. Interfaces are defined using a series of check boxes and drop down menus that match the parameters of ChemStation. All of the setup screens use the terminology and have the same look and feel as ChemStation CDS, creating a familiar and comfortable environment for implementing and maintaining the interfaces. The first interface has been implemented with the assistance of Labtronics' Professional Services Group who also provided on-site training at the Chinese facility in the configuration of new methods. This training will allow local personnel to support their interfaces and add new interfacing methods as their needs change.. For details, visit http://www.labtronics.com.

MODA Technology Partners and Northwest Analytical Announce Partnering Agreement

MODA Technology Partners (MODA), a software company that provides mobile data acquisition solutions to the pharmaceutical manufacturing industry and Northwest Analytical Inc (NWA), a leading provider of Statistical Process Control (SPC) and Manufacturing Analytics software, have announced a partnering agreement. This agreement will leverage the power of NWA’s Quality Analyst SPC tool with MODA’s quality control and environmental monitoring product, MODA-EM. MODA-EM improves the efficiency of Quality Control and Microbiology operations while providing a regulatory compliant platform for the paperless collection, management and reporting of environmental monitoring, utility testing, and product testing information. NWA’s Quality Analyst SPC software adds best-of-breed, easily-understood statistics-based analysis and decision support tools to the MODA-EM platform. "Northwest Analytical SPC tools enable our clients to further maximize their automated EM and QC operations” states Michael Goetter, MODA co-founder and VP of Product Strategy. “In particular, we see tremendous value in the application of these tools for investigation support in both a corrective action and preventative action capacity”. "MODA-EM delivers the secure data collection and management needed in regulated manufacturing” says Jeffery Cawley, VP Market Development, Northwest Analytical. “By integrating analytics, the system provides the decision support needed for both the process management and improvement needed to maintain compliance.” For details, visit http://www.modatp.com or http://www.nwasoft.com.

Bruker Announces Pittcon Editors' Gold and Bronze Awards for Two of its New Breakthrough Products

Bruker Corporation introduced numerous innovative high-performance systems and solutions for life science and materials research, for molecular imaging research, for homeland security and environmental monitoring, as well as for applied and industrial analysis at Pittcon 2008. In addition, the prestigious Pittcon Editors' Gold Award was been awarded to the breakthrough benchtop Bruker AXS SMART X2S Crystal-to-Structure small molecule X-ray system which for the first time allows chemists without crystallography training to obtain routine small molecule 3D structures under full automation. In addition, the Pittcon Editors' Bronze Award was been awarded to Bruker AXS' novel benchtop S2 PICOFOX TXRF (total reflection XRF) system for easy-to-use and robust ultra-trace elemental analysis with straight-forward and cost-effective sample preparation. The transportable S2 PICOFOX is expected to complement or replace AA and ICP in many pharma, geological, mining, environmental and food testing applications. Moreover, the Pittcon Editors have given an 'honorable mention' to Bruker Daltonics' unique new high-performance apex-ultra MALDI-FTMS platform for drug and metabolite tissue imaging at therapeutic dosing levels. For details, visit http://www.bruker.com/pittcon-press.

Thermo Fisher Scientific Launches New Software Control for the Accela High-speed LC System Featuring Atlas CDS

Thermo Fisher Scientific Inc. has launched a new Thermo Scientific Atlas CDS add-on control software for the Thermo Scientific Accela high-speed liquid chromatography system. The solution offers integrated instrument control, digital data acquisition, chromatography data processing and reporting. The award-winning Atlas Chromatography Data System (CDS) provides chromatographers with a client/server chromatography-based software solution available for controlling the Accela system. A new Atlas Extension Kit integrates full instrument control and chromatography data handling for the Accela high-speed pump, autosampler and PDA detector, and it is designed to integrate the rapid data analysis, processing and reporting of Atlas with the high-speed liquid chromatography (LC) separations of the Accela. The unique Accela high-speed LC with sub 2-micron particle columns can operate at the standard pressures of conventional HPLC to 15,000 psi and separate samples faster, with better resolution and efficiency, all in a single instrument. For details, visit http://www.thermo.com/lc.

Bruker Introduces A Broad Range of New Life Science and Analytical High-Performance Systems and Innovative Solutions at Pittcon 2008

Bruker Corporation introduced numerous innovative high-performance systems and breakthrough solutions for life science and materials research, for molecular imaging research, for homeland security and environmental monitoring, as well as for applied and industrial analysis at Pittcon 2008. Several new Bruker solutions are available for cutting-edge small molecule analysis in the pharmaceutical and biotech industries, as well as in academic and clinical research: the unique new Complete Molecular Confidence solution for small molecule analysis combines unambiguous on-the-fly SmartFormula 3D molecular formula determination by our new ESI-Qq-TOF mass spectrometer with automated structure verification by NMR. Similarly exciting, drug and metabolite tissue imaging at therapeutic dosing levels is now enabled by a novel high-performance MALDI-FTMS imaging platform. Moreover, the new FlashFormula NALDI-TOF solution allows very rapid, high-throughput small molecule detection and identification without time-consuming LC separations. Finally, the breakthrough X2S Crystal-to-Structure small molecule X-ray system for the first time allows chemists without crystallography training to obtain routine small molecule 3D structures under full automation. Other major Bruker product introductions further enhance proteomics research: the new ETD II module for high-capacity spherical ion traps takes automatic PTM analysis to a new sensitivity level and protein mass range. The novel MALDI-TDS top-down solutions on high-end TOF/TOF systems facilitate drug development and quality control of biologics and now typically allow 100% sequence determination, C- and N-terminal assignments, and the determination of PEGylation sites and other modifications in recombinant proteins . In materials research and industrial analysis, a novel benchtop TXRF (total reflection XRF) system for facile, low-cost ultra-trace elemental analysis may replace AA and ICP for many applications. The new G8 GALILEO ONH Combustion Analyzer is a result of their recent JUWE acquisition, and complements their new Q4 TASMAN spark-OES system, both for metals analysis. For environmental monitoring and homeland security, they offer several new FT-IR based systems for stand-off chemical agent and toxic industrial chemical detection, as well as a new, small and portable FT-IR system for the identification of suspicious or unknown powders. For details, visit
http://www.bruker-biosciences.com.

DEACOM Integrated ERP Software to be Exhibited at American Coatings Show

Deacom, Inc., a leading producer of integrated accounting and Enterprise Resource Planning (ERP) software for specialty chemical manufacturers, will showcase its DEACOM Software System at Booth #1036 on June 2-5 at the 2008 American Coatings Show in Charlotte, NC. The DEACOM System integrates all functions of a specialty chemical manufacturers, including formulation and laboratory management, regulatory reporting, sales order entry, purchasing, inventory and lot tracking, production, accounting and financials, and retail Point-of-Sale (POS), in one software system. By linking all company departments together in a single database, companies have the ability to perform data drill-downs, conduct real-time transactional posting, maintain software updates easily, and simplify training with a consistent user interface. The American Coatings Show will replace the International Coatings Expo (ICE) this year as part of the recent merger between the National Paint & Coatings Association (NPCA) and the Federation of Societies for Coatings Technology (FSCT). For details, visit http://www.deacom.net.

ABB Switzerland Ltd Combines its Analyzer and Software Businesses

ABB Switzerland Ltd has announced that it has merged with immediate effect its analyzer and software businesses for the cement industry. The Collaborative Production Management unit now comprises Expert Optimizer, Knowledge Manager and SpectraFlow in one group headed by Dr. Hans-Helmuth Jung. The merger took place to ensure that a full client service can be supplied from one ABB team. The Expert Optimizer (formerly known as LINKman) and Knowledge Manager solutions have a long and successful history of bringing benefits to the cement industry. Expert Optimizer includes solutions for Raw Mix Preparation (RMP) and for Economic Process Optimization (EPO). Knowledge Manager includes the Laboratory Information Management Systems (LIMS) module and the Production Information Management Solution (PIMS). There are over 500 installations worldwide. SpectraFlow was launched to the market in the middle of 2007 and already there are installations providing safe, online, real time analysis for three major cement manufacturers. One of the factors that drove the development of the non-nuclear online SpectraFlow bulk material analyzer was to be able to provide EO and KM with good quality chemical composition data. Merging Expert Optimizer, Knowledge Manager and SpectraFlow means that ABB’s CPM team will provide turn key solutions across the entire cement manufacturing process, from Mine to Market. The sales team, headed by Thomas Marx, operations team headed by Mario Drinovac, and service team headed by Marie O’Grady have already been aligned to support this new structure. Dr Leopold Blahous, Head of Research and Development for cement optimization, said “Combining the analyzer and software teams and providing total solutions makes much more sense for us and the clients as it allows us to have everything in one group, covering the whole process from start to finish. Combining these two aspects of the business allows us to focus on the clients needs and to provide the best solution available in the market”. For details, visit http://www.abb.com.

Health Canada Publishes Draft Biosimilar Guidance

As U.S. lawmakers discuss legislation that would enable the FDA to approve similar versions of biologic products, Health Canada has begun the process of creating a biosimilar regulatory framework. The agency recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway. Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes. A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product. Comments on the draft guidance are due April 16, and Health Canada says there will be a two-day consultation in May. The draft guidance, “Information and Submission Requirements for Subsequent Entry Biologics,” along with forms for submitting comments or requesting to participate in the consultation, are available at http://www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/consultation/seb-pbu/index_e.html.

FDA Setting Up Shop in China

The FDA is establishing three permanent offices in China to monitor drug safety, which will be staffed by eight FDA employees along with five Chinese nationals to assist them. The State Department has approved the plan, but the Chinese government has yet to do so. The posts are to be established by September 2009 at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou as part of the agency’s Beyond our Borders initiative. This region is the first of at least five where the FDA intends to establish an overseas presence, FDA Commissioner Andrew von Eschenbach said. India, Europe, South America and the Middle East also are on the list. FDA spokeswoman Stephanie Kwisnek said the regions are listed in no particular order. The new FDA offices in China will give the agency greater access to local manufacturing facilities for inspections and improve its interactions with Chinese manufacturers, helping ensure that food and drug products shipped to the U.S. meet its standards for safety and manufacturing quality. For details, visit http://www.fda.gov.

FDA Names Janet Woodcock as Permanent CDER Head

FDA Commissioner Andrew von Eschenbach named Janet Woodcock to be the permanent director of CDER. She has been the center’s acting director since last October. Woodcock, a 21-year agency veteran, held the drug division job from 1994–2005. Under her leadership, the FDA launched the Critical Path Initiative designed to bridge the gap between basic scientific research and the medical product-development process. She will continue to be involved in this initiative, as well as the emerging postmarket surveillance collaborations with the private sector. An internist and rheumatologist, Woodcock previously held several other leadership positions in the FDA, most recently as a deputy commissioner and chief medical officer, and previously as director of the Office of Therapeutics Research and Review and acting deputy director of the Center for Biologics Evaluation and Research. For details, visit http://www.fda.gov.

EPA Grilled On Chemical Maker Conflicts

A House committee opened an investigation March 17, 2008 into potential conflicts of interest in scientific panels that advise the Environmental Protection Agency. The House Energy and Commerce Committee cited the case of eight scientists who were consultants or members of EPA science advisory panels assessing the human health effects of toxic chemicals while getting research support from the chemical industry on the same chemicals they were examining. In two cases, EPA advisers were employed by companies that made or worked with manufacturers of the chemicals being evaluated, the committee said. Rep. John Dingell, D-Mich., the committee's chairman, said such conflicts appear to be in stark contrast to EPA's decision last summer to remove a public health scientist and expert in toxicology, from a panel examining the health impacts of a flame retardant because of critical comments she made about the chemical. The American Chemistry Council, the industry trade group, had called for the removal of Deborah Rice, a toxicologist from Maine, as chairman of an independent EPA panel assessing the health risks from ''deca'', a flame retardant in electronic equipment, after she urged the Maine state legislature to ban the chemical. "The routine use of chemical industry employees and representatives in EPA's scientific review process, together with EPA's dismissal of Dr. Rice raises serious questions with regard to EPA's conflict of interest rules and their application,'' said Dingell in a letter Monday to EPA Administrator Stephen Johnson. Rice, an employee of Maine's Department of Health and Human Services, was never alleged to have any monetary interest associated with deca and her dismissal ''seems to argue that scientific expertise ... is a basis for disqualification,'' the letter continued. The letter, also signed by Rep. Bart Stupak, D-Mich., chairman of the committee's investigations subcommittee, demanded documents related to Rice's ouster, as well as records related the appointment of scientists with chemical industry ties. Rice's removal, as chairman of the deca chemical review board ''does not seem sensible on its face'' given the EPA's acceptance of scientists with ties to the chemical industry and even to companies who make the chemicals being reviewed, the congressmen wrote. The House committee also questioned a case where a consultant to an EPA review panel, promoted his research on a chemical while he also prepared the chemical industry's public comments on the cancer-causing potential of the same chemical. Also cited was a case where a scientist who, while a consultant to an EPA review panel, promoted his own industry-supported research arguing the chemical was not a carcinogen. In light of Rice's removal, Dingell and Stupak asked the EPA about the appointment of a Harvard University epidemiologist to a recently convened panel reviewing the possible cancer risk from acrylamide, an industrial chemical used as a thickener but also found in some foods. They said that the epidemiologist on a number of occasions has said the exposure to acrylamide through food does not appear to pose a cancer risk. The examples cited by the House committee were included in a report last month by the Environmental Working Group, a Washington-based advocacy group, that said its investigation found that among seven external EPA review panels, it found 17 reviewers with potential conflicts of interest. For details, visit http://www.epa.gov.

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

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