LIMSource News: What's New - May to June 2005

• Teranode Chosen as 2005 Venture All Stars Top 25 Emerging Growth Company
• Teranode Launches Teranode XDA 2.7 LIMS
• Agilent Technologies Signs Agreement to Acquire Scientific Software Inc.
• Autoscribe Releases New Neptune LIMS for Water Testing Laboratories
• GenoLogics Introduces ProteusLIMS 2.5
• Siemens Announces New SIMATIC IT MES Enhancements
• ClinPhone's Medication Management Solution Overcomes the Major Challenges Facing Supply Chain Management
• Thermo Expands Vibrational Spectroscopy Software Capabilities
• Northwest Analytical Quality Management Webcast Highlights USDA Supply Chain Quality System
• Denmark Advertising Agency Optimizes Workflow with Group Logic's ExtremeZ-IP Solution
• Prime Technologies, Inc. Announces Version 5.4 Of ProCalV5
• Scientific Software and Labtronics Announce LimsLinkExpress for EZChrom Elite
• Bruker Daltonics Introduces Next Level of ClinProt Biomarker Discovery, Identification and Validation Solution
• Acolyte Biomedica Ltd and Scottish National Blood Transfusion Service Collaborate
• Professor Isaac P. Witz Joins Stone Bond Advisory Board
• FDA Issues Draft Guidance on Bar-Code Label Requirements
• Warning Letter Citing Part 11 Signals FDA's Enforcement Position, Expert Says
• Firms Will Likely Need Upgraded Systems to Submit eCTDs to FDA, Expert Says
• Advisory Committee Recommends Better Use of Electronic Databases
• FDA Releases Draft Guidance on Antiviral Drug Development
• FDA Confident About Deadline for Implementing Electronic Pedigrees
• Drug Safety Oversight Board Consists of Mostly CDER Officials
• IFPMA to Launch Centralized Search Tool for Trial Registries
• EU to Implement New Drug-Safety Requirements this Fall
• SAP’s Provides Several Announcements from SAPPHIRE ’05 Boston
• CDER Releases Guidance Agenda for 2005
• BioAnalyte Releases New Biomarker Discovery Software
• LabVantage Announces the Availability of the Sapphire BioBanking Solution
• QSI Signs Agreement with Business Objects to Enhance WinLIMS Reporting Module
• GenoLogics and the Institute for Systems Biology (ISB) Form Strategic Partnership
• Waters Corporation Announces MassTrak Clinical Solutions
• P-Wave's Partnership with Promium Offers Environmental Labs New Document and Data Management Solution
• Computing Solutions Debuts Notification Agent in LabSoft LIMS v8.02
• New NWA Quality Analyst 6 Supports Corporate Quality Initiatives And Simplifies SPC Integration With Enterprise Applications
• Northwest Analytical Selects ICR3 Cientifica of Brazil to Distribute SPC Software in South America
• Teranode Announces Availability of New White Paper on Experiment Design Automation
• Siemens Holds SIMATIC IT Users Meeting
• Orion Multisystems Ships Highest Performance Personal Supercomputers; First 96-Node Computer Workstation Based on Cluster Technology Plugs Into Standard Power Outlet and Requires Minimal IT Support
• Group Logic Unleashes "Tiger" Compatible ExtremeZ-IP File Server Software
• Applied Biosystems/MDS Sciex is the Top Supplier in the Mass Spectrometer Market
• Thermo Electron Wins Omega NorthFace ScoreBoard Award for Excellence in Customer Service
• Eli Lilly Research Laboratory Installs Protedyne’s B ioCube System at Indianapolis, Indiana Facility
• Protedyne Selects Dr. Lorah Perlee as Director of Scientific Applications
• Atrium Research Publishes Results of ELN Survey
• Protedyne Opens European Office in the United Kingdom
• Agilent Technologies to Open New Scientific Training Center in Shanghai
• FDA Officials Highlight Role of Risk Management in cGMP Inspections
• Study Finds Decline in Number of Clinical Trials, Lead Investigators
• Drugmakers Should Be Wary of Liability for Counterfeit Products, Expert Says
• Senate Bill Would Create Independent FDA Drug Safety Center
• US DOD Issues Proposed Rule for RFID
• FDA Issues Guidance Setting Goal of SPL Implementation by Fall 2005

Teranode Chosen as 2005 Venture All Stars Top 25 Emerging Growth Company

Teranode Corporation has been named a Top 25 Emerging Growth Company as selected by Venture All Stars at the 5th Annual Venture All Stars Awards Gala held Friday, June 3, 2005. The top 25 companies were selected from a nominated group from British Columbia, Oregon and Washington. The 2005 Top 25 Venture All Star companies, which come from all sectors and stages, were selected over a six-week period, and were evaluated from multiple business and funding criteria including strong management, financial backing and high-growth potential. Teranode’s informatics platform, TERANODE XDA, combines computational and experimental biology to automate tasks associated with planning, managing, and analyzing experiments. The 2005 Venture All Stars selection committee consists of representatives from more than 35 venture capital organizations including Motorola Ventures, Madrona Venture Group, Arch Venture Partners, Voyager Capital, OVP Venture Partners, Greenstone VC, Yaletown Venture Partners, and the Puget Sound Venture Club. For details, visit: http://www.ventureallstars.com or http://www.teranode.com.

Teranode Launches Teranode XDA 2.7 LIMS

Teranode, a leading innovator of experiment design automation software for the life science industry, has launched TERANODE XDA 2.7, which they claim to be the industry's first model-driven LIMS to transform experiment designs into automation without programming required. The new LIMS extensions provide a more cost-effective solution for lab automation compared to traditional methodologies, such as standard databases or spreadsheets. "By incorporating LIMS into our award-winning technology, we've created the only informatics software that supports the entire lifecycle of experimentation," said Joseph Duncan, CEO of Teranode. "TERANODE XDA's model-driven platform eliminates programming costs associated with lab automation, allowing labs to put their investments in science, rather than database development." Teranode also launched the availability of TERANODE Screening Automation, a breakthrough solution used to transform assay design into assay automation. The easy-to-deploy informatics solution is ideal for screening labs with changing or emerging assay requirements. Leveraging TERANODE XDA, the solution makes it seamless for screening managers to maintain flexible operations and cost-effectively automate screens. For details, visit http://www.teranode.com.

Agilent Technologies Signs Agreement to Acquire Scientific Software Inc.

Agilent Technologies Inc. and privately held Scientific Software Inc. (SSI) have signed a definitive merger agreement for Agilent to acquire SSI, a leading provider of scientific information management solutions. The transaction is subject to closing conditions. Financial details were not disclosed. The acquisition would bring together Agilent's analytical instrumentation, data systems and services with SSI's strong position in chromatographic data systems and informatics. At closing, Agilent would have one of the largest installed bases of chromatographic data systems, with more than 120,000 installations, and one of the broadest portfolios of laboratory informatics software in the life science and chemical industries. The acquisition would enable Agilent to meet a key strategic objective: to provide a family of software solutions that addresses the complete life cycle of analytical information, from data acquisition to knowledge management and retention. SSI has thousands of customers worldwide and had annual sales of more than $18 million in 2004. Based in Pleasanton, Calif., the company employs about 80 people, most of whom are expected to join Agilent. SSI's key products include: OpenLAB, a Web-based software framework that brings together a modern chromatography data system with comprehensive Enterprise Content Management and Business Process Management; EZChrom Elite, a chromatography data system with more than 60,000 licenses installed and the ability to control more than 290 instruments from 26 vendors; Enterprise Content Manager (ECM), a software platform that provides a secure, central repository and rich content services that allow organizations to capture, manage, legally sign, archive, and re-use business-critical information; and, Business Process Manager (BPM), a workflow solution for streamlining, automating and optimizing laboratory business processes while enabling seamless collaboration between people, processes and content. Following the acquisition, Agilent plans to continue development and support of each of these product lines with a commitment to open systems, industry standards, and interoperability with other instrument hardware and software providers. Agilent also plans to support and enhance SSI Instrument OEM partnerships. For details, visit http://www.agilent.com/chem/scisw.

Autoscribe Releases New Neptune LIMS for Water Testing Laboratories

Today many water testing laboratories are looking to replace earlier systems with a system that is easier to support, has a proven upgrade path and is highly flexible and configurable. Autoscribe’s new Neptune LIMS has been developed with inputs from several large US metropolitan water districts and contains the extensive functionality, automation, traceability and reports needed for this application. Until now, most LIMS targeted at this application were either custom written and therefore expensive to support and hard to upgrade, or were commercial systems that delivered some of the required functionality, but were very rigid and difficult to change. Neptune is built using the extremely powerful and easy to use configuration tools that are part of Matrix LIMS from Autoscribe. There is no custom code to support and no special scripts to write. Neptune delivers most of the functionality required by a water treatment laboratory out of the box. However, as each laboratory has some different requirements, these are satisfied by changes to the configuration rather than using custom code. Every Matrix system and hence, each Neptune system has the same source code. All differences in appearance, terminology, workflow, tests and reports are contained within the Matrix LIMS database. For details, visit http://www.autoscribe.co.uk.

GenoLogics Introduces ProteusLIMS 2.5

GenoLogics Life Sciences Inc., a leader in bioinformatics solutions that help research and pharmaceutical laboratories manage, integrate and analyze enormous volumes of scientific data, has announced the introduction of ProteusLIMS 2.5 software platform f or proteomics and systems biology research. Significant innovations featured in this next version release of ProteusLIMS provide labs exceptional flexibility in configuring novel workflow processes on the fly and auto mating data capture for end-to-end lab process, research workflow and data integration. “GenoLogics continues its commitment to technology leadership with ProteusLIMS 2.5,” said James DeGreef, VP Product Management. “An integrated platform that not only manages sample tracking and complex research workflows, but also automatically captures and integrates high throughput mass spectrometry and other experimental data across scientific disciplines is key to speeding up research in biomarker validation and the identification of new drug targets. Researchers today are looking for a wa y to bring together proteomics, genomics and other relevant data to advance their research and make important go/no-go decisions. GenoLogics continues to enhance the functionality of its software to meet these needs.” For details, visit http://www.genologics.com.

Siemens Announces New SIMATIC IT MES Enhancements

Siemens has introduced SIMATIC IT MES enhancements to provide a new level of integration with their SIMATIC IT Unilab LIMS and Interspec specification management solutions with production operations, PLM and ERP systems. These products were specifically developed to meet and S95 standards to enable better integration with other Siemens and non-Siemens products and applications. In addition to integration enhancements, the new solution expands the business value of their SIMATIC IT MES product portfolio by enhancing features of its SIMATIC IT Unilab LIMS including: Stability Module which supports setup and management of stability studies; Extended multi-plant LIMS support for multi-language; Unicode compliant Web and client architecture; Certified SAP-QM Interface via QM-IDI interface to SAP R/3 QM; Enhanced security; Support for Active Directory; Advanced Web functionality ; and, Integration with third party systems. The new functionality is expected to ease implementation time by improving the laboratory workflow by optimizing data collection, analysis, validation and reporting processes. For details, visit http://www.siemens.com.

ClinPhone's Medication Management Solution Overcomes the Major Challenges Facing Supply Chain Management

In a recent poll conducted by ClinPhone, a global leader in clinical technology solutions, over half of the participants indicated that managing the logistics of large, multi-national studies is the biggest challenge facing the supply chain management of clinical trial materials. The opinion poll was conducted as part of ClinPhone's recent webinar series, "Demystifying the Black Box: Automated Medication Supply Chain Management." A further 24% of poll respondents felt that accurately forecasting the amount of drug supplies needed is another major challenge of supply chain management. The webinar series, attended by over 300 biopharmaceutical employees from mainly clinical development and clinical supplies departments, cited how ClinPhone's industry-leading Medication Supply Management solutions can help to overcome these challenges. The benefits include automated site and depot medication inventory control, pooling medication supplies across protocols and managing supplies with limited overage. This greatly simplifies the logistics of managing large, multinational clinical trials. In addition, ClinPhone's supply management consultancy enables sponsors to accurately forecast drug supply requirements. ClinPhone uses a proprietary solution, MedSim , which is a strategic decision tool that allows sponsors to compare supply strategy options, assess risks and calculate supply quantities. MedSim uses sophisticated simulation modelling techniques to provide accurate and reliable forecasts and predictions. Real world unpredictability, such as the logistical issues of multi-national trials, is included in the simulations to determine the range of possible outcomes and provide an accurate confidence interval for model forecasts. For details, visit http://www.clinphone.com.

Thermo Expands Vibrational Spectroscopy Software Capabilities

Thermo Electron Corporation has announced the release of version 7.2 of the OMNIC Professional Software Suite for laboratory FT-IR and Raman spectrometers. This update adds significant new features providing enhanced capabilities for advanced spectroscopy, image analysis, high-throughput chemistry and regulatory compliance in research, routine analysis and QA/QC environments. The OMNIC 7.2 Professional Software Suite offers analytical chemists, spectroscopists and lab managers a number of new tools to improve their productivity: New SpectraCorr software in the OMNIC suite enables two-dimensional correlation spectroscopy (2DCOS) with new algorithms and advanced imaging graphics. SpectraCorr software addresses the most demanding spectroscopic analysis of dynamic chemical processes such as perturbation, reactions, temperature-dependant behaviors and photoacoustic depth profiling. OMNIC’s Atlµs imaging software, with its microscopic visualization and spectral analysis capabilities, now includes advanced image analysis. This provides chemically qualitative or quantitative answers from complex image maps using techniques such as principal component analysis (PCA) and multivariate curve resolution (MCR). By combining Atlµs software with Thermo’s Continuµm XL FT-IR imaging microscope, it is now possible to perform chemical imaging with infrared spectroscopy. OMNIC’s Array Automation software is designed for high-throughput chemical screening applications using FT-IR and Raman. The software provides screening tools that enable data processing capabilities in parallel, high-throughput data collection activities. Automated tools rapidly process spectral data and analysis tools such as cluster analysis produce results in vivid graphical representations OMNIC’s Array Automation software reduces data evaluation time from hours to minutes. For details, visit http://www.thermo.com/informatics.

Northwest Analytical Quality Management Webcast Highlights USDA Supply Chain Quality System

The USDA Agriculture Marketing Service (AMS) has successfully implemented a world-class vendor certification and supply chain quality system to ensure the quality and safety of ground beef bought for the School Lunch Program. Northwest Analytical (NWA) invited AMS to present their results in a webcast on Supply Chain Quality Management.Jeffery Cawley, a vice president at NWA, discusses supply chain quality monitoring and the SPC (statistical process control) systems that help to ensure successful execution. Steve Olson, a Livestock and Meat Marketing Specialist at USDA AMS, reviews the School Lunch Program’s ground beef vendor certification and lot quality reporting systems. He shares results that include higher quality and safer meat delivered to the School Lunch Program - with greater control of value. The archived webcast can be seen at http://www.nwasoft.com/webcasts/20050330.htm.

Denmark Advertising Agency Optimizes Workflow with Group Logic's ExtremeZ-IP Solution

enVision, one of Denmark's largest full-service advertising agencies, has announced its success optimizing communications and workflow processes between Macintosh and Windows platforms using the latest version of Group Logic's award-winning ExtremeZ-IP product. enVision has used several different Macintosh-to-Windows file sharing programs over the years, including Microsoft’s Services for Macintosh (SFM) and MacServerIP from
CyanSoft. "The most important thing in file sharing is the need for speed and stability," explains Thomas Kaaber, Director of IT for enVision. "When we were using MacServerIP, we had issues communicating with the Windows servers. With ExtremeZ-IP we don't have those problems anymore. We have a very stable working environment."
ExtremeZ-IP 4.0 delivers higher availability, scalability and performance for cross-platform environments. Its advanced caching strategy, radically reduced memory usage and other key features (such as single sign-on authentication and active-active clustering) translate into significant operational benefits for customers. Greater
control and flexibility create streamlined administrative support and increased functionality. Since implementing ExtremeZ-IP, enVision has also seen significant value in Group Logic's ongoing support and product development. ExtremeZ-IP is used by thousands of customers worldwide who depend on it to deliver reliable file sharing between their Mac desktops and Windows file servers. The product is the only solution on the market that fully integrates both Mac OS X and Mac OS 9 with Windows 2003 and 2000 Server versions as well as Windows 2003 Storage Server and Windows XP Professional. The newest version, ExtremeZ-IP 4.0, provides stable and compatible Windows-based file and print server platforms for Mac OS X and Mac OS 9 users. For details, visit http://www.grouplogic.com.

Prime Technologies, Inc. Announces Version 5.4 Of ProCalV5

Prime Technologies, Inc. has announced the release of version 5.4 of ProCalV5, its sophisticated calibration management software. The Windows“ based program is a mature professional solution, that manages device engineering records, schedules and tracks calibration activities and provides electronic distribution of critical notifications, reminders and alerts. The new version 5.4 incorporates many enhancements that will benefit users in many industries, but more specifically for Life Sciences, Biotechnology, and companies that are regulated by the FDA. New features include: Automatic Non-Compliance Incident Reporting System; Advanced Calibration Features for Laboratory & Manufacturing; Multi-Time Zone Support on Oracle Platform; Available L-DAP Authentication; Real-time Out of Tolerance (OOT) Notification; Electronic Change Control; Improved Mobile Workstation Utility; and, System Configuration Reports. The Non-Compliance Reporting System auto-generates, distributes and manages critical non-compliant events. Incidents involving calibrations with found out-of-tolerance observations, failed calibrations and calibrations performed past their scheduled date communicated to those who need to know. For details, visit http://www.primetechpa.com.

Scientific Software and Labtronics Announce LimsLinkExpress for EZChrom Elite

Scientific Software, Inc. (SSI) and Labtronics Inc. have announced the development of LimsLinkExpress
for EZChrom Elite, a connectivity module integrating SSI's EZChrom CDS to LIMS packages. LimsLinkExpress provides an off-the-shelf solution for integrating over 30 commercial third party LIMS systems to SSI's EZChrom Chromatography Data System. "This unique package will make it easier for laboratories to ensure integration
between EZChrom Elite and complimentary software products such as LIMS," says Edward Long, vice-president of Marketing at Scientific Software, Inc., "We are very pleased to work with technology partners such as Labtronics to develop these solutions." Major LimsLinkExpress capabilities include: Automatic creation of EZChrom sequences from LIMS worklists; Automatic transfer of EZChrom results to LIMS; Automatic data conversions and reformatting; and, Optional end user interaction and review of information before it is transferred to/from EZChrom to LIMS. LimsLinkExpress is available from Scientific Software or Labtronics Inc. It can be added to any EZChrom Elite Chromatography Data System version 3.1.6 or greater. For details, visist http://www.scisw.com or http://www.labtronics.com.

Bruker Daltonics Introduces Next Level of ClinProt Biomarker Discovery, Identification and Validation Solution

Bruker Daltonics Inc. has announced the next level of its leading ClinProt solution for advanced biomarker discovery, identification and validation in clinical proteomics. The extensive ClinProt portfolio of magnetic beads for sample pre-fractionation has been further expanded with novel capabilities to address 1) biomarker analysis of large proteins, 2) targeted glyco-protein analysis, and 3) antigen-specific enrichment of selected biomarker molecules, combined with high-performance MALDI-TOF read-out. New ClinProt 'Large-Protein Beads' are designed to overcome previous limitations of biomarker discovery to peptide and small proteins, and to exploit the full mass range of up to several 100k Daltons supported by Bruker Daltonics' cutting-edge MALDI-TOF mass
spectrometers. These novel Large-Protein Beads are complemented by a new DHAP matrix product, which is optimized for high molecular weight proteins. In addition, new ClinProt 'Glyco-Beads' bridge the gap between
clinical proteomics and the important field of glycomics. The Glyco-Beads offer multiple methods for glyco-protein enrichment, including both chemical capture or lectin-capture strategies. The new ClinProt bead products are complemented by the new, advanced ClinProTools 2.0 bioinformatics package for streamlined data interpretation. ClinProTools 2.0 combines intuitive data visualization with sophisticated pattern recognition algorithms for the determination of predictive biomarker panels. Spectra not reaching the desired quality standard can be excluded from the analysis in the graphical user interface. For details, visit http://www.bruker-biosciences.com.

Acolyte Biomedica Ltd and Scottish National Blood Transfusion Service Collaborate

Acolyte Biomedica Ltd ('Acolyte') and the Scottish National Blood Transfusion Service ('SNBTS') have entered into a joint research programme with the objective of establishing the suitability of Acolyte's proprietary AK Rapid technology in the rapid and highly sensitive detection of bacterial contamination within blood platelets. Under the agreement, both parties will collaborate and share resources in order to develop a version of Acolyte's BacLite diagnostic test system which has the potential to detect bacteria in platelets within 2-4 hours, thus dramatically improving the current testing time which can take several days. Sensitivity and speed of result are critically important because donated platelets routinely have a shelf life of only five days and must be stored at ambient temperature. For those rare units that may be contaminated with bacteria the need to store at room
t emperature promotes bacterial growth. Testing at the time of preparation may not detect low levels of bacteria. There are more than 4 million platelet transfusions worldwide per annum each playing a critical role for leukaemia sufferers, patients with bone marrow failure and those undergoing post transplant and chemotherapy treatments. Acolyte will launch its first commercial application of the AK technology in its BacLite Rapid MRSA screening test in June this year. Adenylate Kinase (AK) is a constitutive enzyme present in all micro organisms and its detection provides a uniquely sensitive test perfectly suited to the platelet contamination role. AK technology was originally developed by the UK based Defence Science and Technology Laboratory (Dstl) and Acolyte has been granted an exclusive licence to exploit the technology in the field of clinical diagnostics.For details, visit http://www.acolytebiomedica.com.

Professor Isaac P. Witz Joins Stone Bond Advisory Board

Stone Bond Technologies, a leading provider of business integration software, has announced the appointment of Professor Isaac P. Witz to its advisory board. Professor Witz holds the David Furman Chair in Immunobiology of Cancer at Tel Aviv University. His research focuses on interactions between tumor cells and tumor microenvironmental factors such as components of the extracellular matrix, cytokines and immunocytes, and the involvement of such interactions in tumor progression and metastasis formation. Professor Witz holds a Ph.D. from the Hebrew University of Jerusalem. "Stone Bond has demonstrated the benefits of applying business
integration technology in the research laboratory environment," said Prof. Witz. "I look forward to working with Stone Bond to expand the use of this technology in both the research and clinical fields." Stone Bond solutions facilitate administration in research laboratories so that lab members can focus on research rather than administrative tasks. With its recent installations at Baylor College of Medicine, MD Anderson Cancer Center and Weill Medical College of Cornell University, Stone Bond Technologies continues to extend its reach and experience with laboratory information management systems. For details, visit http://www.stonebond.com.

FDA Issues Draft Guidance on Bar-Code Label Requirements

Products with low medication error rates aren't exempt from the FDA's final bar-code rule implemented early last year, according to a draft guidance. Numerous drugmakers have queried the FDA about exemptions to its bar-code labeling rule, but the agency clarified in a recent draft guidance that products won't be exempted for having few medication errors. "If the type of medication error is serious, such as an error that results in death, it would be difficult to justify an exemption on the grounds that few deaths occur," states the draft guidance. "We also have no basis to establish a threshold or baseline number of medication errors that would determine whether a drug should or should not be subject to the bar-code requirement." The guidance, titled "Bar-Code Label Requirements: Questions and Answers," addresses a variety of questions posed by manufacturers since the bar-code labeling rule was released last February. Created to reduce medication errors in healthcare facilities, the rule requires drugmakers to put linear bar codes on both exterior labeling and interior unit-dose packaging. The rule applies to drug products, biological products and OTC drug products commonly used in hospitals. To view the draft guidance, go to http://www.fda.gov/cder/guidance/6383dft.htm.

Warning Letter Citing Part 11 Signals FDA's Enforcement Position, Expert Says

A recent warning letter citing 21 CFR Part 11 validation and control requirements is a clear signal that the FDA will enforce the electronic records and signatures regulation even as the agency moves toward revising it, according to an industry expert. In an April 11 warning letter addressed to Kenneth Rosenthal of Rosenthal Eye and Facial Plastic Surgery in Great Neck, N.Y., the FDA notes that the Rosenthal clinic uses an electronic medical record (EMR) system for patient clinical data in lieu of paper records. "Please note that Title 21, Code of Federal Regulations, Part 11, 'Electronic Records; Electronic Signatures,' outlines specific requirements that must be met for any system that is being used to maintain required records," the letter states. The letter's rare mention of Part 11 caught the attention of compliance consultants and their clients. "In the [good manufacturing practices] area, we've seen much more attention paid to computer-related things in the medical device area than for drugs," said Lisa Olson, principal consultant at SEC Associates in Morrisville, N.C. "What's interesting about this [letter] is the specific focus on asking how the investigator has validated the system, how they have addressed being able to generate copies and [that the FDA is] expecting an audit trail." "This letter indicates that these medical records are considered required regulatory records (part of the larger scope of 'case histories') and that data integrity should be demonstrated by accurate functioning of the system and the ability to tell if changes have been made to the records," Olson said. "This warning letter would seem to indicate that Part 11 is not a 'dead' issue after all (as some have hoped)." For details, visit http://www.fda.gov.

Firms Will Likely Need Upgraded Systems to Submit eCTDs to FDA, Expert Says

Pharmaceutical companies planning to submit electronic common technical documents (eCTDs) to the FDA will likely have to upgrade their systems, despite claims from the agency that system enhancements won't be needed, according to an industry consultant. "The FDA says no new technology [is] needed other than third-party applications to build eCTDs," said Victoria Lander, corporate compliance manager at Waters Corporation, a Milford, Mass.-based scientific technology provider. "But as far as system capabilities, you have to think about adding storage capacity for archiving and electronic transmissions. You need resources to put this together," Lander said during a recent FDAnews audioconference, "Preparing Successful eCTDs: Compliant Submissions the First Time, Every Time." One area companies will likely have to make improvements is electronic signatures. "As far as signature capability, so many applications don't have 21 CFR Part 11-compliant electronic signatures," Lander said. "I see that so often, and that's why there are so many hybrid systems that are common. And then eventually when you get to the digital signature idea on top of plain electronic signatures, then you're adding more functionality that most people don't have." That means you will need to implement new tools or "strongly encourage your vendors to provide you that functionality." Regardless of what the FDA says, companies will have to upgrade systems, capacity and applications, she said. Some upgrades could require outside experts, according to Lander, who said firms will need someone knowledgeable in extensible markup language (XML), which is the standard language being used for electronic submissions. "Not a lot of people in this industry really understand [XML]," Lander said. To order a CD/transcript of the audioconference, go to http://www.fdanews.com/wbi/cds/1838-1.html.

Advisory Committee Recommends Better Use of Electronic Databases

The FDA intends to listen carefully to recent recommendations made by its drug-safety advisers, particularly to suggestions that the agency begin tapping emerging electronic databases to improve its oversight of marketed drugs, the FDA's top drug-safety officer said. Using new electronic databases to identify drug-safety signals was one of the key recommendations to emerge from a two-day meeting of the FDA's Drug Safety and Risk Management Advisory Committee meeting, said Paul Seligman, director of the FDA's Office of Pharmacoepidemiology and Statistical Science. "The take home message from the advisory committee is that we need to take advantage of many of the changes occurring out there in the healthcare world, particularly in the utilization of various kinds of databases that are created from electronic medical records," Seligman said during a webcast sponsored by the Drug Information Association and the Center for Drug Evaluation and Research. "Clearly, the federal government is going to be more closely monitoring drug payments for the elderly when Medicare Part D takes effect," Seligman said, referring to the new Medicare Rx drug benefit that starts in January 2006. "There will be databases associated with that program that the FDA should utilize, as well as increasing opportunities to link different kinds of data sets." Because of the new possibilities for studying drug-safety problems using these kinds of databases, this "is something we should be focusing our attention on and trying to take advantage of," Seligman said of the committee's recommendation. One of the FDA advisers, in fact, suggested the FDA consider focusing its resources on enhancing active database surveillance rather than on trying to improve the agency's existing passive adverse-event reporting system. For details, visit http://www.fda.gov.

FDA Releases Draft Guidance on Antiviral Drug Development

Drugmakers should conduct nonclinical studies of antiviral drug candidates before initiating Phase I clinical trials, according to an FDA draft guidance. The guidance, "Antiviral Drug Development — Conducting Virology Studies and Submitting the Data to the Agency," outlines parameters for submitting nonclinical and clinical virology data to support the review of investigational antiviral drugs. Regarding nonclinical studies, the guidance recommends drugmakers consider studies that identify the mechanism of action, establish specific antiviral activity of the compound in a model system and provide data on the development of viral resistance to the drug candidate. Additionally, antiviral candidates to be used in combination with other drugs should be subjected to in vitro combination activity studies to identify possible negative interactions, the agency says. Regarding clinical studies, the FDA strongly recommends comprehensive resistance testing be undertaken in all phases of drug development. Plans to monitor the development of resistant viruses should be submitted to the FDA before clinical studies begin, the guidance says. These plans should be included in the nonclinical studies and in the overall clinical development plan contained in the investigational new drug application, according to the guidance. The FDA will accept public comment on the draft guidance for 60 days. To view the document, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/2005-0183-gdl0001.pdf.

FDA Confident About Deadline for Implementing Electronic Pedigrees

The FDA believes it is well on its way to implementing an electronic pedigree system for drug products by its 2007 goal, according to a progress report on the agency's counterfeit drug initiative. "We are pleased with the progress stakeholders, standard-setting bodies, and software and hardware companies have made thus far toward implementing an electronic pedigree for drug products," the FDA stated in the progress report. "We recognize that there have been, and continue to be, challenges along the way. However, we are optimistic that this progress will continue in an expeditious manner toward meeting our 2007 goal." The use of electronic pedigrees has been a touchy subject in the drug industry, as most drugmakers have been pushing the FDA to implement a paper-based pedigree system before moving forward with an electronic system. The FDA was poised to establish a paper-based system when it released a final rule on paper pedigrees in 1999, but the agency later decided to delay implementation of the rule to examine the possibility of developing an electronic system. Most recently, the FDA issued a stay last February delaying implementation of the paper pedigree rule until Jan. 1, 2007. Shortly before issuing the most recent stay, the FDA announced a broad anticounterfeiting initiative, which, among other goals, established a Dec. 31, 2006, target date to implement electronic pedigrees for pharmaceutical products. To view the progress report, "Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update," visit http://www.fda.gov/oc/initiatives/counterfeit/update2005.html.

Drug Safety Oversight Board Consists of Mostly CDER Officials

Center for Drug Evaluation and Research (CDER) officials hold 14 of the 18 seats on the FDA's recently established Drug Safety Oversight Board (DSB) — a majority position some observers say could prevent the board from making impartial decisions. When the FDA announced the creation of the DSB in February, the agency said the board would "enhance the independence of [the FDA's] internal deliberations and decisions regarding risk-benefit analyses and consumer safety." Industry observers, however, said that goal could be difficult to achieve given the final make-up of the board. "How can the oversight board make objective decisions on drug safety when the vast majority of the board members are from the same center that is approving the drugs?" said one industry source, who declined to be identified. "If the agency really wants to promote independence, it needs to either diversify the membership or move the board out of [CDER]." The DSB consists of 18 members total, three of which are nonvoting members, including the board's chairman and executive director. CDER acting Deputy Director Douglas Throckmorton is chairing the board and Susan Cummins is its executive director. Eleven of the DSB's 15 voting members are CDER officials, led by Office of New Drugs Director John Jenkins, Office of Drug Safety Deputy Director Anne Trontell and Office of Pharmacoepidemiology and Statistical Science Director Paul Seligman. The board's four remaining voting members hail from the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Department of Veterans Affairs and the NIH.For details, visit http://www.fda.gov.

IFPMA to Launch Centralized Search Tool for Trial Registries

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is launching an internet search portal this fall that will provide a centralized location to access clinical trial registries and databases worldwide. The search engine, which will be developed by IBM for a September launch, is part of the pharmaceutical industry's ongoing efforts to increase the transparency of clinical trials, said IFPMA, whose membership organizations include PhRMA, the European Federation of Pharmaceutical Industries and Associations, and the Japanese Pharmaceutical Manufacturers Association. "Disclosure of clinical trial information can provide an important benefit to physicians and to their patients and families when evaluating the latest biomedical research information and details about clinical trials currently underway that might help alleviate their suffering," IFPMA President Daniel Vasella said. "The internet portal will ensure that we help those in need and the medical community rapidly and easily find the data that can help facilitate medical decisions about therapies and future potential treatments." IFPMA announced in January that its members would voluntarily disclose summary results of all industry-sponsored clinical trials. The trial data will be published in a standard, nonpromotional summary that will include a description of trial design and methodology, results of primary and secondary outcome measures described in the protocol, and safety results. Currently, U.S. drug firms are only required to publish the results of studies investigating life-threatening diseases. PhRMA members will post results from all hypothesis-testing clinical trials on the National Library of Medicine's (NLM) website, http://www.ClinicalTrials.gov. PhRMA also has launched its own clinical trials registry at http://www.ClinicalStudyResults.org. IFPMA's portal will connect to both the NLM site and PhRMA's registry, as well as other industry- and government-sponsored trial registries, such as those launched by drugmakers Eli Lilly, GlaxoSmithKline and Roche.

EU to Implement New Drug-Safety Requirements this Fall

Pharmaceutical companies will be required to submit mandatory adverse-event reports as well as risk management plans for their drug products under a series of broad new drug-safety requirements to be implemented by the European Union (EU) this fall. Drafted by the European Medicines Agency (EMEA) and the Heads of Medicines Agencies (HMA), the reporting requirements will be included in new "Community" legislation that EU regulators will begin enforcing in November, the agencies announced. "The new legislative provisions will allow for an intensive supervision of the undesirable effects of medicines in order to take appropriate regulatory action, including, where needed, a rapid withdrawal from the market of any medicinal product presenting a negative benefit/risk balance under normal conditions of use," the EMEA and the HMA said. The agencies emphasized that the new measures are not designed to slow the drug development process and won't result in an increase in regulatory data requirements during the premarket approval phase. The Community legislation was drafted as part of the EU's broad European Risk Management Strategy (ERMS) initiative, which was launched in 2002 to enhance the EU's monitoring of drug safety. In addition to spawning the drug-safety legislation, the ERMS is focused on numerous other goals, including improving the EU's overall drug monitoring system. To view the EU's ERMS action plan, go to http://www.mhra.gov.uk/EU_risk_action_plan.pdf. To view the progress report on the implementation of the ERMS, go to http://www.mhra.gov.uk/EU_risk_report.pdf.

SAP’s Provides Several Announcements from SAPPHIRE ’05 Boston

During SAPPHIRE '05 Boston -- held May 17-19 at the Boston Convention & Exhibition Center – SAP AG made a series of announcements, including the next evolution of mySAP Customer Relationship Management; new Master Data Management capabilities for SAP NetWeaver; Business Intelligence Flexibility and Performance with HP and Intel;and, Channel Program for Global Partner Network Serving Small and Midsize Businesses. mySAP CRM 2005 will reportedly deliver new levels of innovation across key business processes for the telecommunication, public sector and financial services industries, as well as key cross-industry business capabilities such as service management, marketing resource management and mobile sales for handhelds. Powered by the SAP NetWeaver platform, complete with embedded analytics and featuring enhanced dashboard-like analytical applications, the new version of mySAP CRM focuses on helping customers enhance user productivity by empowering users with a complete view of all relevant information from diverse enterprise systems to drive insight, decisions and cross-enterprise collaboration. mySAP CRM 2005 will bring a slate of custom-developed extensions into the globally available CRM capability stack, including cross-industry processes to address all lines of business across marketing, sales and service through all customer interaction channels. Master Data Management (MDM) capabilities for SAP NetWeaver reportedly will help companies achieve master data consistency and accuracy across a set of heterogeneous systems and databases within and across enterprise boundaries. SAP NetWeaver MDM allows business applications to work from a common master data foundation, leading to superior business decisions based on clean, synchronized and integrated master data across the globe. SAP also announced the completion of a development project with HP and Intel that produced a low-cost, appliance-like offering designed to provide breakthroughs in both performance and flexibility for SAP NetWeaver Business Intelligence. This offering combines the technologies of the three companies to accelerate the performance of the analytic applications debuted at SAPPHIRE '05 Copenhagen on April 26, 2005. Developed in collaboration with Intel as an integral capability of the SAP NetWeaver platform, the "Enterprise Services-Ready" technology is pre-loaded on highly flexible and scalable HP ProLiant servers running on 64-bit Intel Xeon processors and HP StorageWorks storage area network (SAN) systems. Finally, SAP announced a next-generation channel program for its global partner network as part of its strategy to expand its applications software business with small and midsize companies. The new SAP PartnerEdge Channel Partner Program is a multilevel program that will provide enhanced infrastructure and business-enabling support to allow success and profitability for resellers, ISVs and other partners who market, develop, sell and implement SAP solutions for the growing market segment. As part of the announcement, SAP also issued a special invitation to partners of competing vendors to join the new program at preferred status. For details, visit http://www.sap.com.

CDER Releases Guidance Agenda for 2005

The FDA's Center for Drug Evaluation and Research (CDER) is planning to develop nearly 50 new guidances in 2005, including recommendations on direct-to-consumer advertising and product labeling, according to CDER's recently released guidance agenda. The agenda includes 47 guidance topics related to advertising, clinical/medical developments, pharmacology, compliance, labeling and procedures. To view CDER's 2005 guidance agenda, visit http://www.fda.gov/cder/guidance/CY05Agenda-51005finalver.pdf.

BioAnalyte Releases New Biomarker Discovery Software

BioAnalyte has released its flagship software under a revolutionary software license that binds the product to data. The product, ProteinTrawler, is a tool for the rapid reduction of gigabyte-size raw scientific data sets to manageable lists of potential biomarkers, or diagnostic indicators of disease. The new proNets license allows the ProteinTrawler software to analyze individual data sets. Users pay once and analyze many times on one computer or several. "We’ve taken $10,000 software and have found out how to sell it $15 at a time and increase revenues by a factor of 100” said Peter Leopold, president of BioAnalyte. Vladimir Georgiev, BioAnalyte’s software production manager, commented that the “monolithic” nature of biotech data makes the license scheme possible. “We couldn’t do this for a text editor, but we can for a two-hour chromatogram that contains 40 million individual measurements.” The proNets license as a business model is aided by FDA requirements for data integrity, Leopold added. "Our new license enforces data integrity while promoting the sharing of scientific data between colleagues,” Leopold said. For details, visit http://www.bioanalyte.com.

LabVantage Announces the Availability of the Sapphire BioBanking Solution

LabVantage Solutions Inc., a leading provider of browser-based laboratory information management solutions, has announced the availability of the Sapphire BioBanking Solution. Built in conjunction with the original developers of the widely-recognized Spectrum repository management tool, the solution offers a complete, out-of-the-box sample management and tracking system for biological specimens. Large-scale research in genomics and proteomics, and clinical development for tomorrow's drugs and medical treatments, especially with the emergence of biomarker research and personalized medicine, necessitates accurate, compliant and efficient management of biospecimens. Although many software products have addressed smaller pieces of sample management, LabVantage has recognized the need to bring together "best of breed" information management, location tracking, logistics and compliance features to the life sciences industry. The Sapphire BioBanking Solution is designed to address the unique challenges of specimen collection and banking for pharmaceutical discovery and clinical operations, academic and biosciences research centers, medical institutions, and contract research organizations. It provides a browser-based user interface for quick user acceptance, and a built-in Evergreen(tm) configuration tool to tailor the same solution to the needs of each laboratory within an organization. This flexibility also allows the Sapphire
BioBanking Solution to readily adapt to a variety of data capture, result management, storage and specimen handling circumstances. This biospecimen tracking module is seamlessly integrated with Sapphire's existing laboratory information management solution for life sciences R&D which can manage experiments and track vital genomic, proteomics, phenotypic and other result information about samples. Furthermore, it can easily be
integrated with third party public databases, instruments, clinical trail management systems, electronic data capture systems, and existing laboratory information management systems. For details, visit http://www.labvantage.com/pr/biobanking.

QSI Signs Agreement with Business Objects to Enhance WinLIMS Reporting Module

QSI has signed an agreement with market leader Business Objects to license their Crystal XI and Business Objects Enterprise technology for the WinLIMS reporting module. BO Enterprise provides a secure, central control and publishing facility and repository for documents and reports and also includes a wide range of management tools. Reports can be filed and controlled by category - for example according to the roles of those needing to access them such as lab manager, technician or customer. In the same way information within a report can be segregated in such a way that different elements of a report can be sent to different recipients depending on their specific needs or security profile. For audit purposes, it helps to know when reports are run outside the controlled WinLIMS environment, e.g. via the web. The reporting module can maintain a history of each report, recording each time it is run and the data within it at the time. The latest version of Crystal Reports now offers dynamic prompts and cascading prompt lists to simplify report design. When designing client reports that allow the entry of data selection criteria, the user is prompted when such an entry is required. With dynamic prompts, the available choice of criteria is presented automatically as well. For example, if one of the criteria were a raw material type, the prompt would return in a list all raw materials within the database, enabling the user to select from the list rather than having to enter the data manually. As the prompts can cascade, if the next criterion were a method, the list would only contain methods appropriate to the selected raw material type, and so on. There is no restriction to the number of cascades. These tools help to speed up report design and clearly reduce the potential for error. According to QSI, this new agreement means that for the first time even small laboratories can now achieve the industry standard when it comes to reporting, and at an affordable price. For detials, visit http://www.lims-software.co.uk.

GenoLogics and the Institute for Systems Biology (ISB) Form Strategic Partnership

GenoLogics Life Sciences Software Inc. has announced that it has established a strategic partnership with the Institute for Systems Biology to collaborate on increasing the widespread utility of ISB’s open source software tools within the life sciences community.ISB has played a pioneering role in developing new open source tools for
data collection and analysis as well as new scientific instruments and approaches supporting genomics, proteomics, and high-speed cell sorting. GenoLogics will collaborate to enhance the functionality and usability of ISB”s open source tools and integrate these tools into its industry leading lab management and informatics platform – ProteusLIMS. In addition, the GenoLogics value-added support network will facilitate installation and broaden the reach of the tools for a wider group of researchers.For details, visit http://www.genologics.com.

Waters Corporation Announces MassTrak Clinical Solutions

Waters Corporationhas has announced MassTrak Clinical Solutions, a systems approach aimed at clinical research applications to respond to the growing, complex needs of this demanding market. Waters MassTrak Clinical Solutions provide a comprehensive answer to monitor and measure drug therapies, perform toxicology screening and confirm and quantify biomarkers quickly, reliably and accurately. They include methodology, HPLC, mass spectrometry, software, chemistries and service and technical support from Waters worldwide clinical team. The heart of Waters MassTrak Clinical Solutions is Waters LC/MS/MS technology encompassing the Quattro series of tandem mass spectrometers and the Alliance series of HPLCs with software optimized for clinical research applications and methodology. The MassTrak Clinical Solutions approach enables researchers to measure trace levels of analytes with high specificity and sensitivity in a robust, high throughput system with simple sample preparation. For details, visit http://www.waters.com.

P-Wave's Partnership with Promium Offers Environmental Labs New Document and Data Management Solution

P-Wave, Inc., a leader in web-based document and records management solutions for regulated industries, has announced its partnership with Promium. The partnership integrates LabCORE, P-Wave’s laboratory document management system, with Promium’s Element Datasystem LIMS. The result is a much more effective and efficient document and records management solution for environmental testing and contract laboratories. This partnership allows Promium to offer its clients P-Wave’s LabCORE product for their document and records management needs. According to Buddy Wilson, Promium’s President, “This state-of-the-art program empowers the laboratory to electronically store data from various sources and to attach the data to reports, based on each client’s requirements. Contents of the stored files are not limited to just raw data, but also include chromatogram and spectral snapshots. Currently many laboratories use valuable, time-consuming human resources to generate such data packages. With this offering, laboratories using Element Datasystem can now automatically collate, paginate, and report their analytical and instrument data with the corresponding spectral representation to their clients, at the click of a button. This reduces the laboratory’s dependency on valuable human resources, making the LabCORE offering a truly powerful tool.” For details, visit http://www.promium.com or http://www.lab-core.com.

Computing Solutions Debuts Notification Agent in LabSoft LIMS v8.02

Computing Solutions, Inc., a premier LIMS provider, has extended the features of LabSoft LIMS to include
Notification Agent. The Notification Agent increases efficiency and streamlines workflow by alerting LIMS users of events that require their attention or warrant recognition. Notification Agent is an automated service that runs in the system tray while LabSoft LIMS is operating. The Agent searches for pre-configured Notification Events and displays a window when an Event is found. Example Events are: a COA was created, a COA was created with Out of Spec data, a Specification Agreement requires approval, n consecutive points ascending or descending, n points above or below the mean, Out of Spec data, Out of 3 Sigma, etc. The Notification Agent window does not remove focus from the active LabSoft LIMS window when it displays. Instead, the Agent's title bar will flash to alert the user of a Notification Event. The user can double click the subject or body in the Agent window to immediately review the Event. The Agent window will automatically close after the Event has been addressed. The Notification Agent is available in LabSoft LIMS v8.02. For details, visit http://www.LabSoftLIMS.com.

New NWA Quality Analyst 6 Supports Corporate Quality Initiatives And Simplifies SPC Integration With Enterprise Applications

Northwest Analytical, Inc. (NWA), a leading provider of statistical process control (SPC) software, has announced a major update to NWA Quality Analyst, its award-winning SPC charting and analysis software solution. NWA Quality Analyst, the flagship product in the NWA SPC software suite, helps manufacturers understand and improve their processes to increase product quality, reduce defects, waste and costs, meet customer requirements, certify vendors and comply with regulatory requirements. NWA Quality Analyst Version 6 enables manufacturers to more easily analyze their process data to identify process improvements and execute quality initiatives such as Six Sigma, CAPA (Corrective Action/Preventative Action) and ISO. The new Version 6 also includes several key enhancements that further simplify the integration of SPC and process quality data with plant-level and enterprise manufacturing information systems such as ERP, MES and LIMS. Many of the enhancements in Version 6 were developed for users engaged in corporate quality initiatives. These include: Assignable Cause/Corrective Action (AC/CA); Better Access to Chart Information; More Powerful Presentation of Chart Data; New graphics viewer; Rainbow charts; and, More graphic output formats Other key enhancements address the growing need to integrate SPC and quality reporting with plant-level and enterprise manufacturing information systems including ERP, MES, LIMS and SCM (supply chain management). These include: Improved Setup of Database Connectivity; Database Synchronization; Read Specifications from External Databases; and, XML Output and Parameter Files. For details, visit http://www.nwasoft.com/qanew.htm.

Northwest Analytical Selects ICR3 Cientifica of Brazil to Distribute SPC Software in South America

Northwest Analytical, Inc. (NWA) has announced that the company has selected ICR3 Cientifica to distribute its SPC software in South America. Headquartered in Sao Paulo, Brazil, ICR3 Cientifica will provide localized sales, training and support for all NWA SPC software solutions in South America. Through this agreement, manufacturers and laboratories in South America will now have a single source for all their quality and laboratory automation needs. ICR3 Cientifica is a leading provider of laboratory automation and instrumentation to the petrochemical, pharmaceutical and tobacco industries in Brazil. ICR3 is also the South American distributor for LabWare LIMS. The partnership with NWA will allow ICR3 to deliver more value to its customers by expanding its business to provide complete laboratory automation solutions.NWA’s SPC software enables manufacturers to improve process efficiency and product quality, reduce manufacturing costs, automate quality data collection, improve enterprise and supply chain communication and demonstrate compliance with customer and regulatory quality requirements For details, visit http://www.icr3.com.br or http://www.nwasoft.com.

Teranode Announces Availability of New White Paper on Experiment Design Automation

Teranode Corporation, a leading innovator of experiment design automation (XDA) software for the Life Sciences industry, has announced the availability of a new research report discussing experiment design automation as an emerging solution for boosting R&Dproductivity in Life Sciences R&D. "Experiment Design Automation: A Potential Solution for Fragmented Informatics in Biopharmaceutical Research and Development," sponsored by Teranode, and authored by Life Science Insights' (LSI), an IDC Company, outlines the current state of Life Sciences R&D productivity and the various methods being deployed today. The white paper, which includes case studies with several Teranode customers in two multi-national pharmaceutical companies, concludes that some of the key barriers to R&D productivity are bottlenecks of data access, analysis and collaboration created by the fragmented and rigid landscape of informatics and data management systems. The report suggests that tools that encompass both computational biology and model-based experiment design will be very important to improving the speed and quality of lab work. For details, visit http://www.teranode.com/docs/LifeScienceInsights.pdf.

Siemens Holds SIMATIC IT Users Meeting

Siemens hosted their Siemens SIMATIC Users Meeting, providing a glimpse of the future via demos where SIMATIC IT exchanged information in realtime - via B2MML - with an SAP system in Walldorf. P2B Interoperability was a key theme at the event in Tampa, FL. By more easily connecting the plant floor to business and supply chain systems, better performance and new opportunities can be expected. With major suppliers like SAP and Siemens embracing it, P2B Interoperability is finally on its way to becoming a reality in the industry. The demos showcased an Enterprise-level platform (SAP NetWeaver with SAP ERP), and a plant-level platform (SIMATIC IT with SIMATIC IT Framework), with B2MML in between. In addition to the live demo, this concept was echoed in presentations by SAP, Siemens, ARC, and several other featured customers. Held in conjunction with the established Siemens PAS user event, this was the first of its kind for Siemens in the North American market. For details, visit http://www.siemens.com.

Orion Multisystems Ships Highest Performance Personal Supercomputers; First 96-Node Computer Workstation Based on Cluster Technology Plugs Into Standard Power Outlet and Requires Minimal IT Support

Orion Multisystems, Inc. has announced it is shipping the 96-node deskside Cluster Workstation, a personal supercomputer that fits under a desk and is the highest performance general-purpose computing platform that can be plugged into a standard power outlet. The launch follows a successful introduction last year of Orion’s 12-node desktop Cluster Workstation, a system now in use by customers in multiple countries and market segments worldwide, including life sciences, geosciences, engineering, manufacturing, financial analytics, media and entertainment. "Having a cluster available at your desk as an individual resource, rather than a shared one down the hall, fosters a more interactive experience," said Jim Lux, senior member of the engineering staff, NASA Jet Propulsion Laboratory. “Orion is making clusters a convenient, low maintenance product with the user experience of an integrated device, like a PC. The new 96-node deskside system provides an order of magnitude higher performance than the desktop, still without requiring extensive support staff and infrastructure.” Designed for an office or laboratory, Orion Cluster Workstations are innovative productivity tools for individual engineers, scientists, financial and creative professionals. The 96-node Cluster Workstation, stackable up to four systems, significantly expands Orion’s capabilities from a company providing mobile supercomputing with its 12-node desktop, to true capacity computing, saving customers the usage time, costs and IT infrastructure associated with large, shared backroom clusters. For details, visit http://www.orionmulti.com.

Group Logic Unleashes "Tiger" Compatible ExtremeZ-IP File Server Software

Group Logic, developer of best-selling network workflow software, has announced the release of ExtremeZ-IP File and Print Server 4.0.4 a product update that delivers compatibility with Apple's new "Tiger" platform (Mac OS X 10.4). This release highlights Group Logic's ongoing commitment to actively maintain compatibility with the latest Macintosh operating platforms. ExtremeZ-IP is the only Windows-based Apple Filing Protocol (AFP) software on the market that supports the new Mac Tiger platform and integrates Mac OS X and Mac OS 9 with Windows 2003/2000, Windows 2003 Storage Server and Windows XP Professional. ExtremeZ-IP 4.0.4 has undergone extensive testing with the new Mac Tiger platform. In addition to maintenance changes that ensure the product is qualified for the new Mac OS X Tiger 10.4, ExtremeZ-IP version 4.0.4 also incorporates a number of additional performance improvements, including gigabit networking for hi-speed networks. ExtremeZ-IP is used by thousands of customers worldwide who depend on it to deliver reliable file sharing between their Mac desktops and Windows file servers. The ExtremeZ-IP product line provides stable and compatible Windows-based file and print server solutions for Mac OS X and Mac OS 9 users. For details, visit http://www.grouplogic.com/support/tiger.

Applied Biosystems/MDS Sciex is the Top Supplier in the Mass Spectrometer Market

According to a recent survey of life scientists using mass spectrometry (MS) in their research, Applied Biosytems/MDS Sciex is the leading mass spectrometer brand in all regions and market segments, followed by
Agilent Technologies and Thermo Finnigan. Customers of these three leading brands are significantly more
satisfied with their most recent mass spectrometer acquisition than purchasers of other brands—as compared to other market players such as Waters, Bruker Daltonics and PerkinElmer Life and Analytical Sciences. These findings were recently published by BioInformatics, LLC—an Arlington, VA-based market research and consulting firm—in its latest report “Mass Spectrometry: Opportunities in the Life Science Market.” Based on a survey of more than 600 scientists who use mass spectrometry (MS), the report provides a comprehensive look at researchers’ experimental design, instrument specifications and future purchasing plans as well as assesses opportunities for suppliers to expand their reach into markets characterized by key parameters such as application, instrumentation type, sample complexity and throughput. Suppliers in this market will benefit from the 19% of current mass spectrometer users who have plans to purchase a new instrument—the majority of whom will do so within the next year. These scientists are most likely to seek new mass spectrometers that have greater mass accuracy, the ability to perform more applications and greater sensitivity, and most respondents anticipate acquiring them from Applied Biosystems/MDS SCIEX and Thermo Finnigan. “Current brand usage and/or most recent MS purchase are strong predictors of future brand purchase, but are not absolute indicators. Other factors, such as research objective, MS applications and motivation for purchase will all enter into the decision to obtain one system as compared to another,” predicted Dr. Robin Rothrock, Director of Market Research at BioInformatics, LLC. For details, visit http://www.gene2drug.com.

Thermo Electron Wins Omega NorthFace ScoreBoard Award for Excellence in Customer Service

Thermo Electron Corporation has recently been presented with two Omega NorthFace ScoreBoard awards for excellence in customer service. The awards were established in 2000 by the Omega Management Group Corp. to recognize companies that receive high scores when rated by their own customers for their product quality, technical support, documentation, sales and marketing, field service, account management and training. Omega surveyed more than 3,000 of Thermo's customers during 2004 to evaluate two unique areas of customer service - installation satisfaction and field service. Results indicated that 97% of respondents would recommend the company's products and services to others. Understanding the challenges facing today's laboratories, Thermo Electron develops comprehensive solutions that lead to more effective laboratory management, improved productivity and lower cost-of-ownership. A dedicated team of trained and certified engineers works in a broad range of disciplines, from system installation, training, maintenance and technical support to complete asset management and regulatory compliance consulting. Thermo Electron creates support plans tailored to each customer's specific requirements making sure that systems and processes are up to date, laboratories meet regulatory guidelines, operators are proficient and replacement parts are available when and where needed. Plans can include a selection of guaranteed response times and predictable per-visit costs that include travel expenses, labor and replacements parts. For details, visit http://www.thermo.com/informatics.

Eli Lilly Research Laboratory Installs Protedyne’s BioCube System at Indianapolis, Indiana Facility

Protedyne Corporation, a leading laboratory automation supplier, has announced that it has completed the installation and site acceptance of its BioCube System LX2000 in Eli Lilly’s Indianapolis facility. The Lilly research facility will use the BioCube System to perform compound solubilization for drug discovery research. Protedyne’s unique approach combines scientific and automation expertise, industrial-quality automation and sophisticated data management. The foundation of the Company is the BioCube System, which brings advanced industrial automation capabilities into life science and diagnostic laboratories in a fast, flexible, and reliable package. For details, visit http://www.protedyne.com.

Protedyne Selects Dr. Lorah Perlee as Director of Scientific Applications

Protedyne Corporation, an industry leading high-throughput automation provider, hasannounced that Lorah Perlee, Ph.D, has joined the company as Director of Scientific Applications. Dr. Perlee will lead the Protedyne science team and investigate advanced scientific applications for the BioCube System, the company’s automation
platform. Prior to joining Protedyne, Dr. Perlee was Vice President of Operations for Molecular Staging, Inc., a biotechnology company that developed and commercialized products and services for protein biomarker discovery and whole genome amplification. While at Molecular Staging, she served as principal investigator for
biomarker discovery projects and authored multiple patents involving the identification of drug and disease biomarkers using protein arrays. Dr. Perlee has also served as Vice President of Operations for DiagXotics, Inc. where she developed and manufactured novel diagnostic assays for the detection and management of animal disease, and Director of Laboratories at Lifecodes Corporation, overseeing the high-throughput bone marrow screening service testing operation. She is board certified in histocompatibility and immunogenetics and has been published extensively in scientific and medical journals. For details, visit http://www.protedyne.com.

Atrium Research Publishes Results of ELN Survey

Atrium Research has announced the availability of their 2005 Electronic Laboratory Notebook Survey Report. This study comprises the results and analysis of a survey of key Information Technology (IT) and laboratory decision-makers in the life sciences, chemical, medical, environmental and food markets. The report highlights management and scientists’ viewpoints on the emerging market for Electronic Laboratory Notebook technology (ELN) including their purchase interest, feature requirements, project goals, funding, integration needs, and supplier brand awareness. The market for Electronic Laboratory Notebook (ELN) technology is exploding. One of the fastest growing informatics markets with a growth rate of over 30% per year, ELNs have the potential to radically improve the effectiveness of R&D. ELNs replace traditional paper notebooks which have been used for centuries to record experiments, data and conclusions. Bound laboratory notebooks are a poor communications medium, restraining researchers from sharing information and collaborating on experiments. An ELN can create virtual teams of scientists who freely share their knowledge and experiences - decreasing the time to discover and develop new molecular entities. "We forecast double-digit growth for ELN over the next four years” said Michael Elliott, President of Atrium Research. “Our study shows strong interest in the technology to eliminate a major barrier toward the vision of electronic R&D. As was the case with LIMS in the early 1980’s, the life sciences market is leading ELN adoption and deployment.” For details, visit http://www.atriumresearch.com.

Protedyne Opens European Office in the United Kingdom

Protedyne Corporation, a leading laboratory automation supplier, has announced the opening of an office in
the United Kingdom. Located in Essex, England, the new office will house the company’s European sales and support groups. Industry veteran Ashley Gould, the company’s regional manager for Europe, will oversee the U.K. facility. "Protedyne’s fast growing European customer base, coupled with our strong focus on customer support, has provided us with a timely opportunity to expand our presence in Europe,” said Catherine Williams, Vice President, Sales, Marketing & Customer Care. “Having a sales and support office located in the United Kingdom will enable us to rapidly respond to the needs of our European customers.” For details, visit http://www.protedyne.com.

Agilent Technologies to Open New Scientific Training Center in Shanghai

Agilent Technologies Inc. has announced it is opening a new Life Sciences and Chemical Analysis (LSCA) Technical Training Center in Shanghai. The center will be used to train scientists across the Asia-Pacific region on key measurement technologies used in food safety, environmental testing, petrochemical testing, pharmaceutical testing and life sciences. The new training center is located next to Agilent's R&D and manufacturing center in Shanghai, which opened in 2002. It will serve scientists from the industrial, government and academic sectors within China and throughout the Asia-Pacific region, including Japan, South Korea, India, Thailand, Singapore and Malaysia. Approximately 500 people will be trained within the first year by scientific experts from China and overseas locations. Trainees will receive hands-on instruction on the use of chemical analysis and life sciences technologies that make possible the precise identification, quantification and analysis of chemical compounds and facilitate the study of biological processes. This training will help scientists advance basic research and drug discovery, as well as quality control and other key test and measurement capabilities. Alarge percentage of trainees will be from China, which is one of Agilent's largest and fastest-growing markets. Key areas of focus for Chinese trainees will be technologies involved in food safety, environmental testing, and the petrochemical, pharmaceutical and traditional Chinese medicine industries, all which are important and growing industries in China. The Shanghai training center is the third such Agilent facility worldwide. The other centers are located in the United States and Germany. For details, visit http://www.agilent.com.

FDA Officials Highlight Role of Risk Management in cGMP Inspections

Risk management plays a critical role in determining an investigator's approach to a current good manufacturing practice (cGMP) inspection, dictating everything from how the inspection is conducted to who is placed on the investigative team, FDA officials told a recent industry conference. Risk management changes priorities, sometimes on a daily basis, said Rebecca Asente, a compliance officer in the FDA's Office of Regulatory Affairs. The focus on an individual inspection will be determined largely by the type of facility that is being inspected and the risk inherent to that type of operation, said Asente, who participated in a recent panel discussion, on "Current Approaches to Regulating Product Quality Through GMP Oversight," at the FDA Science Forum in Washington, D.C. Risk management is a key element of the FDA's new systems-based approach to drug manufacturing, which was unveiled last September as part of the agency's pharmaceutical cGMP initiative. Asente said the systems-based approach has "improved the FDA's regulatory effectiveness because it helps investigators hone in on those systems that are most important, which in turn has helped to better organize our investigative approach." For details, visit http://www.fda.gov.

Study Finds Decline in Number of Clinical Trials, Lead Investigators

Pharmaceutical firms are conducting significantly fewer clinical trials than they were in the 1990s, a trend reflected by a rapid decline in the number of principal investigators (PIs) in the U.S. between 2001 and 2003, according to a study completed by the Tufts Center for the Study of Drug Development (CSDD). The study, believed to be the first to assess the PI landscape, determined that the number of PIs in the U.S. decreased by 11.4 percent between 2001 and 2003. During that same period, the number of clinical trials dropped by 10.6 percent, the study says. In addition, turnover rate among PIs in the U.S. has nearly doubled since 2001, and regional and gender disparities have widened, according to Tufts CSDD. "The decline in the number of principal investigators and the high turnover rate pose several threats to research sponsors," said Ken Getz, research fellow at Tufts CSDD and author of the study. "The capacity of the market to conduct clinical trials for industry sponsors is eroding and efforts to establish a well-trained, experienced pool of clinical investigators may be more difficult." Tufts CSDD based its findings on analyses of FDA data on more than 100,000 registered PIs who conducted clinical trials on investigational drugs between 1977 and 2004. For details, visit http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=54.

Drugmakers Should Be Wary of Liability for Counterfeit Products, Expert Says

Pharmaceutical firms not only have to worry about counterfeiters taking a chunk out of their bottom lines, but they must also protect themselves from being held liable for those bogus products, according to an expert on the counterfeit drug trade. The liability of counterfeit products will be an increasingly important issue facing the drug industry, said Christopher Michie, an attorney with the law firm Dechert. "Believe it or not, pharmaceutical and medical device manufacturers have been sued, and some judges have said, under some circumstances, they can be held liable for injuries caused by products they did not even manufacture," Michie said during an FDAnews audioconference on combating counterfeit drugs. The liability suits are based on the alleged failure of firms to act aggressively toward the counterfeit products, he said. If a drugmaker has a brand, for example, and is aware that another party is misusing that brand, then the courts might be willing to impose liability on the company in certain circumstances, Michie said. To order a transcript of the audioconference on combating counterfeit drugs, go to http://www.fdanews.com/wbi/cds/598-1.html.

Senate Bill Would Create Independent FDA Drug Safety Center

The FDA would have new authority to withdraw previously approved drugs, require postmarketing clinical trials and vet direct-to-consumer (DTC) advertising under a drug safety bill introduced by two influential senators.
The Food and Drug Administration Safety Act of 2005, drafted by Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Christopher Dodd (D-Conn.), would establish an independent Center for Postmarket Drug Evaluation and Research (CPDER) to carry out a series of proposed drug safety measures. The center, which would receive $500 million over five years, would report directly to the FDA commissioner. "The new center is needed because the existing office of new drugs is hampered by real and perceived conflicts of interest," Grassley said during a recent press conference. "If you want accountability, it doesn't make sense to have the office that reviews the safety of drugs to be under the thumb that puts the drugs on the market to begin with." Under the legislation, the FDA's existing Office of Drug Safety (ODS) would transfer to CPDER. "The center's independence would not exist solely on an organizational chart like it presumably does right now," Grassley said of the current drug safety office. The independent center would be in a better position to regulate drugs once they're on the market, he added. For details, visit http://www.fda.gov.

US DOD Issues Proposed Rule for RFID

The US Office of Management and Budget has released a proposed rule regarding the Defense Federal Acquisition Regulation Supplement (DFARS), adding policy pertaining to package marking with passive radio frequency identification (RFID) tags on April 21, 2005 and updated it on April 27, 2005. The proposed change requires contractors to affix passive RFID tags at the case and palletized unit load levels when shipping packaged operational rations, clothing, individual equipment, tools, personal demand items, or weapon system repair parts, to the Defense Distribution Depot in Susquehanna, PA, or the Defense Distribution Depot in San Joaquin, CA. A copy of the proposed rule, which includes the requirements for use of EPCglobal Class 0 and Class 1 passive RFID tags and Advanced Shipping Notices (ASNs), is available at: http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.ac cess.gpo.gov/2005/05-8369.htm.

FDA Issues Guidance Setting Goal of SPL Implementation by Fall 2005

Manufacturers should begin submitting electronic labeling changes for previously approved drugs in structured product labeling (SPL) format by fall 2005, according to a final FDA guidance. The FDA currently accepts labeling changes in both PDF and SPL format, but the agency's goal is to transition exclusively to SPL, which provides numerous advantages over PDF format, including increased flexibility and compatibility across different computer operating systems. Under the "Providing Regulatory Submissions in Electronic Format — Content of Labeling" final guidance, drugmakers should switch to SPL format by this fall for all labeling submissions for approved products. The agency didn't establish a transition date for labeling submissions for unapproved drugs.
To view the final guidance on SPL submissions, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0041-gdl0002.pdf.

What's New - May to June 2005 The following is a wrap-up of news of interest during the months of May to June 2005

What's New - May to June 2005
The following is a wrap-up of news of interest during the months of May to June 2005