LIMSource News: What's New Novermber to December 2006

• Thermo Fisher Scientific Provides Choice of Database for Informatics Customers
• NorthWest Analytical's White Paper Tells How to Manage Lab Analysis with SPC
• Labtronics to Contribute to Technical Program at Pittcon 2007
• QSI States WinLIMS Rental Pays for Itself
• Labtronics Informational Webcast Series Well Received
• Thermo Fisher Scientific Announces that PEMEX Standardized on Thermo Scientific LIMS and CDS
• National Instruments LabWindows/CVI 8.1 Boosts Cross-Platform Communication
• Thermo Fisher Scientific Engages New Partner in Brazil
• Bruker Daltonics and HealthLinx Expand Biomarker Discovery Collaboration
• Axion Control Systems to Distribute LimsLink
• Labtronics Introduces Collect 6.0 Data Acquisition and Integration Control Software
• GAO States Flawed Drug Development System Needs Changes
• FDA Gets Permanent Leadership; Von Eschenbach Confirmed by Senate
• Funding Levels, Anti-Terrorism Provisions Stand in Way of Biodefense Compromise Bill
• FDA on Track for Record Year in NDA Approvals
• FDA Releases Concept Paper on Pharmacogenomics
• Thermo Introduces Retriever Software for Expanded Data Access, More Knowledgeable Decision-Making
• University of Glasgow’s Sir Henry Wellcome Functional Genomics Facility Installs GenoLogics’ Proteus Solution
• onCore UK Licenses LabVantage's Sapphire BioBanking Solution to Support its Cancer Biosample Resource
• GenoLogics Targets Translational Medicine, Cancer Research and Other Areas with Partnership Strategy of End-to-End Solutions
• Roswell Park Cancer Institute Licenses LabVantage’s Sapphire for Translational Research
• LabPas CT Selected by Arkansas Research Medical Testing
• University of Leuven Selects GenoLogics Solution for Lab and Data Management
• Double-Digit Growth Predicted for ELN Market
• Biotechnology Development Costs Top $1.2 Billion Per Project
• Chenomx Inc. Releases Version 4.6 of Metabolomics Software Suite
• Life Sciences Organizations Drive Innovation with GraphLogic Technology
• Thermo Expands Its Informatics Presence in Saudi Arabia
• STARLIMS Publishes Article on How LIMS Facilitates Lean Manufacturing Processes in the Laboratory
• Thermo Develops Advanced Protein Identification and Quantitation Software
• Cerno Bioscience Signs Agreements with Leading Pharmaceutical Research Programs in Shanghai, China
• ClinPhone Acquires DataLabs
• Thermo’s High Resolution GC/MS System Satisfies Regulatory Requirements for Low Detection Limits of Dioxins and Furans
• Savi Technology's Active RFID Supply Chain Products Approved for Use in China
• SciGene Moves to Larger Manufacturing and Research Space
• GenoLogics Closes Additional Financing
• Bruker BioSciences Reports Significantly Improved Earnings and Strong Revenue Growth for the Third Quarter of 2006
• Enzi Calls for Von Eschenbach Confirmation During LameDuck Session
• FDA to Hold Public Meeting on Electronic Drug Registration Rule
• FDA Sets Its Priorities for Drug Safety Debate in Next Congress
• Senate Democrats Will Likely Target Generics, Drug Safety, Patent Protections
• Part 11 Revision Not Likely Until 2007
• Mandatory Part 11 Risk Assessment Could Cost Industry Billions
• FDA Announces Guidance on Out-Of-Specification Test Results
• FDA Changes Generic Drug Policy to Accelerate Reviews
• FDA Aims to Issue Proposed Rule on Combination Products Next Spring
• Domestic, Global Pharmaceutical Market Growth Expected to Slow
• Market Opportunities Abound for Life Science Suppliers in Multi-Billion Dollar U.S. Market for Biodefense Research

Thermo Fisher Scientific Provides Choice of Database for Informatics Customers

Thermo Fisher Scientific has announced that version 9.1 of its Thermo Scientific LIMS, SampleManager LIMS, now supports the use of Microsoft SQL Server 2005 as a database option, in addition to Oracle’s database platform. Microsoft SQL Server, part of Windows Server System, is a complete database and analysis offering that stores information captured by SampleManager LIMS. "Having a choice of databases was important to many of our customers," said Dave Champagne, vice president and general manager of Thermo Fisher Scientific’s informatics business. "We’re pleased that Thermo Fisher Scientific is broadening its leading laboratory information management system to include support for Microsoft SQL Server,” said Paul Mattes, industry solutions director, life sciences, Microsoft’s U.S. Healthcare and Life Sciences Group. “Customers will ultimately benefit from SQL Server’s scalable architecture, built-in analytics, familiar interface and seamless integration with Microsoft’s suite of products." For details, visit http://www.thermo.com/informatics.

NorthWest Analytical's White Paper Tells How to Manage Lab Analysis with SPC

Northwest Analytical (NWA) has released “Monitoring Laboratory Methods to Ensure Data Reliability”. The white paper details how to properly employ SPC control charts and process capability analysis to monitor analytical performance and apply continuous process improvement methods to laboratory process management. The discussion includes how to identify the types and sources of errors in laboratory methods and improve capability to meet expected levels of performance. NWA specializes in laboratory SPC charting. Major commercial LIMS either directly incorporate NWA ActiveX SPC components (NWA QAx) or link with standard NWA software (NWA Quality Analyst and NWA Quality Analyst Webserver) to provide their SPC charting, analytics and reporting. For details or to download a copy of the white paper, visit http://www.nwasoft.com/scilabtestdata.asp.

Labtronics to Contribute to Technical Program at Pittcon 2007

Labtronics will be contributing to the technical program at this year’s Pittsburgh Conference. Two talks will be given on Sunday February 25th, during the Laboratory Informatics Oral Sessions. This year's presentations will include: "A New Approach to Laboratory Informatics", which will present a new concept in informatics that integrates the strengths of existing components with new real-time management control capabilities; and, "Electronic Laboratory Notebooks for Routine Procedures" is focusing on a web-based approach of moving to a paperless environment, while streamlining typical quality processes and ensuring control during procedural execution. In addition to the technical program, Labtronics will be exhibiting the latest features in their LimsLink and Nexxis products and unveiling their latest offering, Nexxis iLAB. For details, visit http://www.labtronics.com.

QSI States WinLIMS Rental Pays for Itself

Figures recently released by Quality Systems International (QSI) have shown that the cost savings achieved by the introduction of WinLIMs to a typical laboratory exceed the monthly payments required under the company's new WinLIMS Rental scheme. A time and motion study was undertaken at a client's premises to examine the impact of the new system. Looking at just one WinLIMS function, automated reporting, and comparing it with the previous error-prone and time-consuming spreadsheet system, significant savings were identified. The client's laboratory issues nearly 6000 reports a year: COA, SQC and "out-of-spec" reports to customers, plus management and instrument status reports for internal use. Using the previous spreadsheet reporting system, each report required between 5 and 15 minutes manual intervention by laboratory staff. The fully automatic WinLIMS reporting was shown to save over 70 man-days a year, at today's labour rates more than twice the monthly WinLIMS rental fee of only £265. Other WinLIMS functions, like automatic invoicing, would yield parallel savings, not to mention those accruing indirectly from the elimination of data transcription errors and rework. For details, visit http://www.lims-software.co.uk.

Labtronics Informational Webcast Series Well Received

Labtronics recently hosted a series of informational webcasts highlighting the technologies and challenges associated with systems integration and automation. In excess of 300 people registered for the events and overall attendances hit all time highs. All the informational webcasts were recorded and are available for viewing. Topics from this Series included: Webcast 1: Realizing the Full Value from Integrating Your Laboratory Technologies; Webcast 2: Improving Lab Performance by Integrating CDS with LIMS; and, Webcast 3: Web-Based ELN for QA/QC Laboratories. For details and to view a recording of the sessions, visit http://www.labtronics.com.

Thermo Fisher Scientific Announces that PEMEX Standardized on Thermo Scientific LIMS and CDS

Thermo Fisher Scientific has announced that PEMEX Gas and Basic Petrochemical (PGBP), a subsidiary of Petroleos Mexicanos (PEMEX), the largest company in Mexico, has standardized its laboratory automation by deploying Atlas CDS alongside SampleManager LIMS, two Thermo Scientific-branded enterprise software solutions. Just months after deploying the flagship Thermo Scientific laboratory information management system (LIMS), SampleManager, across its nine gas processing plants in Mexico, PGBP contracted to deploy Atlas, a Thermo Scientific chromatography data system, in those same facilities. "The use of Atlas CDS and its integration with SampleManager LIMS makes operations, maintenance, and incidence resolution easier, now that we are working with a single system and under standardized operations," said Jose Manuel Cardel Gonzalez, Laboratories Coordinator for PGBP, who served as project manager for the SampleManager implementation. "This allows us real-time control and access to the whole production process." The LIMS and CDS are part of a technical platform that includes SAP/R3 Enterprise Resource Management System and OSI/PI Process Information Management System to support business operations. PGBP, which processes over 600,000 samples per year, with 325,000 chromatography samples tested annually, piloted SampleManager at its Tabasco gas processing facility before deploying the LIMS across all nine sites in 2006. The decision to incorporate Atlas CDS was made in July 2006. "Since first implementing SampleManager in 1998, PEMEX Gas and Basic Petrochemicals has continued to turn to us for solutions that increasingly automate their processes and raise productivity while driving down the total cost of ownership," said Dave Champagne, vice president and general manager of informatics for Thermo Fisher Scientific. For details, visit http://visit www.thermo.com/informatics.

National Instruments LabWindows/CVI 8.1 Boosts Cross-Platform Communication

National Instruments has announced NI LabWindows/CVI 8.1, the latest version of the proven ANSI C integrated development environment for test, measurement and control applications. LabWindows/CVI 8.1 builds on nearly 20 years of reliability and innovation and delivers new technology that gives engineers a simplified interface for communicating between local or distributed LabWindows/CVI applications as well as a single toolchain to easily control and communicate with real-time targets. LabWindows/CVI 8.1 features new, easy-to-use distributed communication and control tools to help engineers maximize their productivity. Using the new Network Variable Library, engineers can publish and share live measurement data between test systems located on the factory floor and remote supervisory machines without the complexity of low-level TCP programming, making it easy for them to design and manage large applications that publish measurement data. The network variables in LabWindows/CVI 8.1 also give engineers the option to remotely monitor and control applications developed in National Instruments LabVIEW or Microsoft Visual Studio. In addition, engineers can use LabWindows/CVI to deploy their test and control applications to multiple operating systems such as Microsoft Windows, Linux and select real-time operating systems. For details, visit http://www.ni.com.

Thermo Fisher Scientific Engages New Partner in Brazil

Thermo Fisher Scientific has announced a new partnership with Interfusão to market, distribute and deploy Thermo Scientific-branded laboratory information management systems (LIMS) and chromatography data systems (CDS) to Brazil’s growing metals, minerals and mining industries. More than 100 mining companies operate over 210 mining plants around Brazil, the world’s largest producer of iron and niobium and a main producer of aluminum, zinc, gold, and other metals and minerals. Brazil’s mining companies deploy LIMS to optimize their laboratory processes, thus reducing costs while raising quality. "As specialists serving the mining industry, Interfusão is excited to represent Thermo Scientific LIMS and CDS in Brazil," said Renato Marino, sales and engineer manager for Interfusão. "Working with a world leader like Thermo Fisher Scientific enables us to deliver the solutions and strategies that will help our customers be successful." Interfusão was created in 1985 to provide economical solutions to the mining and cement industries in partnership with global suppliers, including Thermo Fisher, Dow, Cheminova, Eral, and Moly-Cop. Interfusão today supports many leading mining companies in Brazil, such as CVRD, Yamana, Anglo American, Kinross, Samarco, Votorantim, and CBMM. "Our partnership with Interfusão strengthens and deepens our commitment to Latin America, especially mining customers in Brazil who demand greater efficiency and productivity from their informatics investment," said Oliver Faidi, Thermo Fisher Scientific’s informatics representative for the region. "With more than 20 years serving these industries with SampleManager LIMS, and now working with Interfusão on a local level, we are well-positioned to help Brazilian customers reduce risk and total cost of ownership as they deploy informatics solutions to improve their operations." For details, visit http://www.thermo.com/informatics.

Bruker Daltonics and HealthLinx Expand Biomarker Discovery Collaboration

HealthLinx Limited has announced the signing of a joint patent agreement with Bruker Daltonics Inc. to further develop biomarkers that have been discovered under an existing collaboration between the two life science companies. These biomarkers are candidates for a number of pregnancy complications based on scientific research using Bruker Daltonics' ClinProt platform. Associate Professor Greg Rice of HealthLinx and Dr. Gongyi Shi from Bruker Daltonics' Fremont, California, USA applications laboratory discovered the biomarkers as a
result of the two companies' on-going collaboration and, accordingly, both will be recognised as co-inventors. Under the new agreement, Bruker Daltonics and HealthLinx will file a joint PCT patent application and share costs associated with the patent and development of the biomarkers. The patent will focus on the use of the biomarkers as a diagnostic test for the detection of "Complications of Pregnancy". It is envisaged that the "test" will be a blood test performed at the first antenatal visit and/or subsequently during pregnancy. The test will seek to diagnose women with a predisposition to a number of complications in pregnancy including pre-eclampsia, pre-term labour, miscarriage and gestational diabetes. Women will be classified as either having a high risk or a low risk of developing complications of pregnancy, allowing the gynecologist and/or general practitioner to undertake more appropriate management and/or intervention strategies during the pregnancy to
improve outcomes for both mother and baby. For details, visit http://www.bruker-biosciences.com.

Axion Control Systems to Distribute LimsLink

Labtronics has announced that Axion Control Systems will now resell the LimsLink Suite of products. These offerings will include LimsLink, LimsLink CDS and LimsLink Express. Axion Control Systems was established in 1998 with a main focus on providing control System Integration and industrial IT services to the Australian manufacturing sector. Leveraging on its core technical and marketing competencies Axion has successfully expanded its portfolio of products and services and now provides System Integration, IT and software programming services to diverse sectors such as Food & Beverage, Utilities, Petrochemical, Mining, Forensic & Science Laboratories and others. LimsLink’s industry leading technology complements Axion Controls Systems growth strategy, offering the industries most recognized and used instrument interfacing tool in the world. For details, visit http://www.labtronics.com.

Labtronics Introduces Collect 6.0 Data Acquisition and Integration Control Software

Labtronics Device Integration Group has introduced Collect version 6.0 Data Acquisition and Integration Control software for Windows 2000, Windows XP Professional or the new Windows Vista Ultimate. The software provides a direct connection between instruments and devices with serial RS232 or TCP/IP Ethernet ports and interfaces them to any Windows program that requires their results such as Excel, Database Applications, Files, or Data Management systems. The all-new Collect is a powerful, highly configurable, and yet, incredibly easy to setup and use application for automating data collection, experiments, routine monitoring or analyses. The software includes an library of interfaces to support over 500 different instrument and device models and over 20 ready to use Methods for weighing applications, electrochemistry, photometry, environmental monitoring, barcode and label sheet creation, point of care instrument interfaces and more. New Methods and Instrument interfaces can also be easily created using existing, already in use templates. For details, visit http://www.labtronics.com/col.htm.

GAO States Flawed Drug Development System Needs Changes

A new congressional report has concluded that the drug industry's increasing investment in R&D is not resulting in sufficient increases in the new drug pipeline and structural changes are necessary to fix a "stagnant" system.
While drug companies are spending more on R&D, the number of new drug applications (NDAs) submitted to and approved by the FDA has "not been commensurate with these investments," the Government Accountability Office (GAO) said in the Dec. 19 report. The industry increased its R&D spending from $16 billion in 1993 to nearly $40 billion in 2004, a 147 percent increase, the report found. However, the number of NDAs submitted to the agency increased by just 38 percent during this time. Furthermore, the number of applications for new molecular entities (NMEs) increased by only 7 percent during this time. The report also found that most NDAs were for non-innovative drugs, also known as 'me-too drugs.' "These submission trends indicate that the productivity of research and development investments has declined," the report, "New Drug Development: Science, Business, Regulatory and Intellectual Property Issues Cited as Hampering Drug Development Efforts," said Democratic lawmakers are using the report to criticize the drug industry. Sens. Dick Durbin (D-Ill.) and Edward Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.), who requested the study, argue that the report contradicts industry's basis for rising drug costs. Kennedy used the report to support his call for the FDA's Critical Path Initiative, which is focused on improving drug development. But HHS differed with these findings on two points. The agency disagreed with the report's premise that a product with an NME was more innovative than products not containing NMEs. Such a characterization is "misleading," the agency said in an Oct. 20 letter to the GAO. "Being an NME in and of itself does not mean innovation." Many times, an NME is just a minor modification to an existing product, the agency said. HHS also concluded that statutory changes would be necessary to implement the recommendations on changing the FDA's regulatory process. Allowing drug approvals using fewer numbers of patients would probably "require statutory change," the agency said. Industry officials said they were unable to respond to requests for comment. The GAO report is available at http://www.gao.gov/new.items/d0749.pdf.

FDA Gets Permanent Leadership; Von Eschenbach Confirmed by Senate

Outgoing Senate Majority Leader Bill Frist's (R-Tenn.) last-minute effort to push through the Bush administration's choice to be the FDA commissioner was successful as the Senate voted overwhelmingly last night to approve the nomination. But the agency's main critic, who attempted to block a vote on the nomination, remains determined to hold the FDA's feet to the fire during the next session. The Senate voted 80-11 to confirm Andrew von Eschenbach as FDA commissioner. Frist said earlier in the week he was making to push for confirmation because the agency must have permanent leadership and von Eschenbach is the right person for the job. The nominee "has done a superb job in the position he is currently occupying," Frist said. The Senate had agreed earlier in the day to cloture by a vote of 89-6, overcoming holds on the nominee. Cloture, which ends debate on an issue, requires 60 votes to pass. Sen. Chuck Grassley (R-Iowa), one of the agency's fiercest critics, offered a blistering attack on the nominee, arguing that his confirmation will make oversight of the agency more difficult in the next session. Grassley placed a hold on the nomination Nov. 16, saying the agency has been uncooperative in providing information he requested on clinical trial fraud involving sanofi-aventis' antibiotic Ketek (telithromycin). Democrats should be wary of a commissioner who has resisted congressional efforts at oversight, Grassley said during the debate prior to the cloture vote. The senator also challenged Democratic leadership who will control the Senate in January to keep focusing on FDA reform and oversight. "Are you going to keep your promise to the American public?" he asked. "A vote for this nominee would be a vote for stonewalling and disrespect for this Congress." Von Eschenbach has shown a "complete and utter disrespect for congressional authority," he added. For details, visit http://www.fda.gov.

Funding Levels, Anti-Terrorism Provisions Stand in Way of Biodefense Compromise Bill

The Senate is attempting to enact biodefense protections before Congress recesses, but faces the daunting task of getting the House to agree to the language. The Senate passed its biodefense legislation, S.3678, Dec. 5, but lawmakers face two obstacles to work out with the House-passed version: different funding levels and agreement on bioterrorism provisions, a Senate staffer said. There is no time for a conference committee to hammer out differences between S.3678 and the House version, H.R.5533, the source said, meaning the House must adopt the Senate version in its entirety before Congress adjourns for the year this week for the bill to become law. The Senate bill, the "Pandemic and All-Hazards Preparedness Act," attempts to improve federal and state responses to both natural and man-made health crises by clarifying HHS' role, setting uniform state preparedness standards and accelerating emergency response activities. The legislation places HHS in charge of the nation's response to these threats and requires the development of a national health security strategy that will be submitted to Congress every four years, beginning in 2009. But the Senate is seeking considerably more in authorizations for biodefense. The Senate bill requests $1 billion in funding, while the House seeks $320 million, an industry source said. The Senate also includes specific bioterrorism provisions, such as a requirement for a vaccine tracking system, which the House version lacks, the Senate source added. A House source declined to comment, citing the sensitive nature of the negotiations. Industry officials, who originally had misgivings about biodefense legislation, supported the Senate bill. Groups such as the Biotechnology Industry Organization (BIO) have wanted liability protections and guaranteed government purchases as part of legislation. BIO is "very satisfied" with S.3678 because there are adequate liability protections and a milestone payment system so companies get the funds to cover their costs, the industry source said. For details, visit http://www.fda.gov.

FDA on Track for Record Year in NDA Approvals

October saw the highest number of drug approvals of any month in 2006, which could become a record year for drug approvals, according to research by Friedman, Billings, Ramsey (FBR). So far in 2006, the FDA has approved 83 new drug applications (NDAs), on track with results from 2004, the best year for approvals during the Bush administration. October contributed 15 of the approvals. By comparison, October 2005 had only six approvals, and there were 68 approvals total at this point last year. The pickup in approvals supports the view that 2007 will see a significant increase in drug launches, FBR said. It added that the FDA seemed to be handling applications that had piled up after safety controversies surrounded Cox-2 inhibitors in late 2004.
Average drug approval numbers are significantly lower under the current administration than under the previous one, according to FBR. The Bush administration averages 82 approvals a year, as opposed to 92 a year under the Clinton administration. Having a permanent agency commissioner in place could help increase the number of approved NDAs by calming the "endemic risk aversion of the bureaucrats in the FDA," FBR said. For details, visit http://www.fda.gov.

FDA Releases Concept Paper on Pharmacogenomics

The FDA has released a preliminary concept paper on pharmacogenomic data submissions. The paper expands on the recommendations in a March 2005 guidance, based on the agency's experience over the past two years with voluntary genomic data submissions, various clinical trial protocols and data submitted under investigational new drug applications, new drug applications and biologics license applications. Areas covered in the new document are:
* Gene expression data from microarrays, including sections on RNA isolation, handling and characterization, labeling reactions, RNA labeling situations to be avoided, proficiency testing to avoid procedural failures, hybridizations and fluorescence reader settings for microarrays and differentially expressed genes and their biological interpretation;
* Genotyping methods and reporting, as well as DNA isolation, handling and characterization;
* Genomic data in clinical study reports; and
* Genomic data from nonclinical toxicology studies. The agency is soliciting additional public comments on the pharmacogenomics guidance documents. The concept paper can be seen at http://www.fda.gov/cder/genomics/conceptpaper_20061107.pdf.

Thermo Introduces Retriever Software for Expanded Data Access, More Knowledgeable Decision-Making

Thermo Electron Corporation has introduced Retriever version 3.0, a web-based data extraction and presentation solution that enables secure access to laboratory data, no matter the originating data system. Retriever extracts aggregates and transforms data into "laboratory information with a business context," so that the data can be used to make rapid, informed business decisions. "The market is ripe for a solution like Retriever," said Dave Champagne, vice president and general manager of Thermo's Informatics business. "Multiple systems resulting from mergers and acquisitions, partial migrations that leave data in legacy systems, and the growing need for non-users to be able to access laboratory data – all these challenges and business pains can be immediately alleviated with Retriever." Often captured in individual systems within an enterprise, the volumes of laboratory data that drive product quality and process efficiencies are difficult to gather in a single solution for business use. Retriever users – from laboratory managers and executives to customers – do not require access to the original system from which the data is extracted. Instead, Retriever delivers the information via a single, intuitive user interface. In version 3.0, reports, which can include textual, graphical and tabular data, are configured using the new Thermo Report Designer. This application was designed to allow laboratory-centric functionality to be delivered through the report-writer, reducing the pain of report development associated with generic report-writing tools. "We are using Retriever v2.1 and are beginning to realize significant benefits in data sharing throughout the organization," said Brad Huddleston, LIMS Administrator at Schwarz Pharma Manufacturing, Inc. "The introduction of the Thermo Report Designer with version 3.0 will enable Thermo to deliver the functionality we require for our lab reporting directly in the report-writing application. With our current generic report-writing application, we have to program the logic ourselves and be experts in the software." Retriever enables information from laboratory information management systems (LIMS), as well as database applications such as Enterprise Resource Planning (ERP), Process Information Management Systems (PIMS), and Chromatography Data Systems (CDS), to be shared across the organization and externally with approved users, securely and rapidly. Precise control over which reports and data views are available to which users is maintained by the Retriever security system. In addition, the data, because it is reported directly from the source database, is displayed in real-time. For details, visit http://www.thermo.com/informatics.

University of Glasgow’s Sir Henry Wellcome Functional Genomics Facility Installs GenoLogics’ Proteus Solution

GenoLogics has announced that the University of Glasgow’s Sir Henry Wellcome Functional Genomics Facility (SHWFGF) recently installed GenoLogics’ Proteus solution for their proteomics research and will be adding the Geneus solution to tackle their genomics research projects in the near future. GenoLogics will provide the Sir Henry Wellcome Functional Genomics Facility and the RASOR Interdisciplinary Research Collaboration with a solution for systems biology that enables a cross-science approach to genomics and proteomics research. Dr. Andrew Pitt, Director of the Sir Henry Wellcome Functional Genomics Facility and RASOR, stated, “We chose GenoLogics because of its partnering philosophy and commitment to systems biology and open standards, as well as its ability to customize a cross-science solution combining genomics and proteomics, with the promise of further developments in new fields. This will greatly enhance the productivity of the SHWFGF and our RASOR initiative.” Dr. Pitt continued, “I’m increasingly convinced that it is crucial that software and database informatics technologies complement and accelerate the use of proteomics and genomics instrumentation and technologies in order to make research advances. The GenoLogics solution integrates with our instruments and allows flexible workflows, which frees our researchers to focus on science rather than data management issues.” GenoLogics looks forward to developing a long-term partnership with the SHWFGF and supporting its goal of becoming a European leader in multidisciplinary functional genomics research. Michael Ball, GenoLogics CEO said, “We are very impressed with the range of technologies being developed in the Glasgow facility. We are particularly looking forward to their feedback once our new Geneus solution is installed and operating alongside Proteus, which will enable the Facility to combine proteomics and gene expression data in real systems biology applications.” The University of Glasgow’s Sir Henry Wellcome Functional Genomics Facility combines state-of-the-art technology and expertise in genomics, proteomics, tissue microanalysis, and bioinformatics with the aim of promoting biological and biomedical research by providing efficient service to the research community in Scotland and beyond. RASOR, a £14Mi investment by the UK Research Councils and Scottish Funding Council, is a unique collaboration between the Universities of Glasgow, Dundee, Edinburgh, and Strathclyde with the purpose of designing new proteomics methods and equipment to solve cutting edge research challenges. For details, visit http://www.genologics.com.

onCore UK Licenses LabVantage's Sapphire BioBanking Solution to Support its Cancer Biosample Resource

onCore UK has licensed LabVantage's Sapphire BioBanking Solution to support the launch of its large scale operational cancer biobank. Founded as a collaboration between the Department of Health (England), the Medical Research Council (MRC), and Cancer Research UK (CRUK), onCore UK will create and run this national biosample resource, collecting and storing tissue and blood samples donated by patients and making them available to cancer researchers on a scale unprecedented in the UK. To be successful, onCore UK needs to streamline the collection and management of varying types of samples and associated data through its biosample donation network. The biosample bank also needs to provide controlled access for data entry, analysis and reporting, while ensuring compliance with patient privacy/consent restrictions and government regulations. "After a thorough competitive request for proposal and review process, we decided that LabVantage's Sapphire BioBanking Solution would provide us with the informatics infrastructure to help us achieve our objectives," said Mahendra Navarange, Head of Informatics and IT at onCore UK. "The Sapphire BioBanking Solution provides out-of-the-box biorepository workflow and compliance features that will ensure the intricate tracking and management needed for our biosamples throughout our operations. Also, as a configurable solution, we know we will be able to tailor the technology to our specific needs, both now and in the future," he added. Sapphire's interface will serve as the portal to the biobank, providing secure, browser access for researchers, clinicians, and third party collaborators. As a flexible, thin-client solution, Sapphire will provide onCore UK with lower total cost of ownership, without the reliance on high cost programming resources, maximizing its return on investment. For details, visit http://www.labvantage.com.

GenoLogics Targets Translational Medicine, Cancer Research and Other Areas with Partnership Strategy of End-to-End Solutions

GenoLogics Life Sciences Software Inc. (GenoLogics), a leading developer of lab and scientific data management software solutions, is developing a sophisticated network of key partners, to create end-to-end lab and scientific data management solutions, for various proteomics and genomics applications such as cancer research, biomarker discovery, and translational medicine. Company leaders are actively selecting and pursuing partners with best-in-class, complementary products to provide robust end-to-end solutions to GenoLogics customers. GenoLogics has built an open, user configurable platform that acts as the central nervous system for laboratory automation and operations. It integrates specialized software tools, multiple lab instruments, analysis packages, and new technologies to offer researchers a seamlessly integrated lab and data management solution that is flexible and will adapt to meet their future needs. GenoLogics' specialized solutions for proteomics and genomics research, Proteus and Geneus, are both built on this core platform. On the open source software ( OSS ) partnering front, GenoLogics supports and integrates the Trans Proteomics Pipeline (TPP) and the Computational Portal Analysis System (CPAS). These are among the company's first OSS integration initiatives, and GenoLogics product managers are pursuing other opportunities to provide additional high-value OSS integrations to their customers. For details, visit http://www.genologics.com.

Roswell Park Cancer Institute Licenses LabVantage’s Sapphire for Translational Research

Roswell Park Cancer Institute (RPCI) has licensed LabVantage's Sapphire LIMS suite, including LabVantage's Sapphire BioBanking Module, as the cornerstone of its enterprise-wide translational research initiative. A public benefit corporation that is partially funded by New York State, RPCI is a comprehensive cancer center, providing cancer treatment, research and teaching facilities located in Buffalo, New York, and is a member of the
prestigious National Comprehensive Cancer Network. To achieve translational research, the lines of demarcation between the clinic and research data must be removed, while strenuously protecting patient personal information. Too much knowledge is bottled up within each data silo within the organization. Using Sapphire, RPCI will remove the current departmental data silos by integrating the biorepositories with the core research laboratories and interfacing with disparate clinical systems. With NCI's caBIG initiative as a guide, RPCI and its partners will use Sapphire to query across the RPCI enterprise providing meaningful results to researchers and clinicians to realize the promise of translational research. "The vision is to have Roswell biobanks act as the 'sanctioned pathway' between the hospital/clinic and research, maintaining compliance with NCI's Guidelines for NCI-Supported Biorepositories," states JoAnne Ruh, VP of Information Technology for RPCI. "By moving aggressively to eliminate 'islands of knowledge,' Sapphire will enable RPCI to accelerate research through the power of collaborative research," she added. This is a large-scale project that will ultimately touch every part of Roswell Park's enterprise, from the clinic to the research side. It encompasses more than twelve core laboratories and four biobanks, including several from the University of Buffalo's Center of Excellence co-located at Roswell Park. After a lengthy review of numerous competing laboratory information management systems (LIMS) and biobank software packages, RPCI selected LabVantage's Sapphire. "Sapphire is designed to address the distinct challenges of translational medicine," explains David Manning, Research Applications Administrator for RPCI. Manning elaborates, "It provides for data capture, information management, storage, and compliance features on a flexible and open enterprise platform. One example of this is that Sapphire will allow RPCI to import and instantiate multiple data dictionaries creating and enforcing a common syntax that will eventually optimize queries across the Institute." For details, visit http://www.labvantage.com.

LabPas CT Selected by Arkansas Research Medical Testing

Green Mountain Logic has announced that Arkansas Research Medical Testing, a premier 200-bed, early-phase clinical research facility located in Little Rock, has selected LabPas CT to automate their phase I clinical trials.
According to Steve Bethel, Chief Operating Officer at Arkansas Research, " LabPas CT will empower us to improve quality and save time by automating our recruiting function and deploying a comprehensive barcode system in our lab. They really understand the Phase I environment." Green Mountain Logic's LabPas CT is a leading software solution for Phase I clinical trials, comprehensively integrating data from recruiting through EDC. LabPas CT deploys PDAs on clinic floors to scan patient and collection vessel barcodes/RFIDs, eliminating the potential for errors. It provides real-time electronic data entry for collection times, comments, dosing, vital signs and adverse events. LabPas CT is also unique in its ability to adapt to individual study environments and changing protocols, rather than burdening CROs with the need to adapt to the software. For details, visit http://www.labpas.com.

University of Leuven Selects GenoLogics Solution for Lab and Data Management

GenoLogics Life Sciences Software Inc. (GenoLogics), a leading developer of lab and data management software solutions, has announced the ProMeta Interfaculty Centre for Proteomics and Metabolomics at Belgium’s University of Leuven has selected GenoLogics’ Proteus as the lab and scientific data management solution for its proteomics and metabolomics research. The ProMeta Centre specializes in providing mass spectrometry and chromatography-based technology services (such as MALDI-TOF/TOF-MS, 2D LC-MS, and FT-MS), complemented by its capability of handling gel-based proteomics samples, to proteomics and metabolomics researchers. GenoLogics’ Proteus solution will provide benefits to ProMeta including increased automation of instruments and data integration with downstream search engine processes such as Sequest and Mascot, resulting in more efficient provision of services to ProMeta’s academic and industry clients. ProMeta expects to realize a decrease in turnaround time, thus increasing profitability by implementing Proteus at the centre. Professor Etienne Waelkens, leader of the ProMeta initiative, appreciated GenoLogics’ commitment to the rapidly evolving fields of proteomics and metabolomics. Professor Waelkens stated, “GenoLogics’ knowledge of our industry, and their flexibility and independence from instrument vendors, which lets us choose the best equipment and instruments, influenced our decision to choose Proteus.” Professor Waelkens added, “When we were considering solution providers, GenoLogics was set apart by their commitment to partnership and collaboration. We are pleased that GenoLogics will be partnering with us to evaluate the commercial merits of using Proteus in ancillary applications such as MALDI imaging, which is currently being explored by our researchers.” For details, visit http://www.prometa.kuleuven.be or http://www.genologics.com.

Double-Digit Growth Predicted for ELN Market

The ELN market is set for double-digit growth over the next four years, according to the latest Electronic Laboratory Notebook Survey from Atrium Research. The market for ELNs is expanding, with more than 30 suppliers offering commercial solutions. One of the fastest growing informatics markets with a growth rate of over 30 per cent a year, ELNs have the potential to improve the effectiveness of laboratory operations. ELNs not only replace traditional paper notebooks which have been used for centuries to record experiments, data, and conclusions, but also enable new approaches to data and information integration. An ELN can create 'virtual teams' of scientists who freely share their knowledge and experiences. "We forecast double-digit growth for ELN over the next four years," said Michael H. Elliott, founder and CEO of Atrium Research."Our study shows strong interest in the technology to eliminate a major barrier in the vision of the electronic laboratory. As was the case with LIMS in the early 1980s, the life sciences are leading ELN adoption and deployment." For details, visit http://www.atriumresearch.com.

Biotechnology Development Costs Top $1.2 Billion Per Project

The average cost of developing a new therapeutic biotechnology product is more than $1.2 billion, including the costs of drugs that fail in testing and the time associated with bringing these products to market, according to a new study by the Tufts Center for the Study of Drug Development. The study's authors defined a biotechnology product as "any therapeutic biological compound, including recombinant proteins, monoclonal and polyclonal antibodies, antisense oligonucleotides, therapeutic genes and recombinant and DNA vaccines," as distinguished from "traditional" pharmaceuticals. The $1.2 billion figure includes an average out-of-pocket cash cost of $198 million for preclinical development, which rises to $615 million when fully capitalized, and an average out-of-pocket cash cost of $361 million for clinical development, which rises to $626 million when fully capitalized. Capitalization increases biopharmaceutical costs relative to traditional pharmaceutical costs because of a longer development timeline and a higher cost of capital, the study found. A new biotech product takes 97.7 months on average to make its way through clinical development and regulatory review, about 8 percent longer than for traditional pharmaceuticals. On the other hand, biopharmaceuticals have an overall clinical approval success rate of 30.2 percent, as opposed to 21.5 percent for traditional drug pipelines. For details, visit http://www.tufts.edu.

Chenomx Inc. Releases Version 4.6 of Metabolomics Software Suite

Chenomx Inc. has announced the release of Chenomx NMR Suite 4.6, reflecting over six years of software and chemistry research and development. Chenomx NMR Suite is a set of integrated software applications for performing NMR-based metabolomics. By integrating tools for creating and manipulating metabolic profiles, Chenomx NMR Suite allows users to identify and quantify metabolites in complex NMR spectra with unparalleled speed and accuracy. Chenomx NMR Suite can import data acquired with Varian, Bruker or JEOL spectrometers, as well as data from any JCAMP-DX data source. Chenomx Profiler, part of Chenomx NMR Suite, allows users to rapidly identify and quantify metabolites of interest using Chenomx compound libraries representing over 260 metabolites. Chenomx Signature Builder, also part of Chenomx NMR Suite, allows users to add their own compounds to a custom compound library, making it easy to identify and quantify any metabolite of interest. Chenomx NMR Suite 4.6 introduces a new method for combining global and targeted profiling techniques called "residual-based binning." Residual-based binning captures spectral information that remains after performing targeted profiling of certain compounds. By combining both targeted and global spectral profiling, the user retains the benefits of targeted profiling for known compounds, and gains the extensive spectral coverage of global profiling techniques. Also new in 4.6 are substantially improved processing features, including novel baseline correction and automatic phasing algorithms. For details, visit http://www.chenomx.com/products.

Life Sciences Organizations Drive Innovation with GraphLogic Technology

GraphLogic, Inc. has announced that 454 Life Sciences, Sequenom, The Virginia Bioinformatics Institute, and
Clinical Data are the most recent life sciences companies to license GraphLogic technology to streamline their scientific operations. "Scientists have raised their expectations for software applications," explained GraphLogic CEO Steven Gold, PhD, "Life sciences innovators are under incredible competitive pressure. GraphLogic offers a level of customization and development speed previously not available. We deploy applications in a fraction of the time offered by others, helping end users accelerate productivity in their unique environments." Leading life sciences businesses and academic institutions embrace GraphLogic's powerful new technology that provides the benefits of a custom laboratory operations solution without the prohibitive cost and lengthy development time that plague custom systems created with traditional software technology. The Virginia Bioinformatics Institute has installed a custom microarray application developed by GraphLogic. This web-based system, currently in alpha release, is expected to bring significant advantages of data sharing and data mining to microarray studies. The specialized capabilities of these organizations illustrate the flexibility and broad applicability of GraphLogic's technology. For details, visit http://www.graphlogic.com.

Thermo Expands Its Informatics Presence in Saudi Arabia

Thermo Electron Corporation has established a new local customer support center for its informatics software and services in Dammam, in the Eastern province of Saudi Arabia. Demonstrating its express commitment to its Middle East-based informatics customers, the new helpdesk has been developed in close collaboration with the Yusuf Bin Ahmed Kanoo group, Thermo’s partner in the region. Located within Kanoo’s regional IT facility, the new office will work in close partnership with Thermo’s local support center in Dubai in order to provide comprehensive support services to informatics customers located across Saudi Arabia. The new helpdesk will offer timely and reliable local language technical assistance, ensuring maximum benefit from the latest Thermo informatics technology and applications. For details,visit http://www.thermo.com/informatics.

STARLIMS Publishes Article on How LIMS Facilitates Lean Manufacturing Processes in the Laboratory

Laboratories can leverage their LIMS to obtain the data that managers need to improve the performance of the laboratory operation, as descibed in an article from the September 2006 issue of American Laboratory. Despite the well-documented success of lean manufacturing in the past decades, by and large, laboratories have been
slow to adopt lean manufacturing principles to help improve their performance and the services they provide to
their customers. Yet this is far from unavoidable. On the contrary—as data rich environments very familiar with
principles of measurement, laboratories are actually well positioned to effectively implement and take advantage of lean improvement techniques. This article explores tools for lean implementation, the role of measurement, leveraging data to streamline operations, and resource planning and scheduling in the lab. For details, visit http://www.starlims.com.

Thermo Develops Advanced Protein Identification and Quantitation Software

Thermo Electron Corporation has extended its protein identification and quantitation software package with the newly designed BioWorks 3.3. Featuring unique PepQuan capabilities, BioWorks 3.3 enables automated quantitative analysis of iTRAQ, SILAC and ICAT labeled samples, as well as label-free quantitation techniques. A new probability-based scoring algorithm delivers increased confidence in protein identification. Additionally, a unified Search Results File (SRF) simplifies and accelerates the review and transfer of results by allowing all of the information to be stored in a single file. With new pre-search and post-search filters, BioWorks 3.3 removes unwanted spectra from the search resulting in faster search times, allowing users to focus only on the proteins of interest. Reporting and documenting results is also improved with the new software package. Spectra and tables can be quickly and easily transferred to Microsoft Office documents, while the new Protein Report feature enables printing of data directly from search results or the creation of PDF files. BioWorks 3.3 features the SEQUEST protein search algorithm, which automatically identifies proteins by comparing experimental tandem mass spectrometry (MS/MS) data with standard protein and DNA databases. It can analyze a single spectrum or an entire LC/MS/MS data set containing spectra from a mixture of proteins. The proprietary "cross-correlation" identification algorithm within SEQUEST extracts information and correctly identifies proteins even at low concentrations. Accurate mass capability is also incorporated in the new BioWorks 3.3 software package to enable SEQUEST searching on data acquired using Thermo’s hybrid mass spectrometers. The new software package can also process datasets acquired using vMALDI equipped LTQ XL systems Featuring enhanced SEQUEST Queue and Batch Search capabilities, users will also be able to launch searches on Mascot server from Bioworks 3.3 and compare SEQUEST and Mascot search results. For details, visit http://www.thermo.com/bioworks.

Cerno Bioscience Signs Agreements with Leading Pharmaceutical Research Programs in Shanghai, China

Cerno Bioscience has announced two major agreements have been reached with leading research institutes in China for the use of its ground-breaking MS data analysis software, MassWorks. Cerno has entered into collaborative research in drug metabolism with Dr Dafang Zhong, Director of Drug Metabolism Research at Shanghai Institute of Materia Media, Chinese Academy of Sciences. Cerno has also signed an agreement with Egret Pharma (Shanghai) Limited for extensive use of the MassWorks software in small molecule synthesis.
Research by Dr Zhong will focus on obtaining high mass accuracy to aid in metabolite identification using conventional mass spectrometry systems by applying MassWorks. The triple quadrupole systems are specified to provide only rudimentary mass accuracy and therefore lack the high mass accuracy capabilities of a high resolution system considered necessary for metabolite identification. Metabolism researchers will be able to achieve the results of a high-end spectrometer for a fraction of the investment when applying MassWorks’ MSIntegrity calibration technology, which improves mass accuracy by up to 100x. In addition to enhancing and confirming the identity of various metabolites, the software will also improve the signal-to-noise and peak shape of the MS data to further enable elemental composition determination on these unit mass resolution MS systems. The agreement with Egret Pharma, a leading Chinese pharmaceutical research and development company, will see the company using Cerno’s MassWorks software extensively in its small molecule synthesis studies to significantly shorten the turn-around time in the drug discovery process. MassWorks will be used to confirm the identity of target compounds as well as to identify synthesis by-products, impurities and degradation products, all using conventional unit mass resolution MS systems. This identification will provide timely feedback to the organic chemists to reduce turn-around time. MassWorks utilizes Cerno’s DirectRead technology to read most instrument data formats directly, eliminating the need for importing or exporting MS data to the clipboard or utilizing intermediate exchange formats. This saves time, reduces transcription errors, simplifies file management, and saves substantial disk space. As DirectRead does not alter the original data, it assists compliance with common regulatory requirements such as GLP and the FDA’s 21 CFR Part 11. For details, visit http://www.cernobioscience.com.

ClinPhone Acquires DataLabs

ClinPhone has announced the acquisition of DataLabs, a premier Electronic Data Capture (EDC) vendor. This enables ClinPhone to become the first company in the biopharmaceutical sector to offer a comprehensive suite of clinical trial management and data capture systems. The deal could be worth up to $68.768 million to the shareholders of DataLabs if the company meets certain performance targets. All employees within its current headquarters in Irvine, CA and its satellite operations office in Conshohocken, PA will integrate into the ClinPhone organization. ClinPhone has already commenced the integration of the acquired EDC technology with its industry renowned solutions, including randomization and trial supply management (IVR and IWR), Clinical Trials Management Software (CTMS) and electronic Patient Reported Outcomes (ePRO) services. This combination of clinical trials software and services provides its pharmaceutical, biotech and CRO clients with a complete end-to-end clinical technology platform. Sponsors can take advantage of a ‘one-stop-shop’ technology transfer or a service, custom built to individual project requirements. For details, visit http://www.clinphone.com.

Thermo’s High Resolution GC/MS System Satisfies Regulatory Requirements for Low Detection Limits of Dioxins and Furans

Thermo Electron Corporation, world leader in analytical instrumentation, has announced that its new DFS High Resolution GC/MS system is capable of performing precise and reliable confirmation analyses of dioxins and furans in the low femtogram range. The system helps governmental, industrial and commercial laboratories conducting environmental monitoring analyses comply with the new strict US EPA and EU directives. These regulations call for lower detection limits for dioxins and furans in food, environmental and biological samples in order to meet ever decreasing exposure levels. The recently introduced directives require limits of quantitation (LOQ) for dioxin confirmation to be 80% lower than the lowest reported level in the regulation. Thermo’s DFS High Resolution GC/MS system with two Trace GC Ultras and a TriPlus Autosampler achieves the lowest LOQs, thus enabling rapid sample preparation, higher sample throughput and less cost per sample. Moreover, the significantly reduced energy consumption lowers the cost of ownership even further. Thermo’s DFS High Resolution GC/MS system features Multiple Ion Detection (MID) allowing scan-to-scan monitoring with utmost precision while it can be adapted to suit different application needs. Being extremely reliable, sensitive and robust, the DFS High Resolution GC/MS system can successfully analyze even the most difficult samples with heavy matrix effects. For details, visit http://www.thermo.com/ms.

Savi Technology's Active RFID Supply Chain Products Approved for Use in China

Savi Technology, a leading provider of RFID-based supply chain solutions, has received official approval from the China State Radio Regulation Committee (SRRC) to use its family of active Radio Frequency Identification (RFID) products throughout the country. Savi Technology’s tags and readers approved by SRRC, a division of the China Ministry of Information Industry, are compatible with the ISO 18000-7 (International Standardization Organization) standard for active RFID products operating at the 433.92 MHz radio frequency band. "China’s certification of Savi’s hardware products further validates international recognition that active RFID technology standard ISO 18000-7 is the global standard," said Fraser Jennings, vice president of Standards and Regulatory Affairs for Savi Technology. “This milestone event facilitates the deployment of our proven RFID-based solutions to improve the real-time visibility, management and security of global shipments within, to and from China – the world’s largest manufacturing center.” By approving Savi’s hardware equipment, China has authorized the use of active RFID products compatible with ISO-18000-7. These product approvals in China, combined with similar prior approvals in North America, South America, Europe and Pacific Rim markets such as Australia, Korea, Taiwan, Singapore, and Hong Kong, “clearly show the solid support for the 433 MHz frequency as the worldwide choice for active RFID,” Jennings said. Following extensive testing and document reviews, SRRC has issued Savi Technology a Radio Transmission Equipment Type Approval Certificate and Code for five of the company’s flagship hardware products, including tags, readers and signposts. For details, visit http://www.savi.com.

SciGene Moves to Larger Manufacturing and Research Space

SciGene has signed a long-term lease on a new manufacturing facility that nearly doubles the size of its current headquarters. "Our new facility provides much needed room for increased design, assembly, and quality control of our products", says Terry Gill, Director of Product Manufacturing. The new facility will allow the company to remain in Sunnyvale while increasing assembly area to build its popular lines of microarray laboratory equipment; including the BriteSpot Microarray Workstation, Little Dipper Microarray Processor, and the Hybex Microarray Incubation System. The larger building will also be used to expand R&D activities on new products.
“The popularity of our microarray products is growing rapidly, particularly at core laboratories,” said Dr. Jim Stanchfield, President and CEO. “This new facility will allow SciGene to scale up our production, marketing and distribution efforts so that we are well positioned to take advantage of this rapid growth.” Located in Sunnyvale, California in a region referred to as “Biotech Bay”, the total size of SciGene’s new building is approximately 7,000 sq. ft., including more than 3,000 sq. ft. of assembly and warehouse space. For details, visit http://www.scigene.com.

GenoLogics Closes Additional Financing

GenoLogics Life Sciences Software Inc. (GenoLogics), a leading developer of lab and scientific data management solutions, has completed a second round of financing led by OVP Venture Partners in Seattle , along with Growth Works and Yaletown Venture Partners. This round of financing will allow the company to accelerate its systems biology market penetration strategy. This financing round dovetails with the introduction of GenoLogics' latest product, Geneus, which is targeted at the lab and data management segment of the genomics market, and more than doubles the company's market opportunity over the next few years. These funds will also enable GenoLogics to accelerate the development of Geneus and respond faster to the myriad of emerging genomics and systems biology opportunities that are surfacing. For details, visit http://www.genologics.com.

Bruker BioSciences Reports Significantly Improved Earnings and Strong Revenue Growth for the Third Quarter of 2006

Bruker BioSciences Corporation has reported third quarter 2006 financial results. On July 1, 2006, Bruker BioSciences completed its acquisition of Bruker Optics Inc., which was accounted for as a pooling of interests. As a result of this required GAAP accounting treatment, all historical financials have been pooled as if the companies had always been combined. The GAAP results of prior periods reported here accordingly have been pooled, and therefore differ from original pre-pooling GAAP filings with the Securities and Exchange Commission (SEC) for all periods prior to the acquisition of Bruker Optics. For the third quarter of 2006, revenue increased by 22.1% to $104.9 million, compared to pooled revenue of $85.9 million in the third quarter of 2005. Excluding the effects of foreign currency translation, third quarter 2006 revenue increased by 19.8% year-over-year. Revenue in the third quarter of 2006 increased by 48.2%, compared to pre-pooling BRKR revenue of $70.7 for the third quarter of 2005, as reported to the SEC prior to the acquisition of Bruker Optics. For the nine months ended September 30, 2006, revenue increased by 12.9% to $300.2 million, compared to pooled revenue of $265.5 million for the same period last year. Excluding the effects of foreign currency translation, revenue for the nine months ended September 30, 2006 increased by 15.0% year-over-year. Revenue for the nine months ended September 30, 2006 increased by 38.3%, compared to pre-pooling BRKR revenue of $217.0 for the nine months ended September 30, 2005, as reported to the SEC prior to the acquisition of Bruker Optics. Commenting on the financial results, Frank Laukien, President and CEO, said: "The third quarter was a very exciting quarter for us with good progress in many of our product lines, with the acquisition of Bruker Optics, as well as with two targeted acquisitions of handheld XRF and spark-OES product lines to strengthen our industrial analysis business. The continued performance improvements from our pooled core business that now includes Bruker Optics, complemented by our recent smaller acquisitions, have resulted in strong double-digit growth of our pooled GAAP revenue, and more importantly in significantly improved profitability. Our innovative products and solutions for life-science and clinical research, as well as for advanced materials and industrial analysis, have been strengthened further by various internal business initiatives and new collaborations. We expect to leverage our broader technology base and increased market access for further steady progress in our financial performance." For details, visit http://www.bruker-biosciences.com.

Enzi Calls for Von Eschenbach Confirmation During LameDuck Session

The outgoing chairman of the Senate committee with jurisdiction over the FDA is calling on his colleagues to confirm Andrew von Eschenbach as the commissioner of the FDA before the end of the 109th Congress to provide the leadership necessary to change what he calls an agency in turmoil. "This Congress must take up Dr. von Eschenbach's nomination before we adjourn," Sen. Mike Enzi (R-Wyo.), the current chairman of the Senate Health, Education, Labor and Pensions Committee said during a Nov. 16 hearing on drug safety. The confirmation, as well as passage of Enzi's and Sen. Edward Kennedy's (D-Mass.) drug safety bill, is necessary to fix an agency beset by political influence and lacking the authority to adequately protect public health, the lawmakers said. No FDA officials were invited to appear to answer these criticisms, however. "We didn't want the FDA to have to feel defensive," Enzi said. The fact that the agency still lacks a confirmed commissioner also played a role in his decision, Enzi added. But that did not faze the agency. "It is up to the committee to decide who to invite as witnesses," an FDA spokeswoman said, adding that the FDA "shares the committee's commitment to drug safety and appreciates this important public dialogue." The agency also defended its drug safety efforts. "FDA has done considerable work over the past two years to improve its approach to drug safety and is committed to taking additional steps to continue to fulfill its mission to protect and promote public health," the spokeswoman said.
The lawmakers' call for change was echoed by Sheila Burke, one of the authors of the recent Institute of Medicine report on drug safety. The FDA needs permanent leadership to fix an agency that is "dysfunctional," she said. Another witness, Jim Guest, the president and CEO of Consumers Union, said agency staff is "demoralized," with employees rapidly leaving. Burke endorsed the Enzi-Kennedy bill, S.3807, as "enormously important" to clarify the FDA's authority in regulating industry, including giving the agency clearer powers to conduct both pre- and postmarket oversight. For instance, the agency must have unilateral authority to require labeling changes, she said. For details, visit http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.03807:.

FDA to Hold Public Meeting on Electronic Drug Registration Rule

The FDA will hold a public meeting Dec. 11 to discuss its proposed electronic identification system for drugs and other changes to the National Drug Code (NDC) Directory. The agency also extended the period to make comments on the proposals to Jan. 26, 2007. The meeting will be from 9 a.m. to 4 p.m. in Rockville, MD. Attendees must register for the meeting by Nov. 24, the same day that written or electronic comments submitted for consideration at the meeting are due. The proposed rule, published in the Aug. 29 Federal Register, would require manufacturers to electronically register all their products in the FDA's Electronic Drug Registration and Listing System. The proposal came soon after an HHS Office of Inspector General report blasting the agency's NDC Directory as incomplete and inaccurate. The Federal Register announcement can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0403-nec0001.pdf.

FDA Sets Its Priorities for Drug Safety Debate in Next Congress

In its first major announcement since the midterm elections gave control of the next Congress to the Democrats, the FDA outlined what it believes should be the priorities to improve drug safety without sacrificing innovation. This comes as a leading lawmaker prepares to outline his recommendations for the agency. The agency is afraid that in the rush to improve drug safety, Congress will overlook the importance of innovation, Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs, said in remarks given to the Manhattan Institute Nov. 13. "I am deeply concerned that some of the ideas that have been discussed in broader policy circles for improving on drug safety measures will do little to make our drugs safe, but will do a whole lot to limit access to needed medicines and to slow down the development of new innovations," Gottlieb said. Lawmakers have decried the agency's handling of drug safety issues and have pledged to implement policies improving that through legislation and implementation of an Institute of Medicine report's recommendations. On the same day Gottlieb gave his speech, Sen. Mike Enzi (R-Wyo.), the outgoing chairman of the Senate Health, Education, Labor and Pensions Committee, announced a slate of witnesses for his Nov. 16 hearing on ways to improve drug safety and innovation. The hearing is meant to help pass Enzi's and Sen. Edward Kennedy's (D-Mass.) bill, the "Enhancing Drug Safety and Innovation Act." There needs to be greater focus on the science of how drug safety programs are improved, Gottlieb said. "We need to improve the information that the agency receives," including spontaneous reports from sponsors and advisers, along with access to epidemiological data sets, he said. For details, visit http://www.fda.gov.

Senate Democrats Will Likely Target Generics, Drug Safety, Patent Protections

With the Democrats taking control of the Senate, the healthcare agenda will likely focus on increasing the availability of generics in the market, improved drug safety and the role of trade policy in protecting domestic pharmaceuticals, according to industry observers. Based on seniority in key Senate committees, it appears that Sens. Edward Kennedy (D-Mass.), Max Baucus (D-Mont.), Patrick Leahy (D-Vt.) and Herb Kohl (D-Wis.) will shape healthcare policy during the 110th Congress. These lawmakers are all the ranking members in committees that have jurisdiction over healthcare and are in line to take over as chairmen. Kennedy will likely chair the Senate Health, Education, Labor and Pensions Committee, with Baucus chairing the Finance Committee and Leahy running the Senate Judiciary Committee. Kohl is expected to chair the appropriations subcommittee that funds the FDA. Various experts say that the Senate will focus on generics in the next session as part of an effort to lower drug prices. "The cost of drugs is going to be a key issue in the next Congress, and the role of generics is going to be a big part of it," David Adams, chair of the law firm Venable's FDA Practice Group and former director of the policy staff in the FDA's Office of the Commissioner, said. G. Steven Burrill, CEO of Burrill & Co., agreed, calling the new Congress "pro-generics." Not only is the new Democratic leadership likely to push for more generics, but there are also many special interests lobbying for that cause as well, Marc Scheineson, a partner at the law firm Alston & Bird and former FDA associate commissioner for legislative affairs, said. These groups include insurers, benefit managers, pharmacies and large employers, such as Ford, General Motors and Eastman Kodak, he added. Leahy has taken an interest in the generic drug industry, cosponsoring legislation that would both help and hinder that sector. On one hand, the senator helped sponsor, S.3818, which would make it more difficult for generic manufacturers to prove that brand companies deceived regulators. The senator had also sought limits on the time available for generic companies to challenge patents. But Leahy has also collaborated with Kohl on a number of bills that would ease the introduction of generics onto the market. The senators recently introduced legislation that would limit what they call abuses of the FDA's citizen petition process used to delay generic drug approvals. For details, visit http://www.fda.gov.

Part 11 Revision Not Likely Until 2007

The pharmaceutical industry's long — and, so far, fruitless — wait for revisions to 21 CFR Part 11 is about to get even longer. The FDA probably will not meet its self-imposed end-of-year deadline for issuing the revisions, sources close to the agency say. While the regulation was actually completed and presented to the FDA's legal team for review, the revised regulation did not meet the requirements of the legal department and is now back in the hands of the Part 11 team to review, evaluate and revise as needed. Industry analysts concur that the delay has more to do with internal FDA logistical issues and should not be interpreted to mean the rule is going to be broader or more complex. "Part 11 is coming. We are working vigorously on reissuing the regulations for a scientific and risk-based approach," Joe Famulare, acting deputy director of CDER's Office of Compliance, told attendees at the 2006 Generic Pharmaceutical Association Fall Technical Conference Oct. 19. The FDA first issued the Part 11 rule in 1997, but it was almost immediately criticized for its breadth and vagueness. Designed to stimulate regulated companies to embrace electronic record technology, the original iteration of the rule actually stunted its growth, critics charged. The FDA tacitly agreed when it issued what some experts labeled a "kinder, gentler" Part 11 in August 2003 that narrowed and clarified its scope. Industry generally applauded the 2003 revision. For details, visit http://www.fda.gov.

Mandatory Part 11 Risk Assessment Could Cost Industry Billions

The drug, biologics and device industries could face billions in additional costs if the FDA requires risk analysis to be part of electronic recordkeeping regulations, an industry consultant says. The agency seems likely to publish a rule by the beginning of next year requiring companies to do risk analysis as part of meeting their Part 11 requirements, Martin Browning, president of EduQuest, said. But industry is in the dark about this. This development is "under the radar," and industry is likely to be caught unaware, failing to anticipate the additional costs, he said. While the risk factors will be used to determine whether a company can receive regulatory relief from some of the burdens associated with validating its data, the costs will likely overwhelm any benefit, Browning said. The cost of assessing the risks associated with industry recordkeeping could be billions because companies lack a formal, documented risk analysis system, he added. The lack of such a system would result in far more information being necessary to assess risk than to electronically document the records themselves. The FDA first issued the Part 11 rule in 1997, but it was almost immediately criticized for its breadth and vagueness. Designed to stimulate regulated companies to embrace electronic record technology, the original iteration of the rule actually stunted its growth, critics charged. The FDA tacitly agreed when it issued what some experts labeled a "kinder, gentler" Part 11 in August 2003 that narrowed and clarified its scope. Industry generally applauded the 2003 revision. For details, visit http://www.fda.gov.

FDA Changes Generic Drug Policy to Accelerate Reviews

The FDA is changing its generic drug review policy, abandoning its "first come, first served" approach when there is a potential public health risk to ensure that these submissions are not delayed, the agency said. The FDA faces a growing workload that will likely lead to a backlog of abbreviated new drug applications (ANDAs), requiring an exception to long-standing agency policy, the FDA's Oct. 18 "Review Order of Original ANDAs, Amendments and Supplements" said. The FDA will consider expedited review for "products to respond to current and anticipated public health emergencies, products under special review programs such as the President's Emergency Plan for AIDS Relief, products for which a nationwide shortage has been identified and first generic products for which there are no blocking patents or exclusivities on the reference-listed drug." If an ANDA does not qualify for this exemption, reviewers will continue to use existing review policies, which prioritize applications based on when they arrived and consider whether an amendment is major or minor, if it is an original application and other factors. The Generic Pharmaceutical Association lauded the new policy as a means to ensure that the public has timely access to generic drugs. The document is available at http://www.fda.gov/cder/mapp/5240-3R.pdf.

FDA Announces Guidance on Out-Of-Specification Test Results

In an effort to help pharma manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer. The designation also covers in-process laboratory tests. The document, "Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production," is being published in the Oct. 12 Federal Register. It discusses such topics as:
* How to investigate OOS test results;
* The laboratory phase of the investigations;
* Responsibilities of laboratory personnel, such as the analyst and supervisor;
* When to expand the investigation outside the laboratory to include the production process and raw materials;
* Additional testing that may be necessary; and
* The final evaluation of all test results. The guidance does not address process analytical technology, as routine in-process use of these methods might include other considerations. The use of continuous on-line testing technologies will be addressed in other agency guidance, the FDA said. The guidance can be seen at http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-0777-gdl0002.pdf.

FDA Aims to Issue Proposed Rule on Combination Products Next Spring

The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at a recent industry conference. The proposed rule follows a draft guidance on the subject issued Sept. 29, 2004, by the Office of Combination Products (OCP), James Cohen, senior adviser to the office, said. "To date the FDA has not promulgated regulations on cGMP requirements for combination products. Instead we have provisions from the applicable regulations for drugs, devices and biologic products," Cohen said in a speech at the Regulatory Affairs Professionals Society annual conference in Baltimore Oct. 16. In developing the proposed rule, OCP has taken into account the comments it received on the draft guidance, of which there were about 15 that were "generally supportive," Cohen said. The office is trying to "clarify and streamline the regulatory scheme [and] provide a flexible quality management framework," while avoiding "duplicative" regulation of manufacturers. Since there are significant differences in cGMP regulations for drugs and devices, manufacturers of products that bridge these two areas want clarification as to which rules they have to follow. Devices are covered by the quality systems regulation (QSR) issued by the Center for Devices and Radiological Health, so manufacturers want to know "if it's a drug and device [combination], do I have to do the entire QSR?" Cohen said. The 2004 draft guidance can be seen at http://www.fda.gov/oc/combination/OCLove1dft.html.

Domestic, Global Pharmaceutical Market Growth Expected to Slow

IMS Health projections predict a lower growth rate for the global pharmaceutical market in 2007, with the U.S. in particular contributing less due to generic competition and an increase in niche products. Worldwide, IMS predicts a market growth of 5 to 6 percent in 2007, slightly lower than the 6 to 7 percent growth in 2006. The company's 2007 Pharmaceutical Market Forecast, released Oct. 25, said global sales should be between roughly $665 billion and $685 billion next year. The U.S. market will grow only 4 to 5 percent in 2007, IMS said, down from the 6 to 7 percent increase this year. A major reason for the decline is that several brands will lose patent protection next year, opening the door for generics, the company noted. Also, while growth is shifting from traditional markets to emerging ones, new products are generally more specialized and have smaller consumer bases, giving them a smaller impact on the overall market. IMS expects between 25 and 35 new products in 2007, comparable to the anticipated 30 product launches in 2006. In 2002, the U.S. made up 54 percent of total market growth worldwide, whereas in 2007 it is expected to contribute only 36 percent. Countries like China, India, Brazil and Turkey will each expand more than 10 percent in the pharmaceutical business, IMS predicted. In these countries, the markets are largely composed of locally produced generics, IMS said. Countries like these, with growing economies and populations and increasing healthcare availability, are filling in where the U.S. has fallen back.For details, visit http://www.imshealth.com.

Market Opportunities Abound for Life Science Suppliers in Multi-Billion Dollar U.S. Market for Biodefense Research

U.S. homeland security-related R&D is expected to total $5.2 billion in FY 2007. However, a recent study found that despite the massive spending in this market, the unavailability of some critical research resources has been a limitation in the development of new prophylactics, diagnostics, and therapeutics. Among the pathogen-specific tools required to conduct biodefense research are genomics, proteomics, appropriate in vitro and animal models, validated assays and standardized reagents. BioInformatics, LLC, an Arlington, VA-based research and consulting firm, recently published their latest report, "Market Opportunities in Biodefense Research: Trends & Forecasts," based on the opinions of over 500 current and future biodefense researchers. This report outlines how life science suppliers can best serve the important and growing biodefense research market. "Developing new products for the biodefense market requires more than just product development. The rate at which researchers will adopt a new technology is also dependent upon customer preferences, product positioning and market influences. According to the current and future biodefense researchers we surveyed, pathogen-specific ELISA kits and DNA microarrays hold the most promise," stated Dr. Tamara Zemlo, Director of Syndicated Research at BioInformatics. Sigma-Aldrich (NASDAQ: SIAL) and Invitrogen (NASDAQ: IVGN) are the top two companies that come to mind when respondents are asked to think about biodefense-related products, however neither supplier was chosen by more than 10% of scientists surveyed, illustrating that there is no clear leader in the biodefense market. "Suppliers that develop a reputation for innovative product development in critical biodefense related areas have the potential to distinguish themselves as notable biodefense companies within the life science market -- and begin building market share in pathogen-specific product or application areas," noted Dr. Zemlo. For a complimentary Executive Summary of this report, visit http://www.gene2drug.com/reports.

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

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