LIMSource News: What's New Right Now

• QSI's WinLims Rental Helps Food Testing Contract Lab Reduce Turn-Around Times

• Thermo Fisher Scientific Offers Data Management Solution for Mining Industry with SampleManager LIMS

• BIOINQUIRE Releases ProteoIQ version 1.1 Providing Enhanced Time Saving Functionality with Improved Accuracy

• University of Texas Medical Branch Expands Relationship with GenoLogics to Develop a Biomedical Informatics Solution

• Thermo Fisher Scientific Announces its 2008 North American Informatics Conference

• Autoscribe India Dealer Expands LIMS Services

• National Instruments Releases LabView 8.6

• Labmatica Adds Improved FreeLIMS Documentation

• Agilent Technologies' Enterprise Content Management System Now Supports Waters' Empower 2 Enterprise Data Manager

• Labtronics Hosts September Webcast to Showcase New ReDI Technology

• Thermo Fisher Scientific Receives Scientific Computing 2008 Readers' Choice Awards

• Labtronics Announces On-line RS232 Setup and Connection Videos

• Atrium Research Publishes Results of 2008 ELN Survey

• STARLIMS Consolidates Direct Presence in Europe; Hires LIMS Veteran Joe Peden to Head STARLIMS Europe

• Inks and Coatings Manufacturer Cuts IT Costs with DEACOM ERP Software

• Bruker Corporation Reports Second Quarter 2008 Financial Results

• FDA Eyes India Offices by 2009 to Ensure Import Safety

• FDA to Emphasize Safety in Approving Drug Names

• FDA Launches Fellowship Program

QSI's WinLims Rental Helps Food Testing Contract Lab Reduce Turn-Around Times

QTS Analytical, of East Malling, Kent, a contract laboratory that measures pesticide residues in fruit, vegetables and other foodstuffs, has enhanced the organization’s contract laboratory’s customer service by utilising QSI’s WinLims Rental solution for contract laboratories. The ‘out of the box’ LIMS rental solution has helped QTS Analytical to boost efficiency and improve accuracy of its laboratory information management procedures. QTS Analytical’s contract laboratory service, which is aimed at organizations throughout the fruit and vegetable supply chain - growers, wholesalers and retailers, tests for pesticides in a variety of areas including fresh produce, soils, water and environmental analysis. Potential QTS customers include any company importing or growing fruit and vegetables. The QTS laboratory has UKAS accreditation for its pesticide residue analysis, covering a wide range of pesticides in fruit, vegetables and tea leaves. The company also participates in the internationally recognised FAPAS proficiency scheme. Fast turn-around times are vital for most contract laboratories and QTS is no exception. Although the standard turnaround time for QTS is five days the company also offers an industry-leading 12 hour emergency turn-around on residue testing. To achieve such demanding turn-around targets, speed and accuracy of reporting are crucial factors that have been greatly improved with the advent of the WinLims Rental package. Before the QSI solution was introduced the largely manual reporting process was a major bottleneck. At peak times, staff sometimes had to work unsocial hours to keep up, and the administrative load also introduced invoicing delays. "We have benefited considerably from WinLims Rental’s reporting capabilities - our reports vary greatly in format dependent on the type of testing being carried out for each customer. WinLims was able to cater for this requirement straight from the box and as such has made significant time savings, seven hours per week if not more,” explained QTS Analytical’s founder Steve Gardner. “We typically generate 500 to 600 reports a month. With WinLims it is all now done automatically. We simply select the type of report, and based on the type of commodity, the system prints out the report. We also now have the added benefit that it simplifies trend analysis. Reporting had long been a slow part of the process prior to introducing WinLims. Now we get the reports out in less time and with more reliability as well because the report is now automatically generated rather than being generated by a human. In the past it was all too easy to try and lash something together in a hurry in Word and invariably that’s when things could start to go wrong.” Q TS investigates a typical sample load of 500 samples per month. using in-house GC-MS and LC-MS procedures. The contract laboratory has five standard operating procedures (SOPs) that have been developed in house to cover the bulk of the work. The GC based systems routinely handle 200 determinands per sample while the LC systems service up to 80. Based on the WinLims Rental system QTS has recently set up a remote sample booking system via the company’s web site. The new remote facility gives QTS customers the option to directly feed sample data into the company’s WinLims system. QTS is also in the process of setting up the facility to automatically generate invoices using the WinLims system. "QSI’s WinLims Rental solution offered a cost effective way of obtaining a LIMS system that was capable of meeting our exacting requirements and also offered a wide range of additional capabilities that would meet our future needs,” said Gardner. "Even if you go and buy a WinLims it is still a significant cost up front. However, with the WinLims Rental system you can have a really good LIMS right now.” For details, visit http://www.qsiuk.com.

Thermo Fisher Scientific Offers Data Management Solution for Mining Industry with SampleManager LIMS

Thermo Fisher Scientific Inc. has announced that its LIMS offer efficiencies, improved productivity and regulatory compliance for the modern mining industry. LIMS are a key component in the day-to-day management of a modern mining operation, not only to monitor the quality of the mine's output, but also to drive increased productivity and help the mining operations comply with myriad regulatory requirements related to everything from documentation and instrument calibration to environmental monitoring. Thermo Scientific SampleManager LIMS offers the modern mining industry a centralized system to access data and extract information, enabling effective management of laboratory operations. The LIMS provides evidence and documentation to support laboratory compliance with ISO 17025, allowing full traceability of personnel and procedures entered and facilitating the review of all incidents, corrective actions, non-conforming results and other events. SampleManager LIMS also includes built-in functionality to handle environmental monitoring. Within SampleManager, environmental monitoring of key areas of the laboratory can be scheduled, and validation of methods allows laboratory managers to achieve continuous compliance with ISO 17025. The future of mining depends on the industry's capacity to maintain a balance between profitability and preservation of new environments, human capital and the surrounding communities. This requires assessment of risk at all stages to ensure that impacts on the environment and on humans are always understood. Thermo Scientific SampleManager LIMS addresses these requirements, serving as a tool to manage mining data, which enables laboratory and mining operations managers to obtain faster results, improved efficiencies, increased margins, and certification of the end product. An automated information management system can ensure secure documentation and compliance with the many requirements imposed on the industry. Modern mining operations realize these benefits and deliver increased value to their shareholders when they automate their laboratories with world-class LIMS. To further secure its position as a leader in the mining industry, Thermo Fisher is hosting a Laboratory Informatics Symposium - Latin America Mining Day - in Belo Horizonte Lourdes Brazil on August 12, 2008. The Latin America Mining Day will offer an exciting program aimed at introducing the full capabilities of Thermo Scientific laboratory data management solutions to the mining industry. Online registration can be completed at http://www.lis08.com. Information specific to the mining industry, including product information and case studies, may be found at http://www.thermo.com/limsmetal. For details, visit http://www.thermo.com/informatics.

BIOINQUIRE Releases ProteoIQ version 1.1 Providing Enhanced Time Saving Functionality with Improved Accuracy

BIOINQUIRE has announced the release of Version 1.1 of the proteomics software suite, ProteoIQ. ProteoIQ is an innovative bioinformatics tool that analyzes proteomic data and provides researchers with an automated methodology for determining protein expression without the need for tedious manual data analysis. Version 1.1 offers additional time saving features while improving the protein assignment accuracy. ProteoIQ version 1.1 allows users to customize how tandem mass spectra are displayed, including annotation of ion series labels, charge states, and enhanced screening functionality for identifying neutral losses. “The neutral loss mapping feature, provides a powerful method for validating phosphorylated and glycosylated peptide identifications while greatly reducing the frequency of false positive assignments,” said James Atwood III, Chief Operating Officer and co-founder of BIOINQUIRE. Additional functionality of ProteoIQ Version 1.1 enables researchers to export annotated MS/MS spectra for identified peptides and save proteomic results in a format that completely conforms with the Paris Guidelines for the Reporting of Protein Identification Data. Proteomics results generated in ProteoIQ, whether qualitative or quantitative, can now be exported in standard formats that are immediately ready for submission to popular scientific journals saving researchers valuable time. ProteoIQ is particularly well-suited for comparative proteomic analyses, where spectral counting-based quantification is combined with data mining functions to enable researchers to find differences between multiple proteomic data sets. The software generates statistically validated protein sets, which can then be compared. Proteins that are different across multiple proteomes can be easily identified using the difference function. Taking the intersection of two proteomes allows the researcher to obtain expression levels of those proteins in common. For details, visit http://www.bioinquire.com.

University of Texas Medical Branch Expands Relationship with GenoLogics to Develop a Biomedical Informatics Solution

GenoLogics, a leading developer of translational research informatics software, has announced that the Sealy Center for Molecular Medicine at the University of Texas Medical Branch at Galveston (UTMB) has selected GenoLogics to collaborate on developing an integrated biomedical software solution. The Sealy Center for Molecular Medicine (SCMM) is an interdisciplinary research center at UTMB and is part of the newly formed Institute for Translational Sciences (ITS). The mission of the SCMM is to serve as a focal interface between clinical and basic scientists, addressing UTMB's strategic plan for personalized medicine. "The GenoLogics vision to help clients conduct translational research by developing informatics solutions designed for this purpose was completely aligned with the center's strategic plan to connect our clinical and basic research areas," said Dr. Allan Brasier, Director, Sealy Center for Molecular Medicine at UTMB. "In order to enable our goal for personalized medicine, we decided to collaborate with GenoLogics to deploy a biomedical solution that will begin with user-friendly software to efficiently and effectively manage our biospecimens. Investing in a biomedical informatics solution that can also connect to our research data is going to assist the Center with attracting future funding such as the Clinical and Translational Science Awards." The Sealy Center for Molecular Medicine is focused on understanding cell stress response pathways using high-throughput systems-based approaches. The biomarkers program is developing new tools to study and classify human diseases at a molecular level, allowing the prediction of individual susceptibility to disease. This research program in personalized medicine will allow the center to make better diagnostics for common medical diseases such as asthma, cancer, diabetes and degenerative diseases. "In order to validate our biomarkers for common diseases, we needed to exchange information from clinical to research domains, " said Dr. Kevin Rosenblatt, Director for Biomarker Discovery, Sealy Center for Molecular Medicine. "This can only be done with a biomedical informatics solution that not only tracks our biospecimens, but also the clinical annotations and then connects to the data being generated in our research labs. The GenoLogics Biomedical Informatics solution will have this unique capability to bring it all together in a single platform." GenoLogics launched its Biomedical Informatics software solution to address the needs of translational research initiatives. The solution allows clients to track prospective studies, collect patient data at remote sites, provide biospecimen and clinical annotations management and facilitate researchers querying on clinical information and requesting samples. The solution is comprised of five integrated products: BioVault for biospecimen management; BioChronicle for clinical annotations management; BioQuest to enable Web access; BioSphere for study management; and BioSource for electronic patient questionnaires. For details, visit http://www.genologics.com.

Thermo Fisher Scientific Announces its 2008 North American Informatics Conference

Thermo Fisher Scientific Inc. has scheduled its annual North American laboratory Informatics user group meeting, Thermo Informatics World (TIW), from October 6-9, 2008 in Las Vegas, Nevada. The conference will not only profile the company's strategic and product roadmaps, but also demonstrate its latest informatics offerings that address the growing data management and instrument integration challenges of today's laboratories. TIW North America 2008 will provide users with enhanced knowledge, tools and capabilities for integrating Thermo Scientific LIMS (laboratory information management systems) and CDS (chromatography data systems) across laboratory instruments and the enterprise, increasing collaboration and facilitating more informed decision making. This year's theme is "where your solution is asure thing." Thermo Scientific LIMS and CDS are utilized in laboratories around the world and in diverse industries including chemicals, environmental, food and beverage, forensics, metals and mining, pharmaceuticals and bioanalytical, environmental and wastewater. The management of data is a key factor influencing the overall productivity and performance of laboratories in all major industries. Demonstrating its proven expertise in the development of innovative laboratory software solutions at TIW 2008, Thermo Fisher Scientific will showcase its complete range of LIMS, CDS, pharmacokinetic-pharmacodynamic software systems, and spectroscopy software systems. The North American TIW annual user conference provides industry professionals with a unique opportunity to share cross-sector perspectives and become informed on changing business requirements that drive the enhancements and future direction of Thermo Scientific informatics solutions. Designed to encourage customer involvement, TIW features product breakout sessions, including in-depth customer presentations, product updates and onsite training provided by the Thermo Fisher Scientific team of informatics experts. TIW North America 2008 will take place at the JW Marriott Hotel in Las Vegas. Early bird registration is available until September, 5, 2008 and offers a savings of $300. Group discounts are also available. For details and to register, visit http://www.tiw08.com.

Autoscribe India Dealer Expands LIMS Services

Autoscribe's authorised distributor, Mithas Labs, in India has significantly expanded its LIMS capabilities and offerings for pre-sales and post-sales services for Autoscribe’s successful LIMS, Scientific and Business software solutions. The Chennai LIMS team at MithasLabs now has more than ten team members who have been locally trained by Autoscribe to implement, configure, sell and support Matrix Gemini LIMS in India for any laboratory in any industry. Matrix Gemini is a highly scaleable LIMS designed for any laboratory in any industry. The unique OneTime Configuration tools automatically create a unified LIMS configuration for both desktop client and web use. This continues Autoscribe's unique 16+ year history of providing pioneering, industry standard LIMS that can always be seamlessly upgraded to the latest release. Matrix Gemini also provides existing Autoscribe customers with the opportunity to seamlessly migrate their current LIMS desktop applications to the web without programming, java or esoteric scripting languages. For details, visit http://www.autoscribe.co.uk.

National Instruments Releases LabView 8.6

National Instruments has released LabVIEW 8.6, which offers increased performance with the latest parallel technologies, such as multicore processors, field-programmable gate arrays (FPGAs), and Wi-Fi measurements, and includes the features and improvements noted below to boost productivity and offer new measurement capabilities. Enhancements include: Improved Productivity; New Measurements and Signal Processing; Real-Time Updates for Industrial Applications; Increased Multicore Performance; and, Additional FPGA Features. For details, visit http://www.ni.com.

Labmatica Adds Improved FreeLIMS Documentation

Labmatica haqs announced that new documentation and tutorials for their FreeLIMS solution have been added to their to website. The new material includes an installation guide, a video tutorial for System Setup ; and, a video tutorial for fixing problems. For details, visit http://www.labmatica.com/docs.html.

Agilent Technologies' Enterprise Content Management System Now Supports Waters' Empower 2 Enterprise Data Manager

Agilent Technologies Inc. has announced that its OpenLAB enterprise content management system (ECM) for scientific content now supports Waters' Empower 2 database for chromatographic data. "Now, labs that are standardised on Empower 2 can also enjoy the full functionality of OpenLAB, including the ability to search for and view files even when they've been removed from the database," said Kathleen O'Dea, Agilent marketing manager, Laboratory Informatics. "A wider range of users now can access this efficient way to gather, store and manage all data generated by lab instrumentation and processes in a single, secure, repository." OpenLAB is an "operating system" for laboratories, based on Agilent's vision for an open laboratory environment. It integrates analytical instrument control, advanced data analysis, enterprise content management and laboratory business process management into a single, scalable, Web-based system. It accommodates more than 300 different instrument modules from 25 manufacturers, and lets users establish policies and manage file lifecycles using automated archiving and record retention functions. For details, visit http://www.chem.agilent.com.

Labtronics Hosts September Webcast to Showcase New ReDI Technology

On September 9th and 11th, Labtronics will be presenting "Go Paperless in Minutes - Are You ReDI?", a half hour presentation introducing ReDI their new, fast ELN deployment technology that can convert paper documents into electronic forms in minutes. ReDI quickly gets laboratories right to the benefits of going paperless with rapid implementation of electronic forms that can be scheduled, completed, reviewed and approved on-line using Labtronics' Nexxis ELN for Routine Analyses. This presentation will be of interest to any laboratory that is planning on becoming more efficient and productive by replacing their paper based worksheets, SOPs and documents with electronic forms. For details, visit http://www.paperlesslab.com to register for this webcast.

Thermo Fisher Scientific Receives Scientific Computing 2008 Readers' Choice Awards

Thermo Fisher Scientific Inc.has announced that five of its informatics and software solutions have received Scientific Computing 2008 Readers' Choice Awards across four categories: LIMS, bioinformatics, chromatography, and spectroscopy. Thermo Fisher Scientific won more awards than any other company. Dave Champagne, vice president and general manager of informatics at Thermo Fisher Scientific, commented: "The recognition of Thermo Scientific products as best-of-breed underlines our efforts to continue to deliver software solutions that meet the specific needs of our customers. Three gold and two bronze awards from the readers of Scientific Computing acknowledge Thermo Fisher's pedigree of products. Receiving the recognition of our customers is the most valuable testimonial of our standing in the market." Thermo Fisher was recognized in the following categories: Gold awards went to Thermo Scientific Atlas CDS (chromatography category), the leading chromatography data system used around the world and in a wide range of industries; to Thermo Scientific Kinetica (bioinformatics category), which delivers excellence in pharmacokinetic analysis and reporting; and Thermo Scientific GRAMS (spectroscopy category), a world-class solution for capturing, storing, and reporting on data derived from multiple instrument systems (it also received a bronze recognition). Bronze awards went to Thermo Scientific SampleManager LIMS (LIMS category), a leading laboratory information management system for the process industries, and Thermo Scientific OMNIC (spectroscopy category), providing advanced spectroscopy and enabling chemists in analytical and investigative chemistry laboratories to take advantage of the power of FT-IR and Raman. The Readers' Choice Awards are determined annually by the readers of Scientific Computing, a leading publication from Advantage Media providing information technology for the scientific community. For details, visit http://www.thermo.com/informatics.

Labtronics Announces On-line RS232 Setup and Connection Videos

Labtronics Inc. has posted 4 videos on their website to help people who want to collect data from RS232 instruments and devices. The videos provide step by step demonstrations showing how to connect a balance or scale to Excel, how to setup a "wedge" interface, how to create a comma delimited file using serial data collected from a force gauge and how to setup and add new instruments to the Instrument Library in Labtronics' Collect software. "These videos clearly demonstrate how with the right tools anyone can enjoy the real benefits of RS232 data collection without requiring much technical knowledge or needing to spend a lot of time setting up the interfaces", said Mike DeWitte VP Sales & Marketing for Labtronics' Device Integration Group. "After viewing the RS232 tutorials, I'm certain many visitors will want to take advantage of the free Collect software trial download to try it out with their instruments." For details and links to the videos and free software trial requests, visit http://www.labtronics.com/DI/RS232_Software.htm.

Atrium Research Publishes Results of 2008 ELN Survey

Atrium Research, an independent market research organization dedicated to scientific informatics, has announced the availability of the 2008 Electronic Laboratory Notebook Survey. This study contains the results and analysis of a survey of information technology, management, and scientific personnel in the life sciences, chemical, academic, government and food markets. Comprehensive data and analysis are reported on dozens of questions answered by 527 professionals from over twenty countries. This 140 page report containing 130 charts and tables highlights user and prospective user opinions on data management challenges, technology interest, motivations, project goals, purchase timing, integration needs, and supplier product and brand perception. Comparisons are made with Atrium Research's 2006 ELN survey to highlight market trends. The market for ELNs is exploding with over thirty suppliers offering commercial solutions. One of the fastest growing informatics markets with a growth rate of nearly 20 per cent per year, ELN is radically improving the effectiveness of laboratory operations. ELN enables new approaches to knowledge management, collaboration, and data integration. “We project sustained double-digit growth for ELN for at least the next three years” said Michael H Elliott, founder and CEO of Atrium Research. “Our study shows the use of the technology is expanding beyond early adopters in research synthetic chemistry into domains such as biology and analytical chemistry. Commercial life sciences continue to lead adoption; over 30% of biopharmaceutical companies have installed ELN in at least one department.” For details, visit http://www.atriumresearch.com/html/eln_report2.htm.

STARLIMS Consolidates Direct Presence in Europe; Hires LIMS Veteran Joe Peden to Head STARLIMS Europe

STARLIMS Technologies Ltd. has announced the establishment of STARLIMS Europe as a result of the May 2008 acquisition of its long-time United Kingdom partner, and the hiring of LIMS veteran Joe Peden as general manager of the new subsidiary. "Having acquired our long-standing UK partner as the keystone for STARLIMS Europe, we are poised to take advantage of the increasing number of opportunities within Europe, and to enhance our local professional services capabilities,” said STARLIMS CEO Itschak Friedman. “The UK team represents an exceptional LIMS talent pool with many years of experience selling, implementing and supporting STARLIMS products. Having closed the acquisition in May, we are already deep into the integration process and actively hiring additional sales and service staff to support growing UK and pan-European activities. We are delighted to announce that Joe Peden will join us as general manager of STARLIMS Europe, bringing a
wealth of expertise in almost every area of the LIMS business as well as proven leadership experience." Mr. Peden will be responsible for managing the growth of our European business, while also contributing
to corporate product development. “With Joe Peden’s leadership, we believe STARLIMS Europe can make
significant advances in terms of sales, marketing and project delivery, leading to substantial market share growth in this region,” Friedman said. Mr. Peden has two decades of experience in LIMS product development, marketing, sales and executive positions. Before joining STARLIMS, he was president and chief operating officer of Ardenno, a provider of collaborative knowledge management software solutions for research and development. Previously, Mr. Peden worked for Thermo Fisher Scientific, where he became senior director of marketing and product management for the informatics group. Previous responsibilities at Thermo Fisher Scientific included the development of strategic partnerships for the laboratory information management group, and leading launch initiatives for new products in market segments including bio-informatics research and development. Mr. Peden holds a B.Sc. degree in genetics and microbiology and M.Sc. degree in biotechnology, both from the Queen's University of Belfast, where he graduated with honors. He is frequently invited as a speaker at industry conferences. "STARLIMS is uniquely positioned to leverage its leadership position in the global LIMS market and make a significant leap forward in the European region,” said Mr. Peden. “I can think of no other LIMS solution that can deliver a comprehensive, integrated, multi-site, web-based laboratory informatics platform – and that is precisely what many Europe-based companies are seeking. I look forward to working with the STARLIMS team to further develop the company’s reach in the European LIMS markets." For details, visit http://www.starlims.com.

Inks and Coatings Manufacturer Cuts IT Costs with DEACOM ERP Software

American Inks and Coatings has implemented the DEACOM Integrated Accounting and Enterprise Resource Planning (ERP) Software System to simplify its software and hardware environment by integrating its business processes in a single system. Prior to the selection of DEACOM, the producer of high-quality inks and coatings for the commercial packaging industry used three customized software systems and more than 20 servers to manage its six manufacturing facilities, IT office, and home office. "We had interfaces which let our three custom-written systems work together. The problem was they didn't always work," explains Rob Raeke, Controller of American Inks and Coatings. "It took a full-time project manager and a programmer to keep daily tasks running and the system data linked. With DEACOM, our daily suspended batches are gone, we closed our offsite IT office, and our IT staff has gone from four to one." Since going live on the DEACOM System in May of 2008, American Inks and Coatings now handles formulation and lab management, sales order entry, accounting/financials, purchasing, regulatory reporting, inventory control and lot tracking, and production processes in one software system, which runs on two servers. Raeke says, "With fewer servers and only one software system to manage, DEACOM has allowed us to run our department less like an IT software project and more like a business." For details, visit http://www.deacom.net.

Bruker Corporation Reports Second Quarter 2008 Financial Results

Bruker Corporation has reported its financial results for the three and six months ended June 30, 2008. On February 26, 2008, Bruker BioSciences Corporation closed its acquisition of the Bruker BioSpin Group, and renamed itself Bruker Corporation. Under US GAAP, this transaction is accounted for as an acquisition of businesses under common control, and as a result all one-time transaction costs are expensed in the period in which they are incurred, rather than being added to goodwill. In addition, expenses incurred subsequent to the consummation of the acquisition, such as interest expenses incurred on acquisition related debt, are not reflected in the financial results of periods prior to the date of the acquisition, as they typically would be in pro-forma financials in acquisitions of unrelated parties. After the closing of the transaction all historical financial statements are required to be restated by combining the historical consolidated financial statements of Bruker BioSciences Corporation with those of the Bruker BioSpin Group. Accordingly, the financial results for the three and six months ended June 30, 2008 and 2007, included within this release, represent the combined historical consolidated financial statements of Bruker BioSciences Corporation with those of the Bruker BioSpin Group. With regard to financial results, in the second quarter of 2008, revenue increased 31% to $311.5 million, compared to revenue of $238.3 million in the second quarter of 2007. Excluding the effects of foreign currency translation, second quarter 2008 revenue increased by 19% year-over-year. Net income in the second quarter of 2008 was $21.7 million, or $0.13 per diluted share, compared to net income of $17.7 million, or $0.11 per diluted share, in the second quarter of 2007. Included in net income for the second quarter of 2008 were after-tax charges of $0.3 million, or $0.00 per diluted share, for expenses related to the acquisition of the Bruker BioSpin Group. For the six months ended June 30, 2008, revenue increased 23% to $549.9 million, compared to revenue of $445.9 million during the six months ended June 30, 2007. Excluding the effects of foreign currency translation, revenue for the six months ended June 30, 2008 increased by 13% year-over-year. Net income during the six months ended June 30, 2008 was $21.0 million, or $0.13 per diluted share, compared to net income of $32.0 million, or $0.20 per diluted share, during the six months ended June 30, 2007. Included in GAAP EPS for the six months ended June 30, 2008 were Bruker BioSpin acquisition related expenses of ($0.04) per diluted share, foreign exchange losses of ($0.04) per diluted share, and interest expense on acquisition related debt of ($0.03) per diluted share, with a cumulative effect of ($0.11) per diluted share. For comparison, included in net income for the six months ended June 30, 2007 were foreign exchange gains of $0.4 million, or $0.00 per diluted share, and there were no acquisition related charges or acquisition related interest expense. During the second quarter of 2008, Bruker repaid $158 million of acquisition related debt. As of June 30, 2008, Bruker Corporation had a net debt position of $110.4 million. Frank Laukien, President and Chief Executive Officer of Bruker Corporation, commented: “For the second quarter of 2008, we are very pleased with our strong revenue growth, as well as our sequential and year-over-year improvements in net income and EPS. In the first two quarters of 2008 we experienced significant quarterly fluctuations in our growth rates and margins, and we expect these fluctuations to continue going forward. In the first half of 2008, while our GAAP operating income grew by 7%, our adjusted operating income, which excludes expenses related to the acquisition of Bruker BioSpin, grew 22%. However, our adjusted operating margin as a percentage of revenue was essentially flat, and therefore, in the third quarter of 2008, we intend to reaccelerate our gross margin improvement programs and to implement various streamlining and expense cutting steps with the objective of obtaining better margin leverage from our top-line growth.”
Bill Knight, Bruker’s Chief Financial Officer, concluded: “While the present global market environment is more challenging than a year ago, we are optimistic that our various medium-term growth and margin initiatives will continue our positive profitability trends of the last three years. Our goal remains to drive our margins towards and beyond industry standards, while maintaining rapid revenue growth.” For details, visit http://www.bruker.com.

FDA Eyes India Offices by 2009 to Ensure Import Safety

Signaling its intention to enhance monitoring the safety of products destined for America, the FDA says it will open two offices in India by next year. The offices, to be located in Delhi and Mumbai, are part of the agency’s FDA Without Borders initiative, announced by FDA Commissioner Andrew von Eschenbach in March. A growing number of drugs, medical devices and food products from India are being imported to the U.S., and the FDA “believes we can better help assure the safety and manufacturing quality of these products by having FDA personnel full time in India to work with our counterpart agencies there,” Christopher Kelly, a spokesman for the agency’s Office of International Programs, said. The offices will help the FDA “make better, more risk-based decisions on where to use our inspection resources — both in the field and at our borders,” he said.
Besides inspecting India-based companies, the FDA will work with private and public entities interested in certifying that products headed for the U.S. market meet U.S. public health standards. As part of the FDA Without Borders initiative, the agency is finalizing an agreement with the Chinese government to open three offices there, Kelly said. Plans to open offices in the Middle East, Latin America and Europe also are under way. For details, visit http://www.fda.gov.

FDA to Emphasize Safety in Approving Drug Names

The way in which the FDA approves proposed drug names is changing as the agency increases its focus on drug safety through preventing medication errors. The Division of Medication Error Prevention (DMEDP) is taking the lead in regulatory actions related to proprietary name review and medication error prevention, Susan Proulx, president of Med-ERRS, said at an FDAnews audioconference in late July 2008. Previously, DMEDP checked proposed drug names to see if they were similar enough to existing drug names to potentially cause medication errors. It then issued a recommendation to the relevant drug-reviewing division, which could overrule it. Under a memorandum of agreement signed this month between the FDA's Office of New Drugs and Office of Surveillance and Epidemiology (OSE), "there will be more transparency, and DMEDP will have more say," Proulx said. DMEDP may get the final say on whether a proposed drug name can be approved rather than the reviewing division, she added. The goal is to improve drug safety by decreasing the risk of medication errors caused by name confusion. For details, visit http://www.fda.gov.

FDA Launches Fellowship Program

In an effort to attract more scientific talent to the FDA, the agency is launching a two-year fellowship program designed to train scientists and engineers on the scientific foundations of its regulatory actions. The program will start in October, and the agency is considering applicants for 30–40 slots in the first entering class. Applicants must have a doctoral degree in medicine or another scientific field or at least a bachelor’s degree for engineering positions. "To fulfill our mission over the coming decade, we will need to recruit thousands of highly skilled scientists and others with specialized and relevant expertise,” Frank Torti, principal deputy commissioner and chief scientist, said. "The FDA Commissioner’s Fellowship Program is designed to attract these people to the FDA and provide them with in-depth knowledge of the science that underpins regulatory decisions as we meet the challenges of both globalization and rapid changes in science and technology,” he said. For details, visit http://www.fda.gov.

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

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