LIMSource News: What's New - November to December 2005

• Industry Pioneer Mike McGinnis Passes Away
• Thermo Introduces Retriever Software for Expanded Data Access, More Knowledgeable Decision-Making
• Waters Corporation Ships Major Version of Waters' NuGenesis SDMS Software
• Teranode Partners with The Edge Software Consultancy
• Tessella Acquires Analyticon
• Thermo Electron Introduces New Atlas CDS Datasheet for Chromatographers
• Waters Corporation Ships Enhanced MassLynx Software
• Frost & Sullivan Awards Thermo for Informatics Market Leadership
• Indiana University Informatics Study Fuels Debate about Search Engine Bias
• Indiana University's Web-based System Will Speed Drug Discoveries
• Diversa Corporation Purchases Labtronics' ELN Solution
• ACD and Protasis/MRM Announce Collaboration to Offer High-Throughput System for NMR
• ACD/Labs Integrates ChemSketch to Chmoogle Search Engine
• FDA Releases Guidance on Noncontraceptive Estrogen Drug Products
• DoD RFID Rule Now in Effect for New Contracts
• Bio-Rad Signs Second Collaboration Agreement with Caliper
• Caliper Life Sciences Completes Acquisition of NovaScreen Biosciences
• ClinPhone Wins Best IT Solution at European Outsourcing Awards 2005
• Thermo Introduces Migration Agent for Low-Risk, Effective Software Migration
• GenoLogics Advances Clinical Proteomics Research with ProteusLIMS 3.0
• New Quality Management Tools from QSI
• University of Pittsburgh Genomics and Proteomics Core Laboratories Select GenoLogics’ ProteusLIMS
• Group Logic Announces Full Support For Mac OS X 10.4 - Tiger, Safari and Firefox In MassTransit
• GenoLogics Receives Frost & Sullivan 2005 Drug Discovery Technologies Award
• Protedyne Corporation Automates Promega P450-Glo Assay Kit on its High Throughput BioCube System
• Advanced Chemistry Development’s Free Naming Software Service Generates 200,000 IUPAC Names via the World Wide Web
• ACD/Labs Streamlines LC/MS Peak Identification with ACD/Ion Presence Technology
• Waters Strengthens ACQUITY Ultra Performance LC System Product Line with Advanced Detectors
• Agilent Technologies Reports Fourth Quarter 2005 Results - $2.7 Billion "Dutch Auction" Tender Offer Announced
• Simultaneous Acquisitions Strengthen Bruker AXS Presence in Nanotechnology and Advanced Materials Research Markets
• Bayer Workflow Targets Cheminformatics Analysis
• Thermo Enables Detailed Bioanalysis with LCQUAN 2.5 Quantitative Software Package
• Dorado Software Selected for Egyptian Universities Network
• FDA to Drug Makers: Submit Labels Electronically
• Changes to CDER Include New Critical Path Office, New Safety Structure
• New Database Expected to Speed Up ANDA Approvals
• Ex-FDA Commissioner Crawford's Disclosure Forms Boost Claims of Industry Bias

Industry Pioneer Mike McGinnis Passes Away

Mike McGinnis passed away Monday morning, November 21, after suffering a heart attack while eating breakfast with a business associate. Mike McGinnis was one of the early pioneers of the LIMS industry and wrote the
first commercially available LIMS for HP midrange computers. Always ahead of the curve, Mike co-authored and published the first edition of the LIMS Workbook and recently invented the autosampler microVials technology. In 1979, Mike established Transition Labs and as the president and founder he provided laboratory software
consulting and analytical standards to the petrochemical industry. Mike held a BA from Yale University with majors in Biology and Geology. Mike will be missed by all who knew him. He was a husband, father, grandfather, faithful friend, and was loved by all who knew him well. He is survived by his wife, Marianne McGinnis, his mother, V. Jewell McGinnis, his brothers Travis and Dave McGinnis, his children: Seth McGinnis, Kimberly McNeely, Boyd Nelson, Joel Nelson, Mollie Crawford, Loren McGinnis & Sherilyn McGinnis their spouses, five grandchildren, and a host of friends and associates. You can view Mike's as well as register your own tribute to him and read other's tributes to him at http://www.horanandmcconaty.com.

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 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.

Waters Corporation Ships Major Version of Waters' NuGenesis SDMS Software

Waters Corporation is now shipping Version 7.0 of Waters NuGenesis Scientific Data Management System (SDMS) Software. This new version lets scientists convert proprietary data from any analytical technique into the technology-neutral JCAMP-DX standard while preserving investments in instruments and software. The software also simplifies system administration and management while providing more configuration choices to facilitate easier deployment. According to Pat Martell, Director of Informatics at Waters Corporation, "Laboratories are under pressure to improve results and then take those results and amass, correlate and learn from the data. This announcement facilitates the ability of researchers to integrate data from various sources into a logical framework and then share that data across the enterprise." Waters NuGenesis SDMS Software is the industry's leading
electronic-information management repository. Scientists at major pharmaceutical, biotechnology and chemical companies use its patented print to database technology to capture and query printed reports and data files from analytical instruments, scientific and office software packages and then apply that data to today's research for additional relevance. Highlights of the new features include: Automatic conversion capabilities that create JCAMP-DX public data standard files to view data from NMR, MS, UV/Vis, chromatography, hyphenated methods, chemical structures and other techniques right from the desktop without the original application for long-term data preservation; Remote data storage option that optimizes network utilization and improves database performance; Single user authentication strategies to maintain security through support of Active Directory and LDAP technologies; Enhanced electronic signature and other collaboration processes; Expanded Software Development Kit features and on-line documentation to assist in development of Microsoft .Net applications; Support for web-based Help Desk administration of users, groups, privileges and server components; Tighter integration with Waters Empower 2, Waters eLab Notebook, Waters MassLynx 4.1 and Waters Analytical Workflow Manager Software. For details, visit http://www.waters.com/informatics.

Teranode Partners with The Edge Software Consultancy

Seattle-based Teranode Corporation has announced a partnership with The Edge Software Consultancy, a UK based consulting organization, to bring new R&D solutions to European markets. The value-added services relationship is the first in a network of partners Teranode plans to develop to create solutions on the TERANODE XDA platform. For details, visit http://www.teranode.com.

Tessella Acquires Analyticon

Tessella Support Services plc has completed the acquisition of Analyticon Limited, which is now a wholly owned subsidiary of Tessella. A leading provider of custom software solutions to solve scientific, technical and engineering problems, Tessella delivers services to clients across the Life Sciences, Energy and Chemical, Environmental, Instrumentation, Manufacturing and Engineering, Transport, Utilities, and Public Sectors. Analyticon specializes in the design of solutions requiring mathematical modelling, analysis, and creative thinking. Its engineers work by developing a fundamental understanding of a client’s problem in a ‘big picture’ context, such that proposed solutions fit with the needs of the client’s business. Commenting on the announcement, Kevin Gell, Managing Director of Tessella, said: “Tessella has a proven 25-year history of excellence, adding value to demanding public sector and commercial R&D based organizations. Analyticon’s services dovetail exceptionally well with our own, and the expanded group will continue to use its unique blend of scientific, engineering and IT skills to solve the most complex of technical and business problems in a highly cost-effective way.” Dr Peter Townsend, Commercial Director of Tessella, said: “We have ambitious plans to expand both organically and through acquisition. Tessella is approximately five times the size of Analyticon, and hence this step is a bold but controlled expansion step for us to take. With great synergies between the skills and experience of both sets of staff we anticipate a busy future.” Under the terms of the agreement, Analyticon’s founder Steve Colling will work with Tessella over the next three months to ensure a smooth and orderly handover. In the immediate term, Kevin Gell will work with Steve Colling, and senior technical staff in the company, to develop new business with both existing and new clients within the Space and Defence sector. Lawrence Hopkins, Associate Director for Tessella’s Cambridge and Stevenage offices, will manage new business development activities with Analyticon’s Life Sciences clients. For details, visit http://www.tessella.com.

Thermo Electron Introduces New Atlas CDS Datasheet for Chromatographers

Thermo Electron Corporation, a leader in laboratory informatics for multi-lab environments, has developed a new datasheet on the Atlas CDS , available in pdf or printed format. Entitled "Atlas CDS - A scalable, compliant and integrated chromatography data system", this new document is available to chromatographers working in both regulated and non-regulated industries to address the benefits of standardizing on a single solution. Thermo's new datasheet provides information designed for multi-channel, multi-user client server implementations. As well as discussing the challenges in balancing the cost of regularly updating software against the benefits of such updates, the Atlas CDS datasheet also provides an overview of the CDS's data capabilities. This brochure from Thermo further explains Atlas's ability to interface with liquid and gas chromatography systems, as well as capillary electrophoresis instruments manufactured by a variety of vendors. For details, visit http://www.thermo.com/cds.

Waters Corporation Ships Enhanced MassLynx Software

Waters Corporation has announced the shipment of Waters MassLynx 4.1 Software, its market-leading solution for the company’s line of mass spectrometers. MassLynx Software has been enhanced and reconfigured to facilitate high-performance quantification and qualitative analysis so that users can process and review results, and generate reports more easily. MassLynx 4.1 Software also includes a new administrator toolkit that lets system administrators manage resources from a remote PC. The toolkit features software to monitor basic sample information and instrument status for all users. According to Art Coddington, Research Fellow, at Merck West Point, PA, Medicinal Chemistry, "Waters OpenLynx Remote Status Monitor increases the ease and speed with which our chemists -- spread out over 3 floors with long hallways -- can locate the closest Open Access instrument in their areas with the shortest queue. We are seeing efficiency gains, which are critical for laboratories such as ours that are challenged by high-productivity requirements," he said. In addition, the software queues multiple sample runs without disrupting current operations. A new security architecture supports a network file server model for data acquisition so that multiple users have access to data and results. MassLynx 4.1 Software upgrades are available for current support plan subscribers. For details, visit http://www.waters.com/informatics.

Frost & Sullivan Awards Thermo for Informatics Market Leadership

Thermo Electron Corporation's Informatics business received the 2005 Frost & Sullivan Award for Market Leadership, based on the growth consulting company's recent analysis titled The U.S. Laboratory Information Management Systems (LIMS) Market. The award recognizes Thermo's market share leadership achieved through the implementation of market strategy, expanding operations and product innovation. Thermo is credited with a commanding 22 percent share of the U.S. LIMS market, achieved through is multifaceted offering of more than a half dozen solutions, according to Frost & Sullivan's report. "We are honored to receive this prestigious award from Frost & Sullivan," s aid Dave Champagne, vice president and general manager of Thermo's Informatics business. "Our goal now is to expand on our market leadership and make Thermo the standard suite of laboratory software." Apioneer in LIMS with its flagship SampleManager, a leading system with first customers continuing to benefit from modern updates, Thermo through the '90s expanded its informatics offering with the development of Nautilus LIMS for research and development applications and Atlas CDST for multi-industry, global organizations. The 2004 acquisition of InnaPhase Corporation, a leading provider of pharmaceutical-focused software, enhanced Thermo's portfolio and fit strategically with the company's move to commercial-off-the-shelf (COTS) informatics solutions. From the acquisition, Thermo added to its portofolio Watson LIMS, designed for bioanalysis; Galileo LIMS, designed specifically for in vitro ADME/Tox applications; and the pharmacokinetic/pharmacodynamic tools, Enterprise Pharmacology Series and Kinetica. Thermo's efforts now, according to Champagne, are to develop and refine LIMS solutions for specialized laboratory applications, built on a common, unified and robust technology platform. The first product introduction under these guidelines is Darwin LIMS, available in Q1 2006, developed specifically for pharmaceutical quality assurance/quality control.
"Thermo's multifaceted product offering creates a strong sales platform to leverage its LIMS among existing and new client accounts," said Jessica Shah, Frost & Sullivan research analyst. "Product innovation, service excellence, and outstanding end-user training have earned Thermo Electron Corporation its leadership position in the U.S. LIMS market." For details, visit http://www.thermo.com/informatics.

Indiana University's Web-based System Will Speed Drug Discoveries

The process of developing new disease-fighting drugs will be accelerated because of research now under way at the Indiana University School of Informatics and the IU Community Grids Lab. The School has received a grant from Microsoft Smart Clients for eScience to develop a prototype of a Web service and intelligent agent-based system for the potential deployment in the pharmaceutical industry. It is expected the development of such tools will enable scientists to more quickly amass the information they need in their decision-making about which chemical compounds are most likely to be safe, effective drugs. "Currently, early-stage drug discovery is experiencing an information overload, and what results from the prototype we build will make the computer do the grunt work of sorting the information for scientists," says David J. Wild, Ph.D., assistant professor of informatics. Joining Wild in developing these computing tools with the $49,000 Microsoft grant is Marlon Pierce, Ph.D., research associate at the Community Grids Lab, which is part of IU's Pervasive Technology Labs. There is a trend toward making computational chemistry and molecular modeling techniques more accessible to chemists through desktop tools, the IU researchers note. "However, deployment of these technologies in labs is often haphazard, and no serious study has been carried out on how these technologies can work together and integrate into the laboratory environment in the most effective way for the chemist," says Wild. Wild's and Pierce's research adds to IU's already-strong chemical informatics research program. A School of Informatics-led team recently received a $500,000 grant from the National Institutes of Health to establish the Chemical Informatics and Cyberinfrastructure Collaboratory. The project is headed by Geoffrey C. Fox, Ph.D., professor of informatics and director of the Community Grids Lab. The CICC seeks to devise a system of diverse and easily expandable databases, simulation engines and other tools that use emerging high-capacity computer networks and data repositories and develop grid and Web technology. Their research will help chemists better understand drug synthesis and lead to new therapies for cancer, Alzheimer's disease and other disorders. For details, visit http://www.informatics.iupui.edu.

Indiana University Informatics Study Fuels Debate about Search Engine Bias

The notion that search engines such as Google and Yahoo monopolize World Wide Web traffic has taken a sharp detour at the Indiana University School of Informatics. In a recent study, IU researchers conclude that search engines actually produce an egalitarian effect. This challenges the so-called "Googlearchy" hypothesis, the commonly held belief that search engines make popular pages more popular at the expense of new and
lesser-known ones. The researchers' paper, "The Egalitarian Effect of Search Engines," was cited in the Nov. 19 issue of The Economist, a publication known for its analysis of world business and current affairs; and in
www.physicsweb.org, the online version of the Physics World magazine. Since then, the paper has generated much debate and discussion in more than 100 blogs around the world. "The Web is a place where the rich-get-richer dynamic is well established," says Santo Fortunato, Ph.D., a post-doctoral fellow at the School of Informatics. "We believe the empirical data does not support the belief that search engines amplify this phenomenon. In fact, our evidence strongly suggests new pages have a greater chance to be discovered through the use of search engines." Joining Fortunato in the study are Filippo Menczer, Ph.D., associate professor of informatics and computer science; Alessandro Flammini, Ph.D., assistant professor of informatics; and Alessandro Vespignani, Ph.D., professor of informatics. A search engine is a complex system designed to help find information stored on the Web. It allows users to look for content meeting specific criteria - typically those containing a given word or phrase - and retrieves a list of references that match those criteria. The resulting "hits" are returned and ranked by relevance. The researchers, who pooled their expertise in areas such as Web mining, complex systems and networks, constructed models detailing two different cases. In the first scenario, users browsed the Web only by choosing random links; in the second, users visited only pages returned by search engines. From there, the researchers tracked and compared traffic to many Web sites against the number of incoming links. They concluded the existing bias toward popular sites caused by the link structure of the Web is actually mitigated by the queries submitted to search engines and by the way in which users view the results. The methodology employed by the IU researchers has raised
some objections, owing to its reliance on "noisy data" provided by search engines. "We used the best data available," says Fortunato "We conducted extensive statistical analysis to obtain a reliable traffic trend. Our results were confirmed using two independent sources to count the incoming links (Yahoo and Google), and collecting the data twice in a three-month period." The IU study might help understand the social impact of
search engines, as well as aid in the design of future search technology, says Menczer. "Search engine companies always are trying to improve the ways they rank their search results, which really are the secret recipes to their success," he notes. "Our work points to a key ingredient that search engines can manipulate to become more egalitarian or more elitist." " The Egalitarian Effect of Search Engines" can be read at
http://arxiv.org/abs/cs.CY/0511005.

Diversa Corporation Purchases Labtronics' ELN Solution

Labtronics Inc. has announced that Diversa Corporation has chosen NEXXIS qELN, an Electronic Laboratory Notebook (ELN) designed specifically for QA/QC laboratories, to enforce their Standard Operating Procedures (SOPs) during the media preparation and execution of their production processes. Diversa Corporation is a leader
in applying proprietary genomic technologies for the rapid discovery and optimization of novel products from genes and gene pathways. Historically, Diversa's media preparation process has been a paper-based, manual
process. NEXXIS qELN will allow Diversa to create electronic SOPs that interface directly to their laboratory instruments, eliminating manual transcription errors and ensuring complete compliance with all steps of the process. This will decrease laboratory operating costs and improve productivity by removing the need to monitor and confirm the accuracy of operator entry in the SOP. NEXXIS qELN will also increase their diligence on validation of regulatory runs, which is vital to Diversa as they continue to grow their business in regulated markets such as pharmaceutical, agriculture and biotechnology. Diversa also opted to incorporate Labtronics' chemical inventory management module, NEXXIS CIM, as part of the total solution to help them improve their chemical inventory tracking. NEXXIS CIM is fully integrated with NEXXIS qELN allowing Diversa to automatically manage their inventory as chemicals are used during the SOP process of media preparation. For details, visit http://www.Labtronics.com.

ACD and Protasis/MRM Announce Collaboration to Offer High-Throughput System for NMR

Advanced Chemistry Development (ACD) and Protasis/MRM have announced the start of a collaboration to produce the automated high-throughput system for NMR data production and analysis. By combining Protasis’ One-Minute NMR system and ACD’s Automation Server, the entire NMR process—from loading samples to interpretation—is now automated. The system uses a Web-based interface to log in sample lists and proposed chemical structures. Sample loading and data acquisition are automated with One-Minute NMR. When the NMR spectrometer has produced the spectra the information is gathered by the ACD/Automation Server, and data is automatically processed, analyzed, databased, and proposed structures are verified. The results of all the analyzed samples are then sent back to the One-Minute NMR system, where an e-mail is then prepared for each user showing the color-coded plate results in a graphic (HTML) display. The verification results are clearly marked on the plate display, thereby allowing the user to focus their efforts on only those problems that need attention. For details, visit http://www.acdlabs.com.

ACD/Labs Integrates ChemSketch to Chmoogle Search Engine

Advanced Chemistry Development, Inc. has integrated both their commercial and freeware ChemSketch application to the Chmoogle Web site (www.chmoogle.com), created by eMolecules, Inc. Chmoogle is an open-access chemistry search engine with the mission to discover, curate, and index all of the public chemical information in the world, and make it available to the public for free. Chmoogle distinguishes itself by extremely fast searches, an appealing presentation of results, high-quality chemical drawings, and powerful advanced search capabilities like persistent hitlists and hitlist logic operations. ACD has integrated Chmoogle to the commercial ChemSketch software (http://www.acdlabs.com/products/chem_dsn_lab/chemsketch/) and freeware (http://www.acdlabs.com/download/) software, now downloaded by over 530,000 scientists around the world. This integration gives ChemSketch users direct access to Chmoogle’s structure and substructure searches. For details, visit http://www.acdlabs.com.

FDA Releases Guidance on Noncontraceptive Estrogen Drug Products

The FDA has released a final guidance to provide manufacturers with recommendations on prescribing information and patient labeling for noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms. The guidance includes specific prescribing information for healthcare providers, as well as the recommended text for the patient information leaflet for noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms. The final guidance updates draft guidances issued by the agency in October 1998, Feberuary 2003 and February 2004. To view the guidance, visit http://www.fda.gov/cder/guidance/6932dft.htm.

DoD RFID Rule Now in Effect for New Contracts

The US DoD's (Department of Defense) final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to add policy pertaining to package marking with passive radio frequency identification (RFID) tags is now in effect. The rule, effective November 14, 2005, requires all DoD manufacturers and suppliers who have new contracts, issued with the appropriate contract clause, to affix passive RFID tags at the case and palletized unit load levels when shipping packaged operational rations, clothing, individual equipment, tools, personal demand items, or weapon system repair parts to the Defense Distribution Depot in Susquehanna, PA, or the Defense Distribution Depot in San Joaquin, California. Advanced Shipping Notices (ASNs) are also required for tagged items. For details, visit http://www.dod.gov.

Bio-Rad Signs Second Collaboration Agreement with Caliper

Bio-Rad Laboratories, Inc. and Caliper Life Sciences, Inc. have announced a new collaboration, under which the companies will study the feasibility of developing a new microfluidics system platform. Details of the new product concept are not being disclosed at this time. The two companies' previous collaboration, initiated in mid-2003, resulted in the successful launch of a new microfluidics-based electrophoresis product, Experion, in the fall of 2004.
"The success we've enjoyed with the Experion(TM) Automated Electrophoresis System has confirmed our belief that microfluidics is a key strategic technology," commented Norman Schwartz, president and CEO at Bio-Rad. "After our first positive experience collaborating with Caliper, we are looking forward to this next collaboration where we will pursue new ideas regarding LabChip microfluidics as the foundation for innovative new products."
Kevin Hrusovsky, Caliper's president and CEO, also commented, "Bio-Rad is a model partner for our 'Caliper Driven' program, under which we enable life science companies like Bio-Rad to tap into our innovative technologies, expertise and patent portfolio. Their strong reputation in life sciences and diagnostics, and their well-established global distribution very effectively leverage our technology into key markets." For details, visit http://www.bio-rad.com or http://www.caliperLS.com.

Caliper Life Sciences Completes Acquisition of NovaScreen Biosciences

Caliper Life Sciences, Inc. has announced the closing of its previously announced planned acquisition of NovaScreen BioSciences Corporation, a privately held life science services company based in Hanover, Maryland. The acquisition combines NovaScreen's screening, profiling and assay development services with Caliper's proven LabChip(R) and advanced liquid handling products to provide the pharmaceutical and biotechnology industry with a central resource for drug discovery solutions. "By integrating and leveraging NovaScreen's expertise and technology, Caliper has become a "one-stop shop" for scientists and researchers. Customers can rely on Caliper for all in vitro drug discovery needs -- state-of-the-art technologies, products, leading screening assays and profiling services," said Kevin Hrusovsky, president and CEO of Caliper Life Sciences. "We have immediately gained a stronghold in the outsourced assay development and screening markets, especially the high-growth market of secondary screening and profiling services." Consistent with the terms of the previously announced agreement, Caliper purchased NovaScreen for $22 million, subject to future adjustment based on certain financial parameters. NovaScreen shareholders can also earn up to $8 million contingent on the achievement of defined revenue milestones over a 30-month period. The closing consideration was paid 80 percent in Caliper common stock and 20 percent in cash. For details, visit http://www.caliperLS.com.

ClinPhone Wins Best IT Solution at European Outsourcing Awards 2005

ClinPhone Group, a global leader in clinical technology solutions, has been named a winner in the 2005 European
Outsourcing Awards, collecting the honor for Best e-business/IT solution. The Awards were held by CEC Media, specialists in high quality publications and events for the pharmaceutical and science industries. The event, which was held in Madrid, was judged by an acclaimed international panel who took into consideration aspects such as the execution of strategies, the deployment of technology and the effective uptake by users and operators. ClinPhone was presented the award in recognition of its highly regarded electronic Patient Reported Outcomes Solution (ePRO), and its successful implementation with a number of leading biopharmaceutical customers. This award not only acknowledges ClinPhone's innovative ePRO solution, but also the company's ability to effectively support study logistics, providing its customers with powerful yet practical technology which can be seamlessly integrated with other clinical trial technology such as Electronic Data Capture (EDC), Clinical Trials Management Software (CTMS) and Randomization and Medication Supply Management services.
ClinPhone ePRO, powered by the company's Interactive Voice Response (IVR) technology, was recognized at the awards as the best solution for collecting patient self-report data and exchanging data in real-time with other mission critical, clinical databases. ClinPhone, having now supported over 200 ePRO studies, is recognized as a cost-effective and market-leading alternative to the use of hand-held diary devices in clinical trials. The solution is designed with the end-user and the sponsor in mind, allowing patients to use a telephone or mobile phone to give and receive information enabling rapid and accurate progression through the diary questions. Additionally
investigators are able to instantly view all patient data via secure web or faxed reports. Sponsors equally have timely reporting at their fingertips. For details, visit http://www.clinphone.com.

Thermo Introduces Migration Agent for Low-Risk, Effective Software Migration

Thermo Electron Corporation has introduced Migration Agent, a professional services and software solution that reduces risk and overcomes business challenges when migrating from any existing laboratory information management system (LIMS) to a Thermo LIMS. Migration Agent employs services personnel for project management and implementation, as well as an extract, transform and load (ETL) tool to migrate data to deliver an effective and predictable migration. "The difficulties historically associated with migration are virtually eliminated by the 6-step Migration Agent process," said David Champagne, vice president and general manager of Thermo Electron's Informatics business. "We are confident we'll be able to define the timeframes and costs associated with a migration, enabling our customers to exploit the latest that informatics has to offer in terms of productivity, process harmonization and standardization." Migration Agent can successfully move users from any LIMS to a Thermo solution, such as SampleManager LIMS for the petrochemical, chemical, food & beverage, and other process industries, or to Darwin LIMS, Thermo's newest commercial-off-the-shelf LIMS for pharmaceutical QA/QC. In addition to the proven ETL tool for low-risk, low-disruption migrations, customers using Migration Agent work with a dedicated tactical team from Thermo's extensive, global services group in implementing the defined migration process. This process improves involvement and communication while defining roles, responsibilities, schedules and deliverables for a smooth migration. For details, visit http://www.thermo.com/informatics.

GenoLogics Advances Clinical Proteomics Research with ProteusLIMS 3.0

GenoLogics Life Sciences Software Inc., a leading developer of solutions that help proteomics research and pharmaceutical laboratories manage, integrate and analyze scientific data, has announced availability of ProteusLIMS 3.0 – the latest version of ProteusLIMS for proteomics purposed lab and scientific data management and analysis. ProteusLIMS is a comprehensive and integrated lab, instrument, and scientific data management system that transforms the data management process into a sophisticated analytical system to aid research and scien ific discovery. Significant enhancements and new capability improve data integration, data analysis, lab management and tracking to help researchers do more - to turn their data into knowledge. With ProteusLIMS 3.0, researchers have new advanced search and analysis support to make decisions that can improve and accelerate the interpretation and reproduci ility of experimental results. Laboratory managers have more tools such as barcode support, billing support, and workflow templates to improve sample tracking, to increase throughput and ensure data accuracy. IT managers like the open architecture platform, enhanced security features and data standards support. Significant new advances in ProteusLIMS include analytics and new functionality in complex and protein search comparison views enhance interpretation of research data for clinical proteomics and biomarker discovery. ProteusLIMS 3.0 allows researchers to ask complex questions in determining commonalities and differences among samples and various analytes to reveal critical data elements. Researchers can also now easily compare the outcomes of multiple protein search en ine results, both across samples or across multiple searches on the same sample. These powerful new features improve a researcher’s ability to find all the data of interest and better understand the results for interpretation. This is of particular value for biomarker discovery and in clinical proteomics research. For details, visit http://www.genologics.com.

New Quality Management Tools from QSI

Developments at Quality Systems International, an information software group, have greatly extended the range of quality management tools they can offer, according to Managing Director Clive Collier. "Our roots are in Laboratory Information Management (LIMS), and we over 700 successful installations," said Collier. "Very early on, our clients asked us for software tools for a whole range of non-laboratory tasks that would integrate seamlessly with the LIMS - tasks like document management, scheduling, stock control, invoicing, regulatory compliance, skills training management and many others. To provide these integrated solutions "out of the box", our development programme has generated a whole range of software modules that address these needs but are not exclusive to the laboratory, so that the LIMS has become one component of a global quality management system. These modules are not dependent on the LIMS functionality, but are fully-fledged, stand-alone quality management tools. Some, like document control, have universal application; others like health and safety fulfil more specific needs. By maximising our development productivity in this way, we can offer these products at extremely attractive prices compared to dedicated proprietary software." For details, visit http://www.qsiuk.com.

University of Pittsburgh Genomics and Proteomics Core Laboratories Select GenoLogics’ ProteusLIMS

GenoLogics Life Sciences Software Inc. has announced that the University of Pittsburgh Genomics and Proteomics Core Laboratories (GPCL) have selected ProteusLIMS for their laboratory information and scientific data management system. The GPCL offers University of Pittsburgh investigators a range of high-end genomic and proteomic services and expertise, including DNA/RNA extraction, DNA and gene expression analysis, protein profiling, and protein identification and characterization. The implementation of ProteusLIMS will enable the GPCL to greatly improve the services it offers to its researchers, who are studying new approaches for early diagnosis and treatment of a wide range of diseases. Paul Wood, Associate Director of the GPCL notes, “ProteusLIMS will help us meet our clients’ needs for fast turnaround and reporting of their experimental results. As a high volume core facility, the GPCL processes hundreds of samples with complex workflows every day. This system will help us move from a paper and spreadsheet-based system to a robust tracking and data management system, which will help us significantly improve the traceability and reproducibility for our clients’ discovery and validation research.” Michael Ball, CEO of GenoLogics notes, “Advancements in proteomics research have created a data explosion. As a result, systems that manage, integrate and analyze the enormous volume of scientific and lab data are required to realize the benefits of health science research. ProteusLIMS is more than a workflow solution; it’s a comprehensive and integrated lab and scientific data management and analytical system. We are very pleased that the University of Pittsburgh has selected ProteusLIMS as its lab and data management system.” For details, visit http://www.genetics.pitt.edu or http://www.genologics.com.

Group Logic Announces Full Support For Mac OS X 10.4 - Tiger, Safari and Firefox In MassTransit

Group Logic, developer of network workflow software products, has announced that MassTransit is now fully compatible with Safari, Firefox and Tiger, highlighting the company’s continued investment and support of Macintosh-based technologies. As the only enterprise software solution proven to transform digital file transfers into strategic business processes, MassTransit now supports all leading browsers and operating systems for Macintosh and Windows. By adding support for Safari and Firefox, two popular Macintosh Web Browsers, and Tiger, the latest Macintosh operating system, MassTransit provides its users with the flexibility to transfer their
high volume, mission-critical digital files, while using the best operating system or browser for their business environment. Regardless of desktop or browser, the MassTransit Web Client provides users with a flexible, easy-to-use and consistent way to move valuable files. With compatibility to Safari and Firefox, MassTransit enables existing Macintosh Microsoft Internet Explorer customers to continue gaining the benefits of the MassTransit Web client even after Microsoft ceases all support to the Macintosh version of Explorer. For details, visit http://www.grouplogic.com.

GenoLogics Receives Frost & Sullivan 2005 Drug Discovery Technologies Award

GenoLogics Life Sciences Software Inc. has been honored with Frost & Sullivan’s 2005 Drug Discovery Technologies Niche Player of the Year Award for its success in the systems biology market for the fiscal year 2004. GenoLogics has received this Award based on successfully addressing the systems biology market with an innovative solution for data management and scientific analysis. The Award was presented to GenoLogics on November 9, 2005 at the Frost & Sullivan 2005 Excellence in Pharmaceuticals & Life Sciences Awards Banquet in Miami, Florida. Michael Ball, CEO of GenoLogics commented, “We are particularly pleased to receive this prestigious award from Frost & Sullivan and to be recognized for our achievements. We have had exceptional growth over the last year, thanks to the strong partner relationships we have with our growing roster of prominent customers and the dedication and talent of our employees who have brought new and innovative product solutions to market at a rapid pace. This award distinguishes GenoLogics from other companies in the market and we look forward to continued growth in 2006 in the systems biology market as we bring new products to market.” The Niche Player of the Year Award is presented to a company that has a track record of excellence in its market niche and demonstrated business and marketing strategies that ensure market success. Frost & Sullivan conducts in depth research and analysis into companies in the field combined with interviews of market participants in order to gauge the success of a company within its niche. Other elements considered include the company’s position within the specific segment, its ability to compete against multi-segment players, and company growth during the base year. For details, visit http://www.genologics.com.

Protedyne Corporation Automates Promega P450-Glo Assay Kit on its High Throughput BioCube System

Protedyne Corporation, a leading laboratory automation supplier, has announced that it has fully automated Promega’s P450-Glo assay kits on its BioCube System SX1400, providing an automated solution for high throughput screening of cytochrome P450 activity. Cytochrome P450 enzymes play a pivotal role in the metabolism of drug compounds. Detecting adverse compound effects on enzyme activity at an early stage reduces attrition of toxic compounds in later stages of drug development. The BioCube System configured to run the P450-Glo kits includes a fully enclosed 4-axis robot with interchangeable tools, 20 position work deck, plate gripper SmartTool, 384-channel 20 micro liter SmartTool, 160 plate capacity carousel, tip box storage and shaker towers. The system is capable of processing 51,840 samples (135 assay plates in 384 format) during an 8 hour day. For details, visit http://www.protedyne.com.

Advanced Chemistry Development’s Free Naming Software Service Generates 200,000 IUPAC Names via the World Wide Web

Advanced Chemistry Development, Inc. (ACD) is a premier supplier of quality systematic nomenclature generation. New synthetic structures are constantly being developed, making it increasingly important to adopt definitive systematic nomenclature and utilization of a software tool to ensure accuracy and organizational homogeneity in generating chemical names. ACD/Name has grown to support the nomenclature rules agreed upon by the International Union of Pure and Applied Chemistry (IUPAC), the International Union of Biochemistry and Molecular Biology (IUBMB), and the Chemical Abstract Service (CAS). ACD/Name systematic nomenclature software is utilized to quickly and accurately name compounds for reports, databases, and publications. On November 7, 2005, ACD/Labs generated the 200,000th free IUPAC name from their Web site. This service, known as the ACD/Labs Online Service, enables chemists to generate IUPAC names at no extra cost by using the online portal. Free chemical names can be generated according to the systematic application of a preferred set of IUPAC nomenclature rules for molecules containing no more than 50 atoms, and no more than 3 rings, with atoms from among only H, C, N, P, O, S, F, Cl, Br, I, Li, Na, and K. Presently this service generates about 100 IUPAC names per day. To access the ACD/Labs Online service, visit http://www2.acdlabs.com/ilab/.

ACD/Labs Streamlines LC/MS Peak Identification with ACD/Ion Presence Technology

Advanced Chemistry Development, Inc. has announced ACD/Ion Presence, the latest improvement to ACD/MS Manager software for processing, analyzing, and managing mass spectrometric data. ACD/Ion Presence allows users to automatically find and label LC/MS peaks with a specified mass, and identify and label peaks with a user-specified difference from a reference mass value. This new feature is useful for targeting the peaks for a parent drug and searching for expected metabolite transformations, for finding expected impurities, or for quickly identifying the targeted compound in high-throughput purity analysis. This automatic labeling feature allows users to quickly focus in on the peaks of interest. This feature enhances workflow as it can be applied to the extracted data at any time during data review without the need to perform data reprocessing. ACD/MS Manager may be seamlessly combined with other ACD/Labs product branches to combine chromatograms, NMR, UV-Visible, IR, and Raman spectra, and other analytical curves from all major instrument models and makes into a single data repository. For details, visit http://www.acdlabs.com.

Waters Strengthens ACQUITY Ultra Performance LC System Product Line with Advanced Detectors

Waters Corporation has announced the availability of three advanced detectors specifically designed for Waters
ACQUITY Ultra Performance LC (UPLC) system. The three detectors are photodiode array (PDA), evaporative light scattering (ELS) and tunable ultraviolet (TUV) models and bring new versatility to the ACQUITY UPLC
System for high-resolution analysis of a wide variety of compounds. The Waters ACQUITY UPLC is an award-winning, ground-breaking liquid chromatography system that brings laboratories new levels of resolution,
sensitivity, speed, and productivity. Whether these scientists are working on new drugs, looking for markers of disease, detecting low level contamination of food or drinking water supplies, recent advances in detector technology mean that scientists using the company's ACQUITY UPLC system platform can obtain more information per unit of time in the laboratory. Optimized for Ultra Performance LC, these detectors are designed for low dispersion characteristics, high data acquisition rates, and robust performance. Programming and monitoring is easily controlled from within Waters Empower chromatography software or MassLynx mass spectrometry software. For details, visit http://www.waters.com.

Agilent Technologies Reports Fourth Quarter 2005 Results - $2.7 Billion "Dutch Auction" Tender Offer Announced

Agilent Technologies Inc. has reported orders of $1.50 billion for the fourth fiscal quarter ended Oct. 31, 2005, 26 percent above one year ago. Revenues during the quarter were $1.41 billion, five percent above last year. Fourth quarter GAAP net earnings were $26 million, or $0.05 per diluted share, compared with $74 million, or $0.15 per share, in last year's fourth quarter. During the fourth quarter, Agilent announced a definitive agreement to sell its Semiconductor Products business. As such, the business is being treated as a Discontinued Operation in its fourth quarter GAAP financial statements. If Semiconductor Products had been a continuing operation, Agilent would have reported fourth quarter orders of $1.98 billion, 24 percent above last year, and total revenues of $1.90 billion, four percent above one year ago. Included in fourth quarter GAAP net earnings is a $48 million tax charge associated with repatriating $970 million of off-shore earnings under the Homeland Investment Act. Also included in GAAP results is $119 million composed largely of restructuring costs associated with Agilent's announced sale of its Semiconductor Products business and with the planned spin-off of the company's Semiconductor Test Solutions (STS) business. Excluding those costs, Agilent reported fourth quarter adjusted net income of $193 million, or $0.38 per share. On a comparable basis, the company earned $153 million, or $0.30 per share, one year ago. "Agilent had a strong finish to a remarkable year," said Bill Sullivan, Agilent president and chief executive officer. "Including Semiconductor Products, fourth quarter total revenues were slightly above the top end of our expectations, as most of our markets gained momentum during the quarter. The quality of our performance was also good, with adjusted net income at the top of our guidance range. In both the Electronic Measurement and Bio-Analytical Measurement segments, we believe Agilent gained market share. In addition, both segments for the first time exceeded our long-term operating model target of 14 percent operating margins and 21 percent Return on Invested Capital. With our businesses performing well and the planned dispositions of Semiconductor Products, Lumileds and STS all on track, we are excited about the opportunities to create superior value for our owners and customers in fiscal 2006." In the fourth quarter, the company generated $410 million in cash from operating activities and, after $51 million of capital spending, $359 million in operating free cash flow.(4) Both inventory days-on-hand and receivables days sales outstanding were at new record lows. During the quarter, the company repurchased about 8.9 million common shares for $290 million. Separately, the Agilent board has authorized a share repurchase of up to approximately $2.7 billion in the form of a modified "Dutch Auction" tender offer to purchase up to 73 million shares of its common stock at a price per share not less than $32 and not greater than $37. The tender offer is expected to commence on Nov. 15, 2005, and to expire, unless extended, on Dec. 13, 2005. As of Oct. 31, 2005, Agilent had approximately 500 million shares of common stock outstanding. Looking ahead, Agilent expects to receive proceeds from the sale of its 47 percent share of Lumileds within the month, and to complete the sale of its Semiconductor Products business on December 1. Preparations for a planned spin-off of its Semiconductor Test Solutions business continue on schedule with an expected IPO to take place near mid-FY2006. The company remains comfortable with the fiscal year 2006 guidance it provided during its August 15 announcements. For the first quarter of fiscal 2006, the company expects revenues (including STS) in the range of $1.28 billion to $1.35 billion, up 5 to 10 percent from last year and consistent with its normal seasonality. Adjusted net income is expected to be in the range of $0.25 to $0.30 per share, roughly double last year's first quarter comparable earnings. For details, visit http://www.agilent.com.

Simultaneous Acquisitions Strengthen Bruker AXS Presence in Nanotechnology and Advanced Materials Research Markets

Bruker AXS Inc. has announced the closing of two complementary acquisitions in the $150 million per annum X-ray microanalysis market. Applications of microanalysis include nanotechnology and advanced materials research, as well as materials analysis and quality control, with customers in many industries, academia and government research facilities. On October 14th and 26th, 2005, Bruker AXS had announced agreements for the acquisition of Roentec AG and the microanalysis business of Princeton Gamma-Tech (PGT) Instruments, Inc., respectively. Following the completion of the two closings in the last two business days, Bruker AXS has now combined the two units into a newly created 'Bruker AXS Microanalysis' business, under the responsibility of Bruker AXS Executive Vice President Roger Durst, with operations in Berlin (Germany), Coventry (UK), as well as Madison, WI and the Princeton, NJ area in the United States. Bruker AXS also has integrated the management teams of both microanalysis units, and announces the appointment of Mr. Thomas Schuelein, previously with Roentec, as Vice President for Microanalysis. Mr. Douglas Skinner, previously with PGT, has been appointed as Assistant Vice President for Microanalysis. For details, visit http://www.bruker-biosciences.com.

Bayer Work flow Targets Cheminformatics Analysis

The computational chemistry group at Bayer HealthCare AG has struck a deal with workflow software vendor InforSense to help speed its cheminformatics analysis. The project involves setting up high-throughput workflows that include several different types of chemical databases and analysis tools. "Bayer HealthCare has a mix of chemical data repositories, standard analysis tools, and internally developed tools," says Joseph Donahue, chief business officer at InforSense. When it came to integrating tools and data into a workflow, Bayer HealthCare "didn't want to compromise. They wanted to be able to move data seamlessly between the systems that they currently use," says Donahue. To accomplish this goal, Bayer Health Care will use the InforSense KDE workflow-based integrative analysis environment. At the heart of the effort was Bayer HealthCare's desire to speed its cheminformatics analysis. "To identify and optimize potential drug leads, our computational chemists need both rapid processing of large compound libraries via chemical cartridge technology coupled with easy access to best-of-breed proprietary and third- party analytic tools and visualizations," said Alexander Hillisch, head of computational chemistry at Bayer Healthcare, in a prepared statement when t he deal was announced.
Hillisch went on to note that the InforSense technology "offers the appropriate environment for rapidly composing data and applications, including our in-house in silico ADME /Tox tools, to optimize our high-throughput cheminformatics analysis." The deal between InforSense and Bayer HealthCare involves both the purchase of software licenses and some implementation work on the part of InforSense. Essentially, the implementation work is to ensure that the software is installed properly and that it can access the appropriate repositories. Donahue notes that through InforSense's Open Workflow Partner Network (OWPN), the software already works with many of the applications used by customers. In cases where off-the-shelf integration is not available beforehand, InforSense has a Software Development Kit (SDK) that lets a company integrate other software into a workflow. For details, visit http://www.inforsense.com.

Thermo Enables Detailed Bioanalysis with LCQUAN 2.5 Quantitative Software Package

Thermo Electron Corporation, a world leader in analytical instruments, has expanded its software offerings for its Finnigan TSQ Quantum series of triple quadrupole mass spectrometers with its new, improved LCQUAN 2.5 data acquisition system. It features a bi-directional interface with Thermo's Watson LIMS 7.2.0.01 to provide secure,
digital data transfer that is tailored for bioanalysis. Thermo's LCQUAN 2.5 quantitative software package enables 21 CFR Part 11 compliance (treats electronic records the same as paper records) and includes several additional new features. These include remote disc support which allows accessing and processing data from secure remote discs; a workbook-style, centralized file location that ensures fast, easy data archiving and retrieval of relevant project files; a one-window, quantitation environment that features a step-by-step workflow process for easy data acquisition and review; and a digital, secure, bi-directional interface with Watson LIMS. Thermo's Watson LIMS is a highly specialized protocol-driven solution that supports DMPK/bioanalytical studies in drug development and is used by the leading global pharmaceutical, biotechnology and contract research organizations. For details, visit http://www.thermo.com/informatics.

Dorado Software Selected for Egyptian Universities Network

Dorado Software, Inc., a leading provider of infrastructure management software, has announced that the Egyptian Universities Network (EUN) and National Research Institutes have selected the Redcell network configuration and security solution for their Juniper Networks’ infrastructure. A Dorado Software channel partner, Saudi Egyptian Logistics and Electronics Company (Salec Egypt), is deploying and maintaining Redcell Management Center and Redcell NetRestore for real-time network configuration, firmware management, configuration file back up and restoration, and security monitoring. Salec Egypt selected Redcell for EUN’s new network project that will link Egypt’s 16 universities and nine research institutes together with the Egyptian National Scientific and Technical Information Network (ENSTINET), EUN, Ministry of Communications and Information Technology (MCIT), and Bibliotheca Alexandria. "We are implementing the latest IPV6 + MPLS networking technologies and IP Network security solutions. By effectively leveraging the Juniper Networks infrastructure to ensure the project’s success, we’re able to protect the customer’s investment. The Redcell suite is the only industry option that manages the initial network deployment and the services to be deployed, scales from what is required today and tomorrow, and supports a heterogeneous infrastructure,” said Mahmoud Soliman, President and CEO of Salec International. “The integrated suite and device support strategy lets us deploy the solution quickly and add to it incrementally, without interruption, to support new services and technologies.” For details, visit http://www.salec.com or http://www.doradosoftware.com.

FDA to Drug Makers: Submit Labels Electronically

The U.S. Food and Drug Administration is now requiring drug manufacturers to submit prescription drug labels electronically. The change, which went into effect last week, will keep the public better informed and improve patient safety, according to a statement from the FDA. The new regulation will allow health care providers and the public to more easily access product and prescribing information found in FDA-approved packet inserts or labels for all approved prescription medicines in the U.S., the agency said. "Providing health care providers and patients with clear, concise information about their prescriptions will help ensure safe use of drugs and better health outcomes," Health and Human Services Secretary Mike Leavitt said in the statement. "Now medication information will be easy to access on a publicly available Web site, and this will lead to future innovations with health information technology." Drug manufacturers are now required to submit the prescribing and product information in a structured product labeling (SPL) format that provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format, the FDA said. Using embedded computer tags, the data in the SPL format can be electronically managed, allowing a user to search for specific information, according to the FDA. The tags can instruct computers to read specific sections of a drug label including product names, indications, dosage and administration, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied, the FDA said. As the FDA receives the SPL-formatted labeling information, it will become available, free of charge, via the Web. Drug manufacturers, technologists and the FDA worked together to develop the SPL standard, according to FDA spokeswoman Karen Mahoney. "Industry has been having minor problems coding more complicated labeling situations," Mahoney said. "However, we are expecting that these will be sorted out quickly. The FDA has been advising industry in these situations." The new electronic product labels will be the primary source of medication information for DailyMed, a new, free, interagency online health information clearinghouse for consumers, health care providers and health care information providers, the FDA said. Within one year, product labels for most approved prescription medications will be posted on DailyMed, according to the FDA. For details, visit http://www.fda.gov.

Changes to CDER Include New Critical Path Office, New Safety Structure

The FDA proposed realignment of the Center for Drug Evaluation and Research (CDER) calls for the creation of a new office dedicated to the agency’s Critical Path Initiative, as well as a major restructuring of the center’s drug safety activities. The realignment plan, which the FDA hopes to fully implement over the next six months, builds upon last month’s announcement by CDER Director Steven Galson, who revealed the agency was planning major changes to CDER to better align staff functions with CDER goals and FDA public health mission. Among the key proposals, according to a recent memo from Galson, is the formation of a new CDER office devoted solely to Critical Path. Launched in March 2004 as part of the FDA efforts to speed drug development, Critical Path has been touted as a top priority by agency officials but has been largely slowed by funding shortfalls and other hurdles. The Center could greatly enhance the process to develop drugs more quickly, safely and effectively if staffed to provide sufficient assistance and advice to developers and to sustain public/private partnerships to improve drug development,” Galson memo states. “To date, the Center has not been staffed to support needed work on the Critical Path and has not been configured to provide organizational ‘ownership’ of these activities. The new office, which would include the current Office of Clinical Pharmacology and Biopharmaceutics and the Office of Biostatistics, would help CDER prioritize its Critical Path efforts and spur more cooperation with other federal agencies, CDER Deputy Director Douglas Throckmorton said during a recent meeting of the agency Science Board. I am very confident [the new office] will make a difference in the effectiveness of the Critical Path program, Throckmorton added. In addition to creating the new Critical Path office, the reorganization plan calls for the formation of a new advisory group, reporting to the Office of Medical Policy, to address Critical Path projects in the area of clinical trial design and analysis. The second component of the CDER realignment is an overhaul of the center drug safety organizational structure. According to Galson, CDERcurrent structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety (ODS). The realignment will address this misperception by emphasizing the center; multi-disciplinary approach to drug safety activities, Galson added. The proposed organizational changes affecting drug safety include: appointing a new associate center director to focus on broad drug safety policy and safety communication; consolidating certain drug safety-related activities to report to the new associate center director, including the agency MedWatch program and Drug Safety Oversight Board; and elevating the status of the current ODS to report directly to the center director. The name of the ODS will be changed to more accurately reflect the range of activities it performs, Galson said. For details, visit http://www.fda.gov.

New Database Expected to Speed Up ANDA Approvals

The FDA's Office of Generic Drugs (OGD) has launched its Dissolution Methods Database aimed at improving the quality and turnaround time of abbreviated new drug applications (ANDAs). With the database, which went online recently, the OGD aims to provide recommendations for generic drug companies to establish dissolution. Dissolution is the breaking down of a drug product in the body. Generic Pharmaceutical Association (GPhA) spokeswoman Andrea Hoeflich called the database a "welcome development for the generic industry." The tool should help shorten approval times for ANDAs and reduce uncertainty over ANDA requirements, Hoeflich told FDAnews. The OGD has said that many of the questions it receives from manufacturers about generic drugs pertain to the dissolution issue. As it is, generic drug approvals are not keeping pace with the rising number of applications. In fiscal year 2005, OGD received 766 applications, compared to 563 in fiscal year 2004, but the number of approvals only rose from 413 to 467, OGD Director Gary Buehler said at the recent GPhA Technical Conference. At the end of fiscal 2005, there were 780 original ANDAs pending at the FDA, compared to 615 at the end of fiscal 2004, he said. The new database, which provides information on dissolution methods presently recommended by the FDA's Division of Bioequivalence, currently contains information for 214 drugs and will be updated quarterly. It is searchable by a product's generic name and contains: the established name of the product; dosage form; recommended USP (U.S. Pharmacopeia) apparatus; speed; medium and volume; recommended sampling times; and the date that the recommendation was provided or updated. The database is part of a larger effort to help firms improve the quality of their generic drug applications, an effort that has already resulted in more frequent updates to the FDA's Orange Book. The OGD is also planning to post a guidance that will link to a list of drugs and their corresponding bioequivalency recommendations, Buehler said at the GPhA conference. The database will provide bioequivalence recommendations for older drugs as well as drugs not yet off patent. The Dissolution Methods Database can be found at http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm.

Ex-FDA Commissioner Crawford's Disclosure Forms Boost Claims of Industry Bias

Financial disclosure forms showing that former FDA commissioner Lester Crawford or his wife owned stock in FDA-regulated companies as late as 2004 have buoyed critics on Capitol Hill, who contend the agency is too cozy with the industries it regulates. "Lawmakers have been pointing to the lack of ethical standards at the FDA for months, and this just proves that the problems emanate from the very top of the agency," said a Democratic House staffer, who spoke on the condition of anonymity. "If the FDA's leader can't come clean about his ties to industry, what's happening in the rest of the agency?" The latest attacks on Crawford stem from the HHS' release of financial disclosure forms indicating that during his time as acting FDA commissioner, Crawford or his wife held stock in companies that have some of their business regulated by the FDA. The disclosure forms, which were obtained by The Wall Street Journal under the Freedom of Information Act, show that Crawford reported numerous stock sales in 2004, including shares of medical device manufacturers Kimberly-Clark and Teflex; biotechnology firm Embrex; and food distributor Sysco. The transactions were each valued at between $15,000 and $50,000, according to the Journal. "Even if the holdings were small, why were they not divested immediately when he returned to the agency?" the staffer asked. "It raises all sorts of red flags." Crawford rejoined the FDA in 2002 after an earlier stint at the agency and took over as acting commissioner in February 2004 following Mark McClellan's departure to become administrator of the Centers for Medicare & Medicaid Services. President Bush nominated Crawford to become permanent commissioner in February and he was confirmed by the Senate in July in a 78-16 vote. Two months later, Crawford abruptly resigned from the agency, saying only that it was time to "step aside." Allegations surfaced shortly after Crawford's departure that his resignation was prompted by financial conflicts, but both Crawford and the FDA declined to comment on the charges. "I think it's too early to tell what, if any, financial conflicts really existed, but it's certainly looking like there may have been some truth to the original allegations," a Senate staffer told FDAnews. "We'll hopefully know more once the HHS investigation is completed." At the request of Sens. Michael Enzi (R-Wyo.), Edward Kennedy (D-Mass.) and other lawmakers, the HHS Inspector General is investigating the circumstances surrounding Crawford's departure, including the allegations that he failed to disclose certain stock holdings. For details, visit http://www.fda.gov.

What's New - Right Now The following is a wrap-up of news of interest during the months of November to December 2005

What's New - Right Now
The following is a wrap-up of news of interest during the months of November to December 2005