LIMSource News: What's New Right Now

• LabWare Unveils LabWare Web LIMS Version 3.0

• Leading Medical Services Clinic Selects LabVantage’s SAPPHIRE BioBanking Solution for its 3 Core Biospecimen Laboratories

• ChemWare Releases HORIZON LIMS Version 10

• Quality Systems International Introduces WinLIMS.NET Version 7

• LabVantage Adds Integrative Analytics to SAPPHIRE BioBanking Solution

• Thermo Fisher Scientific Expands Watson LIMS Presence in Bioanalytical Services with Leading Contract Research Organization, Advion BioServices

• Laboptimizer Releases New Version of FreeLIMS

• Autoscribe and Aitken Scientific Release Integrated Instrument and LIMS / Sample Tracking Solutions

• Thermo Fisher Scientific Demonstrates New SampleManager LIMS Functionality for ISO 17025

• PerkinElmer, Inc. Introduces EcoAnalytix Initiative and LabWorks Green LIMS

• IO Informatics Releases Sentient Suite

• CSols Introduces QAvalid

• Bio-Rad Expands its KnowItAll Enterprise Solutions for Spectroscopy and Chemical Information and Launches KnowItAll AnyWare Browser Client

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

• Good Products Launches Electronic Document Management Solution

• CambridgeSoft Introduces ChemBioOffice Workgroup 2008

• Cerno Bioscience Launches MassWorks sCLIPS (Self Calibrated Lineshape Isotope Profile Search)

• National Instruments' LabVIEW SignalExpress Tektronix Edition 2.5 Adds Support for New DPO3000 Oscilloscopes

• ACD/Labs Delivers Improved Enterprise Tools for Chemical Research

• PerkinElmer Partners with Cerep for Custom Drug Discovery Solutions

• Intellection and Bruker AXS Sign Strategic Collaboration Agreement

• Bill Would Tighten Safety Regulations for Imported Drugs

• Controversial Patent Reform Bill Hits Roadblock in Senate

• Pharmacogenomics Guidance Harmonizes Definitions

• FDA Releases Five-Year Drug Safety Plan

• Drug Research Increased $2.7 Billion in 2007

LabWare Unveils LabWare Web LIMS Version 3.0

LabWare unveiled Version 3.0 of their LabWare Web LIMS that fully embraces the Web paradigm without requiring customers, using the existing Client/Server LIMS product, to make any configuration changes. LabWare's WebLIMS 3.0 delivers the benefits of thin client computing through a zero footprint Web browser client and the ability to run on virtually any Web device. A Visual Workflows engine helps to train new users quickly. In addition, an Enterprise Web application can adapt to specific corporate computing standards. WebLIMS serves as a powerful new presentation layer within the LabWare LIMS product suite and is compatible with customer’s existing installations of LabWare LIMS. For details, visit http://www.labware.com.

Leading Medical Services Clinic Selects LabVantage’s SAPPHIRE BioBanking Solution for its 3 Core Biospecimen Laboratories

LabVantage has announced that its SAPPHIRE BioBanking Solution has been licensed by one of the world’s largest group medical clinics for its biospecimen accessioning laboratories. The medical institution is dedicated to the diagnosis and treatment of virtually every type of complex illness. As part of a multi-phase laboratory information management project, it will deploy SAPPHIRE to its core laboratories, replacing its disparate, legacy systems and introducing new and efficient processes that will harmonize laboratory processes for each of the core locations. Historically, the clinic has primarily developed and deployed its own "in-house" solutions for its research laboratories. However, when defining the requirements for the multi-phase project, especially for critical biospecimen management, it determined that a commercial solution offering standardization and future proof expansion was the best path to pursue. After conducting in-depth reviews and analysis of commercial solutions, the clinic chose LabVantage’s SAPPHIRE for its comprehensive and configurable-offthe- shelf (COTS) functionality for biospecimen submission, tracking, accessioning, data capture, storage management and reporting. SAPPHIRE’S zero footprint, thin-client architecture was also a decisive factor as it would enable technicians, scientists, principal investigators, and clinical staff with the remote and secure access required when interacting with the biorepository. The clinic has a vision of employing standardized tools for research and operations involving the use of both human and animal biospecimens. The SAPPHIRE BioBanking Solution is a key first step of a more comprehensive laboratory information management rollout designed to change and improve the course of drug discovery and development. With the standardization of its biorepositories in place, it can expand the scope of the SAPPHIRE implementation to further meet research objectives and improve its ability to facilitate personalized medicine. For details, visit http://www.labvantage.com.

ChemWare Releases HORIZON LIMS Version 10

ChemWare has released Version 10 of their HORIZON Oracle-based LIMS for environmental, water quality, drugs of abuse, chemical demilitarization, and toxicology laboratories. HORIZON LIMS automatically captures electronic records from instruments, scanners and other data sources across the enterprise, integrating the content into compound documents, publishing reports via the web portal, and providing self-service, no-programming query tools and management dashboards for highlighting key operations performance indicators. Version 10 is 100% thin client, runs in Internet Explorer, and provides a sophisticated Business Intelligence interface to management reports. New features include next step prompts, full version control and data traceability that can be evaluated within the context of an operation. ChemWare has averaged one major upgrade every 18 months since 2002, and never obsolesced a core LIMS technology. HORIZON version 10 marks a major change from a client/server to a thin client architecture, and includes a new Rules Engine interface, the new Data Layer technology for simplified data mining and reporting, additional multi-site network laboratory features, and numerous Web Portal enhancements.For details, visit http://www.chemware.com.

Quality Systems International Introduces WinLIMS.NET Version 7

Quality Systems International (QSI) has introduced WinLIMS.NET Version 7, a ready-to-use, right out of the box web-based solution. Although the database model remains essentially the same as their previous WinLIMS solution, WinLIMS.NET is essentially a brand new product that is radically different than the existing WinLIMS software for three main reasons. First, WinLIMS.NET is a web-based system that was designed using a newer development tool (Microsoft ASP.NET) so the structure of the system is very different. Second, the WinLIMS.NET user interface is more modern and quite different. Third, the interaction with Crystal Reports and Business Objects is also very different. Many new features have been added to the .NET version, including more query tools, the ability to design the dashboard similar to Google Zones functionality, SmartSearch, interactive Excel functionality, and more. WinLIMS .NET takes advantage of Software As A Service (SAAS) technology to reduce the cost of implementing and maintaining a LIMS. For details, visit http://www.qsius.com.

LabVantage Adds Integrative Analytics to SAPPHIRE BioBanking Solution

LabVantage has announced that its SAPPHIRE BioBanking Solution now has Integrative Analytics. The SAPPHIRE BioBanking Solution with Integrative Analytics couples the best of enterprise biorepository management with the best of data integration and interactive analytics. Because today’s translational
research is critically dependant on biospecimens for biological research, it requires a far more unified and
large-scale software solution to manage and track these biological materials, as well as, the experiment,
sample, and clinical data associated with them. By coupling biospecimen management with integrative
analytics, organizations can not only more effectively operate their biorepositories, execute their
protocols, and manage their samples, but also mine and analyze the data stored throughout their
heterogeneous scientific and operational systems. The approach leverages configurable, modular driven
products, rather than custom developed software or services, for workflow driven laboratory information
management and automation, as well as, workflow driven integrative analytics that enable translational
medicine. For details, visit http://www.labvantage.com.

Thermo Fisher Scientific Expands Watson LIMS Presence in Bioanalytical Services with Leading Contract Research Organization, Advion BioServices

Thermo Fisher Scientific Inc. is expanding its partnership with Advion BioServices, Inc., the bioanalytical services division of Advion BioSciences, Inc. The move by Advion to enhance its bioanalytical capabilities and satisfy the company’s expansion goals is facilitated by a strategic increase in their investment of Thermo Scientific Watson LIMS (laboratory information management system). Developed in collaboration with many of the top pharmaceutical companies specifically for bioanalytical laboratories and contract research organizations (CROs), Thermo Scientific Watson LIMS is specifically designed to support drug metabolism and pharmacokinetic (DMPK) studies in drug discovery and development, and is installed in 18 of the top 20 global pharmaceutical organizations and leading CROs around the world. Because Thermo Fisher Scientific is committed to understanding the needs of the pharmaceutical market in all phases of drug development, and to developing laboratory solutions to meet those distinct needs, Watson LIMS has become the de facto LIMS solution for small to mid-sized Contract Research Organizations, as well as very large CROs performing bioanalytical services. "The additional investment in Thermo Scientific Watson LIMS is essential to Advion’s ability to meet the ever increasing needs of our sponsor organizations and will help Advion keep pace with market requirements,` says David Hardwick, Advion’s Director of Laboratory Operations. `Our long-term partnership with Thermo Fisher Scientific has made a meaningful impact on our operations by providing software solutions to address our data management needs. Our use of the Watson LIMS system has been instrumental in our success as a provider of world-class bioanalytical services.` For details, visit http://www.thermo.com/informatics.

Laboptimizer Releases New Version of FreeLIMS

Laboptimizer has announced the next version of their FreeLIMS solution. FreeLIMS is a client/server solution with multi-user capabilities. It is licensed under GNU General Public Licence (GPL) and written in Java. For details, visit http://www.freelims.com/v0996/v0996.html.

Autoscribe and Aitken Scientific Release Integrated Instrument and LIMS / Sample Tracking Solutions

Autoscribe and Aitken Scientific have released an Instrument Integration and Machine Control Software solution for tracking and management of medical, scientific or food samples. Aitken Scientific have years of experience integrating laboratory instruments together and controlling automated machinery. Aitken Scientific’s unified approach to Sample Tracking / LIMS and instrument integration and machine control is to look for the simplest and most robust design. Simpler systems can often be controlled directly through their connection media (like RS232, ethernet/TCP or custom I/O cards), more complicated automated systems often need to be controlled via the manufacturers software to make best use of the available functionality. Aitken Scientific's and Autoscribe's design process includes a detailed analysis of the user requirements and the hardware required. Working closely together Aitken Scientific and Autoscribe can fully integrate laboratory equipment to provide a fully integrated, compliant LIMS or Sample Tracking solution. For details, visit http://www.autoscribe.co.uk.

Thermo Fisher Scientific Demonstrates New SampleManager LIMS Functionality for ISO 17025

Thermo Fisher Scientific Inc. has introduced new functionality to its flagship SampleManager LIMS that facilitates compliance with the requirements of ISO 17025: 2005. Thermo Scientific SampleManager LIMS is Thermo Fisher's premier product for industrial laboratories that increases productivity, improves access to data, and ensures compliance with regulatory requirements. The 2005 release of ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories, covers laboratories using standard, non-standard, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations, and laboratories where testing and/or calibration forms part of inspection and product certification. This international standard is the accepted standard for analytical laboratories in developing their management system for quality, aqdministrative and technical operations. Thermo Scientific SampleManager LIMS benefits management by providing them with a centralized system to access data and extract information, allowing them to more effectively manage their laboratory operations. SampleManager LIMS provides evidence and documentation that organizations are in compliance with ISO 17025. Thermo Scientific SampleManager facilitates compliance in two principle areas of ISO 17025 (Section 4 Management Requirements, and Section 5 Technical Requirements). SampleManager's enhanced functionality covers a broad range of requirements, including validation of methods, instrument calibration; sampling, control of non-conformance testing and reporting of results. To respond to the Management Requirements of ISO 17025, SampleManager addresses the security required for laboratories conducting testing in their "permanent facilities, at sites away from permanent facilities, or in associated temporary or mobile facilities", by providing for full security controls, including "group security" which can be used to segregate work from different clients or in different laboratory areas. In addition, the laboratory's Quality System procedures are easily stored in SampleManager LIMS for reference at any time by relevant personnel, meeting requirements of ISO 17025 that each laboratory "establish, implement and maintain a quality system", including a documentation of the scope of activities, all policies and procedures, as well as results. For details, visit http://www.thermo.com/informatics.

PerkinElmer, Inc. Introduces EcoAnalytix Initiative and LabWorks Green LIMS

PerkinElmer has launched a new green initiative, EcoAnalytix, a revolutionary problem-solving initiative that addresses the global imperatives of food and consumer product safety, water quality and sustainable energy development to create a healthy and safe environment. This initiative encompasses comprehensive application-focused solutions with innovative thought leadership and public outreach programs that will bring insights from top scientists, industry experts and government agencies directly to customers. One key component of the initiative is to deliver analyzers that combine the necessary product offerings with the applications, methodologies, standard operating procedures and training required to complete specific analyses in food and consumer product safety, water quality and sustainable energy development. To that end, they have introduced a new LabWorks LIMS, LABWORKS Green, which is a pre-configured LIMS specifically for the biofuels industry. documents. LABWORKS Green for Biofuels delivers efficient product and process monitoring, including Automated Certificate of Analysis (COA) generation; work orders organized for regularly repeated tests; pre-loaded ASTM and EU methods; and, lab performance monitoring that tracks all samples status changes. For details, visit http://www.perkinelmer.com.

IO Informatics Releases Sentient Suite

IO Informatics, Inc. has released the latest version of its next generation of informatics software, the Sentient Suite. "We are very pleased to release the latest version of Sentient to the Life Science research community. This represents a major advance for life science informatics and reflects IOI’s commitment to providing life science researchers with state-of-the –art applications to meet their informatics challenges. In addition to input from our customer base, the new version benefited from the knowledge and input received from our Working Group on Semantics for Life Sciences.” said the Company’s CEO, Robert Stanley. “With this release, Sentient applies semantic technology to deliver valuable, well-tested applications suitable for a broad range of end users. These applications make it possible for the first time to easily visualize and characterize complex, inter-related biomarker activity and apply the resulting knowledge at the point of care,” stated Stanley. “Sentient does this by bridging the gaps between our customers’ laboratory and experimental data, published research, clinical endpoints and individual patient information -- allowing researchers and clinicians to build and apply life sciences knowledge and make personalized medicine a reality.” The Sentient Knowledge Explorer is most effected by working group and semantic additions. It leverages the latest semantic web technologies to integrate, model, visualize and explore data, revealing networks and novel relationships in complex data sets from one or multiple sources - greatly aiding in tasks such as biomarker discovery and characterization. Results from database queries, formal ontologies and data in semantic formats can be imported and merged to dynamically build knowledge. Core enhancements include the ability to utilize multiple standards (RDF, N3, OWL, OBO) in combination, connecting directly via URIs, and the use of thesauri for classes and relationships on data import and merging. The Web Query gives users with no database expertise the ability to query and browse multiple data stores quickly and easily from any location using a web browser and to save the results in a number of different formats. The Process Manager is a complete workflow solution providing drag and drop modeling of your business process, coupled with an easy to use web-based user interface to guide users through their tasks and graphical dashboards allowing managers instantaneous status reports on project progress across the enterprise. The Data Manager (v3.1) delivers both ease-of-installation and ease-of-use for user-driven and automated data import and structuring. The Data Manager takes data from virtually any source and format and makes it available in the customer’s choice of uniform, standards-based formats, with integrated support for audit, curation, annotation, security and regulatory compliance. “The Sentient informatics framework provides deployment benefits appreciated by our customers’ financial officers, researchers and IT administrators,” said Chuck Rockey, IO Informatics’ Director of Software Engineering. “Depending on customer needs, we deploy components that complement existing systems and are suitable for use by scientists and clinicians with little computer expertise, as well as by advanced IT and informatics professionals,” he added. For details, visit http://www.io-informatics.com.

CSols Introduces QAvalid

CSols Inc.has introduced QAvalid, an Enterprise Compliance Management Solution for Computer Systems Validation (CSV). QAvalid provides a powerful tool to allow companies to achieve regulatory compliance faster and easier. By removing tedious manual tasks for Quality Assurance, QAvalid drives validation costs down and
diminishes the risk of non-compliance. In addition to QAvalid, CSols' Professional Services Leaders were on hand to showcase their portfolio of world-class Informatics Professional Services that enable organizations to revolutionize their laboratories and enterprises. For details, visit http://www.CSOLS.com.

Bio-Rad Expands its KnowItAll Enterprise Solutions for Spectroscopy and Chemical Information and Launches KnowItAll AnyWare Browser Client

Bio-Rad Laboratories, Inc, a multinational manufacturer and distributor of life science research and clinical diagnostics products, has announced the release of version 3.0 of its KnowItAll Enterprise Server and KnowItAll AnyWare 1.0, a new browser-based client. With the KnowItAll Enterprise Server version 3.0, a database may be built on the server and viewed worldwide at all sites of an organization via the KnowItAll Informatics System Windows client or Bio Rad's new KnowItAll AnyWare browser client. The same server technology that was first introduced in 2003 to deliver Bio-Rad's Sadtler infrared (IR) and nuclear magnetic resonance (NMR) reference spectral databases to users via the Internet can now be used behind an organization's firewall to store and search proprietary structural, spectral, chromatographic, and other textual data from chemical, biological, or process environments. KnowItAll AnyWare, a 100% platform-independent, browser-based, and device-independent client permits the searching and browsing of data stored on a KnowItAll Enterprise Server. The launch of KnowItAll AnyWare extends the reach of the KnowItAll platform client throughout organizations so any user, using any hardware platform, any operating system, or any web browser, can access spectral, structural, or chromatographic data anywhere in the world. "Storing and preserving spectral and chromatographic data is a necessary first step in any organization toward being able to convert data into actionable information — information upon which key decisions can be made," explained Gregory M. Banik, Ph.D., General Manager of Bio-Rad's Informatics Division. "Making this data centrally accessible and connecting laboratories is the next step and critical to the maintenance and the efficiency of an organization. Bio-Rad's KnowItAll enterprise solutions allow companies to achieve these critical steps and connect their data, people, projects, and tools with one system." For details, visit http://www.bio-rad.com.

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

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

Good Products Launches Electronic Document Management Solution

Good Products has launched an Electronic Document Management Solution (eDMS) called g-doc that is easy to configure, requires little IT support, and is cost-effective for organizations of all sizes and are entirely intuitive to use. A part of the Good Products portfolio of products, g-docs, g-train and CoSign are designe dto assist Pharmaceutical and Biotechnology companies to comply with regulations and simultaneously enhance operational efficiency at a fraction of the high cost of legacy ECM systems. For details visit http://www.goodproductsltd.com.

CambridgeSoft Introduces ChemBioOffice Workgroup 2008

CambridgeSoft has introduced ChemBioOffice Workgroup 2008, a suite of solutions that are ideal for smaller organizations or groups that want to organize and search over their inventory, purchase reagents, as well as manipulate and store chemical and biological data in a collaborative fashion. The ChemBioOffice Workgroup applications are compatible with Microsoft SQL Server and accessed through a client side application. "Previously customers could only choose between Desktop or Enterprise solutions, where the Desktop solutions were appropriate for individual users, and the Oracle Enterprise solutions fit large organizations, with extensive customization and service deployment projects typical”, said Michael G. Tomasic, Chairman and CEO of CambridgeSoft. "The new Workgroup suites offer an excellent option for small groups that work collaboratively and need a shared solution, but which may not have the resources to deploy a fully fledged Oracle Enterprise application. We now have solutions for our customers no matter their size or situation. And CambridgeSoft also offers a very easy upgrade/migration path from ChemBioOffice Desktop to Workgroup.” For details, visit http://www.cambridgesoft.com.

Cerno Bioscience Launches MassWorks sCLIPS (Self Calibrated Lineshape Isotope Profile Search)

Cerno Bioscience has announced the launch of MassWorks sCLIPS (Self Calibrated Lineshape Isotope Profile Search), the latest addition to the MassWorks mass spectrometry software suite. Using Cerno’s patented
calibration techniques, users of High Mass Accuracy (HMA) instruments can now dramatically improve the results of formula identification and easily obtain higher quality, reproducible data through accurate line-shape calibration. For the first time, sCLIPS now also enables ion trap users to obtain quality formula identification of unknown formula. MassWorks was originally launched in 2006, and is an easy-to-use post acquisition software
system using Cerno’s patented MSIntegrity calibration technology to work directly with data from a wide range of mass spectrometers. High resolution mass spectrometry instruments often cannot provide a unique formula ID match when using mass accuracy alone. New MassWorks sCLIPS enables users of HMA instruments including TOF, high resolution quadrupoles, Orbitrap, magnetic sector, and FTMS to easily enhance formula ID accuracy without the need to run calibration standards. Cerno’s patented technology provides a calibrant-free method for significantly improving accurate-mass-only formula searches. For details, visit http://www.cernobioscience.com.

National Instruments' LabVIEW SignalExpress Tektronix Edition 2.5 Adds Support for New DPO3000 Oscilloscopes

National Instruments has announced support for new Tektronix value line oscilloscopes in the latest version of LabVIEW SignalExpress Tektronix Edition, an interactive PC-based measurement software for quickly acquiring, analyzing and presenting data without programming. Engineers and scientists can use LabVIEW SignalExpress Tektronix Edition 2.5 to connect to and control all value-line Tektronix oscilloscopes including the new Tektronix DPO3000 and TDS3000C digital phosphor oscilloscopes as well as the MSO4000 mixed-signal oscilloscopes from their PCs with an easy-to-use, drag-and-drop environment. The latest version of the software also introduces time-saving features such as measurement and waveform logging and new interactive reporting capabilities. LabVIEW SignalExpress Tektronix Edition provides plug-and-play setup with Tektronix oscilloscopes as well as more than 400 additional modular and benchtop instruments, making it easy for users to connect their stand-alone instruments to PCs and configure all instrument communication, view live measurement data and take control of the oscilloscope. With a few additional mouse clicks, users can log their data to a disk and export the data directly to a spreadsheet application, such as Microsoft Excel, for easy analysis and reporting. The software also offers advanced data-logging features such as alarm monitoring and condition logging as well as the automation of common measurement tasks such as circuit characterization and frequency sweeping. Additionally, LabVIEW SignalExpress Tektronix Edition provides users with more than 200 analysis and processing functions. The latest version of LabVIEW SignalExpress Tektronix Edition introduces measurement and waveform logging capabilities that make it possible for users to record their measurements directly to their PCs, automating an often tedious and time-consuming task. LabVIEW SignalExpress Tektronix Edition 2.5 also adds new interactive reporting features such as a drag-and-drop report that displays live data as well as the ability for users to save and print their reports as HTML pages. For details, visit http://www.ni.com or http://www.tektronix.com.

ACD/Labs Delivers Improved Enterprise Tools for Chemical Research

Version 11 of ACD/Labs Enterprise software is now available, giving organizations the ability to streamline chemical research; unify processing and reporting of analytical results; and provide a comprehensive system for integration, customization potential, and distribution of analytical data, structures, and sample information. Companies can face a challenge in properly managing all of their information and research knowledge, making it easily accessible to others within the organization, yet keeping it secure, and storing it in a form that will be equally accessible in the future. Considering the demand for more efficiency at all levels in industry, this challenge becomes even greater. ACD/Labs' capabilities in the areas of automated processing, automated data collection, and Workflow Management can help companies build their own solutions that eliminate routine daily tasks and provide easy access to results to make quick and smart decisions, while also protecting intellectual property. ACD/Labs Enterprise software allows information from many analytical techniques to be uniformly processed and centrally stored, enabling a fast, efficient flow of information throughout your organization. ACD/Labs software, with version 11 now released, has flexible modules that can be configured to almost any workflow. ACD/Labs' Analytical Automation Suiteis comprised of Workflow Manager; Automation Server; Web Librarian; and, ChemFolder. For details, visit http://www.acdlabs.com.

PerkinElmer Partners with Cerep for Custom Drug Discovery Solutions

PerkinElmer, Inc., a global leader in Health Sciences and Photonics, and Cerep SA, a leading provider of drug candidate screening and profiling technologies, have announced the signing of a supply and co-marketing agreement to deliver custom drug discovery services. Under the terms of the agreement, PerkinElmer will exclusively market Cerep's target screening and profiling services to its customers, and the companies will jointly promote PerkinElmer's assay technologies and Cerep services to the drug discovery market. "This agreement represents the latest step in our strategy to build the most comprehensive offering in biochemical and cellular screening for drug discovery," said Robert F. Friel, president and chief executive officer, PerkinElmer, Inc. "Our customers will benefit from direct access to Cerep's expertise in high throughput screening and profiling services, while PerkinElmer will be able to extend the reach of our leading assay technologies and assay development services into key drug discovery markets." This agreement provides PerkinElmer customers with an option to work with a single vendor throughout the entire drug discovery process. Cerep customers will now have access to several key assay development and detection platforms from PerkinElmer's Bio-discovery business, including AlphaScreen, AlphaLISA, LANCE, and LANCE Ultra for G protein-coupled receptor (GPCR) and kinase assay development. GPCRs and protein kinases represent a wide range of therapeutic targets in areas including cancer, central nervous system disorders, cardiac dysfunction and diabetes, making them among the most important areas of study in today's pharmaceutical and biotech laboratories. For details, visit http://www.perkinelmer.com.

Intellection and Bruker AXS Sign Strategic Collaboration Agreement

Bruker AXS GmbH, one of the world leading manufacturers of X-ray diffraction and X-ray spectrometry equipment, and mineral analysis technology company Intellection Pty Ltd have announced a new strategic collaboration agreement which builds on the strong existing OEM relationship between the companies. Under this agreement, Intellection will expand its range of products and services, directly supplying XRF (X-ray fluorescence) and XRD (X-ray diffraction) systems from Bruker AXS to its customers. This will allow both companies to develop highly competitive global sales strategies. "Intellection's own technological credentials are impeccable, with our QEMSCAN solutions the international market leader across the resources sector," said Intellection CEO Calvin Treacy. "Bruker's XRD and XRF technologies complement QEMSCAN analysis, making them an excellent business fit for us." X-ray analysis is one of the most advanced analytical techniques for process and quality control in the minerals industry. It is well established as a market leader for its accuracy and precision, ease of use, simple and fast sample preparation, and its high grade of automation and integration into any process control strategy. The new strategic collaboration agreement extends the range of analytical processes offered to customers in the mining and upstream oil and gas sectors, allowing Intellection to provide the most comprehensive range of advanced automated mineralogy solutions available from any supplier on a global basis. For detila, visit http://www.bruker.com.

Bill Would Tighten Safety Regulations for Imported Drugs

Imported drugs and devices, as well as food and cosmetics, would face additional safety regulations under a bill introduced in the House Energy and Commerce Committee. The bill was introduced by Reps. John Dingell (D-Mich.), the committee's chairman, Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, and Frank Pallone (D-N.J.), chairman of the Subcommittee on Health. The bill builds on the Food and Drug Import Safety Act of 2007 and three other bills before Congress, as well as on findings from investigations conducted by the Subcommittee on Oversight and Investigations, a report by the FDA Science Board's Subcommittee on Science and Technology and the Bush administration's Food Protection Plan and Import Safety Plan. Stupak noted that the committee has held 11 hearings in the past 16 months on the safety of imported food, drugs and devices and plans to hold two more this month. The text of the bill is available online at http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf.

Controversial Patent Reform Bill Hits Roadblock in Senate

A controversial patent reform bill has stalled in the Senate because of a disagreement over its damages provision. Sen. Patrick Leahy (D-Vt.), chairman of the Senate Judiciary Committee, expected to introduce the Patent Reform Act, S. 1145, last week but delayed introducing it because of disagreements with Sen. Arlen Specter (R-Pa.), the committee’s ranking member, about language in the bill’s damages provision, a Judiciary Committee aide said. Specter’s office did not return requests for comment by press time. Earlier this year, the Commerce Department notified the Judiciary Committee that the damages section, which would establish a codified system for courts to use when calculating reasonable royalty awards in patent litigation, would seriously harm the U.S. intellectual property system. In a Feb. 4 letter to Leahy and other committee members, Commerce said the bill’s damages provision “will create more problems than it solves.” Specter, who has voiced concerns with the bill, raised issues with the damages language last week. The window for considering the bill this week is closed, and the language is still in dispute, the Judiciary Committee aide said. No date has been set for further consideration of the bill. “It’s difficult to schedule floor time for anything these days,” the aide added. Last year, a version of the bill, H.R. 1908, passed the House of Representatives. A Judiciary Committee staff member said lawmakers are committed to passing the legislation before the end of the 110th Congress.

Pharmacogenomics Guidance Harmonizes Definitions

The FDA took the final step to harmonize pharmacogenomic definitions and sample coding guidance with that of Japan and the European Union by issuing its own guidance for comment. The guideline — “E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories” — provides definitions and additional information related to aspects covered by the definitions and notes that certain principles discussed in the document may be applicable to related disciplines such as proteomics and metabalomics. The guideline defines genomic biomarker as a measurable DNA or RNA characteristic that is an indicator of normal biologic or pathogenic processes or a response to therapeutic or other interventions. It defines pharmacogenomics as the study of variations of DNA and RNA characteristics as related to drug response. Pharmacogenetics is defined as the study of variations in DNA sequence as related to drug response. The guideline also offers harmonized definitions for the four general coding categories of biological samples used to generate data in pharmacogenomic and pharmacogenetic studies. The guidance is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0199-gdl.pdf.

FDA Releases Five-Year Drug Safety Plan

The FDA's drug centers intend to spend their user fees to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance their postmarket drug-safety activities. In its draft, "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan," the agency says it will focus on hiring the staff through fiscal year 2009. It will increase the number of risk-management experts responsible for reviewing proposed and implemented Risk Minimization Action Plans or Risk Evaluation and Mitigation Strategies (REMS). It also will enhance its technological capabilities and communications as it improves its drug-safety system. According to the draft, "it takes at least two to three years of intense training to prepare new staff to be seasoned experts in drug regulation." Under the PDUFA IV program, the agency will get $29.29 million annually plus a yearly inflation factor to increase its drug-safety capabilities. It also is authorized to collect user fees to broaden the focus of drug safety. These fees are designated for implementing REMS, postmarket studies, safety labeling changes, active postmarket risk identification and other activities. The draft plan is available at http://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf.

Drug Research Increased $2.7 Billion in 2007

Pharmaceutical and biotechnology companies spent $58.8 billion on R&D spending last year, an increase of $2.7 billion from 2006, according to figures released by PhRMA and Burrill & Co. PhRMA member companies spent an estimated $44.5 billion on research last year, up from $43.4 billion in 2006. Non-PhRMA member companies spent an estimated $14.3 billion, up from $12.7 billion in 2006. There are 2,700 medicines in development in the U.S. for 4,600 indications compared with only 2,000 drugs in development five years ago, the trade group said. The growth in R&D spending proceeded at a slower rate than in previous years. PhRMA noted challenging economic conditions and sharp deceleration in drug spending affecting the industry. IMS Health recently reported that growth in the U.S. pharmaceutical market slowed to 3.8 percent in 2007, down from 8.3 percent during the prior year. For details, visit http://www.phrma.org

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

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