LIMSource News: What's New - September to October 2005

• Autoscribe Releases Case Study in Harmonizing LIMS and ERP / MRP Systems
• Indiana University Announces Researcher's Program Provides Fantastic Voyage through Human Cell
• Informatics Delegation Poised to Attend UN Summit in Tunis
• Thermo Provides Toxicology Labs with Increased Automation and Productivity
• Crawford's Resignation To Be Investigated
• Critical Path Initiative Slowed by Funding Shortfalls, Controversies
• GenoLogics Expands Management Team to Support Business Growth Strategy
• National Instruments Introduces LabVIEW Version 8.0
• SYSTECH International Launches TIPS Serialized Product Tracking
• Dow Chemical Selects Savi Technology's Chemical Chain-of-Custody Solution to Track Product Shipments
• ACD/Labs Releases Version 9.0 of Chemical Drawing and Nomenclature Software - Now Both InChI Compatible
• Teranode Addresses Role of Semantic Web Standards in Life Sciences with New White Paper
• FDA Could Delay Part 11 Revision
• Public Interest Groups Wary of FDA's Risk-Based Assessment System
• Indiana University Collaboration Strengthens Search for New Drug Discoveries
• Investigation Into Crawford's Resignation Demanded by Lawmakers
• Crawford Steps Down as FDA Chief
• IU Team Designs 'Dream Tool' for Life, Social Sciences Research
• FDA Fiscal 2006 Budget Set at $1.8 Billion
• Waters Corporation Ships Analytical Workflow Manager Software Version 1.4.7
• Computing Solutions Partners with OSIsoft
• Study Finds that Counterfeit Drug Sales Will Reach $75 Billion by 2010
• FDA Issues Proposed Rule on cGMPs for Pet Drugs
• Atrium Research Announces the Second Edition of Report on Electronic Laboratory Notebooks
• Dionex Corporation and Alltech Associates Inc. Settle Lawsuit
• TPO Deploys Group Logic's MassTransit
• Group Logic Delivers Lightning-Quick Search Performance in ExtremeZ-IP 4.1 Update
• Bayer HealthCare Licenses MedScan Text-to-Knowledge Suite by Ariadne Genomics
• Teranode Closes $9.5M Financing Round & Garners F&S Award
• ESA Biosciences Opens Western Regional Office
• Tufts University Study Finds No Link Between Faster Drug Approvals and Safety Problems
• LabVantage’s Sapphire BioBanking Solution Supports Diabetes Research
• Informatics Fellowship Fueled by LabWare Funding
• Fort Dearborn Links with Group Logic to Build System-Driven Workflow
• FDA Holding CGMP Workshops in China
• ATL Announces New Business Location in Newton, New Jersey
• Bika Laboratory Management Tools Open Sourced
• Data Overload Could Lessen Impact of Drug Watch
• Gottlieb States FDA Oversight Not Affected by Critisism of Safety Decisions
• India Offers Robust Growth Opportunities to ERP Suppliers According to ARC Research Survey
• Waters' Empower 2 Software Ships
• Live Online Demonstration of LabSoft LIMS by Computing Solutions
• STARLIMS Showcases International Forensic LIMS Projects at IAFS 2005
• GenoLogics Launches OmixLIMS Software Platform for Systems Biology Research
• GenoLogics Solution Provides Powerful Capability to help Proteomics Researchers in Biomarker Discovery and Data Analysis
• Bruker Daltonics Appoints Michael Schubert as Executive Vice President and Ian Sanders as Vice President
• Labtronics Releases Instrument Integration Solution for Agilent Technologies' ChemLMS LIMS
• Protedyne Corporation Completes D Round of Funding with Investors including Allen & Company LLC
• New FDA Guidance on Risk Management Released
• Survey Reports Firms Using More Technology in Clinical Trials
• Autoscribe Releases New Version of Sample Tracker
• EPA Region 4 Orders EarthSoft's EQuIS 5
• MiraiBio and Redasoft Form Product Alliance for Bioinformatics Products
• Autoscribe' ICMS Enables Cost Effective Regulatory Compliance
• Caliber Systems Launches Caliber Environment Monitoring System (EMS)
• ValGenesis Releases ValGenesis 1.0 Enterprise Validation Management and Tracking System
• Prime Technologies, Inc. Launches ProCalV5 User Group

Autoscribe Releases Case Study in Harmonizing LIMS and ERP / MRP Systems

Autoscribe has released a case study entitled Harmonizing LIMS and ERP / MRP Systems. According to the case study, LIMS underpin the infrastructure of academic and commercial laboratories throughout the world. Their basic function is to handle data from sample registration right through to analysis and reporting stages. However, not all laboratories rely solely on a single LIMS solution. Many run additional software suites with specialist functions. Therefore, the LIMS systems of today must be flexible, highly configurable, upgradeable, supportable and capable of serving additional in-house programs for further requirements. When interfaced to an ERP / MRP system, the LIMS must also feed the final product result data into the ERP / MRP system (for invoicing and resource purposes). Autoscribe's case study highlights the high standards required in all areas of the business, from data handling and sample processing to certificate of analysis generation and invoicing that help companies achieve FDA, ISO 9001:2000, ISO 17025 and ISO 14001 status.For details, visit http://www.autoscribe.co.uk.

Indiana University Announces Researcher's Program Provides Fantastic Voyage through Human Cell

While textbook graphics and illustrations are good tools to teach cellular biology, Albert William of the Indiana
University School of Informatics, focuses on giving novices a more vivid experience. That's what led William, a visiting research associate in the School's new media program at Indiana University-Purdue University
Indianapolis, to create The Cell - A Virtual Tour, a CD/ROM that allows visitors to observe the basic functions and processes critical to cellular life. "My goal was to present complex scientific concepts and ideas in an interactive environment so that they can be more easily understood by users in ways they might not be able to get from standard textbooks," says William, who teaches digital imaging to undergraduates at IUPUI. Users journey to the cell surface membrane and watch 3-D and 2-D animations about life's building blocks - proteins and DNA - and how the cell is formed. From there, they enter into the cell and observe its myriad structures, tiny organs and processes such as reproduction. An interface gives users control to access major topic areas and narrations. William's idea for the program began several years ago when he was a researcher at the IU School of Medicine where he specialized in protein biochemistry and genetic analysis of brain disease. He says that experience inspired him to find a better way to communicate biological and scientific concepts not only to professionals but to general audiences. The Ruth Lilly Health Education Center, which provides health-education programs and interactive displays to more than 90,000 youngsters annually, is working with William to reconfigure some of the animations and content from The Cell for use at its near-northside Indianapolis facility. Sample images and animations of The Cell - A Virtual Tour, and other projects developed by Albert William can be found at
http://informatics.iupui.edu/p/39 <http://informatics.iupui.edu/p/39.

Informatics Delegation Poised to Attend UN Summit in Tunis

The digital revolution has linked the global village, but much of the world remains disconnected and is left
stranded by an ever-widening digital divide. A six-member delegation from the Indiana University School of Informatics has been accredited by the United Nations and will be among those attending next month's UN World Summit on the Information Society in Tunis. The event, hosted by the Tunisian government, Nov. 16-18, brings together heads of state and thousands of representatives from academia, non-governmental organizations, charitable groups and information technology industries from 175 nations. The gathering is the final of a two-phase summit convened by the UN. The first phase was December 2003 in Geneva, Switzerland. "Information technology has transformed society in dramatic and significant ways, but the gulf between rich and poor nations
benefiting from these innovations continues to expand," says School of Informatics Dean J. Michael Dunn, Ph.D. "While our faculty are there mainly as observers, they have expertise and insights they will share to help find solutions to the problems wrought by the digital divide." Attending are Christine Ogan, Ph.D., professor of
informatics; Michael Gasser, Ph.D., associate professor of computer science; John Paolillo, Ph.D., associate professor of informatics; Eden Medina, Ph.D., assistant professor of informatics; David Hakken, Ph.D., professor of informatics; and graduate student Matthew Kane, who is seeking a doctorate in computer science. "Our group members will participate in various conferences and seminars scheduled before the UN summit," says Gasser, whose research focuses on natural language processing and learning. For details, visit http://www.itu.int/wsis/basic/index.html or http://www.informatics.indiana.edu.

Thermo Provides Toxicology Labs with Increased Automation and Productivity

Thermo Electron Corporation has announced the availability of a new application for its ToxLab 2.0 Intelligent Sequencing Software. The application demonstrates the benefits of using the software for analysis of urine samples in drug testing and toxicology laboratories. The solutions maximize productivity and profitability for today's high throughput laboratories where accelerated turn-around time and minimum cost per sample are vital for achieving critical productivity goals. Significant annual savings can result from the use of ToxLab 2.0 for sample acquisition and analysis. This application is the latest addition to Thermo's extensive range of application notes designed to demonstrate the ability of its GC/MS solutions to effectively and efficiently analyze toxicological samples. By combining the applications with its GC/MS capabilities plus real-time decision making software, Thermo is now able to offer its customers a complete solution for toxicological analyses. ToxLab 2.0 makes real-time decisions based on the programmed method and is able to automatically troubleshoot and resolve common issues that arise, such as the need to re-inject a blank. The savings in time and money result from the elimination of wasted time, resources, and labor, and savings increase proportionately as the number of analyzed samples increases. An additional application presented by Thermo features the real-world analysis of oral fluid samples in a high-throughput drug testing laboratory. The application is favorable to drug testing laboratories due to the use of oral fluid, as opposed to urine, as the sample matrix which provides more protection of subject privacy and is easily attainable. For details, visit http://www.thermo.com/gc.

Crawford's Resignation To Be Investigated

The HHS Inspector General (IG) has agreed to investigate the reasons behind former FDA Commissioner Lester Crawford's sudden resignation in response to inquiries from a bipartisan coalition of lawmakers. The IG recently sent a letter to lawmakers, including Sen. Michael Enzi (R-Wyo.) and Rep. Maurice Hinchey (D-N.Y.), stating that the
office is "currently reviewing the circumstances" that led Crawford to resign. Enzi, the chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Hinchey and other lawmakers, requested an investigation to determine whether Crawford left the agency because of a potential financial conflict of interest. Crawford abruptly left the agency only months after being confirmed, leading lawmakers to question his motives. Crawford had also been under fire for his role in delaying a decision over whether to sell the Plan B contraceptive over the counter. This move led to charges that the decision was politically motivated, a charge that was later substantiated by a Government Accountability Office report. The lawmakers have argued that an IG investigation is necessary to address long-term concerns with the FDA leadership. Enzi has claimed that the rumors call into question whether the Bush administration is choosing candidates to run the agency that have too many ties to the industries they regulate. For details, visit http://www.fda.gov.

Critical Path Initiative Slowed by Funding Shortfalls, Controversies

The FDA's Critical Path Initiative, which is supposed to speed the introduction of new products to market, is being held back by limited agency funding, as well as several ongoing controversies, according to agency and industry officials. The agency has long been concerned about the lack of new drugs making it to market, said Larry Kessler, director of the FDA's Office of Science and Engineering Laboratories. The FDA believes efforts to introduce new devices can be improved as well, he said during a recent presentation before the agency's dental products medical devices advisory panel. Aiming to speed such products to market, the FDA introduced the Critical Path Initiative in March 2004, which seeks to use biomarkers and new technologies to weed out unsuccessful candidates early in the development process. But while details have become available about the plan since last year, the agency has yet to implement the initiative. Funding levels have played a role in the delay, according to Kessler and industry representatives. Recent controversies over the FDA's relationship with industry have also delayed the initiative, said Mark Brager, spokesman for the Advanced Medical Technology Association. For example, the FDA has been under fire for how it handled problems with Vioxx (rofecoxib) and implantable cardioverter defibrillators (ICDs). Lawmakers on both sides of the aisle have used these controversies to allege that the FDA is too close to industry. Such scrutiny only chills any agency efforts to collaborate with industry, Brager said. But recent controversies point to the need for greater collaboration, Kessler said. Problems with ICDs are the "poster child" for development of a process that ensures products are manufactured with more consistent quality, Kessler added. Such a process, known as industrialization, along with methods for assessing safety and effectiveness of products, make up the Critical Path program. For details, visit http://www.fda.gov.

GenoLogics Expands Management Team to Support Business Growth Strategy

GenoLogics Life Sciences Software Inc. has announced recent additions to its management team in the areas of sales, product development, marketing and finance to support the business expansion and growth strategy of the company. Michael Ball, CEO said “GenoLogics is now very well positioned to take advantage of increasing demand for its products in a rapidly growing market. The management team brings a depth of knowledge and skills in leading technology start-ups and growing businesses internationally, managing complex software development, building a global market presence and developing strategic partnerships that will enable GenoLogics to accelerate its growth.” Greg Kinch, VP Sales, joins GenoLogics from Silicon Genetics (now owned by Agilent). He previously held sales leadership positions at Genomic Solutions, BI Systems Corporation and other companies in the life sciences industry. His expertise in the proteomics and genomics markets will drive GenoLogics business growth in these markets. Joining GenoLogics as VP Product Development, Rob Milne brings over 20 years experience in engineering and business management, previously holding engineering and R&D executive positions with Nokia, Vienna Systems, Motorola and Mitel. He has demonstrated ability in building technology organizations from start-up to successful business ventures. Gail McBride, VP Marketing joins GenoLogics with leadership experience in marketing at A.L.I. Technologies (now owned by McKesson), and marketing/international business development roles at H.A. Simons Ltd. (now AMEC) and other organizations. She helped A.L.I. expand its market presence in the radiology image management market, making it an attractive investment for McKesson. David Slater-Kinghorn assumes the role of VP Finance. He is a CA, holds a Bachelor of Laws degree and brings international experience in financial leadership and operational management at companies including LifeScan Canada, a Johnson & Johnson Company, CanWel Distribution and Sappi Export Services. Brandie Yarish is Manager Human Resources and brings a wealth of experience in HR management, leadership development and recruitment in several high growth technology companies, including Power Measurement and ACD Systems. Rounding out the management team is James DeGreef, co-founder of GenoLogics who led the start-up and development of the company until the appointment of Michael Ball as CEO in September 2004. James assumes the role of VP Product Management to lead the product vision and roadmap. Michael Ball, CEO has 20 years experience in sales, marketing and business development with technology companies, including five years in executive management with Creo Products Inc. as VP Business Development and VP European Sales and Service. In addition to his Creo experience, Michael was VP at Carmanah Technologies, spent seven years at Digital Equipment Corp. and has experience with several technology start-ups. Michael was instrumental in securing the recent round of venture capital financing for GenoLogics. "GenoLogics sales have been driven by the increasing need of life science and pharmaceutical research facilities to manage the explosion of information generated by proteomics research,” said Michael Ball. “Proteomics researchers and lab managers have been frustrated with the lack of a solution to manage their processes and the unprecedented data volumes. GenoLogics software solves these real world problems and helps researchers accelerate development and advances in health research and drug discovery. We now have all the elements in place to be extremely successful in this emerging market, including a dynamic management team, financial backing, an installed base of prominent academic and pharmaceutical customers to build upon and an increasing demand in North America and Europe for our product. The future is very bright for GenoLogics.” For details, visit http://www.genologics.com.

National Instruments Introduces LabVIEW Version 8.0

National Instruments, a global leader in virtual instrumentation, has released LabVIEW 8, a major upgrade to the LabVIEW graphical development platform that improves the productivity of engineers and scientists in design, control and test. This upgrade introduces distributed intelligence – a powerful suite of new capabilities for engineers and scientists to easily design, distribute and synchronize intelligent devices and systems. LabVIEW 8 also features a new project-based environment for developing and managing large-scale applications as well as the latest in Express technology for simplified instrument control. This release also includes significant updates to the LabVIEW Real-Time Module, LabVIEW FPGA Module, LabVIEW PDA Module and LabVIEW Datalogging and Supervisory Control Module. For details, visit http://www.ni.com.

SYSTECH International Launches TIPS Serialized Product Tracking

SYSTECH International, the leading provider of Packaging Performance Management solutions for manufacturing operations, has introduced its TIPS Serialized Product Tracking solution. Designed to combat counterfeit and diverted product challenges, the solution works in concert with RFID and bar code technologies. "Several key customers in both the pharmaceutical and healthcare sectors have engaged us to provide solutions to improve product authentication capabilities across their supply chains,” said SYSTECH’s CEO Robert DeJean. “Utilizing TIPS Serialized Product Tracking they can better respond to the counterfeit and diverted product challenge and ultimately improve financial, brand, and public perception issues around this epidemic.” TIPS Serialized Product Tracking is part of SYSTECH’s comprehensive suite of machine vision inspection, packaging line automation and information management solutions. For details, visit http://www.systech-tips.com.

Dow Chemical Selects Savi Technology's Chemical Chain-of-Custody Solution to Track Product Shipments

Savi Technology's Chemical Chain of Custody Solution has been chosen by The Dow Chemical Company as its software platform to further enhance the stewardship, security, visibility and accountability of mobile assets that transport products as they move throughout Dow's extended global supply chain. Dow also has designated Savi's enterprise-level solution, which is hosted for Dow in an ASP environment, as a Most Effective Technology (MET) for multiple business units to track a wide range of mobile assets, or shipping vessels, including totes, cylinders, trucks and rail cars. Savi Technology is a leading provider of supply chain management and security solutions leveraging software and Automatic Identification and Data Collection (AIDC) technologies, including Radio Frequency Identification (RFID). For details, visit http://www.savi.com.

ACD/Labs Releases Version 9.0 of Chemical Drawing and Nomenclature Software - Now Both InChI Compatible

Over the past decade, with the ever-increasing reliance on computer processing by chemists, it became evident to many within the IUPAC organization that a new computer-oriented nomenclature protocol had to be developed to facilitate electronic treatment of chemical structures. This new method, called the IUPAC International Chemical Identifier (InChITM), aimed to generate a freely-available, non-proprietary identifier for chemical substances that could be used in printed and electronic data sources. Advanced Chemistry Development, Inc. (ACD/Labs) has announced that with the release of version 9.0 of the chemical structure drawing program, ACD/ChemSketch and the expert nomenclature tool, ACD/Name, they have now introduced full compatibility with the InChITM chemical nomenclature protocol, making it possible to produce unique alphanumeric string representations for chemical compounds that will facilitate the communication of molecular structures electronically. For details, visit http://www.acdlabs.com/publish/press_release.html.

Teranode Addresses Role of Semantic Web Standards in Life Sciences with New White Paper

Teranode Corporation, a leading innovator of experiment design automation (XDA) software for the Life Sciences industry, has announced the availability of a new white paper discussing how the adoption of Semantic Web standards allows R&D organizations to unify data from various sources to accelerate scientific inquiry and Teranode's roadmap for adopting Semantic Web standards. The white paper titled, "Unifying Data with the Semantic Web for the Life Sciences," demonstrates how leveraging Semantic Web standards opens up a new range of application development possibilities, and embraces the distributed decentralized nature of R&D, giving scientists a useful dashboard view of experiments. The paper also outlines the company's roadmap with plans to integrate Semantic Web technologies into its award-winning informatics platform TERANODE XDA. TERANODE XDA, unifies data from in-silico and laboratory experiments to streamline R&D processes and projects. The platform's core application is TERANODE Design Suite, a visual tool for scientists that allows in-silico and lab experiments to be designed, automated, analyzed, and published for the benefit of accelerated R&D. "Data integration remains a bottleneck for scientists in the Life Sciences who have too few tools for searching and aggregating data from multiple databases," said Matthew Shanahan, Chief Marketing Officer for Teranode. "The adoption of Semantic Web standards not only allows data integration to be automated for scientists but provides a flexible framework that accommodates changes driven by R&D discovery and innovation." To access a copy of this white paper, visit http://www.teranode.com/download/file_download.php?1/docs/Whitepaper_UnifyingData.pdf.

FDA Could Delay Part 11 Revision

The FDA is unlikely to complete its long-awaited revision of 21 CFR Part 11 — which regulates the use of electronic records and signatures — by the end of the year as industry observers had expected, an agency official said this month. "It's a very aggressive timeline, and the regulatory process is very cumbersome, so I have to say it will be difficult to meet that goal, but we are actually working hard toward it, and we have a lot of backing at the FDA keeping us moving along as best we can," said George Smith, consumer safety officer at the FDA's Center for Drug Evaluation and Research. "The point there is we really want to get it right," he told attendees at a recent Drug Information Association conference. Pharmaceutical industry leaders have long complained that compliance with Part 11 was too costly and stifled innovation. The FDA formed a working group to address industry comments and consider revisions to the regulation. Until the final regulation is promulgated, the FDA will continue to rely on the approach outlined in its scope and application guidance, Smith noted. "Once the final regulation is put out there ... we will subsequently take away the scope and application guidance, because that final regulation will address all of the petitions the scope and application guidance did," he said. For details, visit http://www.fda.gov.

Public Interest Groups Wary of FDA's Risk-Based Assessment System

Public interest groups are concerned that an FDA initiative to use risk-based reviews to speed drug approvals could cause more problems than it solves. The agency recently announced the establishment of the Office of New Drug Quality Assessment (ONDQA) to facilitate the implementation of a modern, risk-based pharmaceutical quality assessment system (PQAS). ONDQA, which becomes effective Nov. 1 under the auspices of the Office of New Drug Chemistry, will be charged with several goals, the biggest of which is balancing the need for faster drug approvals with the rapid introduction of new technologies into pharmaceutical manufacturing. The PQAS will replace the FDA's current chemistry, manufacturing and controls (CMC) review system, which the agency said may be slowing manufacturers' adoption of new technologies. Under the CMC review system, drugmakers must seek FDA approval through a supplement before implementing postmarketing manufacturing changes. "ONDQA is a science-based organization designed to be more efficient, effective and flexible in managing CMC issues and workload. ... I believe that the establishment of ONDQA is an important step in the continuing improvement of FDA's CMC review practices for the 21st Century," Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said. But activists say the move might not improve the drug-review process, and may potentially result in more harm to patients. "I am wary of any change that seems to make it easier for industry to avoid monitoring," said Celia Wexler, vice president for advocacy for consumer lobbying group Common Cause. Making decisions based on prospective estimates of risk is problematic, Wexler added. Vioxx was not initially seen as being potentially dangerous for patients, but that notion turned out to be very wrong, Wexler said. "FDA does not have a very good track record" in making such decisions, Wexler added. The ONDQA will include dedicated premarketing and postmarketing divisions, focused on investigating drugs. The office will also use Pharmaceutical Assessment Leads focusing on each drug application to determine how extensive of a review is necessary. For details, visit http://www.fda.gov.

Indiana University Collaboration Strengthens Search for New Drug Discoveries

Medical scientists must sift through and analyze mammoth amounts of data to find ways to treat disease, and an
Indiana University School of Informatics-led team has been assembled to help them develop new discoveries. The School has been awarded a two-year $500,000 grant from the National Institutes of Health to establish the Chemical Informatics and Cyberinfrastructure Collaboratory, and it brings together experts in informatics, medicine, computer science, chemistry, biology and from IU's Pervasive Technology Labs (PTL). Chemical informatics is the application of computer technology to chemistry in all of its manifestations, particularly in the drug-manufacturing industry. The group seeks to devise an integrated cyberinfrastructure composed of diverse and easily expandable databases, simulation engines and discovery tools such as PubChem, the NIH's small molecule chemical and biological database. They will use emerging high-capacity computer networks and data repositories and develop grid and Web technology for chemistry research. The CICC also will pave the way for new academic courses and chemical informatics research at IU, notes Informatics Dean J. Michael Dunn, Ph.D. The School offers graduate degrees in chemical informatics at its campuses in Bloomington and Indiana University-Purdue University Indianapolis. For details, visit http://www.informatics.iupui.edu.

Investigation Into Crawford's Resignation Demanded by Lawmakers

Sens. Michael Enzi (R-Wyo.), Edward Kennedy (D-Mass.) and other lawmakers are calling for a federal investigation into former FDA Commissioner Lester Crawford's departure from the agency. The lawmakers are especially interested in confirming whether Crawford resigned his post due to an alleged financial conflict of interest, saying clarification is needed to validate the vetting process for federal nominees. Various press reports have suggested that Crawford's resignation stemmed from his failure to disclose pharmaceutical stock holdings — a charge the former commissioner has denied. In separate letters, lawmakers in both houses have requested that the HHS Inspector General (IG) investigate the circumstances surrounding Crawford's sudden resignation. Enzi and Kennedy ask in a recent letter that the IG "examine [Crawford's] financial reporting in accordance with various ethics laws to determine whether he was in compliance and whether he was forthcoming in his attestations to the White House Counsel, [the HHS], the Office of Government Ethics, and the Committee." A group of House Democrats led by Rep. Maurice Hinchey (D-N.Y.) has also called on the IG to investigate whether Crawford held stock in pharmaceutical companies he was charged with regulating. The "sudden nature of this [departure], combined with both conflicting reports about the resignation and recent difficulties at the FDA, warrant your office's involvement in this matter," the representatives state in a recent letter. Enzi and Kennedy, the chairman and ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, which has jurisdiction over the FDA, contend that Crawford's alleged financial conflicts undermine both the public's and Congress' confidence in the FDA. The lawmakers also claim that the rumors call into question whether the Bush administration is choosing candidates that have too many ties to the industries they regulate. For details, visit http://www.fda.gov.

Crawford Steps Down as FDA Chief

FDA Commissioner Lester Crawford stunned the industry with the announcement late Friday that he was stepping down from the post he had fought to gain just two months before. Crawford, 67, whose nomination was delayed by an anonymous allegation of personal misconduct and political opposition to the agency's decision not to approve the Plan B contraceptive, gave no specific reason for his resignation. He was confirmed by the Senate on July 18, after having served as acting commissioner and deputy commissioner. The White House reportedly named Andrew von Eschenbach, the head of the National Cancer Institute, as acting commissioner. The Bush administration's choice of Andrew von Eschenbach to be the interim FDA commissioner however is raising concerns among various stakeholders, who say his role as director of the National Cancer Institute (NCI) and his alleged decision to continue to run that group shows a lack of the necessary objectivity and dedication needed to run the FDA. These groups also question whether Eschenbach's goal of accelerating approvals of cancer drugs could result in a lowering of drug approval standards. The Bush administration named Eschenbach acting commissioner after Lester Crawford abruptly quit as head of the agency. While the agency has argued that Eschenbach has the experience and expertise to do the job, various sources in Congress, the industry and the public interest sector are questioning the move. Sources from such varied entities as the Senate Health, Education, Labor and Pensions (HELP) Committee, Public Citizen, the Biotechnology Industry Organization (BIO) and the Center for Science in the Public Interest (CSPI) said that Eschenbach's role as head of NCI, an NIH agency that interacts closely with the drug industry, raises objectivity questions. The sources also noted that von Eschenbach's pledge — as reported by the Associated Press — to keep his NCI post while running the FDA is unrealistic. The Bush administration's selection of Eschenbach is a "troubling choice," said CSPI official Merrill Goozner, because the NCI lobbies the agency for changes in policy and has numerous ties to industry. The NCI leader also being in charge of the FDA represents a "structural conflict of interest" that needs to be addressed, Goozner added. Eschenbach's interest in accelerating approvals of cancer-treating drugs has also raised concerns among stakeholders, some of whom noted that a shorter approval window could compromise drug safety. HELP Committee spokesman Craig Orfield noted that Eschenbach has a "sterling reputation," but cautions that his alleged decision to take the FDA position while continuing to run the NCI is a problem. The HELP committee, which has jurisdiction over the FDA, is currently reviewing this issue, Orfield said. Apparently, von Eschenbach will continue to be director of the National Cancer Institute, but will turn over day-to-day decisionmaking to a subordinate while serving as interim FDA commissioner, agency spokespeople say. The decision, while addressing some critics' concerns with Eschenbach, may delay selection of a permanent FDA chief, industry sources say.For details, visit http://www.fda.gov.

IU Team Designs 'Dream Tool' for Life, Social Sciences Research

Indiana University (IU) has received a $1.1 million grant from the National Science Foundation to develop the information technology needed to study large-scale networks in a variety of scientific domains. When completed, the cyberinfrastructure will provide an online data-code-computing resource for researchers, educators and
practitioners. It will primarily support biomedical, social and behavioral science, and physics research but can be used to study other networks as well. Biologists are interested to use this cyberinfrastructure to analyze and
consolidate data from diverse networks to better understand the dynamics of genes and proteins, to assess mutations in diseases, and to develop new drugs to treat them. It will be used by epidemiologists to more accurately forecast and visualize the spread of a pandemic influenza strain or emergent diseases such as Severe Acute Respiratory Syndrome. Internet researchers might apply similar methods to understand the spread of viruses in technological networks. Social and behavioral scientists are interested to study social networks or to analyze and predict the structure and evolution of scientific disciplines. "This project brings together a unique set of biologists, physicists, social and behavioral scientists, statisticians and information scientists," says principal investigator Katy Börner, Ph.D., associate professor in the School of Library and Information Science who holds an adjunct appointment in informatics. "Many of these scientists have made major theoretical contributions. They are now taking on the challenge to build a 'dream tool' for their respective research communities. "It is our hope," adds Börner, "that this shared cyberinfrastructure will provide easy access to the network science theory and tools generated in the diverse fields of sciences and help increase our understanding of the network ecology of which we are an intrinsic part." For details, visit http://www.informatics.iupui.edu.

FDA Fiscal 2006 Budget Set at $1.8 Billion

The full Senate has approved an agriculture spending bill that sets the FDA's fiscal 2006 budget at $1.841 billion — slightly more than what the House approved in June. Under the Senate bill, the FDA's proposed budget is nearly $65 million more than the fiscal 2005 level, and includes an increase of nearly $21 million in prescription drug user fees. The FDA's budget is set by the fiscal 2006 agriculture appropriations bill, H.R. 2744, which the Senate recently approved by a 97-2 vote. Among other things, the Senate spending bill would allocate $515.4 million, including industry user fees, to the FDA's Center for Drug Evaluation and Research (CDER), and $178.7 million, including user fees, to the agency's Center for Biologics Evaluation and Research (CBER). The bill also includes an additional $5 million for drug-safety activities. The House appropriations bill contains similar FDA funding levels. The FDA's fiscal 2006 budget would be set at $1.837 billion under the spending proposal approved by the House by a 408-18 vote June 8 CDER would be funded at $519.8 million and CBER at $178.7 million. The House also approved an additional $5 million for drug-safety initiatives. Under the House bill, the FDA's Office of Drug Safety (ODS) would receive $22.9 million, with the additional $5 million for the program to be used on "the highest priority drug-safety needs," according to details of the budget provided to FDAnews by the Senate Health, Education, Labor and Pensions (HELP) Committee. Within 30 days of enacting the budget legislation, the House would direct the FDA to provide a detailed spending plan for these additional funds and other ODS funds, according to the HELP Committee. The House also expects to receive quarterly reports providing details about the FDA's planned changes for drug safety, including review processes or reprogramming and plans for external review. The House also wants reports on other new FDA safety initiatives, including education efforts or labeling changes, and the result of the Institute of Medicine study on drug-safety issues. Meanwhile, the Senate legislation also requests a report on the FDA's efforts in drug safety as part of the additional $5 million, including those related to orphan products. In addition, the Senate provides $750,000 to support collaborative research — with the Critical Path Institute and the University of Utah — on "cardiovascular biomarkers predictive of safety and clinical outcomes." For details, visit http://www.fda.gov.

Waters Corporation Ships Analytical Workflow Manager Software Version 1.4.7

In response to scientists seeking more control over managing and tracking analytical requests, as well as shortening the time to process these requests, Waters Corporation has announced the shipment of Waters' Analytical Workflow Manager Software 1.4.7. The announcement lets scientists in analytical laboratories from a cross-section of industries including pharmaceutical, biotech and environmental, track and accelerate order processing using an electronic workflow and storage management solution. A single point-of-access, Analytical Workflow Manager Software administers the workflow of the order process cycle from capturing analytical requests, through instrumental measurements and result analysis, to long-term data storage. Analytical Workflow Manager Software (formerly Q-DIS/R) combines work list management, sample tracking, measurement setup and triggering with data
evaluation and result distribution. Scientists in analytical services laboratories can then share their results with colleagues to perform value-added research. The strategic importance of Analytical Workflow Manager Software is summed up by the manager of a mass spectrometry laboratory for a global healthcare leader in the area of pharmaceuticals and diagnostics. He states, "Waters Analytical Workflow Manager Software is one of my corporation's ten most business-critical applications. It has enhanced collaboration and information-exchange among our laboratories and broadened communications to our customer base." With today's enhancements, scientists are now able to: configure workflow processes such that analysis requests are prioritized and transferred to instrument work lists which already include sample and method-specific parameters that are used to process the sample and generate results; electronically review and approve measurement requests and analytical
results either on an ad-hoc basis or automatically, based on pre-configured procedures; provide for integration of streamlined processes into other systems such as the Waters eLab Notebook software, resulting in an optimized digital environment for both document control and management of the sample analysis workflow including analytical methods.For details, visit http://www.waters.com/informatics.

Computing Solutions Partners with OSIsoft

Computing Solutions, Inc. (CSI), a premier LIMS provider, has announced its partnership with OSIsoft, Inc. as
an Independent Software Vendor (ISV). OSIsoft, Inc. defines an ISV partner by stating, "ISV's own, develop,
distribute, and support commercially available applications that are integrated with OSIsoft products." The ISV partnership allows CSI to further support and develop the interface between its LabSoft LIMS software and OSIsoft's Real-time Performance Management (RtPM) Platform, powered by the PI system (PI). The seamless interface correlates the quality data from LabSoft LIMS with the process data from PI when using the LabSoft LIMS Process View tool. Integration with PI also extends the functionality of the LabSoft LIMS Results Entry and Browse Results tools. Results Entry has the ability to export the quality data entered into LabSoft LIMS to the PI System. Whereas, Browse Results can view the process data stored in PI from LabSoft LIMS. The interface between LabSoft LIMS and PI effectively creates a medium that pairs quality and process data for a more efficient, cost effective data management solution.For details, visit http://www.LabSoftLIMS.com.

Study Finds that Counterfeit Drug Sales Will Reach $75 Billion by 2010

Sales of counterfeit prescription drugs are expected to reach $75 billion by the end of the decade, nearly doubling current levels and outpacing the annual growth rate of legitimate pharmaceutical sales, according to a new study.
Counterfeit drug sales are estimated to grow 13 percent annually through 2010, compared to 7.5 percent estimated annual growth for global pharmaceutical commerce, says the report from the Center for Medicines in the Public Interest (CMPI), which is part of Pacific Research Institute, a free-market think tank. CMPI based its growth projections on current estimates of counterfeits from the FDA and World Health Organization. Global pharmaceutical sales are expected to grow to $530 billion by 2010, CMPI said. The counterfeit problem has grown exponentially, according to a representative of Eli Lilly, which has seen its products, including the antidepressant Prozac (fluoxetine HCl) and the erectile dysfunction (ED) drug Cialis (tadalafil), become targets of counterfeiters.
The FDA has recommended that manufacturers adopt electronic track-and-trace technology by 2007, as well as multiple authentication technologies, in order to combat the distribution of counterfeit drugs, according to the February 2004 final report of the agency's Counterfeit Drug Task Force. Lawmakers also have introduced legislation recently that would crack down on counterfeiters of all kinds. A bipartisan group of senators recently introduced the Stop Counterfeiting in Manufactured Goods Act, which would make it a crime to traffic in counterfeit labels or packaging, even when shipped separately from the products to which they are later attached. In a statement, bill co-sponsor Sen. Patrick Leahy (D-Vt.) noted that sick patients should not have to worry that they will ingest counterfeit drugs that, at best, have no effect. Meanwhile, the counterfeit drug issue will likely continue to play a central role in the debate over legalizing pharmaceutical importation. The FDA has opposed Rx importation in part because the agency would be unable to inspect products for safety. For details, visit http://www.fda.gov.

FDA Issues Proposed Rule on cGMPs for Pet Drugs

The FDA has issued a proposed rule on current good manufacturing practices (cGMPs) for positron emission tomography (PET) drugs. The proposed rule will establish minimum standards for the production and testing of PET drugs, the FDA said. The agency has also concurrently published a draft guidance, titled "PET Drug Products — Current Good Manufacturing Practice." The guidance describes acceptable approaches for PET drug producers to meet the requirements of the proposed regulation. PET is a medical diagnostic tool in which a radioactive drug is administered to a patient, most commonly by intravenous injection, and the distribution and uptake of the radioactive drug to various bodily organs is imaged using a scanner. The image helps physicians diagnose diseases such as cancer and heart disease. The FDA Modernization Act of 1997 directed the FDA to establish new approval procedures and cGMP requirements for PET drugs, taking into account their special characteristics, the operations and processes required to produce these drugs, and any relevant differences between not-for-profit institutions that compound PET drugs for their patients, and commercial manufacturers. To view the proposed rule, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0279.pdf. To view the draft guidance, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-0266-gdl0002.pdf.

Atrium Research Announces the Second Edition of Report on Electronic Laboratory Notebooks

Atrium Research has announced the release of Edition II of company's study, Electronic Laboratory Notebooks: A Foundation for Scientific Knowledge Management. Over eighteen months in the making, this comprehensive look at ELN examines the market, customer requirements, legal issues, benefits, industry trends, and best practices for
vendor selection and implementation. Called the "definitive document on ELN" by Indiana University's School of Informatics, the 470 page report includes over 180 pages dedicated to reviewing the latest ELN software from key suppliers. Over 160 charts, tables and figures illustrate key points. Paper laboratory notebooks have been used for hundreds of years. Despite billions of dollars of investment in computer technology and automated instrumentation, the paper notebook has remained as a final repository of experimental data and results. Poised for explosive market growth, ELNs considerably improve laboratory efficiency and enable a collaborative and electronic R&D environment. The potential market for ELN technology is large - over $1.5 billion - but only 12% of the market is fully penetrated at this time. Sales of vendor solutions are growing almost 30% per year. For details, visit http://www.atriumresearch.com.

Dionex Corporation and Alltech Associates Inc. Settle Lawsuit

Dionex Corporation has announced that Dionex Corporation and Alltech Associates, Inc. amicably settled a lawsuit Dionex had filed against Alltech alleging infringement of three Dionex U.S. patents relating to ion chromatography electrolytically regenerated suppressors, including those sold under the Alltech DS Plus mark. Under the settlement, Alltech agreed to cease production and sale of such suppressors. Other terms of the settlement were not disclosed. Dionex Corporation is a leading manufacturer and marketer of chromatography systems for chemical analysis. Their systems are used in environmental analysis and by the life sciences, food and beverage, chemicals, petrochemicals, power generation and electronics industries in a variety of applications.
Alltech Associates, Inc., a subsidiary of W. R. Grace & Co., is a global manufacturer and marketer of chromatographic media, columns, and components for the life science and analytical industries. For details, visit http://www.dionex.com.

TPO Deploys Group Logic's MassTransit

The Press of Ohio (TPO) has deployed Group Logic’s MassTransit software across their entire customer base to deliver both improved speed and increased efficiencies to their file transfer and customer-facing workflows. TPO is one of North America's leading commercial printers, specializing in educational books and catalogs, commercial
and business-to business catalogs and publications. "We ultimately chose the product because of its ease of use, speed and OS independence," explains Joe Jamison, Systems Analyst for TPO. "MassTransit gives us better communication with our customers. The process efficiencies we gained by moving to this product have had a
huge impact on our bottom-line as well as customer satisfaction and service." Prior to implementing MassTransit, TPO was running a base version of Microsoft's FTP package designed to work with Windows Internet Explorer.
Server-based software, MassTransit Enterprise installs at a corporat location(s) and can be easily shared with customers, vendors and other trading partners. Its universal design supports every file transmission workflow - server to server, Web to server, and server to Web. MassTransit is fully compatible with both the Mac OS X and Windows platforms and is a best-in-class solution for businesses that either purchase or offer graphic arts and printing services. The product is used by many global corporations, publishers, printers, prepress companies and advertising agencies MassTransit is designed to provide a complete solution for mission-critical business-to-business file transfers for printers and their customers. It provides customers with everything they need for
successful file transfers, including programmable e-mail notification of file arrival, custom web-based job tickets, bandwidth usage prioritization capabilities, enhanced security, and exportable logging and tracking of transmission data. For details, visit http://www.grouplogic.com.

Group Logic Delivers Lightning-Quick Search Performance in ExtremeZ-IP 4.1 Update

Group Logic, developer of best-selling network workflow software products, has announced the release of version 4.1 of its ExtremeZ-IP software product. This version of the Group Logic file and print server product line is designed to provide organizations operating in dual-platform environments with stable and compatible Windows-based file and print server solutions for Mac OS X as well as Mac OS 9. Available to customers in October, ExtremeZ-IP 4.1 includes major performance improvements that make the product’s file name search functionality up to 150 times faster than Services for Macintosh (SFM) and up to 600 times faster than the Mac OS X SMB Client. This latest update helps improve overall productivity by helping users find and access files more quickly. Group Logic customers who own a license for version 4.0 and have an active Maintenance and Support Contract can update to 4.1 for free. According to GISTICS Incorporated, creative professionals spend 10% of their time managing files, with one-third of that time spent hunting for the file or job they need. “We’re helping people find the resources they need faster,” says T. Reid Lewis, President of Group Logic. “With the Spotlight feature of Mac OS X Tiger, users expect near instantaneous search results. ExtremeZ-IP 4.1 update delivers search results in seconds at speeds unmatched in the industry. Faster access to files eliminates wasted search time and allows users to quickly find what they need to proceed with their work.” Customers implementing ExtremeZ-IP 4.1 can continue to enjoy immediate startup, radically reduced memory usage, and greater flexibility in failover options and functionality that was recently introduced with version 4.0. In addition, the 4.1 update includes a number of bug fixes associated with changes to the product’s internal structure which was rearchitected earlier this year. The ExtremeZ-IP 4.1 product line is fully compatible with Mac OS X.For details, visit http://www.grouplogic.com.

Bayer HealthCare Licenses MedScan Text-to-Knowledge Suite by Ariadne Genomics

Ariadne Genomics, Inc. has announced that Bayer HealthCare AG has licensed its MedScan Text-to-Knowledge Suite for development of an internal molecular interaction database. MedScan extracts pathway-related facts from scientific literature with state-of-the-art natural language processing technology. MedScan is a high performance tool for automated extraction of pathway-related information from TXT, HTML, PDF and MS Office files; catalogs and archives. Extracted facts, ranging from regulation, expression or binding to molecular transport, protein modification and molecular synthesis are stored in XML files. "Bayer HealthCare recognizes the importance of using pathway analysis tools for interpretation of experimental results and hypotheses validation. But to make these tools truly efficient, we need an internal integrated database of pathways and molecular networks, containing all most recent information”, said Michael Seewald, Bioinformatician at Bayer HealthCare AG. “We have chosen MedScan for its advanced natural language processing algorithm, well known for high recovery rate and accuracy, and its ease of integration with our bioinformatics systems.” For details, visit http://www.ariadnegenomics.com.

Teranode Closes $9.5M Financing Round & Garners F&S Award

L ife sciences software vendor Teranode Corporation has closed a $9.5 million Series B round in financing. The round, which brings the company's total funding to over $12.1 million, was led by Cargill Ventures and Trident Capital, with reinvestment by Series A investors Ignition Partners and WRF Capital. Teranode plans to use the funds to expand sales and consulting channels in major biopharma hubs in North America and Europe. Teranode also plans to use the funds for expansion of the company's product with new infrastructure to support translational medicine, as well as establishing a solid developer program for VARs and technology partnerships. In addition, the company has announced that it has been awarded both the 2005 Frost & Sullivan Technology Leadership Award in the field of bioinformatics and the 2005 Technology Innovation Award for its success in the U.S. LIMS market. For details, visit http://teranode.com/newsevents/cmt_pr_detail.php?id=32
or http://teranode.com/newsevents/cmt_pr_detail.php?id=31.

ESA Biosciences Opens Western Regional Office

ESA Biosciences, Inc., a subsidiary of Magellan Biosciences, Inc., has announced the opening of a Western Regional office in Novato, California, near San Francisco. The new outlet will serve as the company's base of operations for Western U.S. and Latin American sales support, as well as functioning as a demonstration facility for ESA's latest analytical instrument technologies. Richard Devereaux, former principal of Richard Scientific, will head the office and coordinate West Coast and Latin American sales efforts. Founded in 1968, ESA Biosciences is a leading manufacturer and supplier of analytical instruments for the life science, clinical diagnostic, drug
discovery and pharmaceutical industries. The company offers a complete line of HPLC systems, components, and advanced detectors, along with a broad range of analytical services. For details, visit http://www.esainc.com.

Tufts University Study Finds No Link Between Faster Drug Approvals and Safety Problems

Faster drug approvals haven't led to more safety-related drug withdrawals, says a study by the Tufts Center for the Study of Drug Development (CSDD), even as critics decry the FDA for not protecting consumers in the wake of the Vioxx scandal. Safety-related drug withdrawals have accounted for just 1.6 percent of product recalls since 2000, compared to 3.2 percent in the 1980s, according to the recently released study. The report is part of an ongoing CSDD investigation into whether a 1992 law requiring drugmakers to pick up part of the cost for drug application reviews has weakened U.S. drug-safety standards. The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from drugmakers to expedite the drug review process. Spurred by revelations such as how the FDA didn't reveal cardiovascular risks associated with Merck's withdrawn arthritis pain drug Vioxx (rofecoxib), critics say the agency isn't doing enough to ensure approved drugs are safe. The CSDD study found not only that drug withdrawals decreased, but also that nearly half of the drugs recalled for safety reasons between 1980 and 2005 were approved before drug companies started to pay user fees in 1993. Moreover, drugs with safety issues are now being taken off the market more quickly, with the length of time between a drug's approval and withdrawal falling from 3.7 years in the 1980s to 0.7 years since 2000. Researchers also found no trend between approval speed and safety withdrawals within drug classes. Withdrawn drugs in some classes had slightly shorter approval times than all approved drugs in those classes, whereas others had the same or slightly longer approval times. Additionally, longer approval times don't necessarily lead to better drug safety, the report shows. Drugs withdrawn since 1980 took an average of 2.14 years to gain approval, compared to an overall average approval time of 2.08 years for all drugs approved since 1980, the report states. For details, visit http://www.fda.gov.

LabVantage’s Sapphire BioBanking Solution Supports Diabetes Research

LabVantage Solutions, Inc. has announced that Amylin Pharmaceuticals, Inc., a biopharmaceutical company based in San Diego, CA, has licensed LabVantage’s Sapphire BioBanking Solution. Sapphire will enhance Amylin’s ability to track the increasing number of samples used in the research and development of treatments for diabetes, obesity, and cardiovascular disease. The Sapphire BioBanking Solution addresses the unique challenges of specimen collection and banking for pharmaceutical discovery and clinical operations, academic and biosciences research centers, medical institutions, and contract research organizations. The solution provides intricate chain-ofcustody functionality, detailed location & shipment management, aliquot/derivative & pooled sample tracking, and electronic signature capture upon transfer and disposition. It offers a browser-based user interface and built-in Evergreen configuration tool to tailor the same solution to the needs of each laboratory within the organization. This flexibility also allows it to readily adapt to a variety of data capture, result management, storage and specimen handling circumstances. The solution is seamlessly integrated with Sapphire’s existing LIMS for life sciences R&D to manage experiments and track vital genomic, proteomics, phenotypic and other result information about samples. Furthermore, it can easily be integrated with third party public databases, instruments, clinical trial management systems, electronic data capture systems, and
existing LIMS. For details, visit http://www.labvantage.com/pr/biobanking.

Informatics Fellowship Fueled by LabWare Funding

Indiana University School of Informatics graduate students now have the opportunity to advance their education and research experiences through a new program established by LabWare Inc. The LabWare Fellowship for Innovation in Laboratory Informatics will aid students enrolled in the Laboratory Informatics Graduate Program at the Indiana University-Purdue University Indianapolis campus. Each recipient will receive a one-time award of $30,000, enabling them to study and pursue their research full time under the guidance of informatics faculty.
“The LabWare gift allows the School to help deserving students attain professional careers that involve the practical application of information technology to laboratory sciences and bench-side research,” says IU Informatics Dean J. Michael Dunn, Ph.D. The LabWare fellowship and the Laboratory Informatics Graduate Program are said to be the first of their kind in the world. The program at IUPUI is designed for students with undergraduate degrees in laboratory-based life sciences whose advanced training in laboratory informatics can lead to careers in the biomedical, chemical, agricultural, food, petroleum and pharmaceutical industries. LabWare is an international software products company focused exclusively on configurable LIMS. “We are pleased to continue our relationship with the IU School of Informatics, which has earned an international reputation in preparing today’s students to become tomorrow’s leaders in laboratory sciences,” says LabWare President Vance V. Kershner. It’s not the first time the two institutions have partnered on a project. In July 2003, LabWare established an active training center at the School’s IUPUI facilities, where professionals from around the country are trained in LabWare LIMS. In addition, LabWare has provided its experts for training and support, and internship opportunities for IU laboratory informatics graduate students. The IU School of Informatics was established in 2000 – the first and the largest of its kind in the nation – and has nearly 1,600 undergraduate and graduate students enrolled in programs at campuses in Bloomington, Indianapolis and South Bend. For details, visit http://www.informatics.iupui.edu or http://www.labware.com.

Fort Dearborn Links with Group Logic to Build System-Driven Workflow

Fort Dearborn Company, a leading manufacturer of high-impact label solutions for high-velocity consumer goods marketers, has completed a full integration of Group Logic’s MassTransit product as a critical component in their automated production workflow process. "In order to maintain profitability, we must be on the leading edge in
identifying opportunities to improve internal workflow efficiencies," explains Murray Oles, Vice President and Chief Technology Architect for Fort Dearborn. "We use MassTransit to manage uploading and downloading of computer-to-plate files which automates the transfer of digital files and integrates this with our own digital asset management system for storage and organization of customer files. What it really allows us to do is move up and down the supply chain seamlessly. In our industry, the logistics side is getting more and more challenging. Labels are getting moved to different locations around the country based on where products are being packed,
creating a just-in-time manufacturing scenario." Group Logic worked closely with Fort Dearborn to create a network that seamlessly integrates Fort Dearborn’s proprietary digital asset management system, which uses Open Source and FlexStor database tools with MassTransit. The automated workflow provides a secure portal for
customers and partners to access or modify image files from Fort Dearborn’s system and then channels these files directly to preflight for approval. Once approved, MassTransit transfers the file through multiple workflow processes for appropriate distribution and production. For details, visit http:// www.grouplogic.com.

FDA Holding CGMP Workshops in China

The FDA is hosting a series of workshops in China aimed at educating participants on methods for complying with current good manufacturing practices (cGMP). The workshops, which will be held in collaboration with Peking University and the International Society for Pharmaceutical Engineering, will occur Dec. 5-7 and April 24-26, 2006, in Beijing. The agency said the workshops are targeted at a variety of pharmaceutical professionals, including process/production engineers, manufacturing personnel, quality assurance/quality control managers, regulatory affairs professionals, consultants, regulatory investigators and cGMP compliance officials. U.S. firms have increasingly been turning to China for active pharmaceutical ingredients and other services, but experts have warned that the majority of Chinese firms don't abide by FDA regulations. Of the approximately 4,200 pharmaceutical plants currently operating in China, only 51, or 1.2 percent, have passed FDA inspections, according to one industry expert. For more information about the workshops, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/cd0534.pdf.

ATL Announces New Business Location in Newton, New Jersey

Accelerated Technology Laboratories, Inc. (ATL), a premier supplier of LIMS, has announced a new business location in Newton, NJ. The company believes that the new office will enhance ATL's ability to meet the increased demand for its LIMS and related data management products and services in the north-east region. This office will primarily concentrate on providing technical support and LIMS implementation assistance to clients in the region. Don Kolva, ATL’s President, remarked, "We are very pleased to expand our business and would like to thank our customers for their loyalty and support which have contributed significantly to the company-wide growth." ATL offers the Sample Master LIMS product line in many industries such as government, environmental, water and wastewater, R&D, manufacturing and public health. ATL also offers ScreenIT Pro for manufacturing environments and NeoMate for clinical data management. ATL is currently headquartered in West End, North Carolina and maintains office locations in Seven Lakes and Greensboro, NC, a West Coast office in Sparks, Nevada, and its newest location in Newton, NJ. For details, visit http://www.atlab.com.

Bika Laboratory Management Tools Open Sourced

Bika Lab Systems have released the source code for its LIMS under the GNU GPL. The Bika v1.0 is already used in production in a range of organisations including at a Western Cape wine bottling co-operative. Bika is built in the Zope and Plone object oriented application server and web content management systems, and programmed in Python. The Bika LIMS is browser-based and can be used by both laboratories as well as clients to monitor production processes. In its standard implementation, Bika stores data in the Zope Object Store (ZODB), but can easily be modified to suit most open source or commercial DBMSs such as mySQL, Postgresql, MS SQL, Ingres, Oracle and Informix. Online security is maintained through the use of SSL, 128 bit encryption and digital certificates. The Bika Sourceforge web page for the project includes links for downloading the latest releases and documentation, issue trackers for bugs and solutions, technical issues, patches and feature requests. Forums and mailing lists are available for developers and users to discuss Bika topics and a news page provides information about new developments. Bika Lab Systems' Joris Goudriaan says that in sponsoring the project the company is committed to keeping the source code for Bika free and open. Goudriaan says the company will also provide the necessary management and organisational skills for the project. Commercially, the company offers professional LIMS services to customers including requirement analysis, customisations, implementation, project management, training, systems administration, customer and technical support and the provision of an on-line LIMS service (ASP). With the participation of open source enthusiasts in the scientific, academic and business open source community, Bika plans to grow the application into a modular cross-industry LIMS and laboratory enterprise solution, featuring accounts and CRM packages available from Upfront Systems. Specifications and design for microbiology modules have been completed and modules are planned for the health, engineering and geology sectors. Laboratories are invited to submit requirement documentation. T he Sourceforge web site for Bika can be found at http://sourceforge.net/projects/bika. Downloads of Bika can be found at http://prdownloads.sourceforge.net/bika/Bika-1.0.0.tgz?download.

Data Overload Could Lessen Impact of Drug Watch

The FDA' proposed Drug Watch website may not pack the punch that many pharmaceutical companies fear, according to one financial analyst. Drugmakers have expressed concerns that the Drug Watch, which will house emerging safety information about drug products, could cast a manufacturer in a negative light if information about one of its products is posted on the website. Such concerns, however, may not surface because the site is likely to be too voluminous to make individual product safety warnings stand out, David Risinger, a research analyst with Merrill Lynch, writes in a recent research note. "Data overload could dilute the impact of the Drug Watch," Risinger writes. "Investors should note that FDA public postings/documents tend to provide large amounts of data without necessarily providing the agency's interpretation of the data. Unless the agency specifically highlights information within Drug Watch as 'new' and 'concerning,' an increase in public disclosure may not have much of an impact on physician, patient or investor perception." The fact that the FDA has already started posting emerging safety information on an interim website could also minimize the effect of the Drug Watch, Risinger notes. In May, the agency unveiled a "Drug Specific Information" web page that provides access to safety information on roughly 250 approved drugs. The FDA has been releasing emerging safety data on the website — http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm — in advance of the pending Drug Watch launch.
The Drug Watch, announced in February as part of the agency's effort to boost drug-safety oversight, has drawn strong criticism from the drug industry. In recent comments to the FDA, PhRMA argues that listing such information "not only is of little or no help in guiding prescribing or treatment decisions, but also is potentially misleading when presented on an official FDA Drug Watch website." But as of early summer, the FDA was still grappling with the threshold it would use for listing a drug. The FDA has heard that the threshold should be low, "so that every signal would not necessarily raise huge alarm bells," said Susan Cummins, medical team leader of CDER's division of pediatric drug development. "It would be just part of the background of information gathering in the practice of medicine," she said. On the other hand, the FDA has heard suggestions that the threshold should be high, she said. For details, visit http://www.fda.gov.

Gottlieb States FDA Oversight Not Affected by Critisism of Safety Decisions

Recent criticism of the FDA's handling of drug-safety issues has not made the agency too conservative in its oversight of drugs, but attacks on advisory committee members could affect the FDA's ability to hold frank scientific discussions, says a top agency official. Scott Gottlieb, the FDA's new deputy commissioner for medical and scientific affairs, rejects claims that the FDA has responded to critics with a new sense of caution and that the agency has changed its drug regulation strategy. A recent report in The New York Times suggested the FDA has tightened enforcement, noting that so far this year the agency has issued twice the number of public health advisories on drug risks than it did during all of last year. Drug applications in the first half of 2005, meanwhile, took almost twice as long to win approval as they did a year ago, according to the Times. "I don't think you can extrapolate from anecdotal data to try and draw a conclusion that the agency is skewed in one direction," Gottlieb told FDAnews. "I don't think the agency moves in a sort of monolithic fashion in one direction or another. FDA divisions typically face different problems and make decisions based on the information they have, he said. "I don't get the sense that there has been a dramatic change in the internal environment in terms of the careful work people do and the science-based approach they bring to the job." Still, firms have expressed concern the FDA will raise approval standards and lower the threshold for withdrawing drugs when safety issues arise. Other top FDA officials have tried to allay such fears, noting the FDA's top priority is to strike the right balance between evaluating risks and benefits, not follow the fashion of the moment. What concerns Gottlieb the most, however, is the recent criticism aimed at FDA advisory committees. "I worry that attacks on [panel members] could inhibit their ability to have frank, open scientific discussions in public," said Gottlieb, who declined to give specific examples. For details, visit http://www.fda.gov.

India Offers Robust Growth Opportunities to ERP Suppliers According to ARC Research Survey

Manufacturing companies in India are investing in Enterprise Resource Planning (ERP) solutions in order to
improve their manufacturing operations. ERP suppliers, both global and homegrown, will find India an important marketplace for their businesses. The Indian ERP market is expected to grow at a Compounded Annual Growth
Rate (CAGR) of 25.2 percent over the next five years. The market was $83 million in 2004, and is forecasted to be over $250 million in 2009, according to a new ARC Advisory Group study, "ERP Software & Services
Outlook for India". Manufacturing companies operating in India face the challenge of having to improve their competitiveness. With the country remaining a low cost economy, they are battling against declining prices and a squeeze on their margins. These challenges drive manufacturers to realize that business decisions should be based on real-time information, resulting from synchronized business and production processes. "Manufacturers in India are increasingly implementing ERP solutions to ensure that decision makers have the required information visibility across the value chain," according to ARC Senior Analyst Libi Baskaran, the study's author. The Indian economy is closely integrated with the global economy and is emerging as a low cost production center for a wide range of products produced to meet the demand arising from both domestic and export markets. As a result of India's sustained economic growth over the last few years, the country is emerging as a demand centric economy. Indian and global companies in the marketplace are subjected to intense competitive pressures. These increasingly competitive pressures drive Indian manufacturers to deliver high quality products at lower prices. Manufacturers, challenged to meet these pressures, seek to optimize their sourcing, manufacturing, and distribution decisions. Indian manufacturers, as they gear up to become more productive and price competitive, have realized the value of ERP solutions. This realization is leading to the
growth of the ERP business. For details, visit http://www.arcweb.com/res/erp-ind.

Waters' Empower 2 Software Ships

Waters Corporation has announced it is shipping Waters Empower 2 Software, the company's flagship chromatography data management software solution. First introduced at the 2005 PITTCON conference and exhibition in February, Empower 2 Software acquires, manages, processes, reports and distributes data generated by Waters ACQUITY UPLC and Alliance systems as well as third-party instruments. Features in Empower 2 Software increase the productivity and efficiency of an analytical laboratory's workflow. A single window interface centralizes the user's experience so that scientists can easily collect, process, customize and print experimental results. Advanced data and system management tools to ensure analytical system availability and automated custom calculations let scientists run samples and make critical decisions during the analysis. Empower 2 Software monitors chromatographic results, compares these results to predefined limits and responds appropriately to any condition to assure scientists of increased system uptime and sample throughput. Empower 2 Software's enhanced integration with Waters NuGenesis SDMS (Scientific Data Management System) Software and Waters eLab Notebook software makes data transfer to information management solutions transparent to the end user. This cohesive informatics environment allows scientists to multi-task among integrated applications and make decisions in real-time, thereby improving the labs efficiency. For details, visit http://www.waters.com/informatics.

Live Online Demonstration of LabSoft LIMS by Computing Solutions

Computing Solutions, Inc. (CSI), a premier LIMS provider, is offering a free live online demonstration of
LabSoft LIMS. LabSoft LIMS is a powerful, fully integrated laboratory information management system that is driving down the Total Cost of Operation (TCO) for LIMS. TCO is reduced through built-in Process Control tools and the backwards compatibility of LabSoft LIMS. Unlike many other LIMS systems, LabSoft LIMS has built-in graphing, viewing, and statistics tools. The built-in tools remove the need for third party Process Control software, thereby reducing the overall licensing and maintenance costs for your data management solution. Backwards compatible updates and upgrades are included in LabSoft LIMS' Annual Maintenance program. Backwards compatibility removes the need for costly reinvestments to stay current on LabSoft LIMS' features
and technology advancements. To schedule a live online demonstration of LabSoft LIMS, visit http://www.labsoftlims.com.

STARLIMS Showcases International Forensic LIMS Projects at IAFS 2005

The upcoming 17th Meeting of the International Association of Forensic Sciences (IAFS) in late August in Hong Kong will highlight STARLIMS involvement in international forensics. STARLIMS is co-sponsoring the event and will be showcasing two case studies: a DNA database laboratory and a comprehensive forensic operation coverin multiple-labs. STARLIMS assists a forensic laboratory in the efficient management of substantial quantities of data relating to evidence collection, analysis and case management. The reliability and accuracy of forensic information provided is crucial to its proposed usage throughout the legal process. By capturing all relevant evidence submission data at the time of receipt, STARLIMS allows the forensic laboratory to perform extensive evidence tracking through the "life cycle" of the investigation. The comprehensive integrated electronic chain-of-custody provides a complete record of evidence submission transfer and laboratory activities, incorporating full transactional audit trails, bar-coding and electronic data storage and signatures. Data migration is facilitated and a backlog of historical data is stored for retrieval. Statistical information is made available pertaining to case results, case cross-reference, analyst performance, case backlog, or other pertinent data related to overall performance. STARLIMS supports compliance with standards such as ASCLD and ISO 17025. For details, visit http://www.starlims.com.

GenoLogics Launches OmixLIMS Software Platform for Systems Biology Research

GenoLogics Life Sciences Software Inc. has announced the formal launch of OmixLIMS as an enabling software platform for systems biology research. OmixLIMS gives laboratories focused on proteomics, genomics, transcriptomics and metabolomics research the ability to implement a lab information and scientific data management system on a common platform, facilitating experimental workflow management, scientific data integration, sharing, and analysis across the systems biology domains. This benefits the many organizations with research and core labs working in different scientific disciplines that need to share and integrate their scientific results, and optimize their research efforts for integrated analytics and biomarker discovery. Multi ‘omics’ research institutes such as Scripps Florida and others have selected GenoLogics software platforms to implement an informatics infrastructure that meets the integration challenges within and between labs. The OmixLIMS platform is a highly configurable and robust solution aimed at life science and biotechnology laboratories, allowing researchers to manage their lab information, provide sample tracking and experimental workflow capabilities, and ultimately capture, integrate, and manage large volumes of scientific data. OmixLIMS is a scalable solution for managing many diverse research lab environments, while providing a unified informatics infrastructure for large research institutes and pharmaceutical/biotechnology companies. The OmixLIMS platform was built using the latest Java programming technologies (J2EE – Enterprise Java) and OmixLIMS offers both a rich user interface for laboratory workstations, as well as a web interface for collaboration work. For details, visit http://www.genologics.com

GenoLogics Solution Provides Powerful Capability to help Proteomics Researchers in Biomarker Discovery and Data Analysis

GenoLogics Life Sciences Software Inc., a leading developer of solutions that help research and pharmaceutical laboratories manage, integrate and analyze enormous volumes of scientific data, announced today added functionality to its ProteusLIMS solution, making it the most powerful system available on the market to speed
biomarker discovery and validation in proteomics and systems biology. The GenoLogics open systems platform and approach to open standards makes ProteusLIMS unique in the industry. Labs are not tied into proprietary software for their equipment and analysis tools. With ProteusLIMS, labs can leverage their IT infrastructure and provide uniform access to data while managing the entire proteomics workflow. Researchers can define how they want their data, it is tied together contextually and it can be viewed and analyzed in multiple ways, no matter where it is stored. ProteusLIMS provides a powerful integrated platform for proteomics research. The GenoLogics solution offers maximum choice to labs – its open systems platform ensures compatibility with any instrument, software analytic tool and process, offering labs the greatest flexibility and use of their existing lab assets for fully integrated proteomics workflows. For protein searches, GenoLogics now integrates with Mascot, Sequest, Peaks, X! Tandem and Spectra Mill, providing superior capability for protein identification and biomarker validation as results can be compared or cross referenced from multiple analyses for a more powerful interpretation. ProteusLIMS integrates to a broad range of robots and virtually any gel analysis software, including Progenesis and now also DeCyder, enabling researchers to view results from any computer. For details, visit http://www.genologics.com.

Bruker Daltonics Appoints Michael Schubert as Executive Vice President and Ian Sanders as Vice President

Bruker Daltonics Inc. has announced two promotions to further strengthen its senior management team. Dr. Michael Schubert has been promoted to Executive Vice President of the Bruker Daltonics group. He retains his previous responsibilities for Bruker Daltonics' global R&D management, as well as his function as Managing Director (Geschaeftsfuehrer) of Bruker Daltonik GmbH, located in Bremen and Leipzig, Germany. In addition, Dr. Schubert now also assumes responsibility for the Company's life-science mass spectrometry business in the Americas. Dr. Schubert joined Bruker Daltonics in 1991, and has held several project and R&D management positions. In 2002, he became Managing Director of Bruker Daltonik GmbH, and in 2004 Vice President for R&D of Bruker Daltonics. He holds a doctorate from the University of Hamburg in physics. Ian Sanders, Ph.D., has been promoted to Vice President for European Life Science Sales, a function that he has previously managed as an Assistant Vice President. He also continues in his role as Managing Director of Bruker Daltonik GmbH. Dr. Sanders joined Bruker Daltonics in 2000 following a ten-year career in drug discovery research for both large pharmaceutical and venture biotechnology companies. Initially responsible for the UK business, in 2002 his role expanded to manage life-science sales in the UK, Scandinavia and The Netherlands. In 2004, he became Assistant Vice President for European Life-Science Sales, and in 2005, Managing Director of Bruker Daltonik GmbH. He holds a Ph.D. in drug discovery technology from The University of Bath, UK. For details, visit http://www.bruker-biosciences.com.

Labtronics Releases Instrument Integration Solution for Agilent Technologies' ChemLMS LIMS

Labtronics Inc., a world leader in laboratory data integration and management solutions, has announced the release of a new version of the industry-leading LimsLink and LimsLinkCDS instrument interfacing solutions specifically designed for Agilent Technologies' ChemLMS. Labtronics' LimsLink and LimsLinkCDS provide an off-the-shelf solution for integrating any laboratory instruments to Agilent's ChemLMS LIMS. "Labtronics and Agilent have a long history of partnering to provide integrated solutions for laboratories," said Robert Pavlis, President of Labtronics Inc. "Our LimsLink and LimsLinkCDS solutions enable Agilent ChemLMS customers to get even more value from their investment by ensuring that ChemLMS and their instruments are sharing data quickly and accurately." For details, visit http://www.labtronics.com.

Protedyne Corporation Completes D Round of Funding with Investors including Allen & Company LLC

Protedyne Corporation, a leading laboratory automation solutions provider, has announced an investment in the Company’s D round of financing by a group of accredited investors including Allen & Company LLC. This investment brings the total raised in the Company’s D round to $10 million. Other participants in this closing were existing investors, including The Sprout Group, Meridian Venture Partners, Long River Ventures, Village Venture Partners and Boston Community Venture Funds. Previous investors in Protedyne’s D round include QIAGEN N.V. (NASDAQ: QGEN), one of the world’s leading providers of technologies and products for the separation, purification and handling of nucleic acids and proteins. Protedyne will use the proceeds of the Series D financing for working capital purposes, including enhancements to the Company’s BioCube System product line and for new product development and expanded marketing activities. "Our BioCube System has changed the face of laboratory automation,” said Protedyne President, Donald Schoeny. “In just five years, Protedyne has deeply penetrated the Diagnostic, Drug Discovery and Genomic markets, giving laboratories the ability to perform research and diagnostic testing faster and more reliably. Our next generation of products will bring even more automation advances to research and diagnostic laboratories. The success of this round of funding demonstrates investors’ confidence in Protedyne’s momentum and expanding market opportunities, particularly in the diagnostics arena. We are elated to have the support of Allen & Company LLC” continued Schoeny. For details, visit http://www.protodyne.com.

New FDA Guidance on Risk Management Released

Drug manufacturers that implement effective quality risk management systems could see fewer government regulators peering over their shoulders, suggests a new guidance on risk management released by the FDA.
Effective quality risk management can facilitate better and more informed decisions by manufacturers and provide regulators with greater assurance of a company's ability to deal with potential risks, according to the International Conference on Harmonisation (ICH) "Q9 Quality Risk Management" draft guidance, released by the FDA. This, in turn, "can beneficially affect the extent and level of direct regulatory oversight," notes the ICH guidance, which supports the FDA's "Pharmaceutical Current Good Manufacturing Practices [cGMPs] for the 21st Century" initiative, which the agency finalized last Fall. The new ICH guidance provides principles and examples of tools for quality risk management that can be applied throughout the life cycle of the drug substance or product. "The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions," the document states. The two primary principles of quality risk management are:
* The evaluation of the risk to quality should ultimately link back to the protection of the patient; and
* The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk, and be based on scientific knowledge.Risk management activities are usually, but not always, undertaken by interdisciplinary teams, the guidance says. Teams should include experts from the appropriate areas involved, and individuals who are knowledgeable of the quality risk management process, it adds. Steps to initiate a quality risk management process include:
* Defining the problem and/or "risk question," including assumptions identifying the potential for risk;
* Assembling background information and data on the potential hazard, harm or human health impact relevant to the risk assessment;
* Defining how decisionmakers will use the information, assessment and conclusions;
* Identifying a leader and necessary resources; and,
* Specifying a timeline and deliverables for the risk management process.The results are represented pictorially in the form of a tree of fault modes, the guidance says. "The method can be used to establish the pathway to the root cause of the failure," it says. "Fault Tree Analysis is a good method for evaluating how multiple factors affect a given issue," it adds. A copy of the ICH draft guidance "Q9 Quality Risk Management," published in the Aug. 8 Federal Register, is at http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0288-gdl0001.pdf.

Survey Reports Firms Using More Technology in Clinical Trials

While most clinical trial sponsors continue to use paper data collection methods, more sponsors are using technology in their studies and recognize the need for electronic standards, according to a recent survey that included drugmakers and investigative sites. There has been a "significant increase" in the use of electronic patient reported outcome (ePRO) technology and electronic case report forms (CRFs), said Dave Iberson-Hurst, CEO of Assero, a UK-based provider of tools for implementing the clinical trial industry's Clinical Data Interchange Standards Consortium (CDISC) standards. In 2004, these tools were implemented in 23 percent of trials, up from 19 percent in 2003, he said. Drugmakers and sponsors of clinical trials believe CDISC standards will help speed regulatory approval and improve data exchange among partnering companies, the survey found. Trial sponsors also believe CDISC standards will reduce the effort required in making a regulatory submission, provide the basis for rapid agreement on standards within an organization and reduce the cost of data transfer, according to the survey, "Attitudes, Adoption & Usage of Data Collection Technologies and Data Interchange Standards." Survey respondents included biopharmaceutical companies, CROs/service providers, investigative sites, technology service providers and consultants. The survey was conducted from October 2004 to January 2005. More than half of the respondents had 10 or more years of experience, he said. For more information about CDISC standards, go to http://www.cdisc.org.

Autoscribe Releases New Version of Sample Tracker

Autoscribe has released a new version of their Sample Tracker Windows based system that enables users to
track the progress of samples and work. Enhancements include: greatly simplified management by tracking work and samples; enhanced traceability and accountability; time savings by automatically allocating tests to samples as they are registered; error elimination by allocating a unique identifier to each sample; immediate feedback on work progress; enhanced information through standard set of reports e.g. trend of sample turnaround times; and, easy upgrade to full LIMS functionality with full protection of entered data. Sample Tracker allows the registration of samples, the creation of worklists, progress/status checking, chain of custody management and reporting. Details of sample submitters, product types and users, with their associated authority, are all stored within the system. For details, visit http://www.autoscribe.co.uk.

Autoscribe' ICMS Enables Cost Effective Regulatory Compliance

The latest version of Autoscribe's Instrument Calibration and Management System (ICMS) includes electrical safety checking in addition to calibration and maintenance. Instrument systems (e.g. HPLC) can be linked to components (e.g. detector, pump, etc) which can be individually managed. Any ODBC compliant reporting tool can be used to develop reports. ICMS is a convenient and easy way to maintain records on the instrumentation and equipment in the laboratory and / or company. It can be supplied as a standalone product or as an integral part of Autoscribe's Matrix LIMS. Furthermore it can be supplied as an 'out of the box solution' or as a fully configurable COTS package that can be integrated with other systems. ICMS is a useful utility in any environment and especially useful for maintaining compliance with regulatory standards. For details, visit http://www.autoscribe.co.uk.

Caliber Systems Launches Caliber Environment Monitoring System (EMS)

With the increased interest in environmental monitoring by regulators worldwide, pharmaceutical company Environmental Monitoring (EM) programs are becoming one of the most critical quality systems. The intent of an EM program is to identify potential routes of product contamination and take appropriate corrective actions prior to contamination occurring. Caliber Systems' new Caliber EMS is designed specifically for environmental monitoring as an out of the box solution to meet all the monitoring requirements including scheduling, trending and analysis. Environmental monitoring data can be simplified, centralized, and standardized through Caliber EMS. Using Caliber EMS, much of the manual effort (and error) around alerts, actions, trend reports, and data analysis can be reduced or eliminated all together, translating into direct bottom line savings. Caliber EMS has been expressly built to promote compliance with GMP regulations and FDA 21 CFR Part 11. The system security, electronic signature and audit trail are designed to provide maximum flexibility and configurability while preserving data integrity. In addition to these features, Caliber EMS has bi-directional interface capability to analytical instruments, tracks samples through user-defined barcode labels, and organizes study results in a unique document management system. For details, visit http://www.caliber-systems.com.

ValGenesis Releases ValGenesis 1.0 Enterprise Validation Management and Tracking System

Keeping up with the latest manufacturing and control technologies are a critical responsibility of any manufacturer in the pharmaceutical, biotechnology, and medical device industries. Over the last several years, health authorities in the United States and Europe have turned their attention to the apparent stagnation in manufacturing and control technologies used throughout the industries. They also have taken a hard look at their own regulatory requirements to identify necessary reforms to accommodate a new ‘innovation revolution’ within the industries. ValGenesis 1.0 was designed to fill the void in these industries for an inventory tracking system for validated entities that is e-signature capable. ValGenesis is an Enterprise Validation Management and Tracking System designed to manage the entire validation life cycle from validation document number generation to online execution. ValGenesis enables organizations to completely automate their validation activities and improve efficiency by eliminating a classically paper driven and time consuming process. ValGenesis conducts validation test script execution electronically equating to a completely paperless validation process. It is a modular, web-based system that is fully compliant with 21 CFR Part 11. Each module in ValGenesis serves a specific function such as tracking the validation status of any GxP entity, developing validation documents in a collaborative manner, executing validation documents online, and scheduling revalidation tasks. ValGenesis also has flexible approval workflows (via electronic signatures) across all modules. For details, visit http://www.valgenesis.com.

Prime Technologies, Inc. Launches ProCalV5 User Group

Prime Technologies, Inc. has established a user group for customers of its ProCalV5 line of calibration software. The user group will be served through a variety of vehicles for the purpose of information exchange and shared experience, as well as for insights and assistance with compliance management issues. "Our goal is to offer the most user friendly calibration software that we can,” explains Nick Volpone, President of Prime Technologies. “We think that this group will provide the kind of interaction necessary to maintain a superior calibration product, as well as sharing experiences, information exchange, assistance with compliance management and enhanced productivity through optimal use of the ProCalV5 system. The new ProCalV5 User Group offers a full compliment of communication vehicles to serve members, including: a user website featuring chat rooms, forums, and Q&A formats regarding product news; a newsletter produced twice a year to provide new product information, case studies, and other user assistance, and, an annual meeting of ProCalV5 customers tied to major industry conventions. For details, visit http://www.primetechpa.com and register for the User Group.

EPA Region 4 Orders EarthSoft's EQuIS 5

Earthsoft has announced that a second EPA Region, Region 4 in Atlanta, has ordered EQuIS 5 Enterprise. The configuration included the modules for automated workflow including Enterprise EDP, Enterprise EZView, and EarthSoft’s Environmental Information Agents to ‘push’ information to data consumers via email. Several licenses of EQuIS for ArcGIS and RockWare’s RockWorks and LogPlot were also ordered along with their EQuIS interfaces. These integrated Professional modules, running against the same database as Enterprise, provide a powerful user interface to generate advanced queries, reports, and data ‘pulls’. Working together, Professional and Enterprise allow for a very few power users to support many casual users. For details, visit http://www.earthsoft.com.

MiraiBio and Redasoft Form Product Alliance for Bioinformatics Products

At the IBC Drug Discovery Technology Conference in Boston in early August, MiraiBio and Redasoft Corporation announced a product alliance between the two companies for the integration and co-development of their respective bioinformatics products - DNASIS MAX and Visual Cloning - for the life science industry. MiraiBio’s DNASIS MAX is a robust sequence analysis software package that delivers industry standard functionality, including molecular biology tools, multiple consensus calling methods, and rapid BLAST searches, as well as unique features that enhance common task performance and allow user-defined product customization. Redasoft's Visual Cloning software accelerates drug discovery by helping life scientists easily access and analyze genetic sequences, visually design and simulate molecular cloning experiments, and quickly create professional quality genetic maps for presentation and publication. Visual Cloning features an advanced editing environment, sophisticated graphics, integration with several existing online bioinformatics tools and databases, and access to Redasoft's Cloning Vector Search Engine. This product alliance will provide MiraiBio and Redasoft customers with extended product capability and a more robust desktop bioinformatics environment. Upgraded versions of each product will be released to accommodate this integration and will be provided free of charge to existing customers. These product upgrades – DNASIS MAX version 2.6 and Visual Cloning version 3.2 - will be available this month. Both companies anticipate extended product and business collaboration in the future.
For details, visit http://www.miraibio.com.

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

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