LIMSource News: What's New - March to April 2005

• California Links up to the STARLIMS Public Health Collaboration Effort
• STARLIMS Corporation Introduces STARLIMS Version 10 at Users Group Meeting
• Siemens A&D Introduces Simatic IT 6.1
• Thermo Electron Names Former Lotus Executive to Lead Informatics Business
• Avecia Selects Waters Empower Software as Strategic CDS Platform for Validation and Regulatory Compliance
• Scientific Software and Labtronics Announce LimsLink for OpenLAB Laboratory Software Framework
• Labtronics to Host Web Casts on Electronic Laboratory Notebooks for the QA/QC Laboratory
• SAFE-BioPharma Members Making Progress on Digital Signature Standard
• Wyatt Technology's Astra-Nomical Light Scattering Software Now Compatible with Waters' Empower Software
• FDA Official Says Drug Labeling to Undergo Major Changes
• PhRMA Optimistic About Paperless Labeling Initiative
• FDA Issues Guidance on Timeliness Disputes for Combination Products
• Internal Timelines for PDUFA Reviews Added to GRMP Final Guidance
• FDA to Discuss Combination Product Cross-Labeling
• FDA Releases Three Final Guidances on Drug Risk Management
• US Air Force Centralizing Control with STARLIMS
• QSI Claims Training Cuts LIMS Failures
• Teranode Names "Cool Vendor" by Leading Analyst Firm
• GenoLogics Introduces ProteusLIMS into Europe
• CISPro Chemical Inventory System Now Delivers Fast Internet Access to New ChemGold2, World’s Largest MSDS Database
• New NWA Quality Analyst 6 Supports Corporate Quality Initiatives and Simplifies SPC Integration with Enterprise Applications
• Accelerated Technology Laboratories Acquires Zimet Associates
• Frost and Sullivan Names Waters Corporation 2005 Leading Analytical Instrumentation Company of the Year
• FDA Reports Increase in Applications, Decrease in Approval Times for 2004
• Varian, Inc. to Focus Efforts on Scientific Instruments and Vacuum Technologies Businesses; Sells Electronics Manufacturing Business
• PennWell Corporation Relies on ExtremeZ-IP for Migration from Novell to Windows Server 2003
• BioAnalyte Appoints New Production Manager of the Regatta Biomarker Discovery Platform
• Advances in Biopharma Sciences, Genomics to Drive Pharma's Future, Experts Say
• FDA E-Submission Gateway Takes Form
• New LabPAS Adaptive LIMS Version 2.1 Unveiled
• PerkinElmer Now Offers Remote Access, Web-Based Capabilities with LABWORKS LIMS
• Autoscribe Introduces LIMS Builder
• Thermo Electron Focuses on Commercial-Off-The-Shelf Laboratory Software Solutions
• Thermo Electron Highlights Leadership in Asset Management at Pittcon 2005
• ABB and Holcim Sign Agreement
• ESA Biosciences Awarded NIH Grant to Further Metabolomics Research
• Open Source Expert Joins BioAnalyte
• Bioanalyte Expands Pact with Positive Probability
• Agilent Technologies Introduces Industry's First HPLC-Chip/MS System for Proteomics
• Bruker BioSciences Reports Fourth Quarter 2004 Revenue
• Bio-Rad's KnowItAll System 5.0 Offers World’s First Multi-Technique Spectral Searching System
• Bio-Rad Extends Powered by KnowItAll Software and Database Outsourcing Services Program
• Bio-Rad Releases Eight New ADME/Tox Databases
• APG Offers Advantage Reporting and Training Verification Tools
• APG and NMi Form Global Distribution Agreement in the Proficiency Testing Industry
• APG Offers Microbiological and Soil Proficiency Testing Samples
• CDER Delays Timetable for New Drug Office Reorganization
• CDER Reports 14 Percent Increase in Adverse Event Reports for 2004
• Lawmakers Introduce Legislation for Clinical Trials Registry
• Analyst Expects Slow Growth for Generics in 2005
• FDA Official Recommends Firms Consult FDA Prior to eCTD Submissions
• FDA Releases Guidance on NDA, BLA Safety Reviews
• 'New' EU Countries Seeing Rapid Pharmaceutical Growth
• GPhA Urges FDA to Create Abbreviated Follow-On Pathway
• FDA Unveils Online User Fee System
• Lawmakers Want Pharma Execs Criminally Liable for Withholding Safety Data
• FDA Should Act on Follow-On Biologics, Waxman Says
• GAMP Forum Issues Guide on Electronic Records and Signatures
• House Bill Would Prevent Political Tampering With Federal Research
• FDA Generic Drug Funding Sees Little Change in Fiscal 2006 Budget
• FDA Drug Inspections Expected to Decline in Fiscal 2006
• FDA Generic Drug Funding Sees Little Change in Fiscal 2006 Budget
• Increased RFID Use Poses Challenges for Drug Industry, Study Finds
• Gardner Named Permanent Director for FDA's DCRMS
• Proposed Fiscal 2006 Budget to Focus on FDA Drug Safety
• FDA Issues Draft Guidance on Immunotoxicity Studies

California Links up to the STARLIMS Public Health Collaboration Effort

STARLIMS Corporation, a leading global provider of LIMS has announced selection by the University of California, Davis on behalf of the California Department of Health Services (CDHS) of STARLIMS for the Richmond Laboratory Campus. STARLIMS will replace several legacy LIMS system currently in place. STARLIMS is purposely designed to fully integrate the daily functions of a multidisciplinary public health laboratory (PHL). STARLIMS Richmond Laboratory Campus implementation will serve approximately 100 lab technicians and scientists across five laboratories located at the Richmond Lab Complex (RLC). Included in the project is a workflow for approximately 200 tests performed within the CDHS, incorporating input from over 110 different instruments. The RLC is the tertiary public health lab for the state of California. It serves as a reference lab for 39 regional public health labs as well as for the testing of reportable disease specimens from private hospital and commercial labs. The complex responsibilities and interactions between public health partners necessitate significant coordination of information technology and information sharing methodologies to meet public health objectives. The specifications required by CDHS were based on industry data and systems standards, including the National Electronic Disease Surveillance System (NEDSS) and Public Health Information Network (PHIN) standards. The implemented STARLIMS system will also interact with the State’s CAHAN, ELR and WebCMR initiatives to provide up to date and easy to access data on which to make quick and educated decisions. STARLIMS is an enterprise level information system that brings together all public health laboratory activities into a single platform, offering comprehensive reporting, surveillance, and networking capabilities compatible with national and international standards. Public health solutions from STARLIMS are designed as a platform for linking between regional public health partners working under the PHIN framework, HL7 messaging protocols and using LOINC and SNOMED as the common vocabulary for test names and observations. This functionality will enable cross site sample transfer and data exchange between CDHS and appropriate federal agencies such as the Centers for Disease Control and Prevention (CDC) and its STARRS transaction engine, Food and Drug Administration (FDA) and other public health partners. For details, visit http://www.dhs.ca.gov or http://www.starlims.com.

STARLIMS Corporation Introduces STARLIMS Version 10 at Users Group Meeting

STARLIMS Corporation instopduced STARLIMS Version 10 at their recent Users Group Meeeting which was held in Orlando, Florida in conjunction with PITTCON. The new STARLIMS Version 10 is a web-based deployed LIMS that utilizes the scalability of Web Services. It is a true distributed application with an extensible design capable of supporting a virtually unlimited number of users connecting to the system via a local network or Internet. From the end-user perspective STARLIMS Version 10 is a web application, running inside the Internet Explorer browser and offering a user experience far more advanced than any other available web application on the market. The most advanced software technology is employed comprising Microsoft .NET platform, XML UIs, and Web Services, together with STARLIMS' LIMS application server. .For details, visit http://www.starlims.com.

Siemens A&D Introduces Simatic IT 6.1

Siemens Automation and Drives (A&D) now offers a new version 6.1 of their MES (Manufacturing Execution Systems) software Simatis-IT. Simatic IT now offers complete fulfillment of ISA-95 requirements, the international standard for manufacturing operations. This is gained by three new software components: Client Application Builder (CAB) is a web-based, zero administration cost MES client development environment. Data Integration Services (DIS) is an XML-based tool to integrate control and production systems with enterprise transactional systems such as SAP. Product Definition Manager (PDefM) is an engineering environment for translating specification into manufacturing actions. Simatic IT version 6.1 will be available in July 2005. For details, visit http://www.siemens.com.

Thermo Electron Names Former Lotus Executive to Lead Informatics Business

Thermo Electron Corporation has announced that David Champagne has been named vice president and general manager of its Informatics business, a world-leading provider of laboratory software solutions and services. Champagne's career includes 13 years at Lotus Development Corporation and two roles as chief executive officer for early-stage software companies. He joined Thermo in April 2003 as director of global services for Informatics and later was promoted to divisional commercial director. Champagne succeeds Dr. Jo Webber, who recently left the company to pursue a long-held desire to return to Europe and spend time sailing the Mediterranean.
"Jo established herself as an industry leader in LIMS over the span of her career and we are thankful for her many contributions to Thermo's industry-leading position," said Dan Kelly, president of Thermo's Informatics and Services division. "We wish her all the best. We asked Dave to take over leadership based on his demonstrated success at Thermo, his global management experience and his deep understanding of what it takes to be successful in enterprise software." On his new role, Champagne commented: "Informatics is a strategic area to Thermo, which has invested in building a market-leading software organization with an amazing product and service portfolio. Our goal is to make a quantum improvement in how customers benefit from software advances to streamline their laboratory business processes and to integrate with their instruments and robotics to create complete, robust solutions. With this change in leadership, we will continue to move forward executing our stated vision and plan." A graduate of the University of Massachusetts with a BS in Industrial Engineering and an MBA from Bryant University, Champagne built his career in enterprise software organizations. While at Lotus, which was acquired by IBM during Champagne's tenure, he led a global support and service organization of over 1,200 service professionals that addressed the needs of customers in more than 80 countries. Prior to joining Thermo, he was president and CEO of ProActivity Software, an early stage venture that provides business process analysis solutions, and, earlier, president and CEO of UPSPRING Software, a development tools vendor before it was acquired by MKS. Dr. Webber joined Thermo in September 2004 as part of the company's acquisition of InnaPhase Corporation, a privately held software company where she had served as chief executive officer since 2002. She is credited with establishing InnaPhase's strategic vision for vertical-oriented, commercial-off-the-shelf software solutions, in particular for the pharmaceutical industry.For details, visit http://www.thermo.com/informatics.

Avecia Selects Waters Empower Software as Strategic CDS Platform for Validation and Regulatory Compliance

Waters Corporation has announced that its flagship chromatography data solution, Empower Software, has been deployed in gas chromatography labs by Avecia, a leading global fine and specialty chemicals company based in Manchester, United Kingdom. Sold with Waters' Ultra Performance LC and HPLC instrumentation, Empower Software allows scientists to collect data, control multiple instruments from Waters as well as third-party vendors and report on their findings using an intuitive interface for increased productivity. Waters Empower Software acquires, processes and archives data generated by liquid chromatography, gas chromatography, mass spectrometry and photodiode array instrumentation. Its capabilities for the collection and reporting of
chromatography data are based on critically-designed user considerations that help scientists be more efficient and productive in their work. For details, visit http://www.waters.com.

Scientific Software and Labtronics Announce LimsLink for OpenLAB Laboratory Software Framework

Scientific Software, Inc., (SSI) a world leader in providing software solutions to the scientific community, and Labtronics Inc., a world leader in providing innovative laboratory data integration and management solutions, have announced the development of LimsLink
for OpenLAB, a connectivity module integrating OpenLAB to LimsLink. LimsLink for OpenLAB provides an off the shelf solution for integrating third party LIMS to SSI's OpenLAB Laboratory Software Framework. In this way, over 30 different commercial LIMS from different LIMS vendors can be integrated into the OpenLAB framework. LimsLink for OpenLAB provides the following capabilities: Extraction and transfer of sample data from LIMS to instruments; Transfer of data from OpenLAB to third party LIMS; Viewing OpenLAB reports from within third party LIMS packages; and, Transfer LIMS data to OpenLAB to make future searches easier. LimsLink for OpenLAB is available from Labtronics Inc. It can be added to any OpenLAB Laboratory Software Framework, version 2.0 or greater. For details, visit http://www.scisw.com or http://www.labtronics.com.

Labtronics to Host Web Casts on Electronic Laboratory Notebooks for the QA/QC Laboratory

Labtronics Inc. will be hosting a series of informational Web Casts entitled "ELN for the QA/QC Laboratory". These free educational Web Casts will help companies understand how an ELN for their QA/QC laboratories can provide significant benefits to their company. The Labtronics' Web Casts will introduce attendees to the latest advances in ELN technology that enable companies to expedite the QA/QC process allowing them to ship their products to the market sooner. Participants will see live demonstrations of the latest available ELN technology and gain perspective on how applying an ELN to QA/QC labs can save companies millions of dollars every year. For those companies that have already implemented ELN technologies into their research labs, this Web Cast will show the differences in ELN requirements between research and QA/QC labs. It will discuss how QA/QC labs can gain significant benefits by using an ELN that has been designed with their requirements in mind and highlight the important features that a QA/QC ELN would need in order to achieve these benefits. For information on dates and times of upcoming seminars or to register please visit:
- Pharmaceutical & Biotechnology http://www.labtronics.com/forms/register-ph-bio.htm
- Other Process Manufacturing http://www.labtronics.com/forms/register-mfg.htm.

Wyatt Technology's Astra-Nomical Light Scattering Software Now Compatible with Waters' Empower Software

Wyatt Technology, a world leader in absolute macromolecular characterization instrumentation and software, has announced at that its HPLC software system - ASTRA V - now interfaces with Waters' Empower chromatography data software system. By incorporating ASTRA V capabilities with Waters' Empower software, Wyatt now offers the ultimate ease-of-use in chromatography data management. The use of light scattering technologies in regulated industries is also now facilitated with the 21 CFR Part-11 compliant ASTRA software. The ASTRA V software complements Wyatt's multi-angle light scattering detectors to make absolute molecular weight determinations a desirable alternative to traditional liquid chromatography methods. By making ASTRA V compatible with Water's Empower chromatography data software system, it is now possible to acquire data using either system and control a variety of instruments including HPLC and light scattering technologies in FDA regulated industries. For details, visit http://www.wyatt.com.

SAFE-BioPharma Members Making Progress on Digital Signature Standard

A coalition of eight pharmaceutical companies is gearing up a public relations campaign for the SAFE (Secure Access for Everyone) digital signature standard that will culminate in major announcements at the Drug Information Association's annual meeting in June, a coalition spokesman said. SAFE-BioPharma, a coalition formed in February by AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble and sanofi-aventis, plan to release details about SAFE submissions to the FDA, as well as details about the group's new leadership, said Ashley Evans, SAFE-BioPharma's program manager. First announced last June, the SAFE standard is designed for business-to-business and business-to-regulatory agency transmissions, Evans said. Sponsors are considering dozens of applications for the standard, including investigational new drug applications and case report forms, he said. SAFE can also be used on any legal contract between a study sponsor and a study site, Evans said. For more information, go to http://www.safe-biopharma.org.

FDA Official Says Drug Labeling to Undergo Major Changes

Pharmaceutical firms will be required to make some of the most significant changes to their drug labels in a generation under various FDA labeling and electronic information initiatives that will soon take effect. Among the initiatives that will shake the status quo in place since the mid-1970s is the agency's final physician labeling rule. The final rule will roll out with a companion guidance, said Rachel Behrman, deputy director of the FDA's Office of Medical Policy. "This is going to be a very new label for us and a very new label for industry," she told members of the FDA Science Board Advisory Committee at a recent meeting in Rockville, Md. "We're going to have to help people learn how to write them; it's not easy, it takes some getting used to." Changes include consolidating drug safety information - such as contraindications, warnings, precautions and adverse reactions - and placing it higher in the label. Under current requirements, the safety information is sandwiched in the middle of the label, Behrman said. Under the final label rule, firms also must adhere to standardized bolding and white space requirements, as well as print the label in 8-point type font. Other changes include the addition of a new "highlights" section, which will be limited to about half a page and will present the most important drug information in a bulleted format, Behrman said. For details, visit http://www.fda.gov.

PhRMA Optimistic About Paperless Labeling Initiative

The drug industry has high hopes for its proposed electronic drug-labeling system, which can provide pharmacies with labeling changes in real-time and do away with the odd-sized paper labels that now must be affixed to the sides of medicine bottles. PhRMA plans soon to release the results of a paperless labeling initiative that was test-marketed in approximately 200 pharmacies nationwide. An earlier proof-of-concept pilot was a "resounding success," said Alan Goldhammer, associate vice president of regulatory affairs at PhRMA. During the larger market test that took place over a three-month period in the fall of 2004, PhRMA was able to update labeling on roughly 150 products, he told the Food and Drug Law Institute's annual meeting. "All of the labeling updates were successful [and] were up the very next day," Goldhammer said. Once the report on the initiative is available in two or three weeks, PhRMA plans to share that information with the FDA and industry and will "work toward full implementation," Goldhammer said. There is still some doubt, however, as to whether the program could be commercialized in 2006, he added. For details, visit http://www.phrma.org.

FDA Issues Guidance on Timeliness Disputes for Combination Products

The FDA has established a dispute resolution process for manufacturers to challenge the timeliness of premarket reviews for combination products. Manufacturers can submit a timeliness dispute resolution request with the Office of Combination Products (OCP) in situations when the FDA does not review and act on a premarket submission within the applicable time frame, according to a recent guidance. The applicable time frame will be determined by the type of premarket review goals to which the application is subjected. Combination products reviewed as drugs will fall under the review times established by the Prescription Drug User Fee Act, while products reviewed as devices will be subject to the review times contained in the Medical Device User Fee and Modernization Act. If a product is reviewed as both a drug and a device, the OCP will consider the time frames associated with each type of premarket application, the guidance states. To view the guidance, "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Products," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0182-gdl0002.pdf.

Internal Timelines for PDUFA Reviews Added to GRMP Final Guidance

The FDA has revamped its guidance on good review management principles (GRMPs) for Prescription Drug User Fee Act (PDUFA) products to include specific timelines for application review milestones - a change that should come as good news to drug manufacturers, many of which criticized the initial version of the document for being too vague. The GRMP final guidance, released by the agency March 30, contains detailed timelines for each of the five phases of the review process for new drug applications (NDAs) and biologics license applications (BLAs). "Adherence to these timelines with key internal milestones helps avoid the potential errors associated with crisis-style management dealing with unresolved issues at the end of the review cycle," the guidance notes. Released in draft form in July 2003, the GRMP guidance is intended to clarify the roles and responsibilities of FDA review staff in managing the PDUFA review process and to identify ways in which NDA and BLA applicants can further the effectiveness and efficiency of that. Implementing GRMPs will increase the number of drugs approved during the first application cycle, thus reducing overall approval times, the agency says. For details, visit http://www.fda.gov.

FDA to Discuss Combination Product Cross-Labeling

The FDA is seeking advice on whether it should consider reviewing — and possibly approving or clearing — a new product labeled for use in conjunction with an already approved product of a different type. To that end, the FDA will hold a meeting May 10, in cooperation with the Drug Information Association (DIA), to discuss such issues. The meeting is being held to solicit stakeholders' views and perspectives about the legal and public health issues that arise when sponsors seek to develop or market a device, drug or biological product that would be labeled for use with an already approved product of a different type for instances in which the approved product's labeling would not be changed. Often, two companies will work together to bring each product to market with mutually conforming labeling, sharing the responsibility to resolve scientific or legal issues that may arise as a result of the products coming from two independent companies. The sponsor of the approved product ordinarily must submit a supplement to its marketing application to amend the currently approved labeling to include directions for using the two products together. However, there are instances when two companies do not work together. The sponsor of the approved product may end up refusing to submit a supplement to allow a new product to be created. In such cases, requiring that the two products have mutually conforming labeling could end up preventing the development of new products. The FDA is concerned that valuable products may not be developed, manufactured or distributed because of sponsor concerns about mutually conforming labeling. A copy of the meeting's program and registration information is available online at http://www.diahome.org/Content/Events/05028.pdf.

FDA Releases Three Final Guidances on Drug Risk Management

A trio of final guidance documents focused on developing new ways to minimize the safety risks of prescription drugs and biologics are not expected to lengthen the product-approval process, a top FDA official said. The three guidances — "Premarketing Risk Assessment," "Development and Use of Risk Minimization Action Plans (RiskMAPs)," and "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment" — suggest new ways and improved methods to assess and monitor risks that arise during a product's life cycle. Recommendations in the final guidances generally mirror those in the draft guidances released last May, FDA officials said. Changes in the RiskMAP guidance, however, are "significant," an FDA official said. The RiskMAP changes place a greater emphasis on evaluation, transparency and stakeholder involvement, an FDA spokeswoman said. To view the guidance documents, visit http://www.fda.gov/bbs/topics/news/2005/NEW01169.html.

US Air Force Centralizing Control with STARLIMS

STARLIMS Corporation, a leading global provider of LIMS, has confirmed selection by the US Air Force Petroleum Office (AFPET) as a replacement for their legacy LIMS system. The US AFPET provides operations and maintenance guidance; technical, scientific and engineering support to Air Force installations and the fuels community worldwide. The Air Force has established ongoing priorities to provide continuing support to contingency and war fighting operations, create a plan of attack to resolve fuel quality issues and transform the Air Force into a service control point that is responsive to customers and strategically focused to deliver state of the art support. This includes world wide quality support to over 200 locations using six area laboratories (Wright-Patterson AFB, OH; Cape Canaveral, FL; Vandenberg AFB, CA; Mildenhall Air Base, United Kingdom; Kadena Air Base, Japan; and Al-Udeid Air Base, Qatar). “The current reshaping of the Air Force from a “cold war” stationary deterrent force to a mobile, rapid deployment force has greatly changed the way Air Force entities conduct business. The US Air Force’s current legacy LIMS will not support its deployable mission requirements nor will it provide timely, worldwide customer access to critical analysis results. The Air Force is excited to be partnering with STARLIMS and adapting their new Version 10 software to provide a fully functional LIMS which supports a worldwide customer and laboratory structure and a deployed laboratory asset, all with centrally controlled architecture,” commented Jeffrey Allen from the Air Force Petroleum Office. STARLIMS Version 10 is a true distributed application with an extensible design capable of supporting a virtually unlimited number of users connecting to the system via a local network or Internet. From the end-user perspective STARLIMS Version 10 is a web application, running inside the Internet Explorer browser and offering a user experience far more advanced than any other available web application on the market. The most advanced software technology is employed comprising Microsoft .NET platform, XML UIs, and Web Services, together with STARLIMS' widely distributed LIMS application server. This technical infrastructure is powered by proven LIMS business-logic and perfected by more than 15 years of experience by STARLIMS Corp. analysts and engineers. For details, visit http://www.starlims.com.

Teranode Names "Cool Vendor" by Leading Analyst Firm

Teranode Corporation, a leading innovator of experiment design automation (XDA) software for the Life Sciences industry, has been included in the list of "Cool Vendors" in the "Cool Vendors in Emerging Trends and Technologies," March 24, 2005 by Carol Rozwell, et al of Gartner, Inc. Teranode was listed in the report which discusses how the future of technology in the Life Sciences is tied to the continued penetration of technology into new areas and the massive proliferation of connected devices. Teranode's award-winning technology, TERANODE Design Suite (TDS), combines computational and experimental biology to automate tasks associated with planning, managing, and analyzing experiments. TERANODE Design Suite is a visual tool and platform that allows protocols and biological systems to be described, simulated, and automatically linked to create higher value physical experiments for the benefit of accelerated R&D. Gartner's listing does not constitute an exhaustive list of vendors in any given technology area, but rather is designed to highlight interesting, new and innovative vendors, products, and services. Gartner disclaims all warranties, expressed or implied, with respect to this research, inclu ing any warranties of merchantability or fitness of a particular purpose. Gartner defines a cool vendor as a company that offers technologies or solutions that are: Innovative, enable users to do things they couldn't do before; Impactful, have, or will have, business impact (not just technology for the sake of technology); Intriguing, have caught Gartner's interest or curiosity in approximately the past six months. For details, visit http://www.teranode.com.

GenoLogics Introduces ProteusLIMS into Europe

GenoLogics Life Sciences Software Inc., a leader in bioinformatics solutions for life sciences laboratories launched its new ProteusLIMS version 2.0 to the European market in London, UK at the InfoTech Pharma / Pharma Solutions Expo, March 15-16, 2005. The event is the premier annual global forum for top-level pharmaceutical IT executives to see the latest innovative IT systems and applications to accelerate R&D for drug discovery. ProteusLIMS is an industry leading software platform that automates, manages, integrates and analyses vast amounts of lab information and scientific data in life science pharmaceutical and academic research laboratories, particularly those in the field of proteomics. GenoLogics introduced ProteusLIMS version 2.0 in the United States at the Association of Biomolecular Resource Facilities (ABRF) conference in February 2005. Michael Ball, CEO of GenoLogics, notes “The life sciences are undergoing a revolution as new technologies are applied to biological research, generating enormous amounts of complex scientific data. With a track record of success providing software systems to proteomics laboratories in North America to manage vast volumes of data, GenoLogics is well positioned to expand its international presence into Europe and introduce the latest version of ProteusLIMS to pharmaceutical and life science laboratories at the InfoTech Pharma / Pharma Solutions Expo.” GenoLogics open bioinformatics software platform, purpose-built for proteomics research, integrates to all instruments, software tools and processes to fit with a laboratory’s current and planned IT infrastructure. ProteusLIMS improves data accuracy, traceability and reproducibility of results and is configurable to any workflow. For details, visit http://www.genologics.com.

QSI Claims Training Cuts LIMS Failures

QSI states that one of the commonest reasons that LIMS fail - or are seen to fail - is poor user acceptance of the system. QSI WinLIMS has a history of successful installations - over 600 world wide - and the company believes that the quality of its client training programmes is a key factor in achieving that success. "Over 60% of other suppliers' LIMS installations fail" said Clive Collier of QSI, "One reason can be that inadequate user training leads to a lack of confidence in the system and an impression that it is difficult to use. We always provide tailored training courses to each client company, mostly on-site and using the actual equipment supplied. We can even use a copy of the customer's own data to make the training totally realistic, while avoiding any risk to the live system." Training can be provided for all job functions, from lab technician to system administrator, and accommodate different levels of computer literacy. General user training is augmented by courses covering specific topics from instrument interfacing to the sophisticated Business Objects Crystal reporting module. "We would use a client's own instruments for an interfacing course, and show how to interface them to WinLIMS", said Collier. "With the reporting module, we would recommend initial on-site training followed by an advanced course after six months or so. Some of our larger clients prefer us to train one of their staff to do their own internal training. We don't regard client training as just another item on the delivery note, it's a vital component that makes all the difference." For details, visit http://www.lims-software.co.uk.

CISPro Chemical Inventory System Now Delivers Fast Internet Access to New ChemGold2, World’s Largest MSDS Database

ChemSW, Inc. has announced that users of their CISPro CIS Chemical Inventory System can now leverage the new ChemGold2 solution from ChemWatch North America. ChemGold2 delivers extensive MSDS information via the Internet, enabling CISPro Web users to subscribe and link to the largest database of independently researched MSDS (materials safety data sheet) documents via the Web. ChemGold2 extends the CISPro product by allowing customers to get even more comprehensive MSDS information much faster. ChemWatch, the world's largest database of independently researched chemical information and MSDSs, is now available on the Web with more information and easier access than ever before. The new ChemGold2 is the Web version of ChemWatch and contains all of the chemicals found in ChemWatch plus a link to a database of more than 1.5 million vendor MSDS. ChemGold2 provides detailed MSDSs on over 40,000 pure substances and 85,000 common mixtures to help laboratory workers comply with hazard communication requirements. It delivers an easily searchable source of chemical properties and toxicological values that will save research time and provide hard to find information quickly. In addition, tools for printing custom designed labels for laboratories and manufacturing sites are include. For details, visit http://www.chemsw.com.

New NWA Quality Analyst 6 Supports Corporate Quality Initiatives and Simplifies SPC Integration with Enterprise Applications

Northwest Analytical, Inc. (NWA), a leading provider of statistical process control (SPC) software, has announced a major update to NWA Quality Analyst, its award-winning SPC charting and analysis software solution. NWA Quality Analyst, the flagship product in the NWA SPC software suite, helps manufacturers understand and improve their processes to increase product quality, reduce defects, waste and costs, meet customer requirements, certify vendors and comply with regulatory requirements. NWA Quality Analyst Version 6 enables manufacturers to more easily analyze their process data to identify process improvements and execute quality initiatives such as Six Sigma, CAPA (Corrective Action/Preventative Action) and ISO. The new Version 6 also includes several key enhancements that further simplify the integration of SPC and process quality data with plant-level and enterprise manufacturing information systems such as ERP, MES and LIMS. NWA Quality Analyst has always been recognized for its ease of integration, and it is even easier now than before. Many of the enhancements in Version 6 were developed for users engaged in corporate quality initiatives. These include: Assignable Cause/Corrective Action (AC/CA); Better Access to Chart Information; More Powerful Presentation of Chart Data; New graphics viewer; Rainbow charts; and, More graphic output formats. Other key enhancements address the growing need to integrate SPC and quality reporting with plant-level and enterprise manufacturing information systems including ERP, MES, LIMS and SCM (supply chain management). For details, visit http://www.nwasoft.com/products.htm.

Accelerated Technology Laboratories Acquires Zimet Associates

Accelerated Technology Laboratories, Inc. (ATL) has purchased Zimet Associates, Inc. a New Jersey firm that provides Engineering and Computer Consulting support. ATL is a provider of LIMS and laboratory automation solutions. Donald Kolva, President and CEO, said, “It is our goal to strengthen our management team and to integrate and leverage the expertise, resources and experience which the team offers. This will allow us to expand into new markets and to continue to provide customers with advanced technology solutions.” Sam Zimet, President of Zimet Associates, Inc. added, “We are all very excited to join ATL as we share the core values of customer responsiveness, providing quality products and services based on the best available technology. Being part of such a strong technical team will allow us to supply our clients with the kinds of technologies they require to grow and expand their business.” Zimet Associates, Inc., a privately-owned IT consulting company, provides a complete solution in hardware, OS software and networking computer systems for clients that lack internal IT resources. They specialize in the installation and maintenance of local area networks, engineering projects, computer systems, peripherals, networking, and eCommerce products, providing the most cost effective solution for business computing. ATL, Inc. is a privately owned company that pioneered Windows-based LIMS with Microsoft SQL Server and Oracle data management solutions. ATL offers the Sample Master LIMS product line in government, environmental, industrial hygiene, water and wastewater, R&D, manufacturing and public health laboratories. For details, visit http://www.atlab.com.

Frost and Sullivan Names Waters Corporation 2005 Leading Analytical Instrumentation Company of the Year

Waters Corporation has announced that Frost and Sullivan has named it the 2005 Leading Analytical Instrumentation Company of the Year for its outstanding contribution to the analytical and scientific instrumentation market. The Award for Company of the Year is presented each year by Frost and Sullivan, a world-class growth consulting and market research firm, to the company that has demonstrated unparalleled excellence within its industry. The Award recognizes Waters' ability to best perceive customer needs, develop products and/or services that meet or exceed customer needs, successfully introduce products and services to the industry, and identify new market segments to expand the existing customer base. Rohit Khanna, Ph.D., Vice President, Worldwide Marketing for Waters Corporation said, "It is indeed an honor to be chosen by Frost and Sullivan for this prestigious award. Our focus has always been on meeting the ever-changing needs of our customers. Through continuous interaction with key analytical scientists in our industry, we are able to drive a product strategy that provides overall solutions to their needs and, in doing so, our product development efforts allow scientists to achieve quality result in less time and with a comprehensive range of systems, product and services." To select the recipient of this Award, the Frost & Sullivan analyst team tracks all the major participants in the industry, paying close attention to their business development efforts, development of new applications, and market share position in new market segments. This process includes interviews with all the market participants, customers, and suppliers, along with extensive secondary and technology research. The companies' business development efforts are then analyzed based on the number of new customers, new segments, customer loyalty, technological leadership, and commitment to business expansion. For details, visit http://www.frost.com or http://www.waters.com.

FDA Reports Increase in Applications, Decrease in Approval Times for 2004

The FDA was able to shave a significant amount of time off the drug-approval process in 2004, despite approving 65 percent more new product applications than in 2003, according to new figures released by the agency. The median approval time for new drug applications (NDAs) and biologic license applications (BLAs) granted priority review fell to six months in 2004, compared to 7.7 months in 2003, the agency said in its 2004 FDA Accomplishments report. New product applications undergoing standard review were approved in an average of 12.9 months, compared to 15.4 months in 2003. The quicker review times came despite an increased number of product approvals. The agency approved 119 NDAs and BLAs in 2004, an increase of 65 percent over the 72 approvals granted in 2003. The 119 approvals in 2004 were the highest total since the FDA approved 121 NDAs and BLAs in 1997. The one category where FDA approval times increased last year was in the review of new molecular entities (NMEs) and new BLAs undergoing standard review. The median approval time for those applications was 24.7 months, compared to 23.1 months in 2003. However, review times for NMEs and new BLAs granted priority-review status decreased slightly, falling to six months in 2004 from 6.7 months in 2003. To view the FDA report, visit http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01346.html.

Varian, Inc. to Focus Efforts on Scientific Instruments and Vacuum Technologies Businesses; Sells Electronics Manufacturing Business

Varian, Inc. has completed the previously announced sale of its Electronics Manufacturing business to Jabil Circuit, Inc. for $195 million (subject to a post-closing working capital adjustment). The company announced on February 7, 2005, that it had entered into a definitive agreement with Jabil for the divestiture. According to Varian, the sale of the Electronics Manufacturing business will allow the company to advance its overall strategy of growing the Scientific Instruments and Vacuum Technologies segments by focusing all of its resources on that core business. In addition, the company previously announced that it would initiate repurchases of up to $145 million of its common stock upon successful completion of the divestiture. That repurchase program is now in effect and replaces a previous authorization to repurchase up to 1,000,000 shares, under which approximately 800,000 shares were repurchased since the company announced the definitive agreement to sell its Electronics Manufacturing business on February 7, 2005. For details, visit http://www.varianinc.com.

PennWell Corporation Relies on ExtremeZ-IP for Migration from Novell to Windows Server 2003

Group Logic, developer of best-selling network workflow software products, has announced that PennWell Corporation, a highly diversified, business-to-business media company servicing strategic global markets, selected Group Logic's award-winning ExtremeZ-IP product to meet the high-performance demands of its Macintosh users. Timed with the company's migration from Novell to Windows Server 2003, the installation of ExtremeZ-IP provides an effective solution for increased stability while meeting the high-volume traffic and access demands on media files. "The built in Mac file sharing from Microsoft was not robust enough to handle the amount of traffic and throughput for our users," notes Tim Ryter, Senior Network Engineer at PennWell Corporation. "We have an extensive file system that uses and shares large numbers of large files," he explains. "With ExtremeZ-IP we were able to effectively support the back-end to meet the demanding needs for performance." ExtremeZ-IP's internal structure and advanced caching strategy gives customers immediate startup, higher availability and radically reduced memory usage compared to other products on the market. Through active-active clustering capabilities, customers have better control of node resources with configuration of multiple virtual servers on the Windows cluster. This translates into better network load balancing, improved uptime, and flexibility in failover options and functionality. For details, visit http://www.grouplogic.com.

BioAnalyte Appoints New Production Manager of the Regatta Biomarker Discovery Platform

BioAnalyte has announced that long-time lead developer Vladimir Georgiev has assumed production management responsibilities for the company’s Regatta biomarker discovery product line. “Vladimir’s leadership and clarity of vision have contributed to the disciplined development of Regatta core components as well as overall platform design,” said Peter Leopold. “We are confident that he will bring similar precision to engineering a distribution solution that will enable our product and sales strategies.” ProteinTrawler, the first component of Regatta, is in final stages of testing and preparation for widespread web distribution. ProteinTrawler reduces gigabyte liquid chromatography mass spectrometry (LCMS) datasets to manageable lists of key features used in biomarker discovery. Georgiev, who is the principal architect of ProteinTrawler, will manage a staff of four developers and designers working in such diverse areas as algorithm design, graphical interface development, release management, license enforcement and web-based license distribution.“Our biggest technical challenge is proNets license distribution,” Georgiev said. “Our design and implementation emphasize ease of use and reliability. When our customers buy and use dataset-dependent licenses over the web, we will have revolutionized the sales model for capital software.” Georgiev, a 2002 graduate of the University of Southern Maine computer science department, joined BioAnalyte in January 2003. In addition to ProteinTrawler, he designed and developed BioAnalyte Gangl/ion+, an embedded biomarker discovery package developed under a US Defense Department subcontract, as well as BioAnalyte SpyGlass, a custom data visualization tool. Previously, Georgiev was a network specialist for Downtime Inc. of Brunswick, ME. For details, visit http://www.bioanalyte.com.

Advances in Biopharma Sciences, Genomics to Drive Pharma's Future, Experts Say

Tremendous advances in the biopharmaceutical sciences, including in the field of genomics, have given pharmaceutical firms vast amounts of new information on which to develop drugs — a key development that will fundamentally change the way drugmakers operate, industry experts say. The drug-development process is going to move from molecule management to information management, said Juan Enriquez, chairman and CEO of Biotechonomy, a life sciences research and investment firm. "That is a very different business," he said in a panel discussion on research and discovery at the PhRMA annual meeting. The changes could be as sweeping as the advent of digital photography was to the camera film industry, he noted. Film giant Kodak went from hiring chemical engineers to electronic engineers, Enriquez said. For example, current technology enables a chemist to examine 700 molecular compounds in the same time it once took to review 50 compounds, he said. The firms that know how to manage this breakthrough technology will be successful in the future, he said. The changing pharma business model also could attract some unlikely competitors, including software and computer giants like Microsoft and IBM, Enriquez noted. Advances in scientific knowledge, including further understanding of the human genome, will also greatly affect drug development. The FDA and industry already are preparing for the day of "personalized" drugs, which are tailored to patients with specific genetic make-ups. The market potential in this area is so large that drugmakers could release new niche products on a weekly basis, Enriquez said. For details, visit http://www.fda.gov.

FDA E-Submission Gateway Takes Form

In a move to simplify and standardize electronic submissions, the FDA has selected GlobalNet Services Inc. and its partner Cyclone Commerce, for the FDA Electronic Submission Gateway project. Once completed, the gateway will provide a single, centralized point for the submission of new drug applications. The project has an aggressive deployment schedule, with initial rollout set for June. At that time, companies will be able to securely submit new drug application documents for review and approval to the FDA's Center for Drug Evaluation and Research (CDER). They'll also be able to make submissions to other FDA centers, including the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA). "The gateway is a single point of entry for receipt of new submissions," says Ori Reiss, president of GlobalNet Services Inc. (GNSI). "The benefit of using the gateway is that more information will be available to reviewers in a more timely fashion." On the IT side, the E-Submission Gateway will include server hardware from Sun Microsystems, load balancing equipment from Radware, and on the back-end an Oracle 9i RAC (Real Application Cluster) system, which provides some redundancy to ensure high system availability. GNSI's partner in the project, Cyclone Commerce, brings expertise in secure collaboration and secure electronic communications. Like GNSI, Cyclone Commerce has a great deal of life science industry experience. "We originally looked at the supply chain, working with pharmaceutical manufacturers and distributors," says Ron Gabrisko, vice president, health and life sciences, at Cyclone Commerce. "And within the last few years, we've gotten involved in some specific regulated [operations] of these companies." One area Cyclone Commerce has focused on is adverse events reporting. For the E-Submission Gateway project, Cyclone Commerce will deploy its business-to-business platform that includes the Cyclone Interchange and Cyclone Director to ensure the secure exchange of drug approval documents. "The software allows you to exchange reports quickly," says Gabrisko. "[So the pharmaceutical company] gets feedback faster." Cyclone software offers document and session-level security by providing such features as encryption, authentication, and signed digital receipts. The software also provides auditing, reporting, and archival services to help follow a submission over its lifetime. Once the entire system is in place, "[We] will deliver to the FDA a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment," says Reiss. "The system will automate current electronic submission processes such as acknowledging receipt of submissions." For details, visit http://www.fda.gov.

New LabPAS Adaptive LIMS Version 2.1 Unveiled

Green Mountain Logic introduced LabPAS version 2.1 at the Pittcon 2005 exhibition in Orlando, Florida. LabPAS is a next-generation LIMS designed to address the complex needs of Life Sciences laboratories. LabPAS incorporates process automation functionality and a highly configurable toolset to adapt to a laboratory’s unique processes. LabPAS version 2.1 offers a number of exciting features. The enhanced Adaptive Workflow Engine now supports nested workflows, optional tasks and place-holding tasks. These workflow improvements allow non-technical lab staff to create even the most diverse and complex life sciences protocols. The version also includes a Sample Genealogy screen. This screen, coupled with a new Pooling Task Template, allows labs to pool and aliquot samples in multiple iterations while being able track the complete sample genealogy. Green Mountain Logic also demonstrated new Mobility Module technology. This technology benefits from their XML web architecture and allows LabPAS screens to be displayed on wireless handheld data collection devices. Highly mobile technicians can now perform important laboratory functions such as sample login, inventory management, and calibration using these portable devices; thus improving productivity while reducing transcription errors. For details, visit http://www.labpas.com.

PerkinElmer Now Offers Remote Access, Web-Based Capabilities with LABWORKS LIMS

PerkinElmer Inc., a leading provider of drug discovery, life science research, and analytical solutions, has announced a new remote access Web-based module called Online Administrator for its LABWORKS ES LIMS customers. Using this new module, customers with browser-based access will now have the ability to securely view test information, results and reports in a timely fashion with the simple click of a mouse. Co-developed with ESI Services, an IT services firm, this new functionality allows real-time access to reliable results, translating into significant cost savings. This functionality enables laboratories to reduce expenses and communication expenditures and eliminate paper-intensive tasks. "This Web-based tool allows PerkinElmer customers to have remote access to results and reports immediately with any Web browser," said Stephen Delity, business unit manager, BioPharma Analytical Solutions for PerkinElmer Life & Analytical Sciences. "These enhancements are top priorities for lab managers because this maximizes productivity while delivering secure, reliable results for better decision making." The new functionality eliminates dependence on paper-based processes by allowing customers to view and print current and historical reports in Adobe PDF, view lists of submitted samples and test statuses and display raw data from those test results. For details, visit http://www.perkinelmer.com/LABWORKS.

Autoscribe Introduces LIMS Builder

Autoscribe has introduced LimsBuilder, a unique configuration tool that allows users to define requirements for a LIMS by creating a prototype of the ideal system. LimsBuilder provides the ability to define system appearance using unique screen and menu design tools and much more. Single or multiple workflows can be created using sets of screens to define requirements at sample registration, sample receipt, testing, test validation and sample approval – and more. Each screen appearance can be designed using customer terminology, the field definitions and positioning required and the placement/functionality/terminology associated with buttons. Multiple menu schemes can be designed together with multiple sample numbering schemes. System security can also be defined. LimsBuilder can be used to create a highly detailed prototype of the system needed or a much simpler overview system. On completion of the configuration task a complete definition of the system can be printed including all screen designs and explanations. Autoscribe states that the real benefit of LimsBuilder is that the system can be visualised rather than just being represented in a textual document. LimsBuilder is available on monthly rental terms and an obligatory training course is provided in the first month within the rental cost. For details, visit http://www.autoscribe.co.uk.

Thermo Electron Focuses on Commercial-Off-The-Shelf Laboratory Software Solutions

Thermo Electron Corporation, a world leader in analytical instruments, presented its expanded offering of laboratory software solutions at PITTCON 2005, Orange County Convention Center, Orlando, Florida, February 27 - March 4. Thermo's portfolio of LIMS and chromatography data system (CDS) includes solutions that require minimum configuration and no customization to address customer demands for commercial-off-the-shelf (COTS) software. "Our goal at Thermo is to provide laboratory software solutions that are plug-and-play," says Dr. Jo Webber, general manager of Thermo's informatics business. "For our pharmaceutical customers in particular, because of the regulatory demands they face, we're developing software for rapid and easy implementation and validation. It is also easier to upgrade, because it requires no custom programming post-installation. We're confident our innovative approach, along with Thermo's scale, enables us to address key challenges in laboratory efficiency." Thermo's exhibit features its industry-leading informatics solutions, including SampleManager LIMS and Atlas CDS, along with complementary laboratory software that was added to the company's portfolio with the September 2004 acquisition of InnaPhase Corporation. With a leadership position in the pharmaceutical industry, InnaPhase's flagship products are now being sold under the Thermo brand. These include Watson LIMS, and Galileo LIMS, as well as the Enterprise Pharmacology (EP) Series and Kinetica, database analytical tools for pharmacokinetics and pharmacodynamics. Thermo is also introducing the Watson-XDI - a bi-directional digital interface that enables secure & seamless data transfer between Watson LIMS and Thermo's Finnigan TSQ Quantum. For details, visit http://www.thermo.com/informatics.

Thermo Electron Highlights Leadership in Asset Management at Pittcon 2005

Thermo Electron Corporation promoted its leadership in laboratory services at PITTCON 2005. Thermo’s industry-leading asset management programs provide tailored solutions that optimize lab performance and reduce costs. Asset management is a portfolio of services that includes managed maintenance and multi-vendor compliance services. Along with product support and other professional services, Thermo provides one of the most comprehensive laboratory services portfolios in the industry. As part of Thermo’s asset management offering, the managed maintenance program provides guaranteed savings on maintenance costs across the customer’s entire facility/enterprise, covering a wide variety of instruments and manufacturers. Additional savings and increased productivity are achieved by replacing numerous individual vendor contracts with a single contract. In addition to gaining control over their assets, customers appreciate the flexibility of the program, which provides them the ability to choose their preferred service provider for maintenance services. Multi-vendor compliance services assist customers in the pharmaceutical and other regulated industries in complying with regulatory requirements. Thermo provides preventive and corrective maintenance, software validation, instrument qualification, and regulatory and laboratory consulting services. These services are provided across a full spectrum of manufacturers’ instruments, equipment and software. For details, visit http://www.thermo.com/informatics.

ABB and Holcim Sign Agreement

ABB, a leading power and automation technology group, signed an agreement for general terms and conditions with Holcim on January 12, 2005. Also, the already existing frame contract for Technical Information Systems (TIS) was renewed for another two years. TIS includes up to 8 modules for information management, laboratory information, emission reporting and an SAP interface. The system is marketed from ABB for other cement customers as KM (Knowledge Manager) and LIMS. In 1999 Holcim and ABB started their TIS cooperation in Europe with Holcim’s requirements significantly influencing the product. Despite competition from best in class MES system providers, ABB was awarded a sole supplier frame contract for TIS worldwide at the end of 2001. This initial contract lasted until the end of 2004. With the renewal of the frame contract both parties are looking forward to a major expansion in the already significant TIS installed base. For details, visit http://www.abb.com.

ESA Biosciences Awarded NIH Grant to Further Metabolomics Research

ESA Biosciences, Inc., a subsidiary of Magellan Biosciences, Inc., has been awarded a Roadmap Initiative grant from the National Institutes of Health (NIH) to accelerate ESA's ongoing work in metabolomics research. Under this grant, ESA will extend and integrate electrochemical (EC) and mass spectrometric (MS) technologies to facilitate a range of metabolomics studies. In addition to ESA, twelve leading academic research institutions were awarded metabolomics technology development grants by the NIH. Metabolomics is the study of an organism's low-molecular weight molecules or metabolites (e.g., amino acids, peptides, lipids, carbohydrates). By understanding and detecting metabolic differences, for example, between normal and diseased states, researchers hope to provide earlier and more precise diagnosis and prevention, and safer and more effective treatment of a wide variety of diseases. One of more than 100 original applicants for funding under the NIH metabolomics program, ESA proposed that integrating EC and MS technologies will substantially extend the scope, qualitative and quantitative capabilities of liquid chromatographic (LC) analysis in the study of cellular metabolites. ESA will work with a number of collaborators in its research: Oak Ridge National Laboratory, Applied Biosystems/MDS SCIEX, Millennium Pharmaceuticals, Cornell University Medical School, Massachusetts College of Pharmacy, Boston University Medical School, and Burke Medical Research Institute. A major aspect of the Roadmap Initiative program is to encourage collaboration among a wide variety of research facilities and institutions. For details, visit http://roadmap.nih.gov or http://www.nih.gov or http://www.esainc.com.

Open Source Expert Joins BioAnalyte

BioAnalyte has announced that noted Open Source expert Vance Wheelock II has joined the company to consult on e-commerce solutions and to help propel the company’s revolutionary software licensing technology into the $8 billion analytical instruments
marketplace. Wheelock will enable the automated, on-demand creation, distribution and revenue collection for BioAnalyte’s proprietary proNets and pepNets licenses. The licenses permit analytical instruments users to process gigabyte datasets using BioAnalyte’s Trawler products. In 2004, BioAnalyte ProteinTrawler helped the FDA Center for Food Safety and Applied Nutrition in College Park, MD, to discover a protein biomarker for a deadly food-borne bacterium similar to the one that causes cholera. Wheelock, a Winthrop resident, is a 1996 computer science and mathematics graduate of the University of Maine, Farmington. Wheelock co-founded the Maine Linux User Group in 1995, and founded the MESDA-sponsored Southern Maine Linux Users Group in 2000. Until last fall, Wheelock was the lead web developer for Blue Marble Geographics, a Gardiner-based mapping software company. For details, visit http://www.bioanalyte.com.

Bioanalyte Expands Pact with Positive Probability

BioAnalyte, Inc., has announced that it has broadened its license agreement with a United Kingdom firm that already produces core components in BioAnalyte's Trawler product. The license expansion creates a new product - Enterprise Trawler - aimed at pharmaceutical, industrial and other high throughput applications. The agreement with Positive Probability Ltd (PPL) of East Anglia, England, extends BioAnalyte's use of proprietary technology for enabling users of analytical instruments to automate the analysis of data-intensive applications, such as assessing diagnostic candidates for early cancer detection. BioAnalyte's products are part of the biotechnology sub-sector known as bioinformatics, or the application of information science to biology for the purposes of uncovering subtle relationships in complex and abundant data. BioAnalyte produces a subscription version of the Trawler program called Nets Trawler, which is a low-cost entry point, intended to widen adoption of the BioAnalyte platform. For details, visit http://www.bioanalyte.com.

Agilent Technologies Introduces Industry's First HPLC-Chip/MS System for Proteomics

Agilent Technologies Inc. has introduced the first high-performance liquid chromatography (HPLC)-chip/mass spectrometry (MS) system for protein identification. This breakthrough microfluidics-based LC/MS technology is expected to significantly increase the speed, ease and productivity of proteomics research. Many biomedical researchers employ proteomics, the systematic analysis of protein expression, structure and function, to study the underlying causes of diseases such as cancer. Traditional techniques used to prepare protein samples for MS analysis, such as nanoflow LC, require complex arrangements of equipment in order to improve separation power, and consume relatively large quantities of sample. Agilent's innovative new system simplifies LC/MS, heightens separation power and sensitivity, and reduces required sample sizes by integrating multiple functionalities on a single microfluidics-based chip. For details, visit http://www.agilent.com.

Bruker BioSciences Reports Fourth Quarter 2004 Revenue

Bruker BioSciences Corporation has reported its financial results for the fourth quarter and year ended December 31, 2004. On July 1, 2003, Bruker Daltonics Inc. merged with Bruker AXS Inc. to form Bruker BioSciences Corporation. All results for periods prior to this merger are historical combined results of the two previously separate companies. For the fourth quarter of 2004, Bruker BioSciences reported a 16% increase in revenue to $85.8 million, compared to revenue of $73.7 million in the fourth quarter of 2003. For the year ended December 31, 2004, revenue increased 9% to $284.6 million, compared to revenue of $260.7 million for the year 2003. In the fourth quarter of 2004, GAAP net income was $0.8 million, or $0.01 per diluted share, compared to GAAP net income of $0.3 million, or $0.00 per diluted share, in the fourth quarter of 2003. In the fourth quarter of 2004, adjusted net income, as defined below, was $0.9 million, or $0.01 per diluted share, compared to adjusted net income of $0.6 million, or $0.01 per diluted share, in the fourth quarter of 2003. For the year ended December 31, 2004, GAAP net loss was $(5.5) million, or $(0.06) per diluted share, compared to a GAAP net loss of $(17.6) million, or $(0.22) per diluted share, for the year 2003. For the year 2004, adjusted net loss was $(2.7) million, or $(0.03) per diluted share, compared to adjusted net income of $2.2 million, or $0.03 per diluted share, for the same period last year. Adjusted net income/loss is a non-GAAP financial measure that excludes the write-off of investments, merger related charges and adjustments for the pre-merger minority interest in Bruker AXS. For details, visit http://www.bruker-biosciences.com.

Bio-Rad's KnowItAll System 5.0 Offers World’s First Multi-Technique Spectral Searching System

Bio-Rad Laboratories, Inc. has announced the release of KnowItAll Informatics System Version 5.0 featuring advanced multi-technique database searching. This powerful search technology enables users to define searches in multiple spectral techniques concurrently in a single software platform--even across multiple databases--and view consolidated results. The KnowItAll spectral searching system gives scientists who analyze samples using multiple spectral techniques the ability to simultaneously and seamlessly combine all spectral information available to yield a single search result. While traditional spectral search and analysis software programs only focus on one spectral technique at a time, the KnowItAll system searches and consolidates data from all spectral techniques at the same time, providing dramatically improved search accuracy and efficiency. Searches may include substructures, properties, and a variety of experimental spectra, including NMR, MS, IR, and Raman. The system also provides additional visualization and data mining tools that simplify results, along with special search tools to weight the importance of each data input and define how it factors into the final result. For details, visit http://www.bio-rad.com.

Bio-Rad Extends Powered by KnowItAll Software and Database Outsourcing Services Program

Bio-Rad Laboratories, Inc. has announced that it has extended its Powered by KnowItAll Program to the Analytical Chemistry/Spectroscopy market segment. Now with Bio-Rad's award-winning KnowItAll software and
database product line, analytical instrument companies can deliver fully customized solutions based on a combination of KnowItAll products. The KnowItAll Informatics System is a fully flexible and customizable
informatics environment with software and database tools that encompass the areas of spectroscopy, chemistry, and in silico ADME/Tox profiling. Because of its unique architecture, the KnowItAll system may be compiled in multiple combinations of software applications and/or database formulations, enabling KnowItAll partners to create and tailor their own toolsets accordingly. This custom application development approach provides several options to Powered by KnowItAll partners, including selection from over 20 standard applications (including structure drawing, reporting, analysis, data management, and data mining), instrumentation integration, and custom interface options. For details, visit http://www.bio-rad.com.

Bio-Rad Releases Eight New ADME/Tox Databases

Bio-Rad Laboratories, Inc. has announced the release of eight new databases that contain measured ADME/Tox properties including Bioavailability, Blood-Brain Barrier Permeability, Carcinogenic Potency, Toxicity, Carcinogenicity of Water Disinfection By-Products, Estrogen Receptor Binding, Mutagenicity, and Water Solubility for a broad range of chemical compounds. These databases are the result of internal literature research and external collaboration with various scientific groups. These new ADME/Tox data collections are useful to those involved in drug discovery, allowing them to benchmark the results of their own experiments against this data, validate the accuracy of predictive ADME/Tox models, or build new models using this experimental data as a training set for their models. For details, visit http://www.bio-rad.com.

APG Offers Advantage Reporting and Training Verification Tools

Analytical Products Group, Inc. (APG) has developed new services called Advantage to help laboratories gain additional value from their participation in proficiency testing (PT) programs. The Advantage Reporting Tool enables laboratories to track, trend, and improve the quality and defensibility of their analytical data. For each APG study in which a customer has participated since 1999, the Advantage Reporting Tool securely presents performance results in two major categories - Accreditation Management and Quality Improvement. The Advantage Reporting Tool includes tabular and graphical representations of proficiency testing results. All study results, even quick-turnaround sample results, are available online with The Advantage Reporting Tool. The system is free to all APG customers. The Advantage Training Verification Tool provides laboratories with training samples customized to their standard operating procedures (SOP). The Advantage Training Verification Tool is an interactive, online reporting system that provides an easy way to monitor and document the demonstration of NELAC performance training requirements. It generates a training certificate and tracks continuing training requirements to relieve laboratories of this burden. The Advantage Training Verification Tool is an affordable system that helps train employees and ensures that laboratories continue to produce the best data. For details, visit http://www.APGQA.com.

APG and NMi Form Global Distribution Agreement in the Proficiency Testing Industry

Analytical Products Group, Inc. (APG) of Belpre, OH and the Nederlands Meetinstituut (NMi) of the Netherlands have signed a distribution agreement to jointly distribute their proficiency testing and quality assurance products in North America and the European Union. This global agreement, the first of its kind, will allow laboratories to benchmark their performance against international peers - an opportunity that has been limited in the past. In today’s global economy, analytical data must be defensible and repeatable across national borders, and this global distribution agreement will help to ensure data quality. The agreement was initiated because APG wanted to expand its presence in the European Union. Likewise, NMi, the National Metrology Institute of the Netherlands, was searching for a distributor that would increase its exposure in North America. Both organizations are well respected in the fields of proficiency testing, quality control standards, calibration, and other certification methods. Representatives from each organization visited the headquarters of the other in January 2005 to define the details of the agreement. APG will market and sell NMi’s natural gas and alcoholic beverages (beer and wine) proficiency testing and quality control products. NMi will market and sell APG’s environmental proficiency testing and quality control products. The organizations will jointly attend trade shows and conferences to promote the products. The organizations will also collaborate on a multi-lingual, e-commerce Internet presence. In the future, the organizations will jointly introduce new products and services to expand the agreement. For details, visit http://www.APGQA.com.

APG Offers Microbiological and Soil Proficiency Testing Samples

Analytical Products Group, Inc. (APG) has added Microbiological and Soil PT samples with the introduction of Wastewater (WP) and Drinking Water (WS) Microbiological PT and QC samples. The WP Microbiological samples are available each year in February, April, July, and October. The WS Microbiological samples are available with each bi-monthly study. APG’s microbiological testing capabilities will be expanded during 2005 to support the additional needs of the environmental market. APG will also release the first trial Soil and Hazardous Waste PT study in March 2005, and the second trial will be offered in the second quarter of 2005. Each trial will include a full set of NELAC RCRA Soil PT samples. It is expected that State Specific Soil samples will be offered in the fourth quarter of 2005. The soils product line has been under development for more than a year, and APG has committed more than $100,000 in new capital equipment to support this project. For details, visit http://www.APGQA.com.

CDER Delays Timetable for New Drug Office Reorganization

The FDA has pushed back its timetable for a major restructuring of the Office of New Drugs (OND), but some activities already are moving forward at the OND, including in the office that reviews cancer products. Implementation of the OND reorganization will be delayed until summer, an FDA spokeswoman said. The drug office had hoped to implement its restructuring plan, which it announced last October, at the same time the Center for Drug Evaluation and Research moved into the FDA's new White Oak, Md., campus this spring. But the move to White Oak has been delayed, the spokeswoman said. "We still plan to move into White Oak in our new structure starting in July," she said. When the move happens, pharmaceutical firms will likely see changes in who oversees their products at the FDA. Under the proposed reorganization, the OND will close one drug evaluation office, split a therapeutic review division, create a new review division and realign others. The goal of the restructuring is to better balance available resources and improve the logical groups of clinical indications within the OND's divisions and office structure. For details, visit http://www.fda.gov/cder.

CDER Reports 14 Percent Increase in Adverse Event Reports for 2004

The number of adverse event reports submitted to the FDA's Center for Drug Evaluation and Research (CDER) increased nearly 14 percent in 2004, according to a preliminary estimate from the agency. The center received approximately 422,500 adverse event reports last year, compared to roughly 370,900 in 2003, an FDA spokeswoman said. The 2004 number is a preliminary estimate, but the agency doesn't expect the number to change when it releases its final report within the next few months. Last year, CDER released its final adverse event figures in late May. The 2004 increase represented the fourth consecutive year in which the number of adverse event reports submitted to CDER has risen. Over the last decade, drug-related adverse event reports have nearly tripled, growing from approximately 156,000 in 1995 to nearly 425,000 in 2004. To view the FDA's latest adverse event data, go to http://www.fda.gov/cder/aers/extract.htm.

Lawmakers Introduce Legislation for Clinical Trials Registry

As expected, Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) have introduced legislation that would create an electronic clinical trials registry to which drugmakers must submit the results of their drug studies or face monetary penalties. The new version of the Fair Access to Clinical Trials (FACT) Act aims to ensure access to clinical trial data by the scientific community and the general public, the senators said. Dodd had introduced the bill last session, and recently garnered the support of Grassley, chairman of the Senate Finance Committee and a leading Republican advocate for improving drug safety. Recent revelations that patients might have been harmed by the suppression of data from drug studies underscore the necessity for public assess to basic information about research studies on healthcare products and drugs, the senators said in a statement. "Increased transparency and openness can lead to greater accountability and, ultimately, safer drugs and increased consumer confidence," Grassley said. Under the FACT Act, drug sponsors would be required to report research outcomes, basic demographic information on subjects, funding sources, significant adverse events and the product's FDA approval status, among other information. The bill also establishes strong enforcement mechanisms, including monetary penalties of up to $10,000 a day for manufacturers who refuse to comply. Results of clinical trials would be maintained through the NIH's ClincalTrials.gov website. For details, visit http://www.clinicaltrials.gov.

Analyst Expects Slow Growth for Generics in 2005

Fewer generic drug approvals combined with increased competition from authorized generics and foreign drugmakers will limit growth in the U.S. generics industry in 2005, a Wall Street analyst predicted at a recent industry event. David Maris, managing director and senior research analyst for Banc of America Securities, expects 2005 to be a light year for generic drug approvals, which will likely mean flat profits for generic firms, he told attendees at the Generic Pharmaceutical Association's (GPhA) recent annual meeting in Boca Raton, Fla. However, Maris said this trend will change dramatically in 2006 and 2007, which are expected to be "very crowded years" for generic product launches. He estimated that brand drugs accounting for more than $50 billion in revenues are expected to come off patent in 2006 and 2007. Another challenge generic firms will face this year is the increasing prevalence of authorized generic products from brand firms, Maris said. "Authorized generics are here to stay," he said. "Any fix would force large drug companies to launch their own generics. In the future you may see multiple authorized generics on the same drug." Maris also predicted that brand drugmakers will continue to take advantage of the FDA's citizen's petition process to delay the entry of generic drugs. In fact, Maris said that generic firms should anticipate that the petitions will become more frequent and "even better crafted." Increased competition from foreign drugmakers is also expected to affect the U.S. generics industry this year, and even more so in 2006 and 2007, Maris said. The rise of foreign generics firms, particularly in India, Latin America and China, will continue to put added pricing pressure on U.S. companies, he noted. For details, visit http://www.fda.gov.

FDA Official Recommends Firms Consult FDA Prior to eCTD Submissions

Drugmakers should consult with the FDA before drafting their first electronic common technical document (eCTD) submission to ensure the documentation is prepared properly and conforms to agency requirements, advises a Center for Drug Evaluation and Research (CDER) official. The FDA has received approximately three dozen eCTDs in the last 18 months, according to Ginny Ventura of CDER's Office of Information, who spoke at the Drug Information Association's Electronic Document Management Conference in Philadelphia. During those 18 months, the agency has noticed some common mistakes in the submissions, which Ventura said range from missing information to improper formatting. For more information about eCTDs, go to http://www.fda.gov/cder/regulatory/ersr/default.htmor write eSub@cder.fda.gov.

FDA Releases Guidance on NDA, BLA Safety Reviews

The FDA has announced the availability of final guidance for industry on how to conduct a safety review of a new drug application (NDA) and a biologics license application (BLA). Released as part of the agency's good review practice initiative, the guidance is intended to assist individuals conducting safety reviews as part of the NDA and BLA process, to provide standardization and consistency in the format and content of safety reviews, and to ensure that critical presentations and analyses will not be inadvertently omitted. The guidance was originally released in draft form in 1996. The safety review has two distinct components: identifying the significance of the adverse events reported in clinical trials, and evaluating of the adequacy of the safety evaluation. The guidance describes an approach that integrates safety findings across all studies and other clinical experience, said the FDA. The guidance is an expansion of Section 7 of the clinical review template and is compatible with that template, which was developed by the Center for Drug Evaluation and Research.
To view the guidance, "Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0057-gdl0001.pdf.

'New' EU Countries Seeing Rapid Pharmaceutical Growth

The pharmaceutical markets of the 10 European Union (EU) member countries added to the EU in 2004 have been rapidly expanding in recent years, despite more subdued growth in the rest of the region, according to a new research report. The drug markets in the 10 states added to the EU on May 1, 2004, have been growing at a rate of 16.5 percent during the past five years, according to research conducted by London-based analysts Frost & Sullivan. In contrast, the pharmaceutical markets in the other EU nations have been growing at a steady rate of 8 percent annually. The countries that joined the EU in 2004 include Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia. The pharmaceutical market in these countries is estimated at approximately $7 billion and represents roughly 8 percent of the EU 15 market, Frost & Sullivan said.For details, visit http://www.frost.com.

GPhA Urges FDA to Create Abbreviated Follow-On Pathway

On the heels of a recent workshop on follow-on biologics, the Generic Pharmaceutical Association (GPhA) is again encouraging the FDA to create an abbreviated approval pathway for generic biologics. "Today, the question is not 'if' generic biopharmaceuticals will become a reality, it is 'how,'" Gordon Johnston, vice president of regulatory affairs for GPhA, said in closing remarks at the FDA/Drug Information Association Follow-On Protein Pharmaceuticals Workshop. While GPhA praised the FDA on the progress made at the meeting, it urged the agency to proceed more quickly on generic biologics, which it said are well "within the scope of current science." "There is no reason to delay consumer access to affordable medicines when sound science supports the approval of biopharmaceuticals under a shortened and less costly pathway," GPhA President and CEO Kathleen Jaeger said during the workshop. "It is possible to permit approval and marketing of a vast array of biopharmacuticals with relatively low to modest complexity, and to expand that system in the coming years to permit the approval of more complex products." Jaeger urged the FDA to issue its highly anticipated white paper and guidance document on follow-on biologics immediately. According to GPhA, the FDA announced four years ago that it would be working on guidelines for insulin and human growth hormone, but the agency has not yet released this information. For details, visit http://www.fda.gov.

FDA Unveils Online User Fee System

The FDA has launched a web-based User Fee System that is integrated with the agency's accounting system, through which customers can create and submit Form FDA 3397, agency officials announced at the Drug Information Association's Electronic Document Management Conference in Philadelphia. Form FDA 3397, the Prescription Drug User Fee Act (PDUFA) user fee cover sheet, provides basic information to enable the FDA to determine whether a drug application fee is required, set the fee and track payments, according to the FDA.
The agency designed the system — a single portal for all user fees — to be user-friendly, with the familiar online "shopping cart" approach, officials said. Industry can access the system at http://www.fda.gov/oc/pdufa/coversheet.html. Customers must register their organization before creating the cover sheet, after which the system will generate a payment identification number. Registration requires an employer identification number, contact name, company name, address, telephone and fax numbers, an email address and a Dun & Bradstreet Number. The system then automatically calculates the cover sheet fee based on the customer's answers to questions about the type of application to be submitted. The data is sent electronically to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research and to the agency's Office of Financial Management, and back again as needed, officials said. For more information, go to http://www.fda.gov, write to userfees@fda.gov or call (301) 827-9539.

Lawmakers Want Pharma Execs Criminally Liable for Withholding Safety Data

Two House Democrats have introduced legislation that would hold pharmaceutical executives criminally liable when they fail to disclose evidence of serious adverse events related to their products. The Pharmaceutical Research and Manufacturers Accountability Act (PhRMA Act), introduced by Reps. Pete Stark (D-Calif.) and Marion Berry (D-Ark.), would impose stiff jail sentences and financial penalties on executives who knowingly withhold safety data. The legislation would also impose heavy fines on drug companies that don't meet FDA requirements for postapproval studies. "It is unfortunate we need this legislation, but the only way to make manufacturers accountable for drug safety is to hit them where it hurts — putting executives in jail and imposing large individual and corporate fines for wrongdoing," Stark told House members while introducing the bill.
To view the PhRMA Act, go to http://www.house.gov/stark/news/109th/legislation/PhRMAtext.pdf.

FDA Should Act on Follow-On Biologics, Waxman Says

Although Rep. Henry Waxman (D-Calif.) continues to support the Hatch-Waxman Act, he acknowledged recently that the law is not a complete solution to the problems generic drugmakers face in trying to bring new products to market, particularly generic biologic products. "The early days [before Hatch-Waxman] were an interesting time because pharmaceutical companies had the ability to develop lots of drugs, but didn't have the ability to get generics on the market," Waxman said at the Generic Pharmaceutical Association's annual meeting in Boca Raton, Fla. "It was a great move forward when we established that legislation. I take great pride in it, and in the success it's had in promoting competition, which has allowed us to lower prices. Since Hatch-Waxman, the generics' share of the market has grown significantly, [but] the law fell short of a full solution to the problem." One of the outstanding issues, Waxman said, is the issue of follow-on biologics, which still don't have a formal approval pathway. Waxman acknowledged that when he co-authored Hatch-Waxman in 1984, he didn't anticipate the problem. "Once [brand] patents have expired, consumers should have access to affordable medicines," Waxman said. "Permanent monopolies by brands are not wise," he continued. "The time has come to approve a system for approving biogenerics, [but] we must get the science right, because if the science isn't sound, the brand industry will destroy the image of [these generic products] in the eyes of consumers and physicians. For details, visit http://www.fda.gov.

GAMP Forum Issues Guide on Electronic Records and Signatures

The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), has released its "GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures." The new guide supplements the "GAMP Guide for Validation of Automated Systems" and supersedes previous ISPE guidance, "Complying with 21 CFR Part 11, Electronic Records and Signatures," according to GAMP. The guide was designed to help quality assurance and computer validation professionals, IT and IT compliance personnel, data owners and users, and systems developers, engineers, and suppliers comply with international guidelines for erecords and signatures. GAMP said the guide covers new and existing automated systems. For details, visit http://www.ispe.org/Template.cfm?Section=gamp_good_practice_guides&Template=/publications/ISPE_technical_guides/gamp_good_practice/ers.cfm

House Bill Would Prevent Political Tampering With Federal Research

A pair of prominent House Democrats has introduced legislation that would prevent government officials from tampering with federal research and scientific policymaking. The Restore Scientific Integrity to Federal Research and Policymaking Act calls for the implementation of strict policies to prevent government officials from influencing scientific research — a problem that the bill's sponsors contend has proliferated under the Bush administration. "From abstinence education to the protection of endangered whales, the Bush administration has twisted and distorted science to further a narrow political agenda," said Rep. Henry Waxman (D-Calif.), the ranking Democrat on the House Government Reform Committee. "We need to act now to protect the scientific integrity of federal agencies." Waxman co-sponsored the bill with Rep. Bart Gordon (D-Tenn.), the ranking Democrat on the House Science Committee. The legislation would implement the following policies: prohibit litmus tests based on political affiliation for appointments to scientific advisory committees; block tampering with scientific analysis; outlaw censorship of scientific reports; stop dissemination of scientific information known to be false or misleading; and extend whistleblower protections to federal employees who expose scientific manipulations. To view a copy of the bill, go to http://www.democrats.reform.house.gov/Documents/20050216120440-04639.pdf.

FDA Generic Drug Funding Sees Little Change in Fiscal 2006 Budget

One of the FDA's major goals for 2005 and 2006 is to speed marketing approval times for generic drugs, but the agency will have to accomplish that task without much of an increase in funding for its generic drug program.
President Bush's proposed fiscal 2006 budget calls for the FDA to receive approximately $56.2 million in generic drug resources — the same figure it received in the fiscal 2005 budget. The $56.2 million request includes funds for both the Office of Generic Drugs (OGD) and the Office of Regulatory Affairs' generic drug activities.
An FDA spokeswoman said the OGD was still awaiting its operating budget estimate for fiscal 2006, but she said the OGD's total "resources" for fiscal 2006 under the proposed budget are $28.9 million, which is a slight increase from $27.2 million in fiscal 2005. Industry observers questioned whether that level of funding would be enough for the OGD, especially in light of the agency's desire to shorten approval times. For details, visit http://www.fda.gov.

FDA Drug Inspections Expected to Decline in Fiscal 2006

The number of domestic field inspections conducted by the FDA's Office of Regulatory Affairs (ORA) will decline across the board in fiscal 2006, with the biggest drop coming in good manufacturing practice (GMP) inspections, according to figures contained in the agency's proposed budget request. Total ORA drug inspections would decrease from 2,815 in fiscal 2005 to 2,668 in fiscal 2006. The FDA's proposed budget calls for ORA inspections of domestic drug facilities to decrease by nearly 5 percent in fiscal 2006, compared to fiscal 2005 levels. GMP inspections will decrease by roughly 5.5 percent, according to the estimates, which forecast that ORA will conduct 1,355 GMP inspections in fiscal 2006, compared to 1,430 inspections estimated for 2005. Inspections of foreign drug facilities are also expected to decline next year, with 485 inspections estimated for fiscal 2006, compared to 515 predicted for fiscal 2005. The reduced inspection estimates come amid an anticipated budget cut for ORA's human drugs program. The FDA's budget requests $80.72 million for the human drugs program, down slightly from $80.96 million in fiscal 2005. The human drugs program and the biologics program, which would have its funding cut by $77,000, were the only ORA components to receive less funding in the agency's budget proposal. For details, visit http://www.fda.gov.

FDA Generic Drug Funding Sees Little Change in Fiscal 2006 Budget

One of the FDA's major goals for 2005 and 2006 is to speed marketing approval times for generic drugs, but the agency will have to accomplish that task without much of an increase in funding for its generic drug program.
President Bush's proposed fiscal 2006 budget calls for the FDA to receive approximately $56.2 million in generic drug resources — the same figure it received in the fiscal 2005 budget. The $56.2 million request includes funds for both the Office of Generic Drugs (OGD) and the Office of Regulatory Affairs' generic drug activities. An FDA spokeswoman said the OGD was still awaiting its operating budget estimate for fiscal 2006, but she said the OGD's total "resources" for fiscal 2006 under the proposed budget are $28.9 million, which is a slight increase from $27.2 million in fiscal 2005. Industry observers questioned whether that level of funding would be enough for the OGD, especially in light of the agency's desire to shorten approval times. For details, visit http://www.fda.gov.

Increased RFID Use Poses Challenges for Drug Industry, Study Finds

Radio-frequency identification (RFID) use in the pharmaceutical industry is growing under state and federal mandates to secure the supply chain and prevent counterfeiting, but technology limitations and security weaknesses may slow full implementation, according to an ABI Research study, "The RFID Life Sciences Market," which looks at the driving forces behind adoption and RFID's benefits. "With the industry losing $2 billion due to overstock and expiry, and $30 billion due to counterfeiting, there is an opportunity for RFID to right the ship," Sara Shah, an analyst with New York-based ABI Research, said. "Supply chain visibility and real-time data-driven supply chain information-sharing solutions can help troubled pharmaceutical makers, distributors and retailers to strengthen performance." The report, which is scheduled for release on Feb. 19, discusses ongoing RFID market initiatives and implementation issues in the pharmaceutical industry, according to ABI Research. The study also includes a technology assessment with quantitative hardware, software and integration market forecasts through 2009, the company said. The research looks at the FDA's RFID plans, as well as states' efforts to secure the supply chain with pedigree laws, Shah said. A pedigree is a legal document that tracks shipments from manufacturer to dispensing pharmacy, she said. For more information on the ABI Research study, go to http://www.abiresearch.com/reports/RPH.html.

Gardner Named Permanent Director for FDA's DCRMS

The FDA has named John Gardner director of the Division of Compliance Risk Management and Surveillance (DCRMS), which operates within the Center for Drug Evaluation and Research's Office of Compliance. Gardner has more than 20 years experience as a chronic disease epidemiologist, as well as a lengthy public health administrative and policy background. A Harvard University-trained physician, Gardner is currently a professor of preventive medicine at Uniformed Services University in Bethesda, Md. He previously worked as a medical epidemiologist at the Armed Forces Institute of Pathology from 1999 to 2000 and then was preventive medicine department chief at Womack Army Medical Center from 2000 to 2002. Gardner replaces Kathy Miracco, who served for two years as acting director of DCRMS. Miracco is the permanent deputy director of the division. DCRMS is responsible for identifying, assessing and prioritizing legal violations based on their public health significance. For details, visit http://www.fda.gov.

Proposed Fiscal 2006 Budget to Focus on FDA Drug Safety

President Bush's proposed fiscal 2006 budget would boost the FDA's drug safety efforts by an additional $6.5 million, giving the agency a total of $747 million for human drugs and biologics programs -- an overall increase of $26 million from fiscal 2005 levels. Under the White House budget request, the FDA's Office of Drug Safety (ODS) would receive a total of $33 million in the next fiscal year, which starts Oct. 1. Of the additional $6.5 million in proposed funding, $1.5 million would come from industry under the Prescription Drug User Fee Act. The overall budget request for the FDA is $1.88 billion for fiscal 2006, an increase of $81 million over fiscal 2005. The proposed increase for the ODS would be used to hire 25 new full-time equivalent employees, bringing total staffing in the ODS to 134 employees. The funds also would support greater FDA access to data on drug use, according to the agency. The FDA plans to increase spending to improve access to a range of clinical, pharmacy and administrative databases, according to the budget blueprint. "As each drug has its own indication(s) that may result in its differential use in different populations, it is essential that the Center for Drug Evaluation and Research have access to a wide range of databases to adequately assess drug safety," the FDA said. The HHS budget request also calls for $600 million to ensure the effectiveness of the strategic national stockpile of medicines in the event of a major health emergency, including the detonation of a weapon of mass destruction. The $600 million would be used to buy additional drugs to replace old ones, as well as provide specialized storage and facilitate the delivery of needed medicines to any U.S. location within 12 hours. The 605-page FDA budget is online at http://www.fda.gov/bbs/topics/news/2005/NEW01155.html. Details of the HHS budget are online at http://www.hhs.gov/budget/docbudget.htm.

FDA Issues Draft Guidance on Immunotoxicity Studies

Manufacturers should begin nonclinical testing of all new investigational drugs to determine what, if any, impact they have on a patientís immune response, according to a new FDA draft guidance released under the auspices of the International Conference on Harmonisation. The guidance states that drugmakers should use standard toxicity studies (STS) and additional immunotoxicity studies to determine a drug candidateís potential to produce immunosupression, a state of increased susceptibility to infections or the development of tumors. If the findings from the STS indicate that there are signs of immunotoxicity, the FDA said the decision to conduct additional immunotoxicity testing should be determined by a weight-of-evidence review of the data. The document also addresses the need for follow-up immunotoxicity tests. "Results of the entire data set should be evaluated as to whether sufficient data are available to reasonably determine the risk of immunotoxicity," according to the guidance. ìIf the overall risk-benefit analysis suggests that the risk of immunotoxicity is acceptable, then no follow-up testing might be called for.î If changes are observed during immunotoxicity testing, however, the FDA recommends that the drugmaker conduct further studies. The draft guidance, titled "S8 Immunotoxicity Studies for Human Pharmaceuticals," was published in the Federal Register Feb. 8. To view the guidance, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0022-gdl0001.pdf.

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

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