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•
Multiple Myeloma Research Consortium (MMRC) Names LabVantage
as Preferred Biobanking Partner
• Nicholas Piramal Implements LabVantage’s
Sapphire LIMS at its Research Center
• Autoscribe's Matrix LIMS Fully Configurable LIMS
Addresses Chemical, Petrochemical and Agrochemical Applications
• Autoscribe's Resource Planner Helps Raise Productivity
• Autoscribe Announces Business Results for Fiscal
Year 2005/6
• Thermo Highlights Modernizations to Leading
LIMS for Process Industries at ACHEMA 2006
• Indiana University Informatics to Offer
Laboratory Graduate Summer Program
• New Software from Cerno Bioscience Makes Debut
at PITTCON 2006 to Win Bronze Award for Most Innovative Product in Show
• PerkinElmer Unveils Several New Analytical Solutions
at Pittcon
• Pittcon Highlights General Release of STARLIMS Version
10
• Agilent Technologies Introduces Application
Software for New LC/MS Portfolio at Pittcon
• Agilent Technologies Introduces LC/MS
Software Solutions at Pittcon
• Bio-Rad Announces Several New Products at Pittcon
• ACD Introduces ACD/IntelliXtract LC/MS Software
at Pittcon
• Cerno Bioscience Announces
MassWorks Software for High Mass Accuracy Data From Any Mass Spectrometer
• Thermo Provides Single Solution for
Water Testing Needs with New SampleManager Interface
• GenoLogics and Institute for Systems Biology Announce
Integration of the Trans Proteomic Pipeline with Proteus
• QSI Offers WinDocs for Comprehensive Document
Control
• QSI Offers Languge Handling Capability with WinLIMS
• GSK Puts RFID Tags on Trizivir Bottles
• SYSTECH International Engages Domino Printing
Sciences plc To Deliver Full Track And Trace Capability For Pharmaceutical
Manufacturers
• SYSTECH International's TIPS Serialized Product
Tracking Solution Achieves Certified Integration with SAP Auto-ID Infrastructure
• Mind the Gap Report Reveals Major Gaps in Long
Term Management of Digital Assets
• The U.S. has Emerged as the World Leader in Important
New Drug Introductions
• STARLIMS Opens Global Center of Excellence
for the Life Sciences
• Axiope Addresses Biomedical Data Archiving with
NIH SBIR Funding
• Prime Technologies Announces New User Interface
to ProCalV5 Calibration Software
• Norgren Systems Introduces CP7200 Colony
Picker for Life Science Researchers
• IU's Chemical Certificate Program Offers Long-Distance
Learning
• IU, Purdue Collaboration Spawns CyberInformatics
Lab
• Mapping Exhibit Plots Course for Better Understanding
of Science
• FDA Unveils Critical Path Opportunities List
• Industry GMP Implementation Delayed by Unfinished
Guidance, Uncertain Enforcement
• After Congressional Meeting, Von Eschenbach Confirmation
in Greater Doubt
• Permanent Appointment of Von Eschenbach May Be Delayed
by Plan B Decision
• Eschenbach's NCI Role Could Affect
Permanent FDA Position
• Bush Likely to Nominate Von Eschenbach
as Permanent FDA Commissioner
• ClinPhone Opens West Coast
Office to Support Local Customers
• ClinPhone Inc Moves Headquarters to Support Significant
Business Growth
• Teranode Expands Management Team with Accomplished
Industry Executives
• Varian Offers Two-For-One GC Purchase
• Sultanate of Oman Licenses LabVantage’s
Sapphire for its Regional Environment and Water Resources Laboratories
• Waters Corporation and Thermo Electron Agree
To Integrate Ultra Performance Liquid Chromatography with Mass Spectrometry
Products
• Waters Corporation and Bruker BioSciences
Announce Collaboration
• TraxStar Announces QATrax v4.0 Auto-Scheduling
• Consortium Planned to Personalize Medicine
• ClinPhone Addresses Key Clinical
Trial Issues with Upcoming 2006 Webinar Schedule
• CDER Releases 2006 Guidance Agenda
• Researchers Propose Blockbuster Benefit to
Encourage Drug Development
• Critics State FDA Should Enforce Penalties for
Postmarket Study Delays
• ACD Releases Latest Version of ACS/Web Librarian
• Ohaus and Labtronics Partner
to Deliver New OEM Version of Labtronics' Collect Software
• Autoscribe Highlights Matrix Gemini LIMS
COTS Configuration at Pittcon 2006
• Shimadzu Scientific Instruments Announces Product
Launches, Presentations, and Workshop for PittCon 2006
• Bruker BioSciences to Host Investor Booth Tour
at Pittcon 2006
• STARLIMS and Tefen Introduce Advanced Resource
Planning and Scheduling Software for Labs
• Commercial-Off-the-Shelf Solutions Highlight
Thermo's Informatics Exhibit at Pittcon 2006
• Thermo Introduces New LIMS Datasheet For the Drug
Discovery and Development Industry
• Agilent Technologies Takes New LC and LC/MS
Systems on World Tour
• Indiana University Study Finds Offshoring of
Software Work Poses Challenges, Offers Rewards
• GenoLogics and Proteome Software Announce Collaboration
Agreement to Integrate their Data Management and Data Visualization Software
for Proteomics
• St. George’s University of London Selects
GenoLogics Platform and Data Management System to Aid Biomarker Discovery
and Systems Biology Research
• Agilent Technologies and Labtronics Partner to
Provide Advanced Integration Solution for Cerity Enterprise Content Manager
• Autoscribe Appoints New Authorised LIMS Distributor
In Brazil
• Bridge-Soft Forms International Partnership
with Simmonds & Bristow to Improve Water Quality for Small and Medium
Water Systems
• ABB Wins Order for Cement Plant Expansion in Oman
• Protedyne Completes Installation of BioCube
System at Correlagen Diagnostics Laboratory
• Scripps Florida Selects GenoLogics Platform for
Lab and Scientific Data Management for Proteomics and Systems Biology Research
• Labtronics Provides Transparent LIMS Integration
for Hanson Research
• Labtronics' Pipette Calibration Software Enables
Regulatory Compliance in Life Sciences
• Teranode
Names Dr. Paul Bleicher to Board of Directors
• Administration's Orphan Drug Proporal Would Increase
R&D for Rare Diseases
• Eurotherm Introduces New 1/8 DIN Controller and
Indicator with Text Display
Autoscribe's Resource Planner Module is a new approach to help managers plan their use of resources in the most efficient manner. This resource planning module is designed to work standalone and / or as a module of Autoscribe’s Matrix LIMS or an existing LIMS or Information Management System that is producing work to be performed by resources, tasks, people, equipment, buildings, training rooms etc. Resource Planner featurs include: resource planning and tracking. Resource Planner is built on the Microsoft .NET technology. For details, visit http://www.autoscribe.co.uk.
Autoscribe
Announces Business Results for Fiscal Year 2005/6
Autoscribe has announced a growth of 58.5% in new software system orders on
a worldwide basis compared to 2004/5. In particular, the company states that
strong performances have been seen in North America (131.9% growth) and the
UK (65.9% growth) with Matrix LIMS contributing most significantly. This growth
is due to doubling the number of systems sold in the year rather than the
booking of one large system order. One other business measure of interest
is the level of inquiries received which has grown monthly, by on average
55 times, over the past 9 months. The company feels that this is due to the
much improved Autoscribe web site and increased global promotional activities.
Although final figures have not been disclosed, the company states that expenses
came in below target and a significant profit is expected to be reported for
the year. "The business growth is very significant particularly as Matrix
Gemini, the new .NET LIMS, did not contribute to the figures but will feature
strongly in 2006-2007. In addition, interest in our general business applications
such as Training Manager and Feedback (for customer complaints management)
is growing fast and expected to contribute significantly towards another strong
growth year in 2006-7,” states John Boother, Managing Director of Autoscribe
Ltd. For details, visit http://www.autoscribe.co.uk.
Thermo
Highlights Modernizations to Leading LIMS for Process Industries at ACHEMA
2006
Thermo Electron Corporation, the leading provider of analytical instruments
and informatics worldwide, will demonstrate modernizations made to the user
interface and architecture of its leading LIMS, SampleManager, at ACHEMA 2006,
the world forum for the process industries. Thermo will also exhibit its Atlas
CDS chromatography data system, which features numerous enhancements in its
version 8 release. Thermo's exhibit can be found on booth B1-C12, Hall 6.1,
at ACHEMA, May 15-19 2006 in Frankfurt, Germany. In line with Thermo's strategy
to build informatics solutions that meet open industry standards, SampleManager
LIMS has adopted the Microsoft .NET framework while continuing to support
existing customers' custom code written in the VGL language. With version
9.0 scheduled for release in Q2 2006, SampleManager users will find a modernized
user interface that is modeled on the familiar and easy-to-use Microsoft template
with drag-and-drop and menu/tree functionality. When users select data sets,
the new, "inductive" i nterface simplifies work by presenting
only certain, pre-defined tasks or steps that can be followed - greatly reducing
errors and saving time. Offering Microsoft .NET architecture, Thermo's plans
for SampleManager include building application-specific functionality for
industrial labs so that users in the petrochemical, chemical and other process
industries will find more of the functionality they require in the base system,
and not have to customize the LIMS to meet their needs. This commercial-off-the-shelf
(COTS) approach significantly reduces the risks and costs associated with
customized implementations, maintenance and upgrades, and, for regulated industries,
the cost of validating the system.For details, visit http://www.Thermo.com/Informatics.
Indiana
University Informatics to offer Laboratory Graduate Summer Program
The intelligent use of information technology is essential to the success
of the modern laboratory, yet the gap between the world of the laboratory
scientist and the IT professional looms wide. To bridge this gap, the Indiana
University School of Informatics and LIMS Institute are teaming to offer unique
graduate courses in an intensive summer session, June 5-9, at the Indiana
University-Purdue University Indianapolis campus. The Laboratory Informatics
Summer School offers two courses. Comprehensive IT for the Laboratorian
is geared for the laboratory scientist and will present a full spectrum of
topics in IT relevant to the uses, needs and interests of laboratory scientists.
The Laboratory Operations for the IT Professional provides
a comprehensive picture of laboratory practice, including important issues
in regulatory compliance.“The goal of these courses is to offer insight
into the two different worlds of laboratory and information technology, and
establish a common ground between laboratory scientists and IT professionals
by presenting subjects of interest to both groups,” says Douglas G.
Perry, associate dean of School of Informatics’ graduate studies and
research and director of the Laboratory Informatics Graduate Program at IUPUI.
The courses are open to currently enrolled graduate students at Indiana University.
In addition, non-IU students can be admitted through IUPUI’s graduate
non-degree program (www.iupui.edu/~gradoff/gnd).
The classes will be held in the Informatics and Communications Technology
Complex. For more information about the Laboratory Informatics Summer Program
or to register, visit http://www.limsconference.org.
New Software from Cerno Bioscience Makes
Debut at PITTCON 2006 to Win Bronze Award for Most Innovative Product in Show
Cerno Bioscience has announced that its novel easy-to-use post acquisition
software package MassWorks has won the PITTCON 2006 Editors' Choice Bronze
Award following its show debut at the Pittsburgh Conference of Analytical
Chemistry and Applied Spectroscopy in March 2006. This prestigious accolade
is given to the best new product introduction for its contribution to the
advancement of science, as judged by a panel of editors attending the show.
Each of the 16 editors voting for this year's awards was allowed to
nominate up to 3 new products being launched at Pittcon for the first time.
Cerno's fast and versatile MassWorks figured strongly among all the nominations
and won the final vote, positioned with the Bronze Award. MassWorks utilizes
Cerno's patented MSIntegrity calibration technology to achieve up to 100X
improvement in mass accuracy on unit mass resolution mass spectrometers. This
allows users to obtain mass accuracies of up to 5ppm making it possible to
perform accurate compound identification through elemental composition determination,
a capability usually only available on more expensive systems. MassWorks
significantly improves the quality of data from any mass spectrometer from
unit mass resolution instruments through to FTMS systems. This innovative,
patented technology has been specifically developed for pharmaceutical and
biotech environments and made its debut at PITTCON 2006. Fr details,
visit http://www.cernobioscience.com.
PerkinElmer Unveils Several New Analytical
Solutions at Pittcon
PerkinElmer Inc., a global leader in Health Sciences and Photonics, announced
new application-based laboratory solutions and product enhancements for the
environmental, pharmaceutical, materials and academic research market segments
at PITTCON 2006. New solutions being showcased included five turnkey
Ozone Precursor Analyzer systems for remote environmental air monitoring,
the latest WinLab32 for Atomic Absorption (AA) software with an integrated
Quality Control (QC) Charting option, the new Jade DSC heat-flux Differential
Scanning Calorimeter for thermal analysis, and LABWORKS™ LIMS v5.9.
The latest version of PerkinElmer’s LABWORKS LIMS is the first release
built on an entirely new computing platform. The new architecture takes
LABWORKS’ long tradition of highly-configurable systems to a new level
of tailoring. Using a new implementation tool kit, users can customize
site-specific data structure and presentation of their LIMS. Version
5.9 also includes expanded security features for greater regulatory compliance
with ISO 17025 and other standards. For details, visit http://www.perkinelmer.com.
Pittcon Highlights General Release of STARLIMS
Version 10
STARLIMS Corporation, a global provider of LIMS, announced the general release
of STARLIMS Version 10, an entirely web-based off-the-shelf LIMS that works
equally well in Internet and Intranet environments. The new version was shown
at PITTCON 2006. STARLIMS V10 offers enterprise-wide interoperability, no
client-side software installations and a short learning curve. At the same
time, it provides the advantages typically associated with client/server applications:
predictable response times and a full-featured GUI for a rich user experience.
"We redesigned our industry-leading LIMS as an entirely web-based solution
to help labs meet today’s demanding interoperability requirements. Advanced
technologies such as programmable XML, .NET and SOAP-based web services translate
into crucial advantages for laboratories and organizations.” said Itschak
Friedman, CEO of STARLIMS Corporation. “Our new version is based not
only on 20 years of LIMS-only R&D, but also on a two-year of concerted
focus creating the industry’s most advanced web-based LIMS. We are confident
that STARLIMS V10 will significantly enhance lab management and overall operational
excellence.” Touted as the first programmable XML-based solution of
its kind by the company, STARLIMS integrates all lab disciplines into a single
fully configurable LIMS platform. Disparate business processes are consolidated
into a single, compliant platform with comprehensive reporting, surveillance
and networking capabilities. The result is vastly enhanced data management
and sharing—within the laboratory and across the enterprise. As a purely
web-based application, STARLIMS V10 offers rapid global deployment without
client-side installation. Ideal for large and distributed environments, the
application is fully scalable, from a single site to the entire organization.
For details, visit http://www.starlims.com.
Agilent Technologies Introduces Application
Software for New LC/MS Portfolio at Pittcon
Agilent Technologies Inc. has introduced advanced software that enables the
high performance and usability of its new 6000 Series Triple Quadrupole and
Quadrupole Time-of-Flight (Q-TOF) LC/MS systems, which are expected to help
Agilent double its market share in LC/MS by 2008. The Agilent MassHunter Workstation
software will allow scientists to transform large amounts of raw data into
meaningful information about the identity and quantity of compounds found
in complex mixtures in applications that include food safety, environmental
and forensic analysis, drug discovery and development, proteomics and metabolomics
research. The software platform supports instrument control, data acquisition,
qualitative and quantitative analysis, and reporting. It combines advanced
functionality, ease-of-use and open architecture to make the power of MS analysis
accessible to a wide range of scientists beyond the traditional core lab users.
The MassHunter Workstation provides an integrated, single point of instrument
control and data acquisition for Agilent's new LC/MS instruments, with powerful
real-time monitoring, method set-up and Agilent's proprietary autotune for
automated MS system tuning and mass calibration. Customers using both Q-TOF
and triple quad LC/MS can easily move from one system to another without having
to master different software or substantially change their methods. MassHunter
.NET-based qualitative and quantitative analysis software modules feature
compound-centric data mining and navigation, providing the most advanced data
processing tools available for LC/MS. Through unique algorithms, the MassHunter
Qualitative Analysis software allows users to automatically find and extract
all spectral and chromatographic information for each component in a sample.
Powerful data navigation capabilities permit users to browse through compound-specific
information in a single sample and compare chromatograms and spectra among
multiple samples. The software also includes a customizable user interface
and the capability to save, export or copy results into other applications.
The MassHunter Quantitative software supports simple and efficient review
of large multi-compound quantitation batches. A graphical "Batch-at-a-Glance"
interface allows users to navigate results by compound or sample, or switch
between the two approaches. A sophisticated quantitation engine allows users
to set up over 20 different outlier criteria, and a novel parameter-less integrator
facilitates reliable unsupervised quantitation. The ability to filter results
and focus on outliers or questionable peak integrations significantly reduces
the data review time for large multi-compound batches. A method task editor
and "Curve-Fit Assistant" provide for simple method and multi-level
calibration setup. The MassHunter Workstation also supports uniquely flexible
results reporting with Microsoft(r) Excel, a custom reporting macro add-in,
and report templates. All results and system parameters are stored in XML
(a standard data interchange format) and therefore can be extracted into Excel-based
reports and imported into proprietary customer databases. The MassHunter Workstation
will eventually support Agilent's entire 6000 Series family of LC/MS systems,
as well as the company's GC/MS and ICP/MS products. Through the use of industry
standards, Agilent also intends to support data generated from multivendor
MS systems. This will enable customers to continue using their existing hardware
investments, while upgrading to the most modern MS processing tools in the
industry. For details, visit http://www.agilent.com/chem/MassHunter.
Agilent Technologies Introduces LC/MS
Software Solutions at Pittcon
Agilent Technologies Inc. has introduced powerful application software for
its 6000 Series portfolio of liquid chromatograph/mass spectrometer (LC/MS)
systems. The Agilent MassHunter Profiling software, Agilent MassHunter Bioconfirmation
software, and upgraded Agilent Spectrum Mill for MassHunter Workstation improve
the productivity and throughput of diverse molecular profiling applications,
protein identification and quantitation, peptide/protein confirmation and
characterization, and metabolomics. MassHunter Profiling software can: Align,
normalize and statistically assess molecular features in a single group; Statistically
compare composite molecular feature sets from two different groups; Visualize
and identify statistically significant feature differences between the groups;
and, Provide detailed inspection of the data for a select feature across all
samples. Comparisons between three or more sample groups are possible via
an export to the GeneSpring bioinformatics platform, where a variety of statistical
techniques are available for analysis and classification. Agilent's MassHunter
Bioconfirmation software is ideally suited for scientists involved in recombinant
protein expression, known protein characterization, or synthetic peptide confirmation.
When coupled with the Agilent 6210 Time-of-Flight LC/MS, the software helps
to confirm identities and identify variants before expensive testing begins.
The MassHunter Bioconfirmation software uses sophisticated algorithmic tools
to generate superior and accurate lists of peptide mass, retention time and
abundance. This improves productivity and throughput by allowing truly automated
and interactive confirmation and characterization of recombinant proteins
or synthetic peptides. Agilent Spectrum Mill for MassHunter Workstation is
designed to facilitate high-throughput proteomics and biomarker research.
The Spectrum Mill software allows users to compare large data sets across
multiple experiments and summarize results at the protein level. Through enhanced
MS/MS spectral-quality filtering and iterative database searching, the software
can increase the speed of protein identification and quantitation ten-fold.
The software can reveal two-fold or greater changes in relative abundance
without the need for labeling. When more precise quantitation is needed, the
Spectrum Mill software now supports a wide variety of stable isotope-based
labeling strategies -- a unique offering For details, visit http://www.agilent.com/chem/MassHunter.
Bio-Rad Announces Several New Products at
Pittcon
Several new products were announced at PITTCON 2006 by Bio-Rad. First, Bio-Rad
introduced technology for Comparative Visualization of Spectral, Chromatographic
and Other Graphical Data. Second, Bio-Rad and Infometrix announced an agreement
to offer an integrated Analytical Informatics and Chemometrics Platform. Third,
Bio-Rad and Infometrix announced an agreement to to jointly releasea new KnowItAll
Metabolomics Software Solution to aid in drug discovery. And, fourth, Bio-Rad
announced the ability to integrate CSIRO's Molecular Modeling Technology into
its KnowItAll Informatics System for In Silico ADME/Tox. For details, visit
http://www.knowitall.com/news.
ACD Introduces ACD/IntelliXtract LC/MS Software
at Pittcon
Advanced Chemistry Development, Inc. (ACD/Labs) introduced ACD/IntelliXtract,
an LC/MS software package for automated molecular weight determination, component
extraction, and sample comparison. ACD/IntelliXtract mimics the approach an
expert mass spectrometrist would use for spectrum interpretation. Ion adducts,
multimers, 12C/13C ratios, isotopes, neutral losses, and fragment ions are
considered, providing accurate molecular ion identification in a fraction
of the time of manual data review. ACD/IntelliXtract is easy to use, with
a unique self-optimizing algorithm to perform complex analysis procedures
with a minimum of user optimization. For details, visit http://www.acdlabs.com/IntelliXtract.
Cerno Bioscience Announces MassWorks Software for High Mass Accuracy
Data From Any Mass Spectrometer
Cerno Bioscience has announced MassWorks, an easy-to-use post acquisition
software package that utilizes Cerno's patented MSIntegrity technology to
achieve high mass accuracy even on conventional mass spectrometers of unit
mass resolution. New MassWorks, developed for pharmaceutical and biotech environments,
integrates the powerful MSIntegrity calibration technology to obtain up to
100X improvement in mass accuracy in a fast and versatile MS software application
package. By combining novel calibration techniques with sound mathematical
principles, Cerno methodologies can provide significant improvements to all
types of MS data, both high and low resolution. This innovative, patented
technology was launched at Pittcon 2006. MassWorks can improve the results
from any mass spectrometer from unit mass resolution instruments through to
FTMS systems. It can routinely extend the capabilities of unit mass
resolution instruments to obtain mass accuracies of up to 5ppm, approximately
100X better than results typically obtained. This makes it possible
to perform accurate compound identification through elemental composition
determination, a capability usually only available on more expensive systems.
MSIntegrity also improves the performance of high resolution MS systems, typically
improving mass accuracy by 3X or greater. On all systems, significant
improvements in signal-to-noise and peak shape are achieved as well. MassWorks
utilizes Cerno's DirectRead technology to read most instrument data formats
directly, eliminating the need for importing or exporting MS data to the clipboard
or utilizing intermediate exchange formats. This saves time, reduces transcription
errors, simplifies file management, and saves substantial disk space. As
DirectRead doesn't alter the original data, it assists compliance with common
regulatory requirements such as GLP and 21 CFR Part 11. In addition to providing
improved mass accuracy, the calibration also improves the signal-to-noise
and the peak shape of the MS data. For details, visit http://www.cernobioscience.com.
Thermo Provides Single Solution for Water
Testing Needs with New SampleManager Interface
Oftentimes the task of collection scheduling, efficient route preparation
and other pre-test activities is separated from in-laboratory testing and
activities performed on water and wastewater samples. The benefits of combining
all these processes and managing them in a single LIMS, such as SampleManager
LIMS from Thermo Electron Corporation, are numerous. SampleManager automates
the tedious and complex pre-testing regimen which includes scheduling of sample
collection to comply with regulatory guidelines, determination of sample locations
and efficient planning of collection routes to avoid wasted time, and even
which bottle types the test agent should take into the field to collect the
samples, eliminating guesswork and errors. This is matched with functionality
to manage and automate in-laboratory sample/bottle tracking, testing, regulatory
compliance verification, reporting and archival of data, particularly to adhere
to regulations. Because organizations that inspect the potable water supply
and wastewater discharge are closely regulated, SampleManager for the water
industry is developed as a commercial-off-the-shelf solution equipped with
necessary functionality – out of the box – to serve these industries,
especially with regard to compliance. Users can easily configure the system
to observe and track such requirements as plastic versus glass collection
bottles, whether a sample must be tested within 24 hours or not allowed to
sit overnight. While potable water samples can be tested to determine if they
are within allowable levels for identified contaminants, other samples can
be tested to determine what, if any, unknown contaminants might be present.
SampleManager is also designed to manage such field results as water temperature,
odor and taste. SampleManager 9.0, scheduled to be released in Q2 2006, features
a new interface that enables users to organize and review data more easily.
Built on the Microsoft.NET framework, this next release can be extended by
the use of internal tools or market-leading open standard tools that support
C# and .NET. This supports Thermo’s strategy to provide solutions based
on open standards. For details, visit http://www.thermo.com/lims.
GenoLogics and Institute for Systems Biology
Announce Integration of the Trans Proteomic Pipeline with Proteus
GenoLogics Life Sciences Software Inc. has announced a cutting edge development
resulting from its strategic partnership with the Institute for Systems Biology
(ISB), an internationally known research institute with a mission of exploring
the complexities of human genes in order to prevent and treat diseases. Through
collaborative development efforts, it is now possible for the ISB’s
Trans Proteomic Pipeline (TPP) -- a set of free, open-source programs developed
with support from the National Heart, Lung and Blood Institute that
run in series to form a ‘pipeline’ -- to be seamlessly launched
from GenoLogics Proteus lab and data management system for proteomics. The
integration of Proteus and the TPP provide numerous benefits for proteomics
researchers, bioinformaticians and managers. It enables automatic statistical
validation of protein search results and calculated quantitation information,
improving accuracy and through-put as many more samples can be researched
and validated automatically. Quantitation information tells the amount of
a protein/peptide in one sample compared to another sample. Researchers can
publish results faster with increased confidence. Collaboration among researchers
is also easier. Researchers can view any spectra on any computer and share
mzXML spectra files with colleagues. There is no need for commercial spectra
viewers since various open source mzXML viewers are available for most platforms.
Users can also view the result files in the TPP’s own viewer, directly
from Proteus. Bioinformaticians do not have to develop their own interface
for the TPP, as it will just work with Proteus. They can data mine the TPP
results through the Proteus database, eliminating the need to parse result
files or build their own database. In addition, it is easy for an organization
to integrate its own data processing tools into Proteus because of GenoLogics
commitment to open data standards and its open integrating platform. For details,
visit http://www.genologics.com.
QSI
Offers WinDocs for Comprehensive Document Control
Electronic document control can provide a secure, convenient solution, and
WinDocs is a new package from Quality Systems International (QSI) designed
to deliver comprehensive document control at an affordable price. WinDoc's
functionality includes: full version control, document review procedures,
distribution and access control. Documents can be cross-referenced and linked
to others. The system offers fast document access with enhanced security protection
against unauthorised viewing. The risk of using out-of-date or unauthorized
documents is eliminated. WinDocs is built on a secure document repository
held within an SQL (Structured Query Language) database, the backbone of most
modern database systems. WinDocs is a single- or multi-user application and
can be used as a stand-alone package or seamlessly linked to QSI's other quality
products like their WinLIMS LIMS. For details, visit http://www.qsiuk.com.
QSI Offers Languge Handling Capability with WinLIMS
Even the simplest information can be misunderstood in a multilingual environment,
so imagine being able to log in your samples in the US (in English) with the
data available immediately and accurately to your laboratory in Japan, in
Japanese! The latest LIMS functionality from Quality Systems International
(QSI) is sophisticated language handling that allows WinLIMS users to run
their system in their chosen language. By translating user interface elements
like screens, menus and dialogue boxes, etc., WinLIMS gives individual users
the convenience and ease of working that comes from using their native language.
Global companies using centralised systems can move data around the world
without the fear that vital information will be "lost in translation".
Operators can have their preferred language assigned to their WinLIMS staff
record, and by simply logging in will then immediately see the whole system
in that language. Users have the ability to change or update the translations
used to reflect changing situations and can even translate actual data - examples
might be product names, method or parameter names or details of raw materials.
Currently, WinLIMS can be supplied with the following languages already set
up: English, German, French, Dutch, simplified Chinese and Portuguese, but
the user can set up any other language that might be needed, including languages
that require double byte character sets like Chinese, Japanese or Korean.
For details, visit http://www.lims-software.co.uk.
GSK Puts RFID Tags on Trizivir Bottles
In an effort to protect patients from counterfeit products, GlaxoSmithKline
(GSK) has attached radio frequency identification (RFID) tags on all bottles
of its HIV treatment Trizivir distributed in the U.S. The RFID-tagged bottles
will begin appearing on pharmacists' shelves in mid-April, the firm said recently.
When scanned at close range, the tags will help verify that the medicine bottle
contains authentic Trizivir. GSK selected Trizivir for the RFID technology
initiative because it has been listed by the National Association of Boards
of Pharmacy as one of 32 drugs most susceptible to counterfeiting and diversion,
the firm said. Approved in 2000, Trizivir is a fixed-dose combination of Ziagen
(abacavir), Retrovir (zidovudine) and Epivir (lamivudine). RFID tagging allows
firms to more precisely account for products as they move through the distribution
chain, GSK said. The technology also allows healthcare workers to authenticate
drugs at the point of dispensation. RFID uses a silicon chip and antenna about
the size of a postage stamp that is attached to each medicine bottle. The
chip stores a unique product code that reflects information about the drug's
manufacturing. For details, visit http://www.gsk.com.
SYSTECH International Engages Domino Printing
Sciences plc To Deliver Full Track And Trace Capability For Pharmaceutical
Manufacturers
SYSTECH International, a leading provider of Packaging Performance Management
solutions, and Domino Printing Sciences plc, a world-leader in ink jet and
laser technologies, have announced an agreement that will combine SYSTECH's
TIPS Serialized Product Tracking solution with Domino's marking and coding
solutions. As a SYSTECH International Authorized Solutions Provider, Domino
will provide pharmaceutical manufacturers with a comprehensive end-to-end
solution to combat counterfeit product and increase patient safety. Various
coding formats are supported, ranging from bar code and data matrix to RFID.
The addition of in-line verification and tag reading capabilities, coupled
with failsafe data and product tracking control ensures that customers are
presented with secure systems representing the best technologies available
for application at the point of manufacture.
Both companies have experience within the pharmaceutical industry, providing
solutions that are fully compliant with the requirements for 21 CFR Part 11
and further supported with GAMP validation packages. For details, visit http://www.systech-tips.com.
SYSTECH International's TIPS Serialized Product
Tracking Solution Achieves Certified Integration with SAP Auto-ID Infrastructure
SYSTECH Internationa has announced that its TIPS Serialized Product Tracking
7.0 solution has achieved SAP certification for integration with the SAP Auto-ID
Infrastructure component of the SAP NetWeaver platform, which powers many
SAP solutions for RFID. The software is one of the first fully 21 CFR Part
11-compliant solutions to earn this designation. Currently piloted by several
pharmaceutical manufacturers in the United States and Europe, TIPS Serialized
Product Tracking supplies mass serialization of products at the item, case
and pallet level to facilitate e-Pedigree, authentication, and track and trace.
This serialization, using Electronic Product Codes (EPCs) on RFID enabled
labels and bar code, is done on the packaging line and is integrated with
existing packaging operations. "For customers, this certification helps
guarantee the seamless integration between our TIPS Serialized Product Tracking's
comprehensive and reliable packaging line device management, data collection,
and 21 CFR Part 11 compliance and the SAP Auto-ID Infrastructure," said
Robert DeJean, SYSTECH's President and CEO. "This combination can help
pharmaceutical manufacturers ensure product integrity across their supply
chain." TIPS Serialized Product Tracking is part of SYSTECH's comprehensive
suite of machine vision inspection, packaging line automation and information
management solutions. SAP provides a rich set of integration technologies
that enable third-party vendors to integrate their software with SAP solutions
seamlessly for more customer satisfaction. SAP's RFID certification process
helps ensure that customers deploying the SYSTECH solution can seamlessly
integrate TIPS Serialized Product Tracking software with the SAP Auto-ID Infrastructure.
SYSTECH has worked closely with SAP Labs throughout the testing and certification
process. Testing was successfully completed for all business processes within
the SAP Auto-ID Infrastructure. For details, visit http://www.systech-tips.com.
Mind the Gap Report Reveals Major
Gaps in Long Term Management of Digital Assets
A ‘state of the nation’ report has revealed that less than 20%
of UK organisations surveyed have a strategy in place to deal with the risk
of loss or degradation to their digital resources - despite a very high level
of awareness of the risks and potential economic penalties. With the release
of the report, Mind the gap: assessing digital preservation needs in the UK,
the Digital Preservation Coalition (DPC) aims to help government, public institutions
and private companies turn high awareness into concerted action. The survey
reveals that the loss of digital data is commonplace – it is seen as
an inevitable hazard by some – with more than 70% of respondents saying
data had been lost in their organisation. Awareness of the potential economic
and cultural risks is high, with 87% recognising that corporate memory or
key cultural material could be lost and some 60% saying that their organisation
could lose out financially. In 52% of the organisations surveyed there was
management commitment to digital preservation – but only 18% had a strategy
in place. A pdf version of the report is available from http://www.dpconline.org/docs/reports/uknamindthegap.pdf.
The U.S. has Emerged as the World Leader in
Important New Drug Introductions
A DukeUniversity study, led by economics professor Henry Grabowski, also found
that the U.S. has become the top country where new drugs are first launched.
Since 1993, the U.S. pharmaceutical industry has become the world leader in
introducing important new drugs, according to a study led by a Duke University
economist. Between 1993 and 2003, U.S. firms introduced 48 percent of first-in-class
or novel drugs, 52 percent of biotech drugs and 55 percent of orphan drugs
that treat rare diseases worldwide. For details, visit http://www.duke.edu.
STARLIMS Opens Global Center of Excellence
for the Life Sciences
STARLIMS Corporation, a global provider of LIMS, has announced the opening
of the STARLIMS Center of Excellence in Life Sciences (COE). The new COE is
part of STARLIMS Canada, which recently became a wholly owned STARLIMS subsidiary
after over a decade of close partnership. The hub of life sciences domain
expertise within STARLIMS, the new COE brings together over 30 professionals
who have rich and varied expertise in life science information management
solutions. The COE will serve STARLIMS’ global customer base in the
pharmaceutical, biotechnology, medical device and CRO industries. Its mission
is to optimize STARLIMS solutions to precisely suit the needs of life science
organizations, while providing industry-specific support for STARLIMS Professional
Service specialists around the world.For detials, visit http://www.starlims.com.
Axiope Addresses Biomedical Data Archiving
with NIH SBIR Funding
Axiope Inc. has completed a $400,000 Phase I Small Business Innovation Research
Grant (SBIR) from the National Center for Research Resources (NCRR) branch
of the National Institutes of Health (NIH). The grant investigated the feasibility
of innovative methods for archiving, auditing, and sharing scientific data.
The system serves the data management needs of individual research labs, core
facilities, and multi-lab research consortia. The improvements to Catalyzer
assist investigators with meeting regulatory and intellectual property requirements
for data archiving. The system also gives the investigator greater flexibility
in modeling research processes while maintaining personal control over the
system’s development and deployment. The new capabilities were field-tested
by Children's Hospital Boston and the National Cancer Institute (NCI), two
institutions with site-wide deployments of Catalyzer. The project also included
feedback from scientists using Catalyzer in over 20 publicly-funded and corporate
biomedical research institutions. This Phase I SBIR project designed, prototyped
and tested a new collaborative, investigator-oriented research data management
system. The system is designed to work with a commercially successful, personal
research data management application, Catalyzer Desktop, which was developed
by consultants to the project. Catalyzer Desktop has been adopted by many
investigators with data organization or database development needs.
It now supports the data sharing, auditing, and archiving needs that often
arise in the life cycle of a project as collaborations are formed or core
facilities begin to scale up. The new collaborative system was devised in
response to direct feedback from scientists using Catalyzer Desktop in over
20 publicly-funded and corporate biomedical research institutions. The system
serves the data management needs of individual research labs, core facilities,
and multi-lab research consortia. This project developed and tested
Catalyzer Workgroup Server (CWS), a scalable multi-user server that complements
the existing database development environment of the Catalyzer Desktop application.
CWS assists investigators with meeting regulatory and intellectual property
requirements such as audit trails and secure archiving as well as the NIH
data-sharing requirements. CWS enables collaboration through on-line data
sharing and reporting, and addresses the scalability and security issues that
arise in the growth of projects. It gives the investigator the flexibility
in modeling research processes and support for evolving data types, while
maintaining personal control over the system’s development and deployment.
The project focused on multi-user access to collaborative data services designed
for high scalability. Subsequently it focused on the creation, maintenance,
and navigation of all historical data modifications in a fully searchable
archive. For details, visit http://www.axiope.com.
Prime Technologies Announces New User Interface
to ProCalV5 Calibration Software
Prime Technologies, Inc. has announced the latest release of its line of Windows-based
ProCalV5 Calibration Software, a paperless calibration and compliance management
software. This new version offers upgraded screen interfaces designed to both
enhance the user experience and provide new productivity and oversight tools
for managers. It is now even easier to manage devices and engineering records,
perform math functions, schedule and track calibration activities and electronically
distribute critical notifications, reminders and alerts. Advanced features
like forced e-signature routings and out of tolerance compliance reporting
make this the ideal solution for companies in the life sciences industry and
other quality regulated industries. System highlights include: Centralized
ProCalV5 Explorer Toolbar; New “Skins” Mode for Customization
of the Home Screen; Streamlined Reminders and Notifications for immediate
notice; Updated and Customizable Graphical User Interface; Shortcuts from
Toolbar for Calibration or Maintenance entry. For details, visit http://www.primetechpa.com.
Norgren Systems Introduces CP7200 Colony
Picker for Life Science Researchers
Norgren Systemshas introduced its CP7200 colony picker. The CP7200 offers
users high speed picking, ease of use, and ultimate reliability for under
$100K Ultra-fast picking rates up to 7,200 colonies per hour, advanced imaging
software that makes it easy to go from plate to plate and even run to run
without timely recalibration efforts, and the smallest footprint of 22”x
20” to optimize lab space are some of the features users can benefit
from. The CP7200 was designed for maximum reliability and minimal downtime,
utilizing a continuous picking configuration which provides simultaneous picking,
inoculation, washing and sterilization. Additionally, users can easily change
individual tungsten needles on the picking turret as necessary without having
to remove the whole head. The system was designed to allow high throughput
users continuous workflow of picking and inoculation without sacrificing the
ease of use and short start-up time required by the average user. The CP7200
has been optimized to provide the most accurate and precise picking rates.
Users typically report a no grow rate of <1% with greater than 90% of pickable
colonies identified by the software and picked by the system. For detials,
visit http://www.norgrensystems.com.
IU's Chemical Certificate Program
Offers Long-Distance Learning
Chemists and other life sciences researchers can learn new techniques and
advance their education through a new graduate level program offered by the
Indiana University School of Informatics. A graduate certificate in chemical
informatics will be available beginning with the fall 2006 semester. “The
certificate is designed specifically to help practitioners in industry, government
and academic enters gain the skills they need to use chemical informatics
techniques in their approaches to information technology,” says Gary
Wiggins, director of the School’s Chemical Informatics Program. Chemical
informatics is the application of computer technology to chemistry in all
of its manifestations, particularly in the pharmaceutical industry. Students
enrolled in the program have the option of attending classes on the Bloomington
or Indiana University-Purdue University Indianapolis campuses. Or, they can
join classes remotely using a teleconference or Web-conferencing system. All
that is required for remote access is an Internet-connected computer and telephone,
dialing into a toll-free number. Successful completion of four courses (three
credit hours each) earns students the certificate. The classes must be completed
within a maximum of three years. The classes include chemical information
technology; computational chemistry and molecular modeling; programming for
chemical and life science informatics; and independent study in chemical informatics.
Participants in the certificate program must have a bachelor’s degree
with appropriate computing skills, and must demonstrate a strong need to learn
and use chemical informatics techniques. Formal admission to IU is required
as a continuing non-degree student For details, visit http://www.informatics.indiana.edu.
IU, Purdue Collaboration Spawns
CyberInformatics Lab
The Indiana University School of Informatics and Purdue University School
of Engineering and Technology have forged a partnership to strengthen their
research and internship programs. The schools, located at Indiana University-Purdue
University Indianapolis, have signed a memorandum of understanding to establish
the CyberInformatics Lab. The agreement calls for shared office and laboratory
space, and a visiting researcher position at CyberLab. The CyberInformatics
Laboratory will be a component of the IUPUI CyberLab. CyberLab, located near
the IUPUI campus, is an advanced information technology research and development
facility. Its faculty researchers and student interns have developed Web tools
such as Oncourse, ANGEL and Epsilen, currently at use at IU. ANGEL is commercially
licensed to hundreds of institutions worldwide. The CyberInformatics Lab will
offer undergraduate students unique opportunities they cannot get anywhere
else. Students selected for internships will participate in “real-life”
research and development projects that are intended to market as commercial
products. Information about the School of Informatics at IUPUI is at
www.informatics.iupui.edu.
The Purdue School of Engineering and Technology site is www.engr.iupui.edu.
The IUPUI CyberLab is www.cyberlab.iupui.edu.
Mapping Exhibit Plots Course for Better Understanding
of Science
Maps help us navigate along blue-ribbon highways and dusty back roads, through
rugged jungles, across teeming oceans and even explore the moon, Mars and
those pinpoints of light beyond our solar system. Now comes a new method that
charts the landscape of science. It’s called Places & Spaces:
Mapping Science, a public exhibit traveling the United States and
one of its chief pilots is Katy Börner, associate professor of information
science at the Indiana University School of Library and Information Science
and adjunct associate professor at the IU School of Informatics. Its next
stop is the Science, Industry and Business Library of the New York Public
Library in midtown Manhattan, opening April 3 and running through Aug. 31,
2006. “This unique exhibition uses innovative mapping techniques to
visually show what and where science is today, and how the different branches
of science relate to one another,” says Börner.“An initial
theme of this exhibit is to compare and contrast the first maps of our entire
planet with the first maps of all of science as we know it,” says Börner.
“The second iteration contrasts four existing reference systems with
six potential reference systems and aims to inspire discussion about a common
reference system for all of mankind’s scientific knowledge.” Mapping
Science also gives viewers a chance to see where science disciplines are heading,
where cutting-edge science is erupting and how it all relates back to the
physical centers of research. The exhibit is the first public display of high-resolution
maps of science. Börner shares the role of curator of the Mapping Science
exhibit with Deborah MacPherson of Accuracy & Aesthetics, a Vienna, Va.-based
organization that promotes the advancement of education, cultural heritage
and science. Together, they headed a team of information technology experts,
scientists, designers and artists from various disciplines who in some cases
redesigned and in most cases created these maps for the exhibit. For more
information about the exhibit, visit http://vw.indiana.edu/places&spaces.
Industry GMP Implementation Delayed by Unfinished
Guidance, Uncertain Enforcement
Industry officials are hesitant to adopt the FDA's planned changes to its
good manufacturing practices (GMP) policy until the agency finalizes its new
manufacturing requirements, sources say. Manufacturers are also concerned
that FDA field inspectors won't consider the new requirements when taking
enforcement action.
The FDA is attempting to change companies' manufacturing practices to accelerate
drug development and improve product safety and efficacy. To ensure these
changes, the agency is implementing new approaches through its initiative,
"Pharmaceutical Current Good Manufacturing Practices for the 21st Century."
In particular, the FDA is encouraging the adoption of state-of-the-art quality
control systems. These systems call for companies to continually review how
they manage variations in temperature, particle size, pressure and flow rate
to ensure the final product's quality. Such changes will allow industry to
ensure quality in their product designs up front, rather than making changes
after the fact through trial and error, said Moheb Nasr, director of the agency's
Center for Drug Evaluation and Research's Office of New Drug Quality Assessment.
The FDA wants companies to take a "new, more proactive approach"
to manufacturing. While industry believes that a quality control approach
is a good move, a lack of regulatory consistency is slowing implementation,
said Gordon Richman, vice president of strategic compliance and general counsel
of the consulting firm EduQuest. There are "lots of growing pains"
within both industry and the FDA, he added. Specifically, industry is waiting
for the agency to finalize its quality systems final guidance, Richman said.
The FDA issued its draft policy on GMP, "Quality System Approach to Pharmaceutical
Current Good Manufacturing Practice Regulations," in September 2004.
Industry hopes the agency will be "more prescriptive and clear"
in what it expects from companies in the final version, Richman added. But
the FDA has nearly completed its final guidance, and that document will not
be substantially different from the draft, said Joe Famulare, acting director
of the Office of Compliance in the agency's Center for Drug Evaluation and
Research. The final guidance will be completed this summer, Famulare added.
For details, visit http://www.fda.gov.
FDA Unveils Critical Path Opportunities List
The FDA has unveiled its long-awaited Critical Path Opportunities List, focusing
on projects that will advance the use of biomarkers and streamline clinical
trials. The agency is planning an extensive review of 76 potential projects,
with an eye toward whittling down the list over the next few weeks to a few
plans the FDA will implement. The FDA is focusing on six key areas for Critical
Path: better evaluation tools, biomarkers and disease models, streamlining
clinical trials, harnessing bioinformatics, improving manufacturing processes,
products that address urgent public health needs and at-risk populations.
Based on its outreach efforts, the agency has determined that the two most
important areas for improving medical product development are biomarker development
and streamlining clinical trials. Most researchers agree that a new generation
of predictive biomarkers would dramatically improve the efficiency of product
development, help identify safety problems before a product is on the market
(and even before it is tested in humans), and facilitate the development of
new types of clinical trials that will produce better data faster, said Janet
Woodcock, the FDA's deputy commissioner for operations and head of the Critical
Path Initiative. "Similarly, researchers stressed that reforming the
clinical trial process — both trial design and trial conduct —
would dramatically improve the efficiency of product development, which means
getting products to patients faster at less cost," she said. One factor
the agency will consider in choosing projects is whether it has sufficient
funding for Critical Path. The FDA will begin in April to consider its ability
to use agency funding to support selected Critical Path projects. The agency
has asked for $5.9 million in the fiscal year 2007 budget to help fund the
program, Woodcock said. The possibility that acting FDA Commissioner Andrew
von Eschenbach may be confirmed as the permanent head of the agency will bolster
the FDA's push for full funding of Critical Path, industry sources said. But
the agency's delay in making a decision on the controversial Plan B contraceptive
could slow his confirmation, sources say. Woodcock declined to comment on
whether the agency would accelerate the Plan B review to help ensure that
von Eschenbach is confirmed. Meanwhile, the agency plans to work cooperatively
with other government agencies and private entities to implement the Critical
Path plans, which should help fund these programs, agency officials said.
"The Critical Path is all about collaboration," said Woodcock. Critical
Path is "a shining example of how we can share resources." Cooperation
was the watchword for the agency during the unveiling of the list of key areas.
The FDA believes that greater cooperation among the public and private sector
is essential to improve the drug development pipeline, which is the essential
goal of Critical Path. For details, visit http://www.fda.gov.
After Congressional Meeting, Von Eschenbach
Confirmation in Greater Doubt
Senate Democrats lifting their hold on president Bush's nomination of Andrew
von Eschenbach as permanent FDA commissioner diminished after several key
senators recently met with the nominee, a congressional staffer says. Von
Eschenbach, the agency's acting commissioner, sat down with Sens. Patty Murray
(D-Wash.), Hillary Rodham Clinton (D-N.Y.) and Mike Enzi (R-Wyo.) to discuss
the FDA's pending review of the controversial contraceptive Plan B. Democrats,
including Murray and Clinton, have vowed to hold the nomination until the
agency sets a timeline for deciding whether to grant Barr Laboratories' application
to sell the drug over the counter (OTC). But the senators are less likely
to lift the hold after meeting with von Eschenbach, Murray's spokeswoman Alex
Glass told FDAnews. Von Eschenbach refused to provide a timeline for an agency
decision, which heightens the lawmakers' concerns that he will not be sufficiently
independent of outside influence, Glass said. The FDA has been accused of
letting political pressure from the Bush administration influence its decision
on Plan B, a claim the agency has repeatedly denied. The lawmakers had hoped
the nominee would provide some detail as to the FDA's future schedule on Plan
B approval, Glass noted. Instead, the senators "got nothing" from
von Eschenbach. "It's the same old, same old with them," Glass said.
Von Eschenbach needs to show he is willing to take a different approach to
sensitive policy issues by being independent of outside influence, she added,
noting this does not seem to be the case based on the meeting and that is
"certainly a concern." The lawmakers have scheduled no further meetings
with the agency and are not likely to meet with the FDA again on the issue,
Glass said. The same obstacle faced former FDA Commissioner Lester Crawford,
as opponents held his nomination pending a decision on Plan B. Lawmakers,
including Murray, lifted that hold when HHS Secretary Mike Leavitt pledged
last September that the FDA would make a decision on the application, Glass
said. But no decision occurred, and lawmakers do not intend to lift their
hold on von Eschenbach based on a mere pledge. "We won't make that mistake
again," Glass said. Enzi, chairman of the Senate Health, Education, Labor
and Pensions (HELP) Committee — which has jurisdiction over the agency
— has been a key supporter of the von Eschenbach nomination. The HELP
committee staff has told the White House that the FDA must make a decision
on Plan B in order to get Von Eschenbach confirmed by the Senate, an Enzi
spokesman said. The FDA declined to provide details of the meeting. "We
are not commenting, other than to confirm the meeting took place," an
agency spokeswoman said. The agency has previously said it has not made a
decision yet because it is still reviewing public comments received on the
Barr application. Barr first sought OTC status for Plan B (levonorgestrel)
in 2003, but the FDA rejected the request, saying the application lacked scientific
data on the product's OTC use among adolescents younger than 16. The agency
also rejected the advice of an FDA advisory panel that recommended OTC use.
For details, visit http://www.fda.gov.
Permanent
Appointment of Von Eschenbach May Be Delayed by Plan B Decision
Senate Democrats are threatening to hold up the nomination of Andrew von Eschenbach
to be the permanent head of the FDA over delays in the agency's decision on
whether to allow the controversial Plan B contraceptive to be sold without
a prescription. President Bush recently announced the nomination, following
weeks of speculation that von Eschenbach was the administration's choice to
run the FDA. Lawmakers from both sides of the aisle are supporting the move.
But some Senate Democrats are planning to place a hold on the nomination until
the FDA makes a decision on Plan B. For example, Sen. Edward Kennedy (D-Mass.),
the ranking member of the Senate Health, Education, Labor and Pensions (HELP)
Committee, seems poised to oppose the nomination pending a Plan B decision.
"I expect the [Bush] administration will have to address the Plan B issue
fair and square before he can be confirmed," Kennedy said. Sen. Patty
Murray (D-Wash.) also is planning to place a hold on the nomination.
Rep. Maurice Hinchey (D-N.Y.) also challenged the nomination, arguing von
Eschenbach is more interested in protecting pharmaceutical companies than
the American public. "I'm also concerned about Dr. von Eschenbach's close
ties to the Bush family because I want to make sure that the new FDA commissioner
can stand firm in opposition to the White House when needed and doesn't become
just another 'yes' man for the president," Hinchey said. However, the
nominee does have strong allies, including Sen. Mike Enzi (R-Wyo.), the chairman
of the HELP committee, who has jurisdiction over the nomination. Enzi said
that he is "pleased" with the nomination. Referring to von Eschenbach,
Enzi noted the agency "needs a leader with the vision to cope with the
many advances in genetics, pharmacology and related fields." The HELP
committee has primary jurisdiction over the nomination. Critics of the FDA,
including Sen. Barbara Mikulski (D-Md.) and Rep. Rosa DeLauro (D-Conn.) are
also supporting von Eschenbach. "I am pleased to see that the [Bush]
administration has appointed a competent, permanent head of FDA instead of
a temp," said Mikulski. "Today's announcement is a move towards
reforming FDA as the agency recovers from several years of weak leadership."
However, some activists have questioned the nomination, arguing that von Eschenbach's
experience as head of the National Cancer Institute represents a conflict
of interest. Public Citizen blasted the move, calling von Eschenbach "unqualified"
and out of touch. "Von Eschenbach continues to exhibit extraordinarily
bad judgment, a lack of being in touch with reality and insensitivity to the
hopes and fears of other cancer patients and their friends and families, as
evidenced by his oft-stated 'plan' to eliminate the suffering and death from
cancer by 2015,"said Sidney Wolfe, director of Public Citizen's Health
Research Group. "Eradicating cancer within 10 years is not realistic,
and by making this statement, von Eschenbach is cruelly raising people's hopes."
For details, visit http://www.fda.gov.
Eschenbach's NCI Role Could Affect Permanent FDA Position
Andrew von Eschenbach's
dual role as acting FDA commissioner and head of the National Cancer Institute
(NCI) is a key factor in arguments both for and against his likely nomination
to become the permanent FDA commissioner, sources say. While proponents laud
von Eschenbach's experience with cancer issues and dedication to finding a
cure for the disease, opponents argue his ties to the NCI present substantial
conflict-of-interest concerns that may hinder his nomination. These issues
have arisen as the FDA has ramped up its efforts to address cancer. Industry
officials and cancer patient advocates argue that von Eschenbach is the right
man to lead the agency. Von Eschenbach's background as the longtime head of
the NCI, an oncology clinician and a cancer survivor makes him uniquely qualified
to lead the agency's growing attempts to treat and cure the disease, these
sources say. Von Eschenbach's expected nomination is "an extraordinary
opportunity" to move cancer research forward, said Ellen Sigal, chairwoman
of the Friends of Cancer Research. With his background and personal experiences,
von Eschenbach can provide "an important perspective" about the
significance of the disease and how to cure it, she added. The acting commissioner
fully supports the agency's efforts to address cancer and his likely nomination
as permanent head of the FDA will only bolster those efforts, said Peter Pitts,
director of the Center for Medicines in the Public Interest and a former FDA
official. Von Eschenbach's potential nomination could put him in a position
to work more aggressively to ensure the agency's cancer agenda is properly
funded, Pitts added. The rumors surrounding von Eschenbach's possible appointment
to head the FDA have arisen as the agency has laid out an aggressive agenda
to fight cancer with a focus on improving the scientific tools, information
tools and management approaches needed to address the disease. "We need
to do all these things to make the process for bringing new medical innovations
to patients more timely, less expensive and [less risky]," Scott Gottlieb,
the agency's deputy commissioner for medical and scientific affairs, told
attendees at a recent cancer conference.
For details, visit http://www.fda.gov.
Bush Likely to Nominate Von Eschenbach as Permanent
FDA Commissioner
It is anticiapted that Andrew von Eschenbach, the FDA's acting commissioner,
will soon be nominated to take over the job permanently, according to several
industry sources. Von Eschenbach, who has served as acting commissioner since
late September 2005, will likely be nominated within the next few days, Peter
Pitts, director of the Center for Medicines in the Public Interest and a former
FDA official, told FDAnews. Other industry sources confirmed that prediction.
The FDA did not confirm the rumor. "The White House will announce the
nomination of FDA commissioner. In the meantime, Dr. von Eschenbach continues
to lead the agency's efforts to protect and promote the public's health as
acting commissioner of the FDA," said agency spokeswoman Susan Bro. Von
Eschenbach is the right choice to ensure the agency continues to reform its
drug-safety and drug-approval policies, industry sources said. The consensus
among industry observers is that von Eschenbach is an experienced and respected
administrator who has already been vetted by lawmakers. Von Eschenbach is
the best choice as commissioner because "he's already Senate confirmed
. . . has done a good job so far" and wants to "drive [the agency]
toward change, which it requires," Pitts said. PhRMA would support the
nomination. "We certainly believe that Dr. von Eschenbach has impressive
research and management credentials," said Jeff Trewhitt, PhRMA's spokesman,
who added that nomination decisions were for the Bush administration to make.
The Senate also is eager to have a permanent commissioner in place. Sen. Mike
Enzi (R-Wyo.), chairman of the Senate Health, Education, Labor and Pensions
(HELP) Committee, has "always felt the importance of having a permanent"
commissioner, said the senator's spokesman Ryan Taylor. Enzi has jurisdiction
over the nomination.
If confirmed, von Eschenbach would speak with greater influence — allowing
the agency to take more aggressive steps to institute new initiatives —
and have more influence over the FDA's budget, industry sources agreed.
Having a permanent commissioner is "a very important development"
because a confirmed commissioner speaks with "greater authority"
before Congress, Trewhitt said. Lawmakers are more likely to heed a permanent
commissioner's budget recommendations. A permanent commissioner will more
engaged and successful in implementing long-term policy changes, and will
offer "greater stability and consistency" in policy developments
at the FDA, Trewhitt said. Von Eschenbach's confirmation would likely result
in the FDA taking a more aggressive stance toward Critical Path, the agency's
high-profile initiative to improve the drug development process, Pitts said.
The FDA has repeatedly delayed releasing a list of priorities for the plan.
A permanent commissioner will help improve support for Critical Path and other
initiatives among agency staff, Pitts added. For details, visit http://www.fda.gov.
ClinPhone Inc Moves Headquarters to Support
Significant Business Growth
ClinPhone, a global leader in clinical technology solutions, announces the
relocation of its US headquarters to
accommodate the company's exceptional growth. The new, larger facility
in East Windsor, NJ will house the company's business development, finance,
human resources, marketing and operations departments. The ever-increasing
demand for ClinPhone's electronic trial management services has driven the
expansion of its US headquarters. Building on its telephone and web-based
randomization and medication supply management expertise, ClinPhone offers
a range of innovative products covering many aspects of clinical trials, including
Electronic Patient Reported Outcomes (ePRO), Patient Recruitment Technologies
and Clinical Trial Management Software (CTMS). The new address is: 50
Millstone Road, Building 100, Suite 200, East Windsor, NJ 08520. For details,
visit http://www.clinphone.com.
ClinPhone Opens West Coast Office to Support
Local Customers
ClinPhone, a global leader in clinical technology solutions, has established
a new facility near San Francisco. With numerous West Coast companies having
already benefited from using ClinPhone's technologies, this new office will
provide customers within this district with a local point of contact. This
is the latest development in ClinPhone's exceptional business growth over
the past 12 months, which has seen a new office open in North Carolina alongside
the expansion of the Chicago operation and the relocation of the New Jersey
Headquarters.
The new office will become fully operational with project managers, operations
and support staff all on hand to assist local clients within their own time
zone, enabling increased face-to-face contact and trial consultations. Staff
at the office will be on hand to provide expert project and account management
throughout the entire business cycle. For details, visit http://www.clinphone.com.
Teranode Expands Management Team with Accomplished
Industry Executives
Teranode Corporation, a leading innovator of experiment design automation
(XDA) software for the Life Sciences industry, has announced the appointment
of Murthy Srinivas, vice president of product and platform development, John
Ohrn, vice president sales and Yoram Lapid, vice president services and support.
The appointments highlight the commitment by Teranode to incorporate the expertise
and experience needed to create and sustain value for its growing list of
customers. Murthy Srinivas joins Teranode with 25 years of enterprise software
experience, a proven record of shipping software and a deep technical knowledge
in a broad set of areas including distributed systems, databases and systems
and network management software. Most recently, Srinivas was a founder, CTO
and VP of Engineering at Consera Software, an enterprise data center management
software company which was acquired by HP in 2004. Murthy was also a key member
of the initial technology startup teams at Banyan Systems and Atria Software
before going on to hold a variety of senior management and technical roles
at Microsoft in the Windows group. John Ohrn comes to Teranode with 15 years
of experience in sales, support and management in the life sciences and software
industries. Prior to joining Teranode, John provided award-winning service
to customers with Accelrys, Inc. As the director of sales and support, John
lead a team of scientists, consultants and sales people within research and
development for the pharmaceutical, chemical and nanotechnology industries.
Under John's leadership, his team was able to secure the largest deal in Accelrys
history and show consistent growth year after year. John also played a significant
role in transforming Accelrys from a point product orientation to a provider
of solutions and services. John began his career as a top sales representative
for Software Developer's Corporation, which was later sold to Borland. Yoram
Lapid brings over 20 years of customer-focused engineering leadership experience
as well as business management, consulting services and project management
experience. He held a variety of positions with Cadence Design Systems most
recently as group director of design and consulting services and as client
partner. Yoram was vice president of engineering with fabless IC startups:
Solidum Systems and Philsar Semiconductors (acquired by Conexant). Additionally,
Yoram has served as an independent international business and project management
consultant through his own company. For details, visit http://www.teranode.com.
Varian Offers Two-For-One GC Purchase
Varian has announced a program that allows companies to purchase two Varian
single channel 3900 GCs, each with an 8400 or 8410 Autosampler, for less than
the cost of a single GC. They list the advantages of the program as: Two ovens=dual
throughput; Flexibility to run dual simutaneous methods; Two autosamplers
for streamlined productivity; Same bench space with 2x the throughtput; Ultra
low-bleed Varian FactorFour capillary column technology; and, No switchover
costs. Installatino is included as well as two high performance Varian FactorFour
columns for the price of one; free onsite method transfer and setup assistance,
and if the purchaser buys one service maintenance agreement; they get the
second at no cost. The offer is valid for orders placed through April 28,
2006. For details, visit http://www.varianinc.com/cgi-bin/nav?/contact/gc.
Sultanate
of Oman Licenses LabVantage’s Sapphire for its Regional Environment
and Water Resources Laboratories
LabVantage Solutions, Inc. has announced that the Sultanate of Oman has licensed
LabVantage’s Sapphire LIMS for its regional environment and water resources
laboratories. The Sultanate of Oman is one of the wealthiest countries per
capita in the world, and as a fast growing nation is seeking to continuously
improve the quality of its food, water, and other environmental resources.
LabVantage will implement Sapphire across the Sultanate’s environmental,
food testing, microbiological, trace element analysis, and organic pollutants
laboratories. With nine regional laboratories situated in different regions
of Oman, the Sultanate will leverage Sapphire’s thin-client technology
for enterprise wide access and visibility. Moreover, LabVantage’s Evergreen
configuration tool will allow the Sultanate’s users to tailor the same
Sapphire solution to meet the unique needs of each of these laboratories while
all running on one enterprise platform. For details, visit http://www.labvantage.com.
Waters Corporation and Thermo Electron
Agree To Integrate Ultra Performance Liquid Chromatography with Mass Spectrometry
Products
Waters Corporation and Thermo Electron Corporation have entered into a collaborative
agreement to provide greater integration and connectivity between the Waters
ACQUITY Ultra Performance LC (UPLC) system and Thermo's full range of innovative
mass spectrometers (MS). These instruments include Thermo's Finnigan TSQ Quantum,
LTQ Linear Ion Trap, LTQ FT Hybrid Linear Trap/Fourier Transform ICR and LTQ
Orbitrap¢ hybrid mass spectrometer. The collaboration is in response
to scientists and laboratory technicians in the mass spectrometry community
who seek the advantages in certain applications of using UPLC with MS, which
includes increased throughput and performance. These same users also
want more unified control and results management software to seamlessly combine
these complementary technologies. UPLC peaks are narrower and sharper, signal-to-noise
ratios are higher, and run times are shorter, which are all key factors in
enhancing the performance of virtually any mass spectrometer thus bringing
laboratories new levels of efficiency. For Waters customers, "the seamless
combination of UPLC technology with Thermo's high performance mass spectrometry
systems promises to bring laboratories more information per unit of time resulting
in greater productivity," said Rohit Khanna, Vice President of Worldwide
Marketing, Waters Corporation. For details, visit
http://www.thermo.com or http://www.waters.com.
Waters Corporation and Bruker BioSciences
Announce Collaboration
Waters Corporation and Bruker BioSciences Corporation have entered into a
collaboration agreement to provide greater integration and connectivity between
Waters ACQUITY Ultra Performance LC system and Bruker's mass spectrometry
(MS) and nuclear magnetic resonance (NMR) products. The collaboration
will allow direct support of Waters ACQUITY System in Bruker's HyStar software
thus unifying control and results management to seamlessly combine these complementary
technologies. The products of both companies play an important role in the
discovery, development, and manufacture of pharmaceuticals, processed foods,
beverages, personal care products, and in environmental and food safety laboratories.
"Scientists are always looking for a competitive edge and many have experienced
the advantages of using UPLC with MS," said Rohit Khanna, Vice President
Worldwide Marketing, Waters Corporation. "Combining UPLC with mass
spectrometry brings scientists measurable improvements in performance and
in the overall quality of information they obtain from their LC/MS and LC/NMR
analyses resulting in improved decision-making, increased productivity and
reduced business risk." Mass spectrometry results are highly-dependent
on the liquid chromatography separation preceding ionization and confirmatory
analysis in the mass spectrometer. Compared to conventional high performance
liquid chromatography (HPLC), UPLC results are significantly better peaks
are narrower and sharper, signal-to-noise ratios are higher, peak capacity
is greater, run times are shorter which are all key factors in reducing the
effects of ion suppression and enhancing the performance of virtually any
mass spectrometer, thus bringing laboratories new levels of efficiency. Fo
WWaters and Bruker customers, the seamless combination of UPLC technology
with mass spectrometry promises to bring their laboratories more information
per unit of time resulting in greater productivity. For details, visit http://www.waters.com.
TraxStar
Announces QATrax v4.0 Auto-Scheduling
TraxStar has announced the release of QATrax version 4.0 Auto-Scheduling release.
Auto-Scheduling provides a significant edge in the dynamic and complex product
development world. QATrax helps minimize the disruptions and time spent in
accommodating schedule changes and the downstream “ripples” they
cause. QATrax v4.0 provides the ability to automatically move the test plan
start date, re-shuffle the resource assignments and update scheduled completion
dates. Assigning specific resources provides a reliable picture of the timing.
Slippages are easier to document and visible. Existing customers will be automatically
upgraded as part of the support program. For details, visit, http://www.TraxStar.com.
Consortium Planned to Personalize Medicine
The pharmaceutical industry and federal agencies are developing legal agreements
to ensure greater cooperation and information-sharing in the interest of accelerating
the development of personalized medicines to treat cancer and other ailments,
sources say. PhRMA and several of its member companies are nearing agreement
on a broad consortium to share research data on biomarkers, said Alan Goldhammer,
the group's associate vice president for scientific and regulatory affairs,
in an interview with FDAnews. Biomarkers are indicators of normal biological
processes that show how well a particular treatment will work. Industry wants
to discover why certain drugs work better in some patients than in others,
and biomarkers are seen as the way to answer that question. "Biomarkers
will play an important role in looking at drug safety and drug efficacy,"
Goldhammer said. "The goal is for scientists from government and industry
to work together to identify and validate new biomarkers from the body for
use in [prevention] and earlier detection of diseases," said PhRMA spokesman
Jeff Trewhitt. The PhRMA consortium would establish a means for different
companies to share their early research on biomarkers, Goldhammer added. This
data would be "precompetitive," Goldhammer said, which means laboratory
studies would be conducted prior to animal or human studies. Industry has
undertaken similar efforts before, such as a multicompany consortium to address
HIV/AIDS. Cooperation will help firms avoid the time and cost of following
the same path their competitors have already taken. "Instead of reinventing
the wheel, it is probably better to have collaboration between industry scientists
and government," Trewhitt added. This cooperative effort will also help
companies select the right patients for clinical trials, said Goldhammer.
The companies will be able to better identify which populations receive more
benefits from a certain drug and which groups should not be given that drug
because of safety concerns. The overall effect will be accelerated drug development
and treatments more likely to benefit certain patients, he said. Industry
efforts come as the federal government begins to implement two high-profile
agreements meant to accelerate the development of new drugs. The FDA, National
Cancer Institute (NCI) and Centers for Medicare & Medicaid Services published
an agreement in the Federal Register to work together to develop biomarkers
for cancer treatment. In their "Memorandum of Understanding," the
agencies will work together under a new initiative to develop biomarkers and
will reach out to the private sector to secure funding for it. Under the Oncology
Biomarker Qualification Initiative, the three agencies will prepare white
papers on various topics including scientific rationales, availability technologies
and general concepts in experimental design. The agencies will also prepare
protocols to evaluate biomarkers in clinical trials and outline approaches
for assessing research progress. The memorandum is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/ora065-m000001.pdf.
ClinPhone Addresses Key Clinical Trial Issues with Upcoming 2006 Webinar
Schedule
Following the success of its 2005 webinar series, ClinPhone, a global leader
in clinical technology solutions, has
announced its 2006 schedule. The 2006 series will continue to focus
on key issues affecting clinical trials and will open with a webinar on "Adaptive
Trial Design and Supply Chain Simulation" in March. The schedule
will also include updated sessions on "Basic and Advanced Randomization
Methodologies" and "Automated Medication Supply Chain Management".
All of ClinPhone's educational webinars are free to any industry professional
with interest in the given topic. The full schedule is now available
and registration for each of these events is quick and easy via the company's
website, http://www.clinphone.com/webinars.
CDER Releases 2006 Guidance Agenda
The FDA's Center for Drug Evaluation and Research has released a list of guidance
documents it is planning to develop during the 2006 calendar year. The guidances
fall under the following categories: advertising, chemistry, clinical/medical,
clinical/pharmacology, combination products, compliance, drug-safety information,
electronic submissions, good review practices, investigational new drugs,
labeling, OTC, pharmacology/toxicology and procedural. To view the list, access
http://www.fda.gov/cder/guidance/CY06.pdf.
Researchers Propose Blockbuster Benefit
to Encourage Drug Development
The FDA should provide
new incentives for the drug industry to speed the development of pharmaceuticals
to treat infectious diseases in developing countries, say Duke University
researchers, who recommend tying priority reviews of potential U.S. blockbuster
drugs to R&D for the infectious disease drugs that generate few profits.
Researchers are working to garner support from the FDA, industry, and Capitol
Hill for their plan to develop a "priority-review voucher," David
Ridley of Duke University's Fuqua School of Business announced at a recent
meeting on global health policy. The plan would allow companies to receive
accelerated FDA review of blockbuster drugs in exchange for developing therapies
for neglected diseases such as malaria or tuberculosis, which are found mostly
in third-world countries, Ridley said. While these diseases are responsible
for a great loss of life in developing countries, they do not get the drug
industry's attention because there is a negligible market in the U.S. and
Europe, Ridley and other Duke researchers told attendees. There is "tremendous
suffering from neglected diseases in the world," Ridley said. The opportunity
to receive priority reviews for blockbusters — which would cut as much
as one year from the usual review time at a potential savings for industry
of $300 million per drug — would encourage R&D for new infectious
disease treatments, he asserted. In developing therapies for infectious diseases,
companies would have to receive FDA or European Medicines Agency approval,
forgo patent rights, and find at least one manufacturer for the product. The
drug would also have to be deemed more effective than existing treatments.
Furthermore, applicants would be expected to pay an additional user fee of
$1 million or more to cover the FDA's costs in undertaking priority reviews
for their blockbusters. The researchers have approached the FDA and industry
officials about their plan and will soon meet with congressional staff and
lawmakers such as Sen. Richard Burr (R-N.C.) to get their support for a legislative
vehicle to implement the voucher, Ridley told FDAnews. But proponents doubt
their plan will get much attention from Congress anytime soon because of upcoming
midterm elections. Getting traction for the bill will "be challenging,
especially in the short run," Ridley said. Thus far, the plan has received
"a great deal of interest" from industry groups such as the Biotechnology
Industry Organization (BIO), he added. However, BIO and other associations
have yet to formally endorse the plan. One potential vehicle for implementing
the voucher plan will be the Prescription Drug Use Fee Act (PDUFA), in part
because the plan would require an increase in user fees to cover additional
priority reviews of blockbuster drugs, according to Ridley and Jeffery Moe,
an executive-in-residence in Duke's Health Sector Management program. PDUFA
"would be a logical fit," Ridley said. The current PDUFA program
is due to expire in September 2007. For details, visit http://www.fda.gov.
Critics State FDA Should Enforce Penalties
for Postmarket Study Delays
The FDA needs the ability to impose financial penalties as an incentive for
drug companies to submit required annual postmarket study reports on time,
according to a public advocacy group. The recommendation by Public Citizen
follows the release of an FDA report that showed half of the required postmarket
reports hadn't been submitted as of Sept. 30, 2005. Most of these studies
had not even been started. Sixty-five percent of the required brand and generic
drug postmarket studies and 37 percent of the biologic product studies had
not been started, the FDA said recently. The FDA doesn't have enough authority
to police these commitments, Peter Lurie, deputy director of Public Citizen's
Health Research Group, told FDAnews. "The only thing the agency can do
is take the drug off the market, which is a decision that often would not
serve the public health very well," he said. "[The FDA needs the]
authority to … fine these companies heavily for each day they are late."
The agency has never withdrawn a drug from the market because a company has
not completed the required safety and other postmarket studies, according
to John Jenkins, director of the FDA's Office of New Drugs. The FDA also does
not impose civil or criminal penalties for late filings of postmarket data,
he added. In a "really serious case," the FDA would consider withdrawing
the drug from the market, Jenkins said. Lurie said companies fully understand
the FDA will never pull a drug off the market, so they keep violating the
requirements. "The great majority of postmarketing studies address safety
issues, at least in part, so patients and physicians are denied critical safety
information when these studies are not completed in a timely fashion,"
he said. Lurie also criticized the FDA's report on the status of postmarketing
commitments, noting there is no way of knowing what the deadlines are for
each stage of the commitment and if they are being met or not. Jenkins explained
the FDA sets the schedule for firms to complete a battery of studies on products
that require a postmarket study. The agency then evaluates each study to see
if the drug company has fulfilled the requirements of the study commitment.
If the company fails to submit data on time, the commitment is considered
delayed, Jenkins said. The agency has been setting commitment schedules for
the last four or five years, he added. The reports must contain information
on the status of each FDA-required study for clinical safety, clinical efficacy,
clinical pharmacology, and nonclinical toxicology. The firm must continue
to submit the report until the FDA determines that the commitment has been
fulfilled or that the agency no longer needs the reports. PhRMA cautioned
the data in the FDA's report should not be "distorted." For details,
visit http://www.fda.gov.
ACD Releases Latest Version of ACS/Web Librarian
Advanced Chemistry Development, Inc (ACD/Labs) has released the latest version
of ACD/Web Librarian, their Web browser-based software for sharing and viewing
spectral, chromatographic and chemical data. ACD/Web Librarian allows chemists
to securely access analytical results from anywhere via the corporate intranet
or a secure internet link, search and retrieve information by spectral parameters
or chemical structures, and create instant reports. ACD/Web Librarian enables
users to view over 130 file and database types. It supports an extensive variety
of 1D NMR, 2D NMR, UV-Vis, IR, Raman, MS, Chromatography, XRPD, DSC, TGA,
and other analytical curve data, as well as chemical structures and metadata.
Information is displayed and maintained in a centralized repository that is
accessed to authorized members of an organization via a Web browser such as
Internet Explorer. Key new features of this release include convenient display
of hyphenated datasets which allow users to scroll through and view individual
scans. Users will now also be able to add images to records, and export raw
spectral data to the ACD/Labs desktop processing tools for re-processing and
review. With the augmented support of ACD/SpecManager, specific interlinking
of various spectral data with individual chromatographic peaks is now possible.
Existing users of the software will find numerous new advancements that augment
the usability of the software for chemists, analysts, and IT personnel. For
details, visit http://www.acdlabs.com/weblibrarian.
Ohaus and Labtronics Partner to Deliver New OEM Version of Labtronics'
Collect Software
Labtronics Inc. has announced that Ohaus, a leading balance and scale equipment
manufacturer, has committed to a substantial quantity of Ohaus' new OEM version
of Labtronics' forthcoming Collect 6.0 software to supply customers with a
complete package of weighing solutions. "Several years ago Labtronics
and Ohaus partnered to create an OEM version of Labtronics' Collect software
for our lab balance product line called Ohaus BalanceTalk," said Sil
Rocchio, Product Manager at Ohaus. "Emerging requirements from
our customers for additional industry applications such as the industrial
scale market, and demand to support multiple languages including English,
French, German, Spanish and Italian, prompted us to update Ohaus BalanceTalk."
"We are extremely excited to be working with Ohaus once again to deliver
the new Ohaus software based on our Collect 6.0 integration solution,"
said Mike DeWitte, Vice President at Labtronics. "The Collect 6.0
solution features significant advances in data acquisition and control for
any instrument or device that is able to communicate through their RS232,
RS485 or TCP/IP Ethernet ports, connecting them to any open Windows application,
directly to Files or Excel." For details, visit http://www.labtronics.com.
Autoscribe
Highlights Matrix Gemini LIMS COTS Configuration at Pittcon 2006
Autoscribe’s Matrix LIMS has evolved over the last 16 years into Matrix
Gemini LIMS, a totally new, fully configurable, COTS LIMS. The product has
been completely re-written in C+, to take full advantage of the Microsoft
.NET tools. It provides exactly the same user experience no matter how you
access the application; rich client on your LAN, thin client on your WAN or
via the Web using your standard browser. Once a screen has been built using
the Matrix Gemini OneTime Configuration Tools, it is immediately available
on the user’s network or via the Web. The Matrix Gemini is a pure Microsoft
.NET product and not a mixture of other technologies. release. Autoscribe
will be demonstrating their Matrix Gemini LIMS at Pittcon in Orlando, FL from
March 13-17 in Booth 2345. In addition, Autoscribe is providing a free hands-on
COTS LIMS Configuration workshop from at their headquarters location in the
UK from March 28-29. For details, visit http://www.autoscribe.co.uk.
Shimadzu Scientific Instruments Announces Product Launches, Presentations, and Workshop for PittCon 2006
Shimadzu Scientific Instruments,
Inc. has announced its upcoming activity for the PittCon 2006 conference and
exhibition (March 12-16, Orlando ). The company, one of the leading developers
of analytical instrumentation in the U.S. , will introduce several new products
during the event, including: QP-2010 Plus Gas Chromatograph/Mass Spectrometer;
TD-20 Thermal Desorption System for GCMS; ICPE-9000 Multitype Inductively
Coupled Plasma Emission Spectrometer; and, ELSD-LTII Evaporative Light Scattering
Detector. Other announcements and products featured include: Prominence HPLC
SIL-20A Autosampler; Prominence HPLC CBM-20A System Controller; ProminenceMD
(HPLC Method Development System); Prominence 2-Dimensional HPLC Application
Systems; HPV-1 HyperVision Ultra-High-Speed Video Camera; GC 50th Anniversary;
and, New Mass Spectrometry/Biotech Applications Laboratory and New Physical
Measurement Laboratory. In addition to numerous posters, Shimadzu Scientific
Instruments will also participate in the Analytical Information Markup Language
(AnIML) workshop. Alex Mutin will present, “Analytical Instrument Control
Using XML-Based Web Service,” at 3:45 p.m. on March 16. For details,
visit http://www.ssi.shimadzu.com.
Bruker BioSciences to Host Investor Booth
Tour at Pittcon 2006
Bruker BioSciences has announced its annual new product booth tour for institutional
investors and analysts at Pittcon 2006 in Orlando, Florida. The investor tour
will start promptly on Tuesday, March 14 at 10 a.m. Eastern Time at the Company's
booth #3155, and will last approximately 45 minutes. Bruker BioSciences expects
to introduce a host of innovative systems and solutions for life science and
advanced materials research. Novel product introductions will include Bruker
AXS' unique QUANTAX QUAD, an innovative EDS system for X-ray microanalysis
on electron microscopes, as well as Bruker Daltonics' novel MALDI Biotyper
system for the identification and classification of microorganisms from protein
profiles measured by MALDI-TOF mass
spectrometry. For details, visit http://www.bruker-biosciences.com.
STARLIMS and Tefen Introduce Advanced Resource
Planning and Scheduling Software for Labs
STARLIMS Corporation, a leading global vendor of LIMS, and Tefen Operations
Management Consulting, have introduced the STARLIMS Resource Planner and Scheduler,
a new module designed to optimize laboratory resource utilization and operational
performance. STARLIMS Resource Planner and Scheduler leverages STARLIMS Corp.’s
20-year track record of LIMS-only development, and the resource planning expertise
of Tefen, an international operations management consulting firm with 20 years
of expertise serving Fortune 500 companies. The STARLIMS Resource Planner
and Scheduler helps improve turnaround time, service levels and analyst efficiency,
by giving managers the real-time information they need for effective and timely
decision-making. Standardized for planning and budgeting across multiple lab
operations, the STARLIMS Planner and Scheduler can perform “what if”
analyses of various operational scenarios. It facilitates ongoing assessment
of performance against known best practices, thanks to a graphical user interface
and easy-to-use executive dashboard. The new module will be presented at the
BioPharma Operations Excellence Consortium Meeting, to be hosted by Genzyme
and Tefen in Geel, Belgium on March 16, 2006. At the same time, it will be
shown during PITTCON 2006 (March 13-16, Orange County Convention Center, Orlando,
Florida). Entirely web-based, the new solution is an integral part of STARLIMS’s
LIMS — eliminating the inefficiencies of running separate LIMS and planning
systems. The STARLIMS Planner and Scheduler can also be implemented as a standalone
module linked with legacy LIMS or ERP systems. For details, visit http://www.tefen.com
or http://www.starlims.com.
Commercial-Off-the-Shelf Solutions Highlight
Thermo's Informatics Exhibit at Pittcon 2006
Thermo Electron Corporation, a leading provider of analytical instrumentation
and informatics, will showcase its purpose-built, commercial-off-the-shelf
(COTS) LIMS and CDS solutions at Booth # 3733 at Pittcon 2006, March 13-16
at the Orange County Convention Center in Orlando, Florida. "Visitors
to Thermo's booth will find tailored informatics solutions, designed to meet
specific industry and application requirements with the minimum amount of
customization," said Dave Champagne, vice president and general manager
of Thermo's informatics business. "Our value proposition is the
reduction in cost, risk and time of implementations, as well as total cost
of ownership, that are associated with extensive customization. Plus, the
greatly enhanced integration between our solutions and the customers' enterprise
yields increased efficiency and greater knowledge from data." Thermo's
informatics exhibit will feature: 1) Darwin LIMS the laboratory information
management system designed specifically for pharmaceutical manufacturing R&
and QA/QC; 2) The latest version of SampleManager LIMS, 9.0, which begins
its evolution as a COTS solution for industrial laboratories; 3) Atlas CDS
8.0, Thermo's renewed chromatography data system with superior integration
with SampleManager and Darwin for maximum productivity; 4) Migration Agent,
a new software and professional services solution that reduces risk and overcomes
business challenges when migrating from any existing LIMS to a Thermo LIMS;
5) Retriever, a web-based data extraction, presentation and reporting solution
that enables secure access to laboratory data, no matter the originating data
system. Thermo has had five informatics oral and poster presentations accepted
by the Pittcon committee as part of the conference program. Topics include
"Using LIMS to Drive Productivity in the Manufacturing Environment"
and "LIMS Implementation Trends in Discovery Research." A full schedule
is provided on www.thermo.com/pittcon,
see Technical Presentations. In addition to its informatics solutions, Thermo
will be exhibiting a wide range of industry leading instrumentation, software
and services.
Thermo Introduces New LIMS Datasheet For the
Drug Discovery and Development Industry
Thermo Electron Corporation has produced a new datasheet to provide an overview
of the capabilities of its purpose-built Watson LIMS. Thermo's Watson is a
highly specialized protocol-driven LIMS, specifically designed to support
drug metabolism and pharmacokinetic (DMPK) studies in drug discovery and development.
The new datasheet is entitled "Watson LIMS - The acknowledged standard
in LIMS for bioanalytical laboratories" and is aimed at scientists in
biotechnology and pharmaceutical companies and Contract Research
Organizations (CROs). As well as providing an overview of the data processing
capabilities of Thermo's Watson LIMS, the new datasheet discusses the challenges
facing pharmaceutical companies and CROs to decrease costs while optimizing
efficiency. As a commercial-off-the-shelf solution, Watson reduces risk
and total cost of
ownership compared to generic LIMS, which require customization to meet the
specific needs of bioanalytical laboratories. The datasheet describes benefits
that have made Watson the leading LIMS deployed in bioanalytical laboratories.
Watson LIMS requires minimal configuration, thereby resulting in fast implementation,
validation, upgrades and immediate efficiency gains. It is equipped with key
functionality specific to the DMPK laboratory, including flexible protocol-based
study design, assay/method standardization and management, integrated sample
management and a configurable re-assay decision tree. To obtain a free copy
of the new datasheet, visit http://www.thermo.com/com/cda/product/detail/1,,10120349,00.html.
Agilent Technologi