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STARLIMS Introduces SDMS Functionalities at PITTCON 2008
• Worldwide Leader in Pharmaceutical Services
Selects LabVantage’s SAPPHIRE BioBanking Solution for Its Global Laboratories
• Sapio Sciences Announces Exemplar LIMS v2
• STARLIMS Selected for $1.1 Million
LIMS and SDMS Project
• Labvantage to Showcase SAPPHIRE at Pittcon
• Thermo Fisher Scientific Announces
LIMS Installation at Fisheries and Oceans Canada
• Global Commercial Products Provider Replaces
Legacy LIMS with LabVantage’s SAPPHIRE in 18-Days
• Waters Opens Registration for Inform 2008, Worldwide
Informatics Users Conference
• IDBS Announces E-WorkBook Suite 8.0, ActivityBase
7.0 and ActivityMart 3.0
• Thermo Scientific Introduces Momentum Process
and Data Integration Software
• Cenetron Announces Implementation of STARLIMS
for Global Clinical Trials
• Rotech Laboratories Chooses WinLIMS Rental
• LabVantage to Showcase Configurable Off-the-Shelf
Enterprise Laboratory Informatics at LabAutomation 2008
• Leading Pharmaceutical Company Selects STARLIMS
for $2.1 million Global LIMS Project
• Ocimum Biosolutions Acquires Gene Logic’s
Genomics Division
• Northwest Analytical Participates in SPC for Food
Safety
• World-leading Bio-banking Repository Selects STARLIMS
• ATL and Microsoft to Host LIMS Seminar
• Autoscribe Announces Compliant Sample Tracking
for Regulated Industries
• Thermo Fisher Scientific to Showcase New Informatics
Offerings at PITTCON 2008
• STARLIMS Asia Pacific Inaugurates New Facilities
• PerkinElmer Introduces WIZARD2 Automatic Gamma Counter
with Advanced Ease-of-Use Features
• Autoscribe's Matrix Chosen by Leading Pharmaceutical
Company
• Thermo Fisher Scientific Announces Major Laboratory
Informatics Symposium in India
• STARLIMS Announces $1 Million Contract with Pharmaceutical
Division of Fortune 500 Company
• Invetech to Demonstrate its Contract Development
Solutions at LabAutomation 2008
• Pittcon 2008 Offers Biofuel Symposium
• STARLIMS Announces Follow-On Contract with Leading
Clinical Research Organization
• Labtronics Announces New LimsLink CDS Release
Combines Four Advanced CDS Interfaces in One Solution
• Labtronics Releases Automated Worksheet Management
for LimsLink 4.1
• Ventana Medical Systems Licenses BioPathwise
DM for Multispectral Image Data Management
• Study Examines Media Preferences of Life Scientists
in Applied Markets
• ABB's Collaborative Production Management Solution
Recognized for Helping Cement Industry Customers Reduce Energy Costs and Consumption
• ABB Wins $25-million Order for Vietnamese Cement
Project
• ABB Tops Process Automation System Market Share
Worldwide
• ABB’s MPC based Expert Optimizer Successfully
Installed at Buzzi’s Signal Mountain Plant
• Congressional Appropriations Subcommittee Denounces
FDA
• AAPS and FDA Announce Signing of a Cooperative
Research and Development Agreement
• NIH Collaborates with EPA to Improve the Safety
Testing of Chemicals
• CDER Slated for 283 New Staff in Proposed Fiscal
2009 Budget
• Lawmakers Push for Biosimilar Legislation in New
Healthcare Initiative
• President’s Request Would Give FDA $2.4 Billion
in Fiscal 2009
• FDA Posts Comments on Bioequivalence Guidelines
Online
• EC Launches Unannounced Inspections in Pharmaceutical
Sector
• Senator Brown Requests Look at FDA Fast Track Designation
• U.S. Planning to Set Up FDA Office in India
• Patni Acquires Life Sciences Services Company
Taratec for $27 million
Thermo Fisher Scientific Publishes New Poster
from Lab Automation 2008 Purpose-Built LIMS for Life Sciences and High Throughput
Screening Laboratories
Thermo Fisher Scientific Inc. has announced the availability of a new technical
poster demonstrating the importance of configurability and flexibility in
laboratory information management systems (LIMS) design for life sciences
and high throughput screening applications. T
he poster was originally presented at the Lab Automation 2008 conference in
Palm Springs, CA and is entitled The New Age of Configurability and Flexibility
in LIMS Design for Life Sciences and High Throughput Screening. The authors
are senior technical and development managers at Thermo Fisher Scientific
with decades of experience in pharmaceutical and biotechnology laboratories.
They highlight the need for plate handling functionality to be built
into the core LIMS solution for high throughput screening (HTS) environments.
The poster is ideal reading for life scientists in the biotechnology
and drug discovery industries. With the increasing workload in high-throughput
laboratories, biotechnology companies require user-friendly LIMS that contain
plate handling functionality out-of-the-box, while remaining flexible in how
the system can be easily configured and extended to meet their needs. With
built-in plate handling functionality utilizing a service oriented architecture
in .NET, Thermo Scientific Nautilus LIMS enables organizations to keep pace
with changing laboratory techniques, automate processes and manage increasing
data volumes. The result is that scientists and organizations are able
to give rise to discoveries, make decisions and run tests faster than ever
before. Plate handling and automation have become increasingly important in
biotechnology organizations where automation and high throughput needs demand
that workflows account for the manipulation of samples in a wide variety of
plate formats and configurations. These laboratories seek a robust LIMS that
can execute and integrate common plate handling operations including replication,
splitting, probing, compression, pooling and cherry picking. A plate design
utility can greatly simply the administration by enabling variable dimensions,
well labeling, common and user-defined fill patterns, specific well configurations
and additional attributes and metadata. Adding to the complexity, automated
processes generally involve groups of plates. The authors demonstrate how
Nautilus LIMS provides the ability to graphically program and emulate dynamic
work processes involving groups of plates, organize workflow activity into
steps, execute actions on groups of plates at each step in process and dynamically
define and assign transition at each step. With trends leaning towards increasing
data volumes, high throughput environments require information management
systems that allow data from automated workflows and processes to be modeled
and integrated easily. To meet this need, these laboratories seek a full-featured
LIMS with an inherent configurable utility that allows for communication with
other applications and enable effortless integration of instruments and robotic
equipment. The system should be able to acquire data from all types of instrumentation,
including serial ports and networked instruments while also applying specifications
and logic to make dynamic decisions based on collected data. Most biotechnology
labs also require the LIMS to integrate older ASCII and CSV file transfers
as well as modern XML schemes and service-oriented architectures. The new
technical poster is available free-of-charge via
http://www.thermo.com/eThermo/CMA/PDFs/Product/productPDF_4365.pdf.
Labtronics' LimsLink CDS Selected for Integration
with LIMS at Chinese Manufacturing Facility
Labtronics has announced that an international manufacturer of industrial
chemicals has selected LimsLink CDS to manage the transfer of data between
ChemStation and SampleManager LIMS at their manufacturing facility in China.
The decision to select LimsLink CDS was based largely on the ChemStation configurable
interface that simplifies creation of the interface with any LIMS, without
requiring programming. Interfaces are defined using a series of check boxes
and drop down menus that match the parameters of ChemStation. All of
the setup screens use the terminology and have the same look and feel as ChemStation
CDS, creating a familiar and comfortable environment for implementing and
maintaining the interfaces. The first interface has been implemented with
the assistance of Labtronics' Professional Services Group who also provided
on-site training at the Chinese facility in the configuration of new methods.
This training will allow local personnel to support their interfaces
and add new interfacing methods as their needs change.. For details, visit
http://www.labtronics.com.
STARLIMS
Introduces SDMS Functionalities at PITTCON 2008
STARLIMS Technologies Ltd. will introduce a new SDMS module (Scientific Data
Management System) at PITTCON 2008 (Morial Convention Center, New Orleans,
March 3-6). Integrated into the Company’s web-based LIMS, this integrated
module creates a comprehensive platform to manage scientific and laboratory
information—consolidating data and documents from the full gamut of
laboratory processes. The STARLIMS solution is unique in that it integrates
LIMS data and SDMS documents into a single web-based platform. Much of the
data created in science-centric organizations is unstructured and not typically
managed in a consistent fashion, making it difficult to implement systematic
procedures necessary to ensure regulatory and legal compliance. The STARLIMS
SDMS module enables organizations to capture, parse, search, manage, share
and archive scientific documents. Such documents may include research reports,
spreadsheets, product specifications, instrument output files and more. The
information extracted from these documents is stored in STARLIMS’s unified
platform, and managed with the same control as structured LIMS data has been.
In addition, the documents are archived and managed in the same platform as
the LIMS data, enabling unified searches and eliminating the inefficiencies
of multiple data repositories. "The release of STARLIMS SDMS is a crucial
step forward in our vision of unifying laboratory, scientific and enterprise
information,” said Itschak Friedman, CEO of STARLIMS. “In addition
to its obvious streamlining of laboratory informatics, it stands to make a
significant contribution to information sharing—and enterprise-wide
collaboration." What makes the parsing approach of the STARLIMS SDMS
unique is its use of artificial intelligence (AI) to automatically extract
content from unstructured documents and store it in a structured environment,
together with the relevant metadata tags. This process transforms unstructured
data into an XML format that is both standardized and highly accessible. STARLIMS
SDMS uses the most recent parsing routine to automatically parse information
from any document, even an unidentified document. Any inaccuracies are later
adjusted with simple drag-and-drop manipulations and the corrections are integrated
into the algorithm in an automatic self-correcting mechanism. The result is
a highly effective way of processing any type of document: the laborious task
of producing parsing scripts becomes trivial; users need not learn complex
parsing applications; and processing times are dramatically accelerated. For
details, visit http://www.STARLIMS.com.
Worldwide Leader in Pharmaceutical Services
Selects LabVantage’s SAPPHIRE BioBanking Solution for Its Global Laboratories
LabVantage has announced that one of the world's largest contract research
organizations (CROs) has licensed LabVantage's SAPPHIRE BioBanking Solution.
The company plans to initially implement SAPPHIRE for eight of its global
laboratories and expects to roll it out to more laboratories over time. As
a global CRO, the company provides clinical product development services and
consulting on product safety and value. Its global central laboratories support
all phases of clinical trials with a centralized network of laboratories across
all of the major international markets. This global CRO's requirements for
biospecimen management were involved and unique given its network of global
central laboratories. They mandated that the solution not only effectively
receive, store, route, and ship both frozen and ambient specimens, but it
must also seamlessly monitor and exchange process information with its existing,
centralized customer business relationship management system. Additionally,
the complexity of managing biospecimens is compounded by its need to track
and bill for services rendered. The company's decision to partner with LabVantage
was based on a number of key factors, most notably the comprehensive functionality
in the SAPPHIRE BioBanking solution and LabVantage’s proven track record
of implementing, deploying, and interfacing SAPPHIRE across a global network.
The company intends to deploy its biospecimen management system as a central
application server and single database solution residing within its data center.
It will leverage SAPPHIRE's multinationalization capabilities to power multi-site,
multi-language access by its employees, partners, and customers around the
globe. As they invest in systems and processes to support its expanding global
specimen management needs, SAPPHIRE takes them beyond a typical Web-based
solution with SAPPHIRE's zero footprint, thin-client architecture that dramatically
lowers software maintenance requirements and reduces total cost of ownership.
For details, visit http://www.labvantage.com.
Sapio Sciences Announces Exemplar LIMS v2
Sapio Sciences has announced the immediate availability of Exemplar LIMS v2.
Key additions in this release include: The Workflow Manager, which enables
easy creation of complex workflows in minutes to track any
laboratory procedure and enforce data collection at key points in any protocol.
Advanced Plug-In Architecture that makes extending Exemplar straightforward
leading to rapid integration with existing applications and equipment/robotics.
Enhancement of Data Management capabilities to allow for easy creation of
point and click export criteria of Biomarker data for analysis by third party
tools. LIMS customization wizard that allows for the creation of forms and
fields in minutes and with no programming and complete backward compatibility.
New reports including storage unit report showing detailed inventory for freezers/boxes/drawers,
etc. and system object inventory reporting. Document management capability
where any type of document such as Word docs (e.g. consent forms), Spreadsheets,
Image files etc. can be loaded into the LIMS and associated with LIMS Objects
like samples, aliquots, clinical subjects, experiments, etc. "This new
release significantly extends the capabilities of Exemplar LIMS and solidifies
it as a complete solution to any laboratories sample/protocol/data tracking
needs,” says Kevin Cramer, VP of Sales and Marketing at Sapio. "Our
development team has done an excellent job of continuing our thesis of developing
key features that are major advancements in our product, yet maintaining our
ease of use and continuing to lower the total cost of ownership of Exemplar
LIMS.” Sapio Sciences Exemplar LIMS v2 is available immediately. For
details, visit http://www.SapioSciences.com.
STARLIMS Selected for $1.1 Million LIMS and
SDMS Project
STARLIMS Technologies Ltd. has been selected by a global biopharmaceutical
company based in the United States for a $1.1 million project. The project
will include both STARLIMS v10 and the integrated scientific document management
system, or SDMS, a module recently released by STARLIMS. Integrating the customer’s
information into a single platform is expected to minimize instances of duplicate
searches, increase data availability, and facilitate information sharing across
the organization. The fully web-based platform will be deployed in several
labs involved in disciplines ranging from bio-analytical science to molecular
biology. These labs perform tests in support of commercial product releases,
stability studies to establish product shelf life, and raw material quality-testing.
"With the release of STARLIMS SDMS, we have made an important step forward
in our vision of unifying laboratory, scientific and enterprise information.
We believe that this integrated LIMS and SDMS offering is particularly relevant
to the life science sector, with its long and complex product development
cycles," said Jeff Ferguson, COO at STARLIMS. As a biopharmaceutical
company operating in the United States, the customer needs iron-clad compliance
with the strict standards outlined in FDA 21 CFR Part 11. Features built into
the core of the STARLIMS v10 platform ensure such compliance, providing complete
traceability together with process versatility. STARLIMS makes it possible
to produce a completely auditable track record of all laboratory resources
taking part in any specific analysis. The STARLIMS solution is unique in that
it integrates LIMS and SDMS functionality into a single web-based platform.
Much of the data created in science-centric organizations is unstructured
and not typically managed in a consistent fashion, making it difficult to
implement systematic procedures necessary to ensure regulatory and legal compliance.
The STARLIMS SDMS module enables organizations to capture, parse, search,
manage, share and archive scientific documents (research reports, spreadsheets,
product specifications, instrument output files, etc.). The information extracted
from these documents is stored together with laboratory data in STARLIMS’s
unified platform, minimizing the inefficiencies of multiple data repositories.
For details, visit http://www.starlims.com.
Labvantage to Showcase SAPPHIRE at Pittcon
Labvantage will be exhibiting and presenting at the upcoming Pittcon 2008,
New Orleans, LA, March 3–6.
LabVantage will be at booth #5555 showcasing the SAPPHIRE Laboratory Information
Management Suite, a zero footprint and configurable off-the-shelf (COTS) solution
consolidating functionality typically found in multiple laboratory systems.
With its combination of solutions-oriented modules and multinationalization
support, LabVantage’s SAPPHIRE delivers a complete and versatile, multi-site,
and multi-language enterprise backbone for laboratory informatics. Demonstrations
of the SAPPHIRE laboratory information management suite will be ongoing. Featured
SAPPHIRE Module demonstrations include: A new SAPPHIRE Reagents and Standards
Management Module; Enhanced Stability & Shelf-Life Analyses Module: Advanced
Storage and Logistics (ASL) Module; Corrective Action & Preventive Action
(CAPA) Module; and BioBanking Module. Additionally, SAPPHIRE Advanced Reporting
& Analytics will be on display. The presentation will highlight the fundamentals,
technology and value proposition of the configurable off the shelf enterprise
laboratory informatics solution. For details, visit http://www.labvantage.com.
Thermo Fisher Scientific
Announces LIMS Installation at Fisheries and Oceans Canada
Thermo Fisher Scientific Inc. has announced that Fisheries and Oceans Canada
(DFO), the lead federal department responsible for Canada's fisheries resource,
oceans and inland waters, will install its purpose-built Thermo Scientific
Nautilus LIMS. After a five-year phased roll-out, more than 150 users operating
out of 12
different laboratories located in seven facilities across Canada will take
advantage of the Thermo Scientific Nautilus LIMS. The volume of data
managed by the LIMS will vary from program to program, but will initially
reach more than 100,000 discrete samples yearly, and this is expected to increase
at a rate of approximately 25,000 samples per year. DFO will use the Thermo
Scientific Nautilus LIMS to facilitate its ongoing commitment to the research,
development and understanding of Canada's three oceans, freshwaters and coastlines.
Specifically, DFO will provide diagnostic services, test method development,
regulatory research and expert scientific advice in collaboration with the
Canadian Food inspection Agency. DFO will implement the LIMS for use in Science
Sector laboratories across Canada, focusing initially on the National Aquatic
Animal Health Program (NAAHP). "What an outstanding opportunity for Thermo
Fisher Scientific to partner and work hand in hand with the Canadian government,
in particular Fisheries and Oceans Canada, on their unique operations worldwide",
says Greg Huelbig, strategic sales executive for Thermo Fisher Scientific.
"The installation of Thermo Scientific Nautilus LIMS will greatly
add to DFO's efficiencies and help them do their many tasks with more confidence
and reliability." DFO plays a leading role in managing and safeguarding
oceans and inland waters and their resources for Canadians. Science
provides an essential basis for the sound management of fisheries and oceans
resources. Research activities fall under a wide range of topics, including:
marine environment and habitat, oceanography, productivity, stock assessment,
hydrography and aquaculture. For details, visit http://www.dfo-mpo.gc.ca
or http://www.thermo.com/informatics.
Global Commercial Products Provider Replaces
Legacy LIMS with LabVantage’s SAPPHIRE in 18-Days
LabVantage has announced that its SAPPHIRE LIMS has been licensed by a leading
global provider of commercial cleaning and hygiene products and solutions.
The company serves the food and beverage industry and other institutional
and industrial end-users such building service contractors, retail outlets
and healthcare
facilities. The company sought a configurable-off-the-shelf (COTS) solution
that could replace its antiquated home grown LIMS application for two of its
quality control laboratories with out-of-the-box functionality that its team
of system administers could rapidly configure and deploy. Using the SAPPHIRE
Evergreen Web
Page Designer, the company and LabVantage configured, tested, and placed SAPPHIRE
into live production within a mere 18-day period. "The entire process
was managed professionally and went without a hitch," stated the company’s
Quality Assurance Manager. "The LabVantage team’s expertise and
ability to think outside the box were critical to the success of the project.
Because of their efforts, I know our organization will continue to build on
the SAPPHIRE LIMS platform and plans have already been initiated to move SAPPHIRE
LIMS globally." The global rollout will leverage SAPPHIRE’s multinationalization
features, including language translation, and its zero footprint, thin-client
architecture for easy, secure access to all user functionality. The
company also leveraged the SAPPHIRE out-of-the-box functionality to configure
and automate a new a
raw materials skip-lot testing process for its LIMS. In addition, the company
has also licensed and is deploying the SAPPHIRE CAPA (Corrective and Preventive
Action) Module. The CAPA Module is a seamless extension of SAPPHIRE and provides
complete functionality for monitoring planned and unplanned incidents, performing
root cause analysis, and implementing risk mitigation procedures. SAPPHIRE’s
CAPA Module ensures a responsive laboratory environment, facilitating the
delivery of quality products. For details, visit http://www.
labvantage.com.
Waters Opens Registration for Inform 2008,
Worldwide Informatics Users Conference
Waters Corporation has opened registration for Inform 2008, its worldwide
informatics users conference to be held April 21-24, 2008 at the Fairmont
Monte Carlo in the Principality of Monaco. The conference is open to scientists
and IT professionals interested in learning about strategies for efficient
scientific data management and for maximizing workplace productivity. Keynoting
the conference will be Prof. Keith Campbell of the University of Nottingham
School of Biosciences who together with colleague Ian Wilmut earned international
acclaim in 1996 for cloning the world's first animal, a sheep they named "Dolly",
while both worked at the Roslin Institute. The conference will also feature
best-practice presentations from many leading organizations including GlaxoSmithKline,
Johnson & Johnson, Teva Pharmaceuticals, and Eli Lilly. Also, educational
sessions on Waters Empower Chromatography Software will be offered in English,
French and German. At the conference, Waters will announce the winner of the
2nd annual Pioneer Award recognizing organizational excellence in the implementation
of laboratory or enterprise data management programs. Last year's winner was
the Mayo Clinic of Rochester, Minnesota for its novel implementation of a
NuGenesis SDMS system. Other contributing sponsors of Inform 2008 include
Microsoft Corporation, Oracle Corporation and IBM. Attendees who register
before February 15 can receive a 20% discount on the cost of registration.
For more information on Inform 2008 and to take advantage of the early registration
discount, visit http://www.inform2008.com.
IDBS Announces E-WorkBook Suite
8.0, ActivityBase 7.0 and ActivityMart 3.0
IDBS has announced the upcoming releases of E-WorkBook Suite 8.0, ActivityBase
7.0 and ActivityMart 3.0. The forthcoming releases are to be delivered in
early 2008 as part of IDBS' continued commitment to developing and integrating
its industry-leading product suites. ActivityBase is IDBS' flagship product
and since its inception has become the industry-standard screening solution,
employed by over 75% of the world's leading biotechnology and pharmaceutical
companies. Enhancements to ActivityBase 7.0 include simplified plate creation,
time savings in results processing and report generation and support for chemical
tautomer searching. Following the success of the ActivityBase Suite, IDBS
launched its comprehensive electronic laboratory notebook (ELN), the E-WorkBook
Suite, in 2005. The imminent release of E-WorkBook 8.0 will deliver major
enhancements in searching and reporting and increased support for chemistry.
ActivityMart drives the decision-making process by providing rapid and intuitive
access to complex research data. Integrating data from ActivityBase and BioBook,
ActivityMart 3.0 further simplifies the searching of results data by presenting
it in an intuitive business context. This solution consolidates the high value
summary test data stored in various LIMS, ActivityBase and BioBook databases,
retaining rich contextual data. ActivityMart provides a rapid querying tool
and is vital when searching high volumes of data. Neil Kipling, founder and
CEO of IDBS, commented: "We are currently doing a lot of ongoing work
to improve the integration capabilities of our solutions and our aim for 2008
is to continue to deliver revolutionary products and services to the marketplace.
Research organizations need an adequate means of managing their data to meet
increasing regulatory requirements. Informatics providers must continue to
improve their systems to deal with the magnitude of data generated. The importance
of having an integrated framework cannot be under-estimated."For details,
visit http://www.idbs.com.
Thermo Scientific Introduces Momentum Process
and Data Integration Software
Thermo Fisher Scientific Inc. has announced the introduction of its revolutionary
Momentum workflow software for laboratory applications. Momentum lets users
define, execute and monitor complex processes in a powerful yet easy-to-use
visual environment. As an intelligent solution, the software enables multiple
workflows via real-time, data-driven decision-making; eliminating the need
for customized data handling. Its open topology editor allows the user to
specify the design, configuration and operation of their individual system
and plug-in different schedulers to support a broad range of processes and
workflows. Users can also manage multiple islands of automation, treating
them as part of a larger connected system. Initially Momentum will be made
available to drug discovery and development labs as the solution is well suited
for numerous automation applications including hit picking & inventory
management, HTS/HCS screening, automated cell/tissue culture applications,
and laboratory workflow management, among many others. The software's topology
editor is so remarkably flexible that the solution can empower a wide variety
of applications including analysis, measurement and control. The composite
user interface is built on a .NET platform for easy configuration and customization.
This state-of-the-art software presents data from a variety of instruments
in a standardized format for consistent storage in the SQL database. Momentum
also provides full audit trails and detailed error logging for process traceability.
Dynamic rescheduling and innovative instrument pooling accommodates workflow
changes, instrument hot-swapping and more. Momentum is compatible with
any combination of instruments and plate movers, independent of vendor. Its
ability to integrate and monitor automated, manual and delocalized systems
facilitates the easy incorporation of new or upgraded technology or processes,
ensuring exceptional operational longevity. For details, visit http://www.thermo.com.
Cenetron Announces Implementation of STARLIMS
for Global Clinical Trials
Cenetron Diagnostics, Ltd., a leading Central Laboratory that specializes
in molecular diagnostics, has announced that it has implemented the latest
version of the STARLIMS Laboratory Information Management System for global
clinical trials. STARLIMS serves as an enterprise-wide system to build and
track clinical trial collection kits, manage and track specimens, manage laboratory
testing workflows, create user-defined laboratory reports and manage study-specific
databases. The advanced security, data integrity, and audit trail capabilities
of STARLIMS enable Cenetron to meet the stringent requirements of its pharmaceutical
clients--for timely reports, for data transfers of absolute quality and accuracy,
and for full compliance with FDA 21CFR part 11 guidelines. "The implementation
of STARLIMS is an important milestone in Cenetron's history," said Dwight
DuBois, MD, Cenetron's President. "We are able to meet and exceed FDA
and sponsor requirements with enormous flexibility. STARLIMS is able to handle
complex data sets generated from molecular testing with traceability, accuracy,
and clarity. STARLIMS' scalability and versatility are also important, allowing
us to add functionalities as our business grows. Our team is currently completing
testing of another module that allows the storage, retrieval, and analysis
of DNA sequencing data." "A leading provider of central laboratory
services for clinical trials and other pharmaceutical applications, Cenetron
is clearly committed to innovation in every aspect of lab automation, and
STARLIMS has been part of that strategy. We are delighted to see that our
long-term collaboration has brought important benefits to Cenetron: full regulatory
compliance, streamlining of lab process, and integration with a wide range
of processes," said Ed Krasovec, Director of Clinical Operations at STARLIMS.
"A series of other important players in the clinical space are implementing
our solutions, and our presence in clinical trial, health care, and public
health labs is growing at a tremendous rate. In large part, this reflects
the success of STARLIMS V10--an entirely web-based LIMS that offers powerful
out-of-the-box capabilities for regulatory compliance; an unparalleled suite
of tools and wizards specifically designed for clinical trial processes; and
universal access to data via standard browsers." For details, visit http://www.cenetron.com
or http://www.starlims.com.
Rotech Laboratories Chooses WinLIMS Rental
Rotech Laboratories, a metallurgical testing and consultancy services operation,
is the latest company to take advantage of WinLIMS Rental from QSI. Part of
the Rubery Owen group, their laboratories provide a diverse range of testing
services including metallurgy, chemical analysis including ICP, mechanical
failure analysis, corrosion and surface finish testing and non-destructive
testing, and offer a 24-hour turnaround on urgent samples. Rotech Laboratories
have UKAS ISO 17025 accreditation and also complies with Rolls Royce requirements.
A standard WinLIMS “out of the box” rental package will handle
internal and external reporting, and is expected to lead to greater efficiency
and accuracy within the operation and improved customer service levels. QSI
Managing director Clive Collier commented: “The availability of software
on a rental basis has dramatically reduced the cost to the larger laboratory
of acquiring a LIMS, and revolutionised access to the technology for smaller
ones. According to one estimate, there are 14-15,000 laboratories of all kinds
in the UK, of which only 20% have a LIMS installed, so there are many laboratories
out there that could enjoy the benefits of a LIMS. Rotech Laboratories’
choice of WinLIMS Rental shows that a really comprehensive “out-of-the-box”
LIMS package can fully meet the needs of a multi-disciplined contract laboratory,
and very cost-effectively too.” For details, visit http://www.qsiuk.com.
LabVantage to Showcase Configurable Off-the-Shelf
Enterprise Laboratory Informatics at LabAutomation 2008
LabVantage will be exhibiting and presenting in the LabAutomation Informatics
Track – 4 at the upcoming LabAutomation 2008, Palm Springs Convention
Center in Palm Springs, CA, January 27-29. LabVantage will be at booth #390
showcasing the SAPPHIRE laboratory information management Suite, a zero footprint
and configurable off-the-shelf (COTS) solution consolidating functionality
typically found in multiple laboratory systems. With its combination of solutions-oriented
modules and multinationalization support, LabVantage’s SAPPHIRE delivers
a complete and versatile, multi-site, and multi-language enterprise backbone
for laboratory informatics. Featured at the booth will be ongoing demonstrations
of the SAPPHIRE Suite as well as several key module demonstrations including:
NEW! SAPPHIRE Reagents and Standards Management module - providing a complete
solution for the management, maintenance, and tracking of laboratory consumables.
SAPPHIRE Biobanking module - delivering a comprehensive and centralized, “Cradle-to-Grave”
solution for managing a complex biospecimen repository. In addition, LabVantage
will be presenting on Monday, January 28th at 12:00 pm, LabAutomation Informatics
- Track 4:For details, visit http://www.labvantage.com.
Leading Pharmaceutical Company Selects STARLIMS
for $2.1 million Global LIMS Project
STARLIMS Technologies Ltd., a leading provider of LIMS, has been selected
by one of the world’s leading pharmaceutical companies for a $2.1 million
LIMS project. STARLIMS v10 will be implemented in the pharmaceutical company’s
Research and Development and Quality Assurance laboratories in North America,
Europe and Asia. "Being selected by one of the world’s largest
pharmaceutical companies is clearly a vote of confidence in our vision of
creating a single web-based platform for laboratory informatics, covering
multiple lab disciplines and reaching across the globe,” said Jeff Ferguson
COO at STARLIMS. “We are seeing more companies standardizing their LIMS
solutions across the enterprise and we believe STARLIMS v10 is well positioned
to meet this demand.” Implementing STARLIMS will facilitate the sharing
of scientific data and best practices across multiple laboratory sites. The
pharmaceutical customer intends to standardize on STARLIMS, beginning with
eight sites. One of the key considerations the customer had in selecting STARLIMS
was its scalability, a benefit of its entirely web-based architecture. In
addition, STARLIMS offers multilingual and multi-time zone support, important
considerations for distributed LIMS implementations. By standardizing on STARLIMS,
the company is expected to enhance regulatory compliance and traceability,
by facilitating more consistent reporting and enhancing data security. The
web based STARLIMS v10 system will simplify deployment, validation, scale
up and upgrade of the system while reducing resource requirements for ongoing
maintenance. For details, visit http://www.starlims.com.
Ocimum Biosolutions Acquires Gene Logic’s
Genomics Division
Ocimum Biosolutions (Ocimum) has announced that it has successfully closed
the acquisition of the genomics division of Gene Logic and will retain the
Gene Logic name and continue to service customers from Gaithersburg. Commenting
on the new partnership, Anuradha Acharya, CEO of Ocimum, said, “We were
looking for a partner that apart from providing growth capital and acquisition
financing has a similar footprint as ours and can understand our business
and our global customer service and delivery model. Kubera’s track record
and their ability to add value in a cross-border sense uniquely qualifies
them to help with businesses such as ours.” She further added, “With
the acquisition of Gene Logic’s Genomics business, we now offer the
largest portfolio of integrated genomic solutions, which further strengthens
our unique positioning in this space. We aim to be the number one genomics
outsourcing company in the world. We will leverage our global positioning
and Gene Logic’s branding and scientific leadership in toxicogenomics,
pharmacogenomics and clinical genomics to become a partner of choice for our
customers.” Ramanan Raghavendran, Managing Partner at Kubera Partners,
LLC said, “We believe genomics outsourcing is at the cusp of significant
growth, given the demands on the drug discovery function for labs around the
world. Ocimum is well positioned to capture this opportunity because of its
leadership in genomics, deep technology knowledge and experience, global delivery
capability and above all its world-class scientific talent and management
team.” Shiraz Bugwadia, Director at o3 Capital Advisors, added, “Ocimum,
with this Series B investment from Kubera Partners is well on path to become
a USD 100 million company by 2011 and a world leader in genomics outsourcing.”
For details, visit http://www.ocimumbio.com.
Northwest Analytical Participates in SPC for
Food Safety
From ground beef to spinach, the food industry has seen the huge downside
of supply chain safety and quality failures. One proven way to reduce safety
risks is to use SPC (statistical process control) to improve supply chain
performance. Since 2003, the USDA National School Lunch Program ground beef
purchasing has demonstrated the success of SPC-based supply chain management.
The program has improved both quality and safety to show the way to get the
food safety job done right. The program, “Improving Food Safety in the
Food Supply Chain” from the Feast or Famine TV series, includes the
people who made it happen including Barry Carpenter, Executive Director, National
Meat Association, Dr. Kenneth Clayton, Associate Administrator, USDA Agricultural
Marketing Service (AMS), and Steve Olson, Livestock and Meat Marketing Specialist,
USDA AMS. The program was filmed on location at Cherry Meat Packers in Chicago.
Northwest Analytical participated in the production and offers clips from
the program and a free Building a Better Burger DVD at http://www.nwasoft.com/appnotes/feastfamine.htm.
World-leading Bio-banking Repository Selects
STARLIMS
STARLIMS Technologies Ltd. a leading provider of LIMS, has announced that
its STARLIMS Version 10 software was selected in September 2007 by Rutgers
University Cell and DNA Repository (RUCDR). The entirely web-based STARLIMS
system will enable hundreds of research sites to obtain bio-banking data in
real time, using a standard web browser. RUCDR is the largest university-based
cell and DNA repository in the world. RUCDR has been designated as the Center
for Collaborative Genetic Studies for the National Institute of Mental Health
(NIMH), the Genetics Repository for the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), the Center for Genetic Studies for
the National Institute on Drug Abuse (NIDA) and the National Cell Repository
for the Collaborative on the Genetics of Alcoholism funded by the National
Institute on Alcohol Abuse and Alcoholism (NIAAA). In addition, RUCDR collaborates
with many other federal, state and private research organizations, serving
over 500 research sites worldwide. “RUCDR has consistently been at the
frontier of new technologies, and leveraging the web to facilitate remote
collaboration in the research community is an enormous step forward in the
bio-banking sector,” said Jeff Ferguson, COO of STARLIMS. STARLIMS solutions
for bio-sample repositories automate molecular based testing workflows, streamlining
sample tracking and management. At the same time, STARLIMS puts lab information
resources on a single globally accessible web platform. Bio-repositories such
as RUCDR can give authorized researchers real-time data access to a searchable
database of annotated specimen information, maximizing the value of the stored
samples. “RUCDR experienced a ten-fold increase in sample acquisition
in the years 1998-2004, and has continued growing steadily since then. To
grow at such rates, while continuing to provide the highest levels of sample
quality, technical consultation and logistical support, we must consistently
choose the most advanced technologies,” said Dr. Jay A Tischfield, Scientific
Director of RUCDR. “Implementing STARLIMS’s web-based software
is part of our long-term vision of providing timely information to all our
project sites, and doing everything in our power to promote collaboration
in the research community.” For details, visit http://www.rucdr.org/index.html
or http://www.starlims.com.
ATL and Microsoft to Host LIMS Seminar
Accelerated
Technology Laboratories, Inc. (ATL) and Microsoft have announced that on Wednesday,
February 13th, 2008 they will be hosting a free, educational seminar which
focuses on why a Laboratory Information Management System (LIMS)
is the key to streamlining laboratory operations and staying compliant.
The event will take place at the Microsoft facility in Bellevue, Washington
located just outside of Seattle. The seminar is a lunch event that will explore
the current challenges that are faced in the modern laboratory and demonstrate
how organizations are automating operations to increase productivity and data
quality while reducing operational costs. This seminar is ideal for
Laboratory Operations or QA/QC Managers in the following industries: water/wastewater,
environmental (air/water/soil), agriculture, chemical, food & beverage,
life sciences and government (public health). Lunch will be provided.
For details and to register, visit http://www.clicktoattend.com/?id=123680.
Autoscribe Announces Compliant Sample
Tracking for Regulated Industries
Autoscribe has announced Sample Tracker, a fully configurable, simple to install,
easy to use, affordable concept in laboratory sample management. Sample Tracker
is the right application for laboratory managers or supervisors, who want
better visibility of their laboratory or pilot plant operations but do not
want to implement a full LIMS. However, if the need to upgrade does arise
there is a simple upgrade path to the Matrix Gemini LIMS family without loss
of your investment in Sample Tracker. Sample Tracker tracks, records and reports
the progress of samples and work through a laboratory or process. It can track
process steps as well as analytical and physical tests. A “Chain of
Custody” is maintained and can be reported for each sample. Comprehensive
version control and auditing is available as standard. Sample Tracker is frequently
implemented with barcode printers and scanners to enter sample identity and
location information. This speeds data input and reduces errors by eliminating
typing mistakes. Each freezer, refrigerator and storage cabinet can be labelled
with barcodes down to each shelf and the exact location for each sample or
box of samples can be stored. The sample inventory report may be printed showing
the status and last entered location for each sample. As each test or process
step is completed, information may be entered and recorded as to what batch
or lot of reagent and supplies were used with that sample. This greatly assists
in investigating process issues. Sample Tracker is supplied with a standard
suite of functional reports including Worksheets, Work Pending, Sample Status
and Audit Trail. Any laboratory system should comply with GLP (Good Laboratory
Practice), and Sample Tracker is no exception. Any changes to data are recorded
along with the date and time of the change and identity of the user who made
the change. All such historical data may be reported as required. For details,visit
http://www.autoscribe.co.uk.
Thermo Fisher Scientific to Showcase New
Informatics Offerings at PITTCON 2008
Thermo Fisher Scientific Inc. will showcase its new informatics offerings
on booth #1741 at PITTCON 2008 at the Ernest N. Morial Convention Center
in New Orleans, Louisiana, March 1-7. Under the theme "Moving Science
Forward", the company will demonstrate a range of innovative analytical
instruments, software and laboratory workflow solutions marketed under its
Thermo Scientific brand. The Thermo Scientific informatics exhibit at PITTCON
2008 will feature Darwin 3.0, the latest version of the innovative Laboratory
Information
Management System (LIMS), which is purpose-built for pharmaceutical manufacturing
R&D and QA/QC laboratories. The added functionality in Darwin 3.0 demonstrates
the company's ability to offer one of the most
comprehensive LIMS for this industry, which can be tailored to a laboratory's
specific workflow. Also on display will be a "sneak preview" of
a next-generation Thermo Scientific Chromatography Data System (CDS), which
integrates with LIMS and other data management systems to control LC/GC instruments
and modules from numerous vendors in a manner that enables compliance with
FDA regulations, including 21 CFR Part 11. Visitors who are interested in
seeing the preview of this new database-driven CDS will also be entered to
win a TomTom GPS navigation system if they submit a form to the Informatics
staff on booth. In addition, attendees can see demonstrations of the entire
portfolio of Thermo Scientific informatics products: SampleManager LIMS, the
flagship offering for industrial applications; Watson LIMS, the industry standard
for bioanalytical laboratories; Galileo LIMS, which enables high-throughput
compound screening for in-vitro ADME screening; and Nautilus LIMS, for dynamic
environments requiring a flexible solution that can be easily modified as
workflow requirements change, typical in research and contract organizations.
Visitors to booth #1741 will also have the unique opportunity to see the company's
food safety laboratory showcase. Here you can see how LIMS and CDS software
are integrated in a comprehensive workflow environment with other Thermo Scientific
solutions such as Atlas CDS and the Thermo Scientific Accela high-speed liquid
chromatography system. For details, visit http://www.thermo.com/informatics.
STARLIMS
Asia Pacific Inaugurates New Facilities
In late 2007 STARLIMS celebrated the official inauguration of its newly renovated
facilities at the Hong Kong Science and Technology Park, underscoring the
company's commitment to the Asia Pacific region. The expansive office was
designed to support the company's growing operations in the Asia Pacific region.
Since 2002, STARLIMS
Asia Pacific has been providing marketing, sales and technical support for
Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore,
Taiwan, Thailand and the Gulf States. A team of 70 professionals, including
staff members and consultants, is available for pre-sales and post-sales support.
Together with its partners, STARLIMS Asia Pacific's dedicated professional
team has implemented STARLIMS solutions for Beijing Food Safety Center for
2008 Olympic Games, Beijing Centers for Disease Control and Prevention, Guangdong
Institute for Drug Control, Shanghai SECCO Petrochemical Company Limited,
Shanghai Environmental Monitoring Center, Chinese Customs, Qatar Gas, Qatar
Agriculture, Hong Kong Government Labs - DNA Database Section, Thailand Central
Institute for Forensic Sciences, Taipei County Police - DNA Labs, Singapore
Health Sciences Authority and Malaysia Ministry of Health, to name a few.
"We are very pleased with the headway we have made in the last few years,
and we fully intend to continue growing at least as quickly," said Linus
Chu, General Manager of STARLIMS Asia Pacific. "To support this ambitious
goal, we of course need the best human resources available, and I believe
that we have made important progress in bringing together a phenomenal team
of professionals. We also need the practical and logistical infrastructure
to ensure our activities in the region go smoothly, and our new facilities
at the Hong Kong Science Park are designed just for that." For details,
visit http://www.starlims.com.
PerkinElmer Introduces WIZARD2 Automatic Gamma
Counter with Advanced Ease-of-Use Features
PerkinElmer Life and Analytical Sciences, a global leader in life science
research, drug discovery and cellular science, has announced the launch of
the new WIZARD Automated Gamma Counter. This next-generation gamma counter
features a user-friendly interface system with a package of technology advancements
for academic, nuclear medicine and pharmaceutical researchers who conduct
radiometric immuno assays (RIA), chromium release studies and positron emission
tomography (PET) research. The WIZARD Gamma Counter, a widely known, market
leading gamma counter used for radiometric detection in clinical and academic
research labs around the world, has been re-engineered to feature Windows
XP software, touch-screen operation, easy networking capability and USB ports
for simple data transfer. For details, visit http://www.perkinelmer.com/CorpPressRoom.htm.
Autoscribe's Matrix Chosen by Leading Pharmaceutical
Company
Autoscribe's Matrix Sample Tracking software has been chosen by the Research
Division of a major, multi-national pharmaceutical company. It is being implemented
at sites in America, Europe and Asia to track samples and slides through the
entire pre-clinical, Safety Assessment Division. Peter Mansfield, President
of Zumatrix said that the initial contract is for 100 concurrent users at
three sites world-wide, with a single Oracle database within the US. He said
that the configurability and flexibility of Matrix software was a major factor
in winning the contract and that the project from start to validation and
completion would be completed in six months. At present it is right on schedule.
Sample Tracker may be used in both highly regulated and unregulated industries
and provides exactly the same user experience no matter how you access the
application; rich client on a LAN, thin client on a WAN, or via the Web using
a standard browser. The OneTime Configuration tools automatically create
a unified Sample Tracking configuration for both desktop and web use. Once
a screen has been built using the unique OneTime Configuration Tools, it is
immediately available on your network or via the Web. Matrix software is developed
by Autoscribe, Ltd in an ISO 9001-2000 certified process at Riseley, near
Reading, Berkshire (UK). The latest releases of Matrix use the Microsoft .NET
platform in order to deploy easily and quickly. Zumatrix, Inc provides
software products and support for laboratories throughout North America as
a distributor for Autoscribe, Ltd. Matrix solutions will be demonstrated at
the upcoming Pittsburgh Conference in New Orleans from March 3-6 in Booth
#5554. For details, visit http://www.autoscribe.co.uk.
Thermo Fisher Scientific
Announces Major Laboratory Informatics Symposium in India
Thermo Fisher Scientific has scheduled its annual Laboratory Informatics Symposium
(LIS), to take place on 14-15 February 2008 at the Le Meridien in Bangalore,
India. The symposium focuses on how the right informatics
strategies and solutions can streamline data management processes in the life
sciences industry and help those laboratories become more efficient, enabling
laboratory personnel to become more focused on the science.
Representatives from the following functions within the life sciences industry
are encouraged to attend: laboratory scientists, lab managers, information
technology managers, systems engineers and operations
executives. Laboratory Informatics Symposium will provide attendees the opportunity
to meet and discuss issues and trends concerning laboratory informatics, evolving
technologies and changing market requirements. The program for 2008 features
compelling customer presentations, product development discussions, user networking
and training - exploring how to take advantage of continually evolving technologies
to drive improvement within laboratories and businesses. The Informatics CARES
(Custom Allegiance through Responsive, Excellent Service) program will be
introduced during the conference as well. This addresses Thermo Fisher Scientific's
ongoing commitment to its informatics customers. Laboratory Informatics Symposium
provides a chance to share industry perspectives and changing business requirements
that drive the enhancements necessary in informatics solutions. The company
continues its tradition of customer involvement by hosting product breakout
sessions which include customer presentations. Laboratory Informatics Symposium
will bring together users of purpose-built Thermo Scientific Laboratory Informatics
Management Systems (LIMS) solutions, Chromatography Data System (CDS), and
spectroscopy software for the pharmaceutical industry. For details, visit
http://www.lis08.com.
STARLIMS Announces $1 Million Contract with
Pharmaceutical Division of Fortune 500 Company
STARLIMS Technologies Ltd., a leading provider of laboratory information management
systems (LIMS), has announced a $1 million contract with the pharmaceutical
division of a Fortune 500 company. The contract covers licenses for the web-based
STARLIMS software, as well as implementation services and first year maintenance.
The STARLIMS Version 10 web-based solution will be implemented in four pharmaceutical
sites in North America and Europe. One of these sites has been using the client/server
version of STARLIMS software, while the other sites have employed a legacy
LIMS provided by another vendor. Aiming to achieve global standardization,
the customer leveraged its STARLIMS upgrade to replace all its LIMS with STARLIMS
Version 10. The result will be a single web-based platform which provides
a unified solution for all four sites. "Based on years of experience
with multiple LIMS vendors, this pharmaceutical manufacturer decided to implement
STARLIMS Version 10 in all its sites. It is gratifying to witness this vote
of confidence in our web-based LIMS technology and in our proven methodology
and professional services to provide enterprise-wide LIMS solutions,”
said Jeff Ferguson, Chief Operating Officer at STARLIMS. For details,
visit http://www.starlims.com.
Invetech to Demonstrate its Contract Development
Solutions at LabAutomation 2008
Invetech, a specialist in development of biomedical products, instruments
and custom automation, will be
showcasing its entire integrated contract development and manufacturing services
at LabAutomation, 26-30 January 2008 at the Palm Springs Convention Centre,
Palm Springs, California on booth #957. Invetech's booth at LabAutomation
will offer visitors the opportunity to discuss specialist solutions and its
turnkey approach with the experts on the booth and learn more about its experience
in development of instruments and custom automation solutions for clinical
in-vitro diagnostics, clinical pathology, point-of-care diagnostics, laboratory
and drug discovery automation and living cell processing systems. David James,
Director for Invetech will co-present the Technical Project Management Workshop
covering typical project management strategies, stages and progress tracking,
with examples of just some of the company's project management tools and their
application. For details, visit http://www.invetech.us.
Pittcon 2008 Offers Biofuel Symposium
The Pittsburgh Conference announces a symposium of special interest, "Analytical
Instrumentation for Biofuels R&D,” organized by Roland F. Hirsch
from the Office of Biological & Environmental Research, U.S. Department
of Energy. This symposium will address the analytical technologies needed
to enable progress in meeting the goals of large-scale substitution of biomass-derived
fuels and chemicals for their fossil-derived counterparts.
The symposium will feature presentations from each of the three new Bioenergy
Research Centers funded by the Office of Science, U.S. Department of Energy:
the DOE BioEnergy Science Center, led by Oak Ridge National Laboratory; the
DOE Great Lakes Bioenergy Research Center, led by the University of Wisconsin,
Madison; and the DOE Joint BioEnergy Institute, led by Lawrence Berkeley National
Laboratory. After describing the mission and goals for their center, each
of the speakers will discuss the analytical instrumentation used in their
center and the limitations of existing technologies that will require analytical
R&D for characterizing the raw materials and processes that will be studied
by their center. Two additional presentations will describe analytical research
projects that focus on characterizing and imaging lignocellulosic materials
undergoing conversion to simpler molecules that can then be converted to fuels
and chemicals. More information on the Centers and the DOE Bioenergy Research
Program can be found at: http://genomicsgtl.energy.gov/centers
and http://genomics.energy.gov. For
details, visit http://www.pittcon.org.
STARLIMS Announces Follow-On Contract with
Leading Clinical Research Organization
STARLIMS Technologies Ltd., a leading provider of laboratory information management
systems (LIMS), has announced an $800,000 follow-on order from a leading contract
research organization (CRO) providing clinical research services to pharmaceutical,
biotechnology, and medical device companies around the world. In 2007, STARLIMS
will record a total of $1 million in revenue from this customer with the current
$800,000 sale covering licenses for STARLIMS Version 10 software. The STARLIMS
V10 software will be implemented in multiple laboratory sites throughout the
customer's clinical laboratory network in North America, Europe and Asia Pacific.
The current license order follows an initial $300,000 license and services
contract which was signed in the third quarter of 2006 and implemented in
2007. Upon the successful completion of the initial project, the customer
elected to purchase the additional licenses for a global roll-out of STARLIMS
V10.
"We are very pleased to have a leading CRO embrace our web-based technology
and decide to standardize their global laboratory operations on our STARLIMS
V10," said Jeff Ferguson, Chief Operating Officer at STARLIMS. "This
is another example of our ability to expand into the clinical laboratory information
systems market and address the complex needs of these diverse customers. We
continue to receive strong interest in STARLIMS's solutions for clinical labs
and see this market as a significant growth opportunity." For details,
visit http://www.starlims.com.
Labtronics Announces New LimsLink CDS Release
Combines Four Advanced CDS Interfaces in One Solution
Labtronics Inc. has announced that the latest release of LimsLink CDS now
combines seamless, embedded CDS/LIMS interfaces for four of the leading Chromatography
Data Systems into one solution. This new release introduces a new interface
for Chromeleon CDS along with an upgraded interface for Empower and our popular
TotalChrom and ChemStation embedded interfaces. These LimsLink CDS v4.1 interfaces
give laboratories direct and transparent connection between their Chromatography
Data Systems and LIMS, allowing analysts to automatically create sequences
and send results straight to LIMS, from within their CDS client. Easy to work
with and highly functional, these interfaces speed up delivery of chromatography
results to LIMS by significantly reducing the amount of time analysts spend
on chromatography data management. Labtronics Special Function Suite is also
a part of the LimsLink CDS v4.1 solution, further extending the data management
capabilities of the core LimsLink CDS application. The Special Function Suite
supports the creation of interfaces that go beyond simple data transfer to
automate as much of the CDS data management process as possible. For details,
visit http://www.labtronics.com/llcds.htm.
Labtronics Releases Automated Worksheet
Management for LimsLink 4.1
Labtronics Inc. has released LimsLink Worksheet Utility v4.1, a stand-alone
application that assists organizations with management of the LimsLink v4.1
worksheets that they generate. LimsLink is Labtronics’ industry leading
solution for connecting laboratory instruments with LIMS. Many LimsLink users
retain LimsLink worksheets in an active state for reference over a specified
period of time (i.e. 30 days) after which they either archive or delete the
worksheets. From within LimsLink, these worksheets can be individually selected
and either deleted or archived as needed. However, in a large volume laboratory
this can become a time consuming task. The LimsLink Worksheet Utility v4.1
is an automated solution that allows organizations to identify when worksheets
should be automatically archived or deleted and to carry out those tasks on
a regular basis. It can be run manually from a desktop icon or it can be setup
as a Scheduled Task to automatically run on a regularly scheduled basis. The
Worksheet Utility can be set up in conjunction with LimsLink security so that
only authorized users are permitted access. All Worksheet Utility archival
and deletion activities can also be recorded in the LimsLink Audit Trail.
LimsLink 4.1 users that implement the LimsLink Worksheet Utility are confident
that their worksheet management activities are being carried out consistently
and efficiently without taking up valuable time from laboratory personnel.
The Worksheet Utility is also available for previous versions of LimsLink.
For details, visit http://www.labtronics.com/ll.htm.
Ventana Medical Systems Licenses BioPathwise
DM for Multispectral Image Data Management
The BioAnalytics Group has announced the licensing of BioPathwise DM to Tucson-based
Ventana Medical Systems, Inc. for use in their image processing research program.
The BioPathwise DM software system makes it easier to capture, secure, share
and publish data from any laboratory instrument in any format - images, spreadsheets,
documents, etc. "BioPathwise allows us to organize our multi-spectral
image data in a way that is conducive to the way we work." says Michael
Otter, Sr. Director, Systems Engineering at Ventana. "The software allows
us to store the data in one consistent set together with its associated metadata
- which is searchable by various attributes, e.g. what and when it was done,
type of reagents, etc. The installation on the enterprise-level server
was quick and the user interface offers versatile entry masks which were already
preconfigured and can easily be expanded without IT involvement or special
programming needs." Developed by The BioAnalytics Group through an NIH-funded
collaboration to stimulate the use of modeling and simulation in biomedical
research, the BioPathwise DM system addresses common laboratory bottlenecks
that impede the efficient use of researcher-generated data. "In our work
with researchers at universities as well as pharmaceutical, biotech, device,
and instrumentation companies," says BioAnalytics Group CEO Scott Lett,
Ph.D, "we have developed a number of initiatives to stimulate laboratory
productivity by helping researchers work with complex data in an adaptable
system that captures both the raw data and the contextual information that
makes it meaningful. We have collaborated with Ventana Medical Systems on
a number of successful projects such as spectral image analysis, and on the
analysis and quantification of many types of data, including that linked to
potential diagnostic panels for cancer. While we were developing the BioPathwise
DM system, we kept in mind strategies that would help small research groups
within large organizations that need to capture, secure, share, analyze, and
publish their findings." The BioPathwise DM system allows labs to make
experimental results available to anyone it chooses in a secure environment,
accessible on the web from any location. Groups of researchers can easily
document, store, and share data along with any reports, records, copies of
peer-reviewed articles, or other relevant information that helps interpret
the raw experimental data. It is part of The BioAnalytics Group's software
suite designed to stimulate the use of modeling and simulation in the biomedical
discovery and development process. For details, visit http://www.bioanalyticsgroup.com.
Study Examines Media Preferences of Life
Scientists in Applied Markets
Faced with modest growth in the traditional life science market, suppliers
are turning their attention to opportunities in agricultural, biodefense and
molecular diagnostics. To help companies navigate these unfamiliar waters,
leading research and advisory firm BioInformatics, LLC released its latest
report examining the marketing and media preferences of scientists working
in these dynamic markets. The report, "Marketing to Life Scientists:
Capturing Customers' Attention in Applied Markets" highlights the importance
of effective marketing in capturing mindshare in markets where product differentiation
can be hard to achieve. "This report can help life science companies
determine the right combination of marketing messages and tactics to efficiently
reach their target audience in these applied markets," said Tamara Zemlo,
PhD, Director of Syndicated Research at BioInformatics, LLC. "Scientists
working in these fields share many similarities with those in basic research
and drug discovery, but there are also some striking differences that marketers
can exploit for optimal effectiveness." The scientists surveyed also
ranked the effectiveness of their suppliers' marketing programs in terms of
"best" Web site, print catalog, exhibits, print advertising and
sales force. Key findings of the report will be shared in a complimentary
webinar presented on January 15 at 1:00 p.m. ET. To register to attend the
webinar, please email webinars@gene2drug.com.
Approximately 570 scientists from North America and Europe participated in
this survey, which was conducted between October 18 and December 3, 2007.
Acomplimentary Executive Summary of the report is available at: http://www.gene2drug.com/reports/default.asp?action=details&report_id=186.
ABB's Collaborative Production Management Solution
Recognized for Helping Cement Industry Customers Reduce Energy Costs and Consumption
ABB’s Expert Optimizer software was honored with the “Most innovative
technology for electrical energy efficiency” award at the second annual
Global Fuels conference in London early in February 2008. Part of ABB’s
Collaborative Production Management portfolio, Expert Optimizer helps cement
plants to significantly reduce their energy consumption and energy costs.
Pro Publications International Ltd. organized the conference; over 100 cement
industry delegates from 27 countries attended the 2008 event. The judges from
Global Cement and Global Fuels Magazines praised ABB’s technologies
for their effective reduction of electrical energy usage in cement plants
worldwide. Pro Publications Editorial Director, Dr. Robert McCaffrey presented
the award to Dr. Eduardo Gallestey, Product Manager for Expert Optimizer at
ABB. "We are truly honored that ABB has been recognized with this award,”
said Dr. Gallestey. “It is great to see that ABB’s commitment
to innovation, and our focus on improving productivity and energy efficiency,
has been acknowledged by the opinion leaders in the market. I was very proud
to accept the trophy on behalf of our team”. Part of ABB’s Collaborative
Production Management suite of solutions, Expert Optimizer allows cement plants
to reduce their specific energy consumption through the intelligent use of
variable speed drives in fans and kiln control, for implementing cooler optimization
in combination with high-efficiency cooler multidrives, and for deployment
of mill optimization and grinding plant scheduling for reduction of
energy consumption and energy costs. Energy monitoring is executed in conjunction
with ABB’s Knowledge Manager solution. During the conference, Dr Gallestey
also presented the paper ‘Effective Energy Management in Cement Production’
which he co-authored with Matthias Bolliger, Michelle Kiener and Gabriela
Crosley from ABB. ABB's suite of Collaborative Production Management
(www.abb.com/cpm) products, which includes Expert Optimizer and Knowledge
Manager, provide productivity improvements to process automation companies.
For details, visit http://www.abb.com.
ABB Wins $25-million Order for Vietnamese Cement
Project
ABB has won an order worth $25 million from Vietnam Cement Industry Corporation
for equipment to maximize productivity, monitor energy use and minimize energy
consumption at a new cement plant. The Binh Phuoc cement factory will be built
about 130 kilometers north of Ho Chi Minh City and produce 5,500 tons of clinker
per day. It is scheduled for commissioning in first quarter of 2009. The scope
of ABB’s order includes engineering, construction and commissioning
services, as well as overall project management supervision. The equipment
ordered includes a 110-kilovolt (kV) distribution substation, automation equipment,
motors, drives and instrumentation. ABB will also provide its Extended Automation
System 800xA for process control, collaborative production management systems,
and other auxiliary equipment. "ABB is committed to providing its customers
with the leading-edge technology, services and know-how needed to make their
operations successful,” said Veli-Matti Reinikkala, head of ABB’s
Process Automation division. “Our comprehensive automation and power
offerings, together with our expertise, give our customers a powerful blend
of productivity, reliability and energy efficiency.” This is the latest
in a series of contracts ABB has supplied to Vicem since 1997. Most recently,
ABB won an order to provide a similar scope of supply for the Phu Huu clinker
grinding project. For details,visit http://www.abb.com/cement.
ABB Tops Process Automation System Market Share
Worldwide
In a recently published study titled “Automation Systems for the Process
Industries,” industry analyst ARC Advisory Group ranked ABB in the leading
worldwide market position in the broad process automation market. In this
new report, ARC includes DCS, PLC, SCADA systems, safety systems, AC drives,
general motion controls, software and machine safeguarding sold to the process
industries. The study forecasts that the total worldwide market for automation
systems in the process industries, which was $30 billion in 2006, will grow
by a compounded annual growth rate (CAGR) of 9.6% by 2011, to over $47 billion.
The ARC report states that increasing pressures from globalization is driving
process manufacturers to improve plant performance in ways that would be inconceivable
without modern process automation systems and business processes. While globalization
expands opportunities for these manufacturers, it also intensifies the challenges
they face—they need to act quickly and with agility to emerging market
opportunities, and improve financial performance, all while dealing with a
shrinking base of educated and well-trained personnel. "As the market
share leader, ABB is very strong and has a lot to offer. Its ongoing success
will come from continuing to provide its customers with sustained and measurable
benefits from automation for a path to continuous improvement for business
performance and profitability,” said Larry O'Brien, Research Director
for Process Industries, ARC. “ABB’s continued focus on delivering
automation solutions that provide reduced cost of ownership, increased productivity
and reduced risk is a good fit with today’s increasing focus on business
value.” In addition to being the leading global supplier, ABB also was
the top supplier in key global verticals, such as Oil & Gas, Pulp &
Paper, and also in the EMEA (Europe/Middle East/Africa) region. ABB was also
the top supplier to the Cement, Pharmaceutical and Pulp & Paper industries
in the Asia market, with sizeable market shares in all other process industries.
In the study, ARC takes a look at the leading indicators shaping the growth
of the global automation marketplace, from capacity utilization to productivity
and industrial production, and how these will affect the market in the coming
years. Despite troubles in the US and Canadian economies, the global outlook
for automation and manufacturing remains bright. Higher energy prices continue
to contribute to increased capital investments and large project backlogs
for oil, gas and refining companies. The pharmaceutical and biotech industries
remain strong, and growth in Asia and other developing regions remain high.
Asia remains the center of growth, but the Middle East, Eastern Europe, and
Latin America continue to show strong growth as well. Additional information
on the Automation Systems for the Process Industries Worldwide Outlook, as
well as other studies on the global automation market, is available at http://www.arcweb.com.
ABB’s MPC based Expert Optimizer Successfully
Installed at Buzzi’s Signal Mountain Plant
ABB Switzerland Ltd has announced the successful commissioning of their MPC
based Expert Optimizer solution at Buzzi Unicem USA Inc.’s Signal Mountain
plant in Chattanooga, Tennessee. Expert Optimizer has been installed
on the vertical raw mill and cement mill at Signal Mountain. ABB was a natural
partner for Buzzi to select for this installation due to the variety of ABB
solutions successfully installed and running on numerous other Buzzi plants
around the world. Installation started in the middle of September and
was successfully completed in the middle of October 2007. Since Expert
Optimizer has been installed there have been production increases from both
the raw mill and cement mill. At times the raw mill was a process bottleneck
for the entire plant. Expert Optimizer’s MPC technology helped
to reduce this limitation. The increase in the performance of the mill
has translated into an incremental increase in clinker production. Expert
Optimizer has also improved the process stability which means there is now
a more consistent feed to the kiln, again resulting in a production increase.
Expert Optimizer is advanced process control software the purpose of which
is to achieve continuous process optimization. Part of ABB’s Collaborative
Production Management suite, it coordinates the setpoints of the different
parts of the process and immediately detects deviations among the different
parts of the operation. By expertly applying MPC, Expert Optimizer is
able to stabilize and then optimize the process which helps plant management
to reach profitability and sustainability goals. Scott Henninger, Production
Manager at Signal Mountain said “We’ve been really pleased with
how the installation went and, of course, with the outcome. Having EO
installed with its MPC has been a real improvement to production and the business.”
For details, visit http://www.abb.com/minerals.
Congressional Appropriations Subcommittee Denounces
FDA
While the FDA doesn’t have enough money to do its job, it uses this
lack of resources as an excuse not to enforce drug safety laws, Rep. Rosa
DeLauro (D-Conn.), chairwoman of the subcommittee that funds the FDA, charged
at a hearing on Februiary 27, 2008. "The FDA has been starved for resources
under seven years of the Bush administration,” DeLauro said in her opening
statement. “But increased funding is only part of the challenge. Funds
alone cannot fix an agency that routinely fails at its most basic responsibilities
— keeping track of clinical trials, preventing conflicts of interest,
following up on critical investigations. Sixty-five percent of postmarket
studies on new medications have not yet begun. This startling fact makes it
clear what a long way we have to go.” DeLauro and other subcommittee
members grilled FDA Deputy Commissioner Janet Woodcock and David Horowitz,
deputy associate commissioner for compliance policy in the FDA’s Office
of Regulatory Affairs, about FDA inspections of drug manufacturing facilities.
Citing a Government Accountability Office report that identified problems
with inspections of foreign facilities in March 1998, DeLauro said, “From
2001–2008, we provided a 62 percent increase in [Center for Drug Evaluation
and Research’s] budget. During that time, foreign inspections dropped
30 percent and domestic inspections dropped 17 percent. That’s the result
of a decision by the agency.” Horowitz said the FDA had 232 inspectors
who went to 300 foreign manufacturing facilities — approximately 10
percent of the total — in 2007 and visited 1,200 domestic manufacturing
facilities. When questioned by Rep. Steven Rothman (D-N.J.), Woodcock said
hiring additional inspectors would be a top priority for the agency if money
were not an issue, but she could not say how many would be needed. For details,
visit http://www.fda.gov.
AAPS and FDA Announce Signing of a Cooperative
Research and Development Agreement
The American Association of Pharmaceutical Scientists (AAPS) has announced
the recent signing of a Cooperative Research and Development Agreement (CRADA)
with the U.S. Food & Drug Administration (FDA). The document was signed
by Janet Woodcock, M.D., the FDA’s Deputy Commissioner and Chief Medical
Officer, and the Executive Director of AAPS, John Lisack Jr., CAE. This CRADA
marks the first time that AAPS has contributed the funding for a specific
research agreement. Under the terms of the CRADA, entitled “Enhancing
Investigational New Drug Application (IND)/New Drug Application (NDA) Review
Quality via Quantifying Prior Knowledge,” AAPS and the FDA will look
to advance current research by supporting the development of Alzheimer’s
disease-state models. These disease-state models will be implemented by the
FDA to review clinical trial data for clinical pharmacology, as well as statistical
and clinical reviews. Another goal is to use modeling and simulation (M/S)
technology to improve efficiency in the drug product development process.
AAPS staff has agreed to provide its expertise in quantitative modeling and
simulation, while FDA staff will provide working experience of disease-state
model use. The AAPS Executive Council voted to support funding of the initiative
in May of 2006 and it has been in development since that point. AAPS and the
FDA will now collaborate to recruit and screen scientific candidates for the
position of Research Fellow. AAPS has pledged to contribute $200,000 over
the 2-year research period to the Oak Ridge Institute for Science and Education
(ORISE) to cover the research process and salary of the yet to be determined
Research Fellow, who will work during that time to develop effective Alzheimer’s
disease-state models. Also included in the process will be one principal investigator
from each organization, with Dr. Joga Gobburu representing the FDA’s
Office of Clinical Pharmacology and Dr. Sandra Allerheiligen representing
AAPS. "We are very pleased to see the initiation of this important collaboration
between the FDA and AAPS,” said Dr. Allerheiligen. “The opportunity
to advance current research by supporting the development of Alzheimer’s
disease-state models represents an important advance for patients. These tools
will help establish quantitative methods to assess disease progression and
to ultimately target the appropriate patient with the correct dose and therapy."
For details, visit http://www.aaps.org.
NIH Collaborates with EPA to Improve the Safety
Testing of Chemicals
Testing the safety of chemicals ranging from pesticides to household cleaners
will benefit from new technologies and a plan for collaboration, according
to federal scientists from the National Institutes of Health (NIH) and the
U.S. Environmental Protection Agency (EPA), who have announced a new toxicity
testing agreement."I launched the NIH Roadmap for Medical Research five
years ago to create collaborations between institutes and centers on big projects
that none of them could do alone. But I never envisioned a trans-agency collaboration
testing for environmental toxins,” said NIH Director Elias A. Zerhouni,
M.D. “This research collaboration has the potential to make crucial
discoveries that will protect the public health by identifying and understanding
chemical toxicants to which people are exposed.” Two NIH institutes
have formed a collaboration with the EPA to use the NIH Chemical Genomics
Center’s (NCGC) high-speed, automated screening robots to test suspected
toxic compounds using cells and isolated molecular targets instead of laboratory
animals. This new, trans-agency collaboration is anticipated to generate data
more relevant to humans; expand the number of chemicals that are tested; and
reduce the time, money and number of animals involved in testing. Full implementation
of the hoped-for paradigm shift in toxicity testing will require validation
of the new approaches, a substantial effort that could consume many years.
This collaboration is being made possible through a newly signed, five-year
Memorandum of Understanding (MOU), which leverages the strengths of each organization.
The MOU builds on the experimental toxicology expertise at the National Toxicology
Program (NTP), headquartered at the National Institute of Environmental Health
Sciences (NIEHS), NIH; the high-throughput technology at NCGC, managed by
the National Human Genome Research Institute (NHGRI), NIH; and the computational
toxicology capabilities at the EPA’s recently formed National Center
for Computational Toxicology (NCCT). The MOU provides for sample and information
sharing necessary to more rapidly and effectively identify chemicals that
might pose possible risks to the health of humans and animals and to the environment.
It addresses opportunities for coordination in four basic areas related to
achieving the toxicant testing goals, including: identification of toxicity
pathways; selection of chemicals for testing; analysis and interpretation
of data; and outreach to scientific and regulatory communities. The
collective budget is yet to be determined. For details, visit http://www.genome.gov/pressDisplay.cfm?photoID=20030
or http://www.nih.gov or http://www.epa.gov/ncct.
CDER Slated for 283 New Staff in Proposed Fiscal
2009 Budget
The president's fiscal 2009 budget request for the FDA includes an estimated
526 new full-time equivalent employees, 283 for Center for Drug Evaluation
and Research (CDER) alone. Twenty-six new employees would be in the Center
for Biologics Evaluation and Research (CBER), 161 would be in the Office of
Regulatory Affairs (ORA) and five would be in the FDA Headquarters and the
Office of the Commissioner, according to the FDA.
CBER requested an additional $5.6 million in user fees and 18 full-time equivalent
employees for its human drug review program, three of whom would review direct-to-consumer
(DTC) television advertisements. The fiscal 2009 is a 5.7 percent increase
- approximately $2.26 million more than the $2.27 billion the FDA received
for fiscal 2008. The FDA is requesting $15 million and 34 full-time equivalent
employees for generic drug application reviews. In fiscal 2009, CDER expects
to increase its abbreviated new drug application actions and maintain its
new generic drug approval performance from fiscal 2007, when it approved 682
new generic drugs.
Congressional committees have begun hearings to discuss the proposed budget.
The House Energy and Commerce Committee has scheduled a hearing on HHS' fiscal
2009 budget proposal Feb. 14. For details, visit http://www.fda.gov.
Lawmakers Push for Biosimilar Legislation in
New Healthcare Initiative
The effort to give the FDA authority to approve follow-on biologics, which
had slow progress in Congress in 2007, may be picking up momentum as part
of a new initiative to improve access to affordable healthcare. Reps. Allyson
Schwartz (D-Pa.), Lois Capps (D-Calif.) and Jason Altmire (D-Pa.), all members
of the New Democrat Coalition, are leading the effort, which also includes
implementing eprescribing. The lawmakers are involved with the three House
committees primarily in charge of healthcare policy — including the
Energy and Commerce Committee, where follow-on biologics legislation has been
introduced. House lawmakers are considering multiple bills, including Rep.
Henry Waxman’s (D-Calif.) Access to Life-Saving Medicine Act, H.R. 1038,
which would let the FDA approve biosimilars as interchangeable with the reference
biologics, and Rep. Jay Inslee’s (D-Wash.) Patient Protection and Innovative
Biologic Medicines Act, H.R. 1956, which would not let biosimilars be deemed
interchangeable. A spokesperson for Energy and Commerce Committee Chairman
John Dingell (D-Mich.) said the committee has not yet finalized its agenda
for this session but noted that the committee is expected to address the issue
of biosimilars in the near future. Similarly, a spokesperson for Rep. Frank
Pallone (D-N.J.), chairman of the House Health Subcommittee, said Pallone
continues to work with committee members to reach a consensus on follow-on
biologics legislation. For details, visit http://www.fda.gov.
President’s Request Would Give FDA $2.4
Billion in Fiscal 2009
The Bush administration is proposing a 5.7 percent increase in the FDA’s
budget for fiscal 2009 to improve drug safety, allow user fees to fund a direct-to-consumer
(DTC) advertisement review program and fund the creation of an approval pathway
for follow-on biologics. The request would bring the agency’s total
budget to $2.4 billion, including $1.77 billion in direct budget authorities
and $628 million in user fees. Most of the user fees would come from prescription
drug user fees reauthorized under the FDA Amendments Act (FDAAA), the agency
said. The request includes $35 million for drug safety activities already
included in FDAAA, $10 million more than in fiscal 2008. The proposed budget
raises again the issue of collecting user fees to fund the agency’s
voluntary DTC advertisement review program. The program was created under
FDAAA last year, but the FDA could not start it because Congress did not allocate
the user fees in the agency’s appropriations bill. Instead, Congress
directly appropriated approximately $6.25 million for the review program for
fiscal 2008. The funding increases in the budget would help modernize drug
safety, speed generic drug approvals and provide cost-of-living increases
to FDA employees. The FDA said it will expand its work force with 526 additional
full-time equivalent staff members in fiscal 2009. In addition, the request
proposes a pathway for approving follow-on biologics that would be funded
through user fees, President Bush said. The FDA could not give more details
on the proposal, but Chief Operating Officer John Dyer said the agency would
work with Congress to create legislation allowing a follow-on biologics approval
pathway. Several lawmakers recently added follow-on biologics legislation
to a new healthcare initiative, giving the issue added momentum in Congress
this year. For details, visit http://www.fda.gov.
FDA Posts Comments on Bioequivalence Guidelines
Online
The FDA has updated its draft product-specific bioequivalence guidelines in
response to public comments posted on its dockets page. The guidelines were
made available last year in conjunction with the draft guidance “Bioequivalence
Recommendations for Specific Products.” The agency is aiming to develop
a full set of online product-specific bioequivalence recommendations that
generic drug applicants can use instead of having to submit individual requests
for assistance in bioequivalence study design. The agency said the guidelines
would be posted on the CDER website first as drafts, and it would accept comments
and eventually publish final versions. The FDA’s draft recommendations
for bioequivalence testing are available at http://www.fda.gov/cder/guidance/bioequivalence/default.htm#E.
The agency’s original announcement about the bioequivalence guidelines,
and the comments that have been submitted, can be found at http://www.fda.gov/OHRMS/DOCKETS/dockets/07d0168/07d0168.html.
EC Launches Unannounced Inspections in Pharmaceutical
Sector
The European Commission (EC) has begun an inquiry into the state of competition
in the pharmaceutical sector — including surprise inspections of drug
company offices — to discover why the number of novel medicines reaching
the market has decreased and why generic market entry is being delayed. The
commission says it is responding to indications that competition in European
pharmaceutical markets may be lacking. The EC plans to examine whether agreements
between pharmaceutical companies, such as patent litigation settlements, may
violate European laws on restrictive business practices. This marks the first
time the commission has begun a sector inquiry with unannounced inspections,
the EC said. Pfizer, sanofi-aventis and Sandoz confirmed they are among the
companies that have received visits from EC officials and said they are cooperating
with the investigation. The EC emphasized that the companies were not chosen
based on specific evidence of wrongdoing. Rather, the inspections are simply
the starting point of a broader inquiry. The commission said it expects to
release an interim report on the findings this fall, with final results planned
for the spring of 2009. For details, visit http://ec.europa.eu/index_en.htm.
Senator Brown Requests Look at FDA Fast Track
Designation
Sen. Sherrod Brown (D-Ohio) is asking the Congressional Research Service (CRS)
to look into the effectiveness of the FDA’s fast track designation for
drug applications. The designation is used to expedite the development and
review of drugs and biologics intended to treat serious conditions and address
unmet medical needs. Brown requested the information to determine the designation’s
effects on drug applications, a spokeswoman said. Brown asked the CRS to provide
a detailed comparison of fast track, priority and standard review procedures.
He requested a definition of each process and the reasons why a company may
choose one procedure over another. He also requested a chart indicating outcomes
for each procedure, such as the review time frame and approval results. The
CRS should indicate other factors that may prompt a drug manufacturer to request
a certain type of review. According to the FDA, the Center for Biologics Evaluation
and Research received 196 Fast Track designation requests between March 1,
1998, and Dec. 31, 2007, and granted 124. For details, visit http://www.fda.gov.
U.S. Planning to Set Up FDA Office
in India
As part of the steps being taken by the United States to ensure the quality
of the food and drug being imported by it, the U.S. is planning to open an
office of its Food and Drug Administration (FDA) in India.
US Health and Human Service Secretary Michael O.Leavitt and Food and Drug
Administration Commissioner Andrew Von Eschenbach went to India to make an
on-the-spot assessment of manufacturing practices existing at drugs and the
food processing units. They met Prime Minister Manmohan Singh and Finance
Minister P.Chidambaram to discuss the possibility of opening the office in
the country. The US has already opened an office of the FDA in China from
where it imports large quantities of food articles. The US imports food and
drug worth $ 2 trillion from eight lakh manufacturers across the world. From
India, the US buys these goods worth $ 56 million. Talking to reporters in
Kochi after visiting the unit of AVT Mccromick Ingredients, a leading supplier
of spices and its value-added products to the US, Leavitt said that he had
initiated this mission since there was a serious apprehension among the consumers
in his country on the quality of food and drugs being imported. "We are
trying to ensure the quality in the entire system of supply chain, right from
the seed to the last outlet from where people buy the goods,” he said.
He also said that the US wanted transparency in the whole process so that
the consumer in the country could know the origin of the goods. Kerala is
a major supplier of spices to the US and the majority of spices exporters
adhere to the standard fixed by the US. .For details, visit http://www.fda.gov.
Patni
Acquires Life Sciences Services Company Taratec for $27 million
Patni Computer Systems, a global IT services provider, has announced the acquisition
of Bridgewater, N.J.-based Taratec Development Corp. through Patni Computer
Systems Inc. a wholly owned subsidiary of the Company, for an aggregate price
of $27.2 million in cash including contingent consideration. With more than
$20m in annual revenues, Taratec is a leading consulting company in the life
sciences industry providing integrated business, information technology, and
regulatory compliance products and services. This acquisition is in line with
Patni's strategy of enhancing its market specific services and provides additional
capability to support the growing and diverse requirements of the Life Sciences
market, from pharmacovigilance to demand-driven supply chains. Patni can now
offer a global delivery model that provides end-to-end capabilities complete
with established, life science expertise in specific, high-demand areas. For
details, visit http://www.patni.com.
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