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•
Waters Corporation Announces Agreement
to Purchase NuGenesis Technologies Corporation
• LabVantage Releases LabVantage
Sapphire 3.2 with Evergreen Studio Web Page Designer
• SGS Selects Comlabs Systems' CCLAS EL LIMS
for Global Rollout
• STARLIMS and Interface Engineering Offer a Global
LIMS for South Korea
• Core STARLIMS Functionality Published as
Web Services
• Quest Pharmaceutical Services Implements InnaPhase
Corporation's Watson LIMS
• Thermo Introduces Instrument Control Development Capability
for its Atlas CDS
• Siemens Releases New Operator Station for Legacy
TI Process Control Systems
• InnaPhase Introduces New
Reporting and Data Mining Tool
• Customers Confirm Matrix LIMS a Success
• Accelerated Technology Laboratories to Exhibit
and Present 12 Technical Papers at Pittcon 2004
• NWA and ASECO Partner to Provide Integrated
Quality Information System
• Agilent Technologies
Introduces Industry-First Features in Pharmaceutical Software for Drug Quality
Assurance and Control
• Industry Partnership Introduces New Interfacing Technology
to the Dissolution Lab
• Labtronics' LimsLinkCDS Connects with
TotalChrom
• Caliper Life Sciences Unveils LabChip 3000 Drug
Discovery System
• Intercon Introduces DynaSQL To Improve Access to Information
• IDC Launches New Subsidiary, Life Science Insights,
to Enable Fact-Based Decision Making for the Life Science Industry
• SAP Financial Results Provide Insight to Market Trends
• Bob Voelkner Joins InnaPhase
Corporation
• LIMS Expert Michael Tyszkiewicz Joins InnaPhase
Corporation
• USDA Announces First Steps To Update Biotechnology
Regulations
• Clinical,
Medical Guidelines to be 2004 Priority for FDA
• In Search for New CMS Chief, McClellan Could Be in the
Running
• Rules for Parallel Drug Trade Clarified
by E.U.
• FDA Guidance on Pharmacogenomics Datas Should be
More Explicit
• FDA Guidance Issued Requesting More Information
on Drug Studies
• FDA’S Call for More Generic Competition
Raises Issues for E.U. and Canada
• ERP Vendors Are Encroaching on Supply Chain
Execution Market Dynamics
• InnaPhase
Corporation Announces Global Release of Newton LIMS
• Blaze
Systems Releases BlazeLIMS H2O
• PerkinElmer Offers
Order Discounts Online
• Applied
Biosystems Releases GeneMapper Software v3.5 for Accurate Allele Calling
• National
Research Council of Canada (NRCC) Picks Biotracker from Ocimum Biosolutions
• ABB Delivers Industrial IT Solutions for New
Production Line of Qassim Cement Company in Saudi Arabia
• Indian Pharmaceuticals File Most DMFs in
Third Quarter 2003
• ARC's New Supply Chain Execution Market Study - Suppliers
Face Encroachments from ERP Vendors
• LabVIEW 7 Express Wins Control Engineering
Editor’s Choice Award for Software
• L.I.M.S.
(USA) Inc. Announces Corporate Name Change to
STARLIMS Corporation
• LABLynx Introduces openLIMS
• Accelerated Technology Laboratories
Releases Sample Master XP LIMS
• LabVantage Sapphire 3.2 to Ship Early 2004
• Applied Biosystems Offers New BioMonitor
Service Remote Management Tool
• Southwest Missouri State University Connects
with Labtronics' Collect XL
• E.U.
Tells Member States to Loosen Importation Laws
• E.U.
Drug Law to Make Europe Pharma More Competitive
Thermo
Introduces Instrument Control Development Capability for its Atlas CDS
Thermo Electron Corporation has introduced completely independent instrument
control for its Atlas Chromatography Data System (CDS), which allows Atlas
users to more quickly incorporate new LC and GC technology into the automated
laboratory environment. Instrument control is an essential requirement for
chromatographers, yet CDS vendors are often unable to keep up with the development
of new and upgraded instrumentation. The Device Development Kit (DDK) provides
instrument vendors, customers and Thermo’s own Atlas development team
with the tools to control new instruments, integrating seamlessly with Atlas
and offering an intuitive user interface that minimizes training requirements.
New features are available with the recently released Atlas version 2003 R2,
including direct import of ChromQuest data files, and enhanced functionality
for managing Thermo instruments – including the Finnigan Surveyor LC
and SpectraSYSTEM LC. Atlas also now offers intelligent run control, taking
action on system suitability (pass/fail). For details, visit http://www.thermo.com/informatics.
Siemens Releases New Operator Station for Legacy
TI Process Control Systems
Siemens Energy & Automation has released PCS 7/505 OS, a PCS 7 operator
station enhancement for its legacy TI process control systems. According to
the company, benefits of the enhancement include reduced time-to-market, secured
investments, and increased productivity. In addition they explained that users
will gain better system performance and additional features while leveraging
investments in existing SIMATIC 505 controller, control algorithms and logic,
IO and field wiring. For details, visit http://www.siemens.com.
InnaPhase Introduces New Reporting and Data Mining
Tool
With the recent global
release of their Newton LIMS, a solution for pharmaceutical development, quality
control,
stability and environmental monitoring, InnaPhase also introduced Retriever,
a powerful reporting and data mining tool that is part of Newton and Galileo
LIMS. Retriever is also fully compatible with LabManager and allows users
to extract quality information from LIMS data enabling users to run their
business more efficiently. It introduces new InnaPhase technology that provides
an added layer of security and practical flexibility while enabling web reporting.
Users can also develop datatree views of LabManager data that until now has
not been possible. InnaPhase is offering every LabManager LIMS customer a
no-charge copy of Retriever. For details, visit http://www.innaphase.com.
Customers Confirm Matrix LIMS a Success
"Matrix LIMS is one of the most functional, highly reliable and well
supported laboratory management software solutions available today."
Those are the findings of a recent customer survey conducted by leading UK
software developer, Autoscribe. Twenty nine Matrix LIMS customers from the
UK and North America responded to the survey, carried out in Autumn 2003.
Autoscribe received a positive scoring of 81 per cent on the question of product
functionality, 83 per cent for product reliability, 94 per cent for support
response, and 89 per cent for support accuracy. Twenty one customers also
said that they would buy Matrix again. It is standard practice for Autoscribe
to canvass customer opinion on a regular basis. This helps the company understand
the expectations of its customers and helps focus efforts towards the product
and service developments of the future. Matrix LIMS is the company’s
primary software solution. Key features include advanced functionality and
high configurability to suit a wide range of applications. Customer support
is further enhanced through an annual
LIMS user meeting, organised by Autoscribe to update customers on current
developments. Autoscribe is expanding further into new market areas with a
new range of management software solutions such as Training Manager, and Feedback
(customer complaints manager). To take account of this growth and demand,
the company recently relocated to new larger premises in Riseley, Berkshire.
For details, visit http://www.autoscribe.co.uk.
Accelerated Technology Laboratories to
Exhibit and Present 12 Technical Papers at Pittcon 2004
Accelerated Technology Laboratories, Inc. (ATL), a supplier of LIMS will exhibit
new features in their SampleMaster Pro XP and ScreenIT Pro LIMS at Pittcon
2004. The annual conference is scheduled for March 7-12, 2004 in Chicago,
IL. Sample Master Pro XP LIMS has a new look and feel patterned after Microsoft’s
XP products. New features include: Time Tracking and Customer Relationship
Management modules, new EDD formats, integrated e-mailing and faxing, expanded
capability for instrument integration and the ability to include GPS coordinates
and multiple locations for a sampling site, with a graphical interface. ScreenIT
Pro LIMS is a user configurable LIMS that is ideal for raw materials and manufacturing
laboratories. New features include: enhanced Workload, Production and Backlog
Reports, Certificates of Analysis, SPC Charts and multiple level specifications
with visual quality alerts and e-mail notification. There is also multi-lingual
support. For details, visit ATL at Booth #657 during Pittcon or go to http://www.atlab.com.
NWA and ASECO Partner to Provide Integrated Quality
Information System
Northwest Analytical (NWA), a provider of statistical process control (SPC)
software, and ASECO Integrated Systems, a manufacturing consulting and system
integration firm, have announced a partnership combining NWA's off-the-shelf
SPC solutions with a set of integration tools provided by ASECO. According
to the companies, the NWA/ASECO solution is tailored to meet individual customer
needs, scaled to meet future requirements, and is easily integrated with other
information systems. The database design is optimized for NWA products, minimizing
configuration, training, and support requirements. They are targetting corporations
with multi-plant operations requiring scalable, reusable software. This partnership
places both companies in a strong position to solve the needs of performance-driven
manufacturing organizations that require up-to-date process information to
operate more effectively. For details, visit http://www.nwasoft.com.
Agilent
Technologies Introduces Industry-First Features in Pharmaceutical Software
for Drug Quality Assurance and Control
Agilent Technologies Inc. has introduced a new version of software for the
pharmaceutical quality assurance/quality control (QA/QC) environment. The
Agilent Cerity Networked Data System for Pharmaceutical QA/QC is the first
system of its kind to provide automated 3-D analysis, generic instrument control
and a spreadsheet-style custom calculator. This functionality, combined with
Cerity's advanced architecture, provides
significant improvements in productivity, cost reduction and compliance support
for IT and laboratory managers.
"The new Cerity enables pharmaceutical companies to evaluate and track
the quality of raw and manufactured chemical compounds with the highest efficiency
and productivity," said Chris van Ingen, senior vice president and general
manager of Agilent's Life Sciences and Chemical Analysis business. "We
have coupled key analytical functionality with our compliance expertise and
an industry-leading architecture to resolve many traditional problems for
both the pharmaceutical IT and laboratory manager. For example, customers
can use one computer with Cerity software to acquire and track data from up
to 30 analytical instruments, a tremendous increase in efficiency from the
usual 1:4 ratio." The new automated 3-D analysis feature enables an automated
compound purity evaluation and confirmation of compound identity based on
retention time, response and wavelength. Automation of this process, performed
daily in the analytical laboratory, reduces compound
confirmation workflow time from hours to minutes. A custom calculator automatically
performs all integral and
mathematic calculations required in standard operating procedures. A new generic
instrument control module enables laboratories to control non-Agilent chromatographic
instrumentation with level-3 instrument control. For details, visit http://www.agilent.com.
Industry Partnership Introduces New Interfacing
Technology to the Dissolution Lab
Labtronics Inc. has announced that Hanson Research has become the newest Platinum
Level member of their Instrument Manufacturers Partnership Program. This plateau
has been reached with the development and release of Bill, a new Dissolution
Data System (DDS) that incorporates the embedded power of Labtronics' LimsLink
LIMS interfacing solution. Labtronics' Partnership Program provides a means
for instrument manufacturers to deliver LIMS interfacing as part of their
total instrument package. Platinum Level Partners team up with Labtronics
to embed LIMS interfacing directly into their products. A Platinum Level solution
gives analysts the ability to connect directly to their LIMS through a menu
item in their instrument software. The analyst can then select samples and
worklists and transfer these to the instrument software in one simple automated
process. Reporting results to LIMS is transparent, using the software's print
report function. For details, visit http://www.labtronnics.com.
Labtronics' LimsLinkCDS Connects with TotalChrom
Labtronics Inc has introduced a new LimsLinkCDS interface that provides
a direct and transparent connection
between TotalChrom Chromatography Data Systems and any LIMS. LimsLinkCDS adds
new menu items to TotalChrom that allow the analyst to access the LIMS from
within the CDS application. Access to the menus is controlled by the TotalChrom
security system, eliminating the need for a separate logon to use the interface.
LIMS worklists can be selected from directly within TotalChrom. The analyst
can view and edit the worklist to ensure it is complete and accurate before
it is automatically expanded to include standards, check samples and replicates.
The final TotalChrom sequence can be approved by the analyst before being
transferred directly to the CDS. Configuration of the LimsLinkCDS-TotalChrom
interface is quick and easy using drop-down menus and check-boxes that use
TotalChrom terminology. Each analyst or group of analysts can store their
own interfacing configurations. LimsLinkCDS can automatically pre-define paths
and names for sequences and results, reducing
the amount of analyst interaction at runtime. This version of LimsLinkCDS
also gives analysts the ability to display TotalChrom chromatograms from inside
their LIMS, allowing for faster more efficient approval of sample results.
For details, visit http://www.labtronics.com.
Caliper Life Sciences Unveils LabChip 3000 Drug Discovery
System
Caliper Life Sciences, Inc. has unveiled the LabChip 3000 Drug Discovery System,
the latest addition to the company's suite of LabChip Microfluidic Systems.
The automated system performs unattended biochemical and cell-based screening
assays using Caliper's microfluidic chips. "The LabChip 3000 instrument
platform is the first major product introduction since Zymark Corp. and Caliper
Technologies combined to create Caliper Life Sciences," stated Kevin
Hrusovsky, President and Chief Executive Officer of Caliper Life Sciences.
"We have successfully merged Zymark's knowledge of automation liquid
handling and discovery applications with Caliper's expertise in microfluidics
to create a system that we expect will be rapidly recognized as the highest-quality
approach to screening candidate drug compounds against biological targets.
Liquid handling and automation have already revolutionized the sector and
advanced systems such as LabChip 3000 Drug Discovery System allow for an even
higher level of discovery capability and efficiency." The LabChip 3000
Drug Discovery System is a significantly updated and improved version of the
Caliper 250 system. Significant user input led to redesigns of the optical,
plate handling and chip interface systems, resulting in improved reliability
and reduced instrument setup time. In addition, the LabChip 3000 Drug Discovery
System is designed on a modular platform, allowing users the opportunity to
evaluate the remarkable benefits of microfluidics in their lab without investing
a large amount of capital. For details, visit http://www.caliperlifesciences.com.
Intercon Introduces DynaSQL To Improve Access to
Information
Intercon has released DynaSQL, a Non-Hierarchical data indexing technology,
for free public review. Non-Hierarchical access to information is fundamentally
different from currently applied access methods. Current Hierarchical access
requires entry of search-key sequentially; single missing, transposed or wrong
character result in missed record. Non-Hierarchical data-access reduces data-entry
restrictions. A simple example for Non-hierarchical access is a search by
ZIP code, instantly retrieving records, ranked and sorted by spatial proximity.
Intercon Systems, a closely held Israeli company, provides US' Pharmaceuticals
companies with Business Intelligence services. Among Intercon's clients were
McKesson, Bristol Mayer Squeeb, GlaxoSmithKline, Novartis, Aventis, Rite Aid
and others. Recently, Intercon applied its proprietary technologies to empower
standard, 'everyday' application. Data Cleansing, Data Refining, Record Matching,
De-duplication, Information Retrieval, Data Mining and Graphical Statistical
Analysis - are methodologies made available to Windows Desktop users, within
single integrated system - DataSet V. To introduce and publicly promote some
of its technologies, Intercon posted DataSet V Beta, free, for public preview
and experimentation, downloadable from Intercon's web site at http://www.ds-dataset.com.
IDC
Launches New Subsidiary, Life Science Insights, to Enable Fact-Based Decision
Making for the Life Science Industry
IDC has launched Life Science Insights, a new independent research and advisory
practice focused on providing life science companies with market and technology
intelligence, commentary and analysis, to help support business decisions.
Life Science Insights will work with pharmaceutical and biotech companies,
life science tools and technology vendors, IT vendors and consultant and professional
services companies, and will provide market sizing and up to date market intelligence.
These services will be provided by Life Science Insights’ analysts,
each with specific technology and market expertise. Life Science Insights
was created to address the explosion of biological data that needs to be analyzed,
managed, stored and transformed from the growing number of new opportunities
in the fields of proteomics, systems biology and other emerging scientific
areas, such as E-diaries and nanotechnology. These new science and technology
endeavors are accelerating the field of bioinformatics or bio-IT and will
play a pivotal role in the next wave of progress for biotechnology and pharmaceutical
companies, diagnostic firms and clinical research organizations. Life Science
Insights will provide research and analysis that enables these vendors and
end users to optimize their business strategies and investments in markets
and technologies. In addition, IT vendors need to better comprehend the evolving
requirements of life science companies. However, relatively few IT suppliers
have implemented effective strategies for meeting the needs of the unique
life science end user audience. To stay ahead of important issues and trends,
they will need special knowledge of the biological and growing IT requirements
to sell successfully to companies in the early stages of drug discovery and
development. IDC is a global market intelligence and advisory firm in the
information technology and telecommunications industries with a strong reputation
built on reliability of market sizing and forecasting and an excellent forward
view of market developments.For details, visit http://www.life-science-insights.com.
SAP Financial Results Provide Insight to Market
Trends
The US remains a tough market for SAP, but software license sales are picking
up. Although SAP's US revenues plummeted 12% to Euro 1.7 billion, software
revenues gained 3.4% to Euro 491 million, mainly due to a good third quarter
gain. This gain was not repeated in the fourth quarter. EMEA revenues remain
resilient with only 2% lower at Euro 3.9 billion, but increasingly of concern
is that 10% of software licenses evaporated, down to Euro 1.2 billion. Japan
remains depressed, with revenues sinking 9.50% to Euro 438 million, and software
revenues submerging 10.9% to Euro 139 million. Fourth quarter software revenues
are down 29%. Reflecting the trend of moving manufacturing from developed
countries such as US, Europe, and Japan to the Asia Pacific region, revenues
in Asia Pacific outside Japan climbed 5.6% and license revenues grew 14%.
Although this represents the one bright spot, at Euro 136 million, revenues
are still tiny given the region’s population. Perhaps this is because
SAP solutions are fairly expensive for this region. In terms of application
license revenues, SCM gained 3% to Euro 477 million and is now greater than
CRM revenues, which were down 7% to Euro 440 million. This suggests that in
tough times companies invest in operational excellence, rather than market
expanding, customer intimacy initiatives. PLM withered 7% to Euro 156 million,
and SAP traditional products including financials and HR, perhaps reflecting
a saturated market, dropped 14% to Euro 801 million. The new products, however,
did well, Business intelligence, portals, and SRM gained 5% to Euro 273 million.
Software maintenance revenues are greater than new product revenues, having
expanded 6% to Euro 2.5 billion, and comprises one third of SAP’s total
revenues. With this volume of maintainance revenues, it is no surprise that
SAP’s net income and earning per share more than doubled in 2003. Although
SAP trimmed marketing and administration spending, R&D expense did increase,
and at Euro 994 million is larger than most of its competitors total revenues,
with the exception of Oracle and Peoplesoft. Currency fluctuations impacted
SAP's 2003 results. Given market conditions and the negative 17% change in
the $/Euro rate, and the negative 9% change in the Yen/Euro rate, the fact
that SAP’s revenues fell 5% to Euro 7.02 billion, and software revenues
fell 6% to Euro 2.14 billion isn’t a bad performance compared to their
competitors. For 2004, SAP is fairly optimistic. They see a strong pipeline
and expect software revenues to increase 10% and net income to grow some 20%.
For details, visit http://www.sap.com.
Bob Voelkner Joins InnaPhase Corporation
Formerly the Director of Worldwide Sales and Marketing for the Laboratory
Automation Operations (LAO) of Beckman Coulter until December, 2000, Bob Voelkner
has rejoined the LAO team as the Director of Business Development for the
InnaPhase Corporation. Voelkner started with Beckman in the early 80’s
as a developer for LabManager and later helped develop PeakPro. He then moved
into field sales and during his last four years at Beckman Coulter, managed
all marketing and sales activities worldwide. After Beckman, he joined Thermo
Electron as the Vice President of Sales for Thermo’s Informatics division.
His responsibilities at InnaPhase range from developing new markets in different
parts of the world to helping support the business needs of LabManager and
PeakPro customers. For details, visit http://www.innaphase.com.
LIMS
Expert Michael Tyszkiewicz Joins InnaPhase Corporation
InnaPhase Corporation has announced the addition of Michael Tyszkiewicz, formerly
of Applied Biosystems, as director of product development. Tyszkiewicz's primary
focus at InnaPhase will be to guide product
development strategies in preparation for a new product release to be previewed
at the 2004 Pittsburgh Conference. With over 30 years experience in laboratories,
he has focused for 20 years on LIMS solutions, including implementation, system
management, sales and product development. Previously, Tyszkiewicz managed
professional services at Applied Biosystems, developing methodology and project
management for the delivery of successfully validated LIMS solutions in the
pharmaceutical industry. He studied chemistry at Rutgers University and information
technology at Louisiana State University. For details, visit http://www.innaphase.com.
USDA Announces First Steps To Update Biotechnology
Regulations
Agriculture Secretary Ann M. Veneman has announced USDA's intention to update
and strengthen its biotechnology regulations for the importation, interstate
movement and environmental release of certain genetically engineered (GE)
organisms. "The science of biotechnology is continually evolving, so
we must ensure that our regulatory framework remains robust by anticipating
and keeping pace with those changes," Veneman said. "A comprehensive
environmental impact statement is the critical first step in the process.
Our regulatory system must be both rigorous and flexible and based on sound
science principles and mitigation of risks." USDA's Animal and Plant
Health Inspection Service (APHIS) will prepare an environmental impact statement
evaluating its biotechnology regulations and several possible regulation changes,
including the development of a multi-tiered, risk-based permitting system
to replace the current permit/notification system, along with enhancements
to the deregulation process to provide flexibility for long term monitoring.
Any proposed changes to the regulations will be science and risk-based. USDA's
APHIS has regulated agriculture biotechnology since 1987, ensuring the safe
field testing of more than 10,000 GE organisms and overseeing the deregulation
of more than 60 GE products. Over the past several years, the Bush Administration
has taken steps to strengthen USDA's biotechnology regulations through the
creation of the biotechnology regulatory services program, enhancements to
its permitting system for plant-made pharmaceuticals and industrials and the
development of a compliance and enforcement unit to ensure adherence to the
agency's regulations. For details, visit http://www.aphis.usda.gov.
Clinical, Medical Guidelines to be 2004 Priority for FDA
The FDA is going to shift its focus this year from extensive guidances on
International Conference on Harmonisation (ICH) initiatives to clinical/medical
guidances and procedural issues, according to an agenda released. Of the 57
guidances released by the FDA in 2003, 14 were related to ICH issues, the
report said. For 2004, the agency plans to focus more than one-third of its
guidances (24 out of a proposed 66) on clinical/medical issues. Proposed topics
include guidances on the clinical evaluation of neuropathic pain drugs, analgesics
and hormone replacement therapy to name a few. Labeling guidances rank as
the second-largest category of guidances expected for release in 2004 with
seven. Topics include content and format of clinical pharmacology sections,
dosage administration sections, and warnings and precautions sections of Rx
drugs; drug-naming issues; pregnancy labeling revisions; and new content and
format requirements. The agency also intends to continue focusing on guidances
covering procedural issues and clinical/pharmacology issues and to release
guidances on topics largely ignored during 2003. For details, visit http://www.fda.gov.
In Search for New CMS Chief, McClellan Could Be in the Running
FDA Commissioner Mark McClellan could be in the running to lead the Centers
for Medicare & Medicaid Services (CMS) — a critical position in
the Bush administration’s efforts to institute far-reaching changes
in the Medicare program, which includes prescription drug benefits approved
by Congress last year. Rumors are circulating in Washington, D.C., that HHS
Secretary Tommy Thompson is touting McClellan for the job. An HHS spokesman
declined to comment on the story, as did the FDA’s press office.
Rules for Parallel Drug Trade Clarified by E.U.
The European Commission (E.C.) has clarified its rules for parallel drug trading
— a practice that drugmakers say costs the industry $5.6 billion in
annual sales. In an official communication to European Union (E.U.) member
states, the E.C. recently updated its 1982 parallel trade policy, emphasizing
the practice is perfectly legal and is guaranteed under the E.C.’s treaty
on free movement of goods within the E.U.’s internal market. Parallel
trade involves wholesalers buying drugs in E.U. states where the government-set
price is low and selling them at a discount in countries where the price is
higher. The E.C. document aims to help businesses and governments that engage
in parallel trade take full advantage of the E.U. market. For details, visit
http://www.fda.gov.
FDA Guidance on Pharmacogenomics Datas Should
be More Explicit
The FDA’s draft guidance on pharmacogenomics that calls for voluntary
genomic data submissions (VGDSs) needs more detail on how drugmakers’
proprietary interests would be protected, Eli Lilly told the agency in comments
recently. The agency wants the data so it can build an internal database to
better address product submissions and learn more about how genetics affect
pharmaceutical use in patients. The premise of the guidance, released Nov.
4, 2003, is to enable the FDA to stay ahead of the curve in pharmacogenomics
as a regulatory framework evolves. Pharmacogenomics holds the potential for
the manufacture of personalized drugs tailored to patients with specific genetic
makeups, though such an outcome is likely to take decades.Among concerns expressed
by Lilly were how the agency would ultimately use the collected genomic data
and its possible impact on drug submissions, as well as the role of the Interdisciplinary
Pharmacogenomic Review Group (IPRG) to be formed within the agency and how
it will interact with drugmakers. “Clarification on how the IPRG will
communicate with each component of FDA, including the review divisions, on
decisions, cross-learning and policymaking is needed,” Lilly said. To
see “Guidance for Industry: Pharmacogenomic Data Submissions”
as published in the Nov. 4, 2003, Federal Register, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0497-gdl0001.pdf.
FDA Guidance Issued Requesting More Information
on Drug Studies
The FDA wants to ensure that drugmakers and other sponsors of clinical trials
for new drugs that treat serious or life-threatening diseases provide more
information about the trials to patients who may not meet the study’s
eligibility criteria.In a draft guidance, the agency offers suggestions for
implementing a provision of the 2002 Best Pharmaceuticals for Children Act
(BPCA), which requires a sponsor of an investigational new drug (IND) study
to respond to requests for access to the therapy outside of the clinical trial
setting. Under BPCA, sponsors of IND studies for serious or life-threatening
illnesses must provide a description of whether, and through what procedure,
they will respond to requests for clinical protocol exceptions, and for single-patient
and expanded-access use of the investigational drug, particularly in children.
Other general information also must be submitted, including the purpose of
each experimental drug, patient eligibility criteria for participation in
the trial, adescription of the location of clinical trial sites, and a point
of contact for those wanting to enroll in the trial. The Jan. 27 draft guidance
can be viewed at http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0014-gdl0001.pdf.
FDA’S Call for More Generic Competition
Raises Issues for E.U. and Canada
Generic drug advocates in Europe and Canada say they face obstacles to increasing
generic competition in their markets — something FDA Commissioner Mark
McClellan has recently argued is necessary as part of a broader solution to
lowering drug costs. Both Canada and the European Union (E.U.) are considering
proposals to increase competition, but both must overcome pricing schemes
that are fundamentally different than those in the U.S., advocates say. The
plan envisioned for the E.U. could boost the bottom lines of both generics
and brands, but it is at least five years away, said Greg Perry, director
general of the European Generic Medicines Association. The European Commission
is considering restructuring the E.U.’s pricing scheme, which provides
a better financial return for brands in the first year of the life cycle through
freer pricing, Perry said. “But this must be compensated by strong generic
competition when the patent expires,” he added. For details, visit http://www.fda.gov.
ERP Vendors Are Encroaching on Supply Chain Execution
Market Dynamics
According to a new study by ARC Research, ERP vendors are encroaching on Supply
Chain Execution (SCE) market dynamics. The SCE market encompasses a variety
of Logistic and Production Management applications. Not all application areas
are growing equally. Further, certain categories of vendors are gaining ground.
Enterprise Resource Planning (ERP) suppliers are steadily gaining market share
at the expense of the best of breed vendors. For details, visit http://www.arcweb.com/Newsmag/ent/sce012204.asp.
InnaPhase
Corporation Announces Global Release of Newton LIMS
InnaPhase
Corporation, a leading provider of LIMS solutions for the life sciences industry,
has announced the global release of Newton LIMS, a solution for pharmaceutical
development, quality control, stability and
environmental monitoring. This is the third technology solution within the
Pharma LIMS Suite which also includes Watson LIMS for bioanalysis and Galileo
LIMS for in-vitro testing. "The world's major pharmaceutical companies
have relied on our Watson LIMS solution for many years for their bioanalytical
work," said Dr. Jo Webber, President and CEO, InnaPhase Corporation.
"InnaPhase is tremendously excited to now provide our customers with
a dedicated LIMS solution to take them through the analytical development
phases and into manufacturing quality control and stability. Built upon a
multi-tier architecture using robust, industry wide accepted technologies
such as XML and Web Services to address pharmaceutical business needs, Newton
will provide scalability, reliability, and legacy compatibility; thereby decreasing
total-cost-of-ownership for pharmaceutical organizations." InnaPhase
will host an invitation-only product launch for both the Newton LIMS and Galileo
LIMS solutions on January 26, 2004 at the National Constitution Center in
Philadelphia, PA. For more information on this event, please contact rsvp@innaphase.com.
For product details, visit http://www.innaphase.com.
Blaze Systems Releases BlazeLIMS H2O
Blaze Systems Corporation has released BlazeLIMS H2O, their latest LIMS offering.
BlazeLIMS H2O includes all the features of BlazeLIMS Enterprise Plus and is
pre-configured and ready to use for the water treatment laboratory. BlazeLIMS
Enterprise Plus is a comprehensive and flexible LIMS designed to improve laboratory
productivity through a complete suite of solutions for laboratory software
automation. The new solutionis
priced to be affordable to the municipal water treatment market. For
details, and to request a download demo, visit http://www.blazesystems.com.
PerkinElmer Offers Order Discounts Online
PerkinElmer is running a promotion from now until March 31, that provides
5% off Web orders or $500 or greater and1 0% off Web orders of $1,500 or greater.
These discounts are in addition to current pricing and can only be used for
products available for purchase on the PerkinElmer Life and Analytical Sciences
Website. The promotion is only open to customers in the U.S., Canada, and
Puerto Rico. All registered
users of the PerkinElmer Life and Analytical Sciences Website who meet eligibility
requirements will also be entered into three monthly drawings for an Apple
iPod - a digital music player that holds up to 5,000 songs! Available products
include: Quartz Torches, Nebulizers & Spray Chambers; DSC Aluminum Sample
Pans; Microplates, Filters, Film, Membranes; Liquid Scintillation Cocktails;
Brownlee Columns for HPLC; Western Blot Chemiluminescence Kits, and more.
For more details and to register online, visit http://www.emaildirectsite.com:80/CT00142805MjEyNzEA.HTML.
Applied Biosystems Releases GeneMapper Software v3.5
for Accurate Allele Calling
Applied Biosystems has released eneMapper Software v3.5, an easy-to-use,
flexible, high-performance application package for quality allele calling
on the ABI PRISM 3100 and 3100-Avant Genetic Analyzers, and the Applied
Biosystems 3730 and 3730xl DNA Analyzers. Tests performed with SNPlex System
data have demonstrated that GeneMapper Software v3.5 can analyze more than
100,000 genotypes per hour, significantly reducing the time and effort required
for successful genotyping. Designed with cluster-plot analysis and display
for the SNPlex System, GeneMapper Software v3.5 also includes SNPlex-specific
process quality values (PQVs). The software’s security and audit features
assist with 21CFR11 compliance, a substantial benefit for users in highly
regulated
industries. Other features include remote auto-analysis, automatic bin builder,
database manager, oligonucleotide ligation assay (OLA) analysis, and improved
plot-performance speed. A new User’s Guide and online help function,
improved printing speeds and views, and drag-and-drop marker management make
GeneMapper Software v3.5 simple to use, intuitive, and fast. For details,
visit http://www.appliedbiosystems.com/genemapper.
National Research Council of Canada (NRCC) Picks Biotracker
from Ocimum Biosolutions
Ocimum Biosolutions has announced that National Research Council
of Canada (NRCC) has chosen Biotracker as its LIMS for their DNA sequencing
facility at Halifax. The implementation partner for Ocimum is UBI, United
Bioinformatica Inc, Canada. NRCC is the Government of Canada's premier organization
for research and development. The IMB lab in Halifax where the solution will
be deployed houses the most active DNA sequencing facility in Canada, with
a steadily increasing capacity to generate and analyze sequence data.
The state-of-the-art facility performs automated sequencing of complete, and
partial, genomes related to fish and shellfish health and nutrition. Current
research also includes sequencing of several bacterial genomes including pathogens
of fish and mammals. Biotracker is a multi-platform GLP compliant LIMS for
the Biotechnology and Pharmaceutical industries. The software enables
life sciences and pharmaceutical labs to keep an accurate track of samples,
reagents, instruments, processes and output from the time these samples or
resources are acquired right through to the final stage of research.
For details, visit http://www.ocimumbio.com
or http://www.ubi.ca.
ABB Delivers Industrial IT Solutions for New Production
Line of Qassim Cement Company in Saudi Arabia
ABB, the global power and automation technology group, has
been awarded a contract by the consortium leader Ishikawajima-Harima Heavy
Industries Co. Ltd. (IHI) of Japan exceeding 20 Million Euro, for the new
cement production line being built for the Qassim Cement Company in Saudi
Arabia. ABB has been involved in the planning, construction and commissioning
of QCC Lines Nr. 1 &2 since 1980, which was, coincidently, the beginning
of QCC. The order was won, among other things, due to the excellent and long-standing
relationship with QCC, the success of previous deliveries, customer satisfaction
with the delivered systems and equipment, as well as the excellent service
performance demonstrated by ABB in the past. Ishikawajima-Harima Heavy Industries
Co. Ltd. was awarded the contract in September 2003. Installation is scheduled
to begin in January, 2005 and commissioning in August, 2005. Commercial operation
of the new production line is planned to start by end of 2005. The scope of
the ABB deliveries encompasses medium- and low-voltage distribution equipment,
DriveIT variable speed drives Type ACS1000 and ACS800, with low- and medium-voltage
motors, IndustrialIT process control, optimization and instrumentation. For
details, visit http://www.abb.com/cement.
LabVIEW 7 Express Wins Control Engineering Editor’s
Choice Award for Software
National Instruments today announced that Control Engineering magazine awarded
National Instruments LabVIEW 7 Express with an Editors’ Choice Award,
naming it one of the most significant software innovations for the industrial
control market in 2003. "Control Engineering editors select winners based
on technological advancement, service to the industry and impact on the industrial
control market," said Mark Hoske, editor in chief at Control Engineering.
"LabVIEW 7 Express stood out in each of these categories. This software
makes it easier to implement advanced functionality in industrial applications
while maintaining critical system reliability." With Express technology
in LabVIEW 7, engineers now can create measurement and control applications
in minutes rather than weeks. This technology adds configuration-based development
to LabVIEW through development tools such as Express VIs and interactive measurement
assistants, and features such as automatic code generation. Engineers can
further reduce their development time with the redesigned data acquisition
driver software, NI-DAQ 7. This software features a streamlined API that speeds
development by up to 40 percent and a multithreaded architecture that increases
performance by a factor of 20. LabVIEW 7 Express also introduces new functionality
that scales from industrial PCs to handheld and embedded devices. For years,
control engineers have used the LabVIEW Real-Time Module with rugged FieldPoint
and PXI hardware to develop industrial data acquisition, machine condition
monitoring and custom embedded control systems. With the latest LabVIEW release,
NI extended the boundaries of virtual instrumentation by making LabVIEW available
on embedded FPGAs, Palm OS and Microsoft Pocket PC handheld PDAs and industrial
NI Compact Vision Systems. For details, visit http://www.ni.com.
Indian Pharmaceuticals File Most DMFs in Third
Quarter 2003
According to an article in the Economic Times, India made the maximum drug
master filings (DMFs) with the U.S. Food and Drug Administration in the October-December
quarter of 2003. Indian companies filed as many as 33 DMFs, accounting for
18 percent of total filings with the FDA during this quarter. Cipla, Ranbaxy
and Dr. Reddy's Lab comprise half of the total filings from India, according
to the latest industry data available. For details, visit http://economictimes.indiatimes.com/articleshow/433849.cms.
ARC's
New Supply Chain Execution Market Study - Suppliers Face Encroachments from
ERP Vendors
According to a new ARC Advisory Group study, pipelines are starting to fill
and a recovery from the downturn in IT spending is in the beginning stages
across the diverse set of Supply Chain Execution (SCE) suppliers. Further,
the worldwide market for Supply Chain Execution is expected to grow at a Compounded
Annual Growth Rate (CAGR) of 9.7 percent over the next five years. The
market was $3.3 billion in 2003 and is forecasted to be $5.2 billion in 2008.
The Supply Chain Execution market encompasses a variety of Logistic and Production
Management applications. Not all application areas are growing equally.
Further, certain categories of vendors are gaining ground. "ERP
suppliers are steadily gaining market share at the expense of the best of
breed vendors," according to Steve Banker, ARC Service Director for Supply
Chain Management. "However, this is not true in all SCE application
areas. Certain areas (an example is Production Management applications
for process manufacturers), have been much less likely to lose market share
to ERP vendors." Dr. Banker is the principal author of ARC's "Supply
Chain Execution Worldwide Outlook." Enterprise Resource Planning (ERP)
suppliers have been steadily taking market share in the Warehouse Management
System (WMS) market. This will continue. For the Transportation
Management System (TMS) market, this trend has not yet occurred to any great
extent. Suppliers of Production Management Systems for the process industries
are in a more protected position. Many of the core process manufacturing
verticals require extremely deep industry specific functionality, and this
is particularly true of industries such as Chemicals, Paper, and Oil &
Gas. The leaders in Production Management for the process industries
are also leaders in automation and control systems in those industries.
Their expertise in critical hardware used to optimally run process plants
provides a certain amount of protection from the encroachments of suppliers
that sell only software and can not provide "total" solutions.
Leaders in Production Management in the process manufacturing industries are
also, based on market shares, among the biggest suppliers of Supply Chain
Execution. This occurs despite the fact that leading ERP and best of
breed Logistics Management suppliers are far better known. While manufacturing
is recognized as a supply chain node, the relative scope and importance of
the leading Production Management suppliers is greatly underestimated. Additional
information on this study can be found at http://www.arcweb.com/res/sce.
L.I.M.S.
(USA) Inc. Announces Corporate Name Change to
STARLIMS Corporation
L.I.M.S. (USA) Inc. has announced that it has changed its name to STARLIMS
Corporation, as part of its enhanced corporate identity strategy. The new
name leverages the company’s well-known product brand, STARLIMS, and
differentiates it from the generic term for the Laboratory Information Management
Systems (LIMS) industry. "The change provides us with a cohesive, instantly-recognizable
identity,” says Isaac Friedman, President & CEO of STARLIMS Corporation.
“This move supports the unification of both company and brand recognition
throughout our major markets in North America, Europe, Latin America and Asia
Pacific.” For details, visit http://www.starlims.com.
LABLynx Introduces openLIMS
LABLynx, Inc. has introduced a new product called openLIMS that will allow
companies to "build their own LIMS". openLIMS is an Open Source
system that allows for custom LIMS development while maintaining an upgrade
path for the product built on the LABLynx Informatics Server. The openLIMS
product compliments a growing family of Informatics products from LABLynx.
All of the informatics products, including openLIMS, are built upon the LABLynx
informatics server product. openLIMS will allow end-users, consultants,
value added resellers and integrators, to build custom LIMS solutions
that are geared to the exact operational needs of many different laboratories.
openLIMS is not meant to replace the current line of LIMS products from LABLynx
but to provide a product that can fill a niche market need for customers who
want a commercial grade application but would also like to fully customize
it for their own specific needs. openLIMS also fills the market need
for consultants and integrators who wish to provide their own LIMS offering
to their customers with their own domain knowledge being added to the openLIMS
product solution. This allows 3rd parties to develop their own value
added products as a seamless integration with openLIMS that can be resold
to customers for very specific industry solutions or for broad range use.
openLIMS is built on the LABLynx informatics server which is a web browser,
data driven application that runs on Oracle or MS-SQL Server. The application
is entirely web browser based and requires no software to be installed on
the client workstation beyond a web browser. The application comes with
full security and audit trail features that allow for 21CFR11 compliance.
openLIMS is priced on a per server, per concurrent user basis. Pricing
for the product is $20,000 for the openLIMS server and comes with 5 concurrent
users. Each additional 5 pack of concurrent users is $5,000. For details,
visit http://www.lablynx.com.
Accelerated Technology Laboratories Releases Sample
Master XP LIMS
Accelerated Technology Laboratories Inc. (ATL Inc.) has introduced Sample
Master XP LIMS. Sample Master XP LIMS delivers a host of new features and
enhancements. In addition to a sleek new graphical user interface, this version
also includes advanced auditing functions, scanning and linking documentation
such as Chain-of-Custody forms, GIS integration with Microsoft’s MapPoint,
and automated faxing and e-mailing capabilities. Sample Master XP LIMS provides
expanded instrument importing capabilities along with a QC batch import/export
sequence list creator. A full feature CRM (Customer Relationship Management)
module allows the laboratory to track customer’s inquiries and link
those to samples, resolution times and track any open incidents. A new Time
Tracking module allows managers to track time expended on various projects
for tracking, billing or for resource allocation purposes For details, visit
http://www.atlab.com.
LabVantage Sapphire 3.2 to Ship Early 2004
LabVantage will begin shipping to customers the latest release of Sapphire
- Sapphire 3.2 in early 2004. Sapphire 3.2, which supports LVX and browser
clients, is a major release that all Sapphire customers will consider a must-have.
From major performance gains, to the significant enhancements in system configuration
facilities, users will find substantial ways to further enhance the value
of their Sapphire LIMS. This release has been driven by customer feedback.
Customers who attended the 2003 UK and US user meetings will see that many
of the requested enhancements are now available in 3.2. T hese enhancements
include: the introduction of Evergreen Studio Web Page Designer - Standard
Edition; Support for Oracle 9i; Enhanced Java API Supporting SDK V1.4.2_02;
New Workflow Actions to Support Crystal Decisions Enterprise Professional
Edition Version 9; and, the introduction of Sapphire Console, a Wizard-based
Installation and Upgrade Capability. Enhancements available in 3.2 include:
For details, visit http://www.labvantage.com.
Applied Biosystems Offers New BioMonitor Service
Remote Management Tool
Applied Biosystems now offers the BioMonitorSM device relationship management
(DRM) service for remote monitoring of the ABI PRISM 3100 Genetic Analyzer
(running Data Collection Software v2.0), and the Applied Biosystems 3730 and
3730xl DNA Analyzer. The BioMonitorSM service allows Applied Biosystems to
perform remote monitoring and analysis of the operational parameters from
each instrument attached to the system, which, in turn, enables remote—and
therefore faster—diagnostics, failure prediction, and notification.
This new value-added remote monitoring feature, which is available for contract
and warranty customers, will improve operating efficiency by increasing uptime.
With the BioMonitorSM service, which was developed with sophisticated technology
from Axeda Remote Service Solutions, service teams from Applied Biosystems
can identify a variety of problems, from lasers that need replacement to operational
issues, including changes in electrophoresis current that may cause loss of
samples and data. Also, instrument problems that arise during data collection
can often degrade analysis quality. The BioMonitorSM service detects such
problems when they occur, which may prevent the loss of valuable samples or
sample data For details, visit http://www.appliedbiosystems.com/service/supportplans.
Southwest
Missouri State University Connects with Labtronics' Collect XL
Southwest Missouri State University and Labtronics Inc. have announced a co-operative
program that will have more than 200 students per year using Collect XL to
automate data collection for their lab experiments. Richard Biagioni, who
teaches the freshman General Chemistry laboratory course at the university,
has his students conduct kinetics experiments that involve collecting data
from spectrophotometers at regular intervals over an extended period of time.
He found that he was having to adjust his experiments becaus students were
having to spend so much of their time manually transcribing data into spreadsheets.
That data entry time was taking away from the time that the students had to
focus on analyzing and understanding the data. Using Collect XL, the data
is now automatically collected at regularly timed intervals and sent directly
into Excel, where it is graphed in real time. Now the students can monitor
their results and get immediate feedback on the quality of the data they are
generating, rather than having to wait until they transcribe the data at the
end of the experiment. Eliminating the time required to manually enter results
also means that they can collect more data points without having to worry
about the time that they need to transcribe the data For details, visit http://www.labtronics.com.
E.U. Tells Member States to Loosen Importation Laws
Several European Union (E.U.) member states have been told by the European
Commission (E.C.) to loosen importation laws that restrict low-priced drugs
from entering their borders, a move that drug manufacturers argue will hurt
their bottom lines. In a series of formal notices, the E.C. warned Germany,
Belgium and France that their drug laws violate E.U. trade rules. The nations
have two months to provide a satisfactory response before the E.C. decides
whether or not to refer the cases to the European Court of Justice. The E.C.,
which oversees the implementation of E.U.-wide regulations, also sent a formal
request for information to Austria to establish whether it, too, is breaking
E.U. trade rules on drugs. Among its complaints, the E.C. cites Germany’s
regulation that forces hospitals to get their drugs from local pharmacies,
and Belgian, French and Austrian laws that restrict the practice known as
parallel trade. Along with the warnings to the four member states, the E.C.
said it is preparing a document to clarify E.U. law on parallel imports, and
to assess whether there is a need for further
action at the E.U. level. For details, visit http://www.fda.gov.
E.U. Drug Law to Make Europe Pharma More Competitive
In a move designed to make Europe's pharmaceutical market more attractive
to global drugmakers, the European Parliament voted to give brand firms up
to 11 years of exclusivity on products before they would have to face generic
competition. Under the long-awaited European Union (E.U.) legislation, which
is expected to also be approved by the E.U.'s upper Council of Ministers,
generic firms must wait eight years after a new drug launch to submit a generic
application for that product, and then wait another two years before going
to market. The law also gives brand firms an additional one year of market
exclusivity — bringing the total to 11 years — if they develop
a new indication for the drug. The U.S., by contrast, has a five-year data
exclusivity period, the time following a new drug launch in which a generic
firm is prohibited from filing a generic drug application. Furthermore, a
generic firm may file an application in the U.S. after four years if it challenges
patents on the drug. The E.U. legislation could be adopted into law by February.
For details, visit http://www.fda.gov.