The following is a wrap-up of news of interest during
the months of September to October 2002.Thermo LabSystems Introduces Release 2 of
Nautilus 2002
LabVantage Solutions Signs Contract with National
Cancer Institute Core Genotyping Center
CREON·LAB·CONTROL Announces Q-DIS/R
Version 1.4.5
Boehringer Ingelheim Chooses CREON·LAB·CONTROL
for their Electronic Record Management Solution
COKZ (Centraal Orgaan voor de Kwaliteitscontrole
in de Zuivel) Strives for Paperless Laboratory Using StarLIMS
StarLIMS for SAP Interface Certified by SAP
InnaPhase Corporation Named One of the Delaware
Valley's Fastest Growing Technology Companies in Deloitte & Touche Technology
Fast 50 Program
Applied Biosystems Introduces GeneMapper v3.0
Software for High Performance Genotyping Applications
Dennis LeTendre Joins Laboratory Expertise Center
as Vice President
ChemSW Announces Update of NIST/EPA/NIH Mass
Spectral Database with 45,000 More Spectra
Agilent Technologies Obtains License for Millennium
Pharmaceuticals' SpectrumMill Software
Agilent Technologies Integrates Spotfire's Web
Services Architecture into its Life Sciences Informatics Solution
WireWorks West Announces Bioreactor Automation
Software
Labtronics Introduces Next Generation Instrument
Interfacing Software
SDI Releases 7th Edition of Global Assessment
Report for the Laboratory Life Science & Analytical Instrumentation
Industry
McClellan Nominated for FDA Commissioner
FDA Publishes E-Record Maintenance Guidance
Thermo LabSystems Reaches New Milestone
in Customer Quality Audits
New Toolkits to Assist Validation
for Atlas CDS from Thermo LabSystems
InnaPhase Signs Technology Agreement
with SGS BioPharma
CREON·LAB·CONTROL Introduces
Q-DIS/WIRELESS for Wireless Data Entry for Q-DIS/QM LIMS
ChemSW Introduces New Portable Inventory
Manager Controls Security and Movement of Stock Room Chemicals
Agilent Technologies Offers New Synapsia
Informatics Literature
Agilent Technologies Makes It Easier
to Run Third-Party Microarrays on New Microarray Scanner
Zymark Acquires Benelux Distributor
Labotec
FDA Announces Plans to Move Biotech
Drug Review to Drug Center
FDA Draft Guidance Addresses Contamination
Issues of Bioengineered Plants in Drugs
FDA Names New Head of Regulatory
Affairs
FDA Launches Electronic Daily Briefing
Thermo LabSystems Introduces Release 2
of Nautilus 2002
Thermo LabSystems, a Thermo Electron business and leader in laboratory
informatics solutions and services, has announced that the latest version
of its Laboratory Information Management System (LIMS), Nautilus 2002 Release
2, has begun shipping to customers worldwide. The new version offers a number
of major advances that deliver increased flexibility in the processing of
microtiter plates, and enhancements to Nautilus' XML (eXtensible Markup
Language) capabilities to offer powerful integration advantages. Also, Nautilus'
new Result Browser provides users with a visualization tool for the presentation
of plate and aliquot results, and enables the dynamic querying of results
and subsequent review in either tabular or graphical format, within a highly
user-friendly interface. Among new plate-handling functionality is a series
of features to support the processing of results and tests at the plate
level, which is of particular benefit in laboratories involved in high throughput
screening and experimentation. The Nautilus LIMS is focused on improving
laboratory productivity and reducing the total cost of ownership. For details,
visit http://www.thermolabsystems.com
LabVantage Solutions Signs Contract with
National Cancer Institute Core Genotyping Center
LabVantage Solutions, Inc., a leading provider of Life Sciences LIMS and
Enterprise LIMS solutions, has announced that the National Cancer Institute
(NCI), the Federal government's principal agency for cancer research and
a component of the National Institutes of Health, has signed a software
and services agreement with LabVantage. NCI's Core Genotyping Facility will
be using LabVantage Sapphire software to perform high throughput genotyping
analysis. LabVantage Sapphire will provide NCI with the ability to manage
and track details of every sample from the DNA provider through to their
Core Genotyping Facility Units. It will also provide the laboratory with
capabilities for electronic worksheet generation, sample and genotype reagent
tracking, and instrument and robotic integration. To increase operational
efficiency, the Sapphire software system will also be used to track costs
of all samples and genotypes processed. Such solutions are necessary to
discover and validate SNPs through the SNP 500 cancer resequencing effort
-- a Cancer Genome Anatomy Project -- and to develop genotyping assays,
to track and genotype DNA samples, and to provide NCI investigators with
access to genotypes at the Core Genotyping Facility. This will further enable
NCI investigators to translate hypotheses into findings with public health
implications. For details, visit http://www.LabVantage.com.
CREON·LAB·CONTROL Announces Q-DIS/R
Version 1.4.5
CREON·LAB·CONTROL has announced the availability of Q-DIS/R Version
1.4.5, an analytical workflow management tool. Developed in consultation
with major pharma and chemical companies, Q-DIS/R combines analytical workflow
management and integrated instrument control with secure raw data archiving.
Newly integrated is a sequence editor to enhance instrument control capabilities
for chromatography software solutions. Also new is an easy-to-use web-interface,
which allows search and retrieval of all information via a standard web
browser. There is no longer the need to install extra software. Unlike general
archiving tools, simple workflow packages, or add-on spectroscopy and chromatography
modules, Q-DIS/R combines analytical workflow and integrated instrument
control with secure raw data archiving. The 1.4.5 release of Q-DIS/R delivers
powerful new capabilities, including a new Instrument Wizard, a new Web-client,
an enhanced intuitive Web-workspace, and a new Sequence Editor. Designed
from the very beginning to operate in a heterogeneous environment of applications
and databases, Q-DIS/R communicates connectivity information via a lightweight
XML schema. This facilitates the integration of Q-DIS/R into an existing
environment of legacy applications and systems while reducing errors by
eliminating the need to manually transfer connectivity information to coworkers
and other applications. For details, visit http://www.creonlabcontrol.com.
Boehringer Ingelheim Chooses CREON·LAB·CONTROL
for their Electronic Record Management Solution
CREON·LAB·CONTROL has announced it has received a corporate license
order for Q-DIS/PANDA software and services from Boehringer Ingelheim, one
of the 20 leading pharmaceutical corporations in the world. Q-DIS/PANDA,
is a platform-independent, 100 percent web based central storage system,
which harvests all kinds of widely dispersed information (electronic records)
to generate a powerful knowledge-based corporate archive. Boehringer Ingelheim
has been using CREON·LAB·CONTROL software solutions for seven
years. Starting as a development partner for Q-DIS/AQV they have helped
to optimize the specification management of analytical testing methods as
well as increase productivity by using the Q-DIS/QM LIMS and Q-DIS/R Analytical
R&D Workflow System. Boehringer Ingelheim plans to lever the Q-DIS/PANDA
software solution for electronic record management and corporate archiving
especially within R&D and production. For details, visit http://www.creonlabcontrol.com
or http://www.boehringer-ingelheim.com.
COKZ (Centraal Orgaan voor de Kwaliteitscontrole
in de Zuivel) Strives for Paperless Laboratory Using StarLIMS
The COKZ (Centraal Orgaan voor de Kwaliteitscontrole in de Zuivel) is the
Central Authority for Quality Control of Dairy Products in The Netherlands.
The laboratory plays a pivotal role within the COKZ, yearly analyzing 81,000
samples and a total of 500,000 analyses. StarLIMS enables the institute
to ensure quality contol by, automating procedures thereby reducing errors,
provides additional functionality performing cost calculations and sending
invoices, and couples the labs instruments directly to the LIMS system.
For details, visit http://www.starlims.com/cokz.htm.
StarLIMS for SAP Interface Certified by SAP
L.I.M.S. Ltd's StarLIMS for SAP interface has been certified by SAP AG for
the component SAP R/3 Enterprise 4.6. The certification of the interface
between StarLIMS and SAP confirms the existence of product functionality
in accordance with SAP's certification procedure. This certification also
meets the SAP requirements for connecting StarLIMS to the mySAP.com platform,
making L.I.M.S. Ltd. one of the latest on a short list of selected LIMS
vendors to receive mySAP.com interface certificate. For details, visit http://www.starlims.com/solutions/integratedsoftware.htm#sap.
InnaPhase Corporation Named One of the Delaware
Valley's Fastest Growing Technology Companies in Deloitte & Touche Technology
Fast 50 Program
InnaPhase Corporation, a leading provider of technology solutions for the
life sciences, has been named to Deloitte & Touche's prestigious "Technology
Fast 50" Program for the Delaware Valley area, a ranking of the 50
fastest growing technology companies in the area. Rankings are based on
the percentage of growth in fiscal year revenues from 1997-2001 (five-year
period). InnaPhase Corporation placed third in the
ranking. To qualify for the Technology Fast 50, companies must have had
operating revenues of at least $50,000 in 1997 and $1,000,000 in 2001, must
be public or private companies headquartered in the Delaware Valley, and
be "technology companies" defined as companies that own proprietary
technology which contributes to a significant portion of the company's operating
revenues or devotes a high percentage of effort to research and development
of technology. InnaPhase Corporation's increase in revenues of 3,619 percent
from 1997 to 2001 resulted in a number three ranking overall in the Delaware
Valley Technology Fast 50. The average increase in revenues among companies
who made the Technology Fast 50 for this region was 826.3 percent. Winners
of the 20 regional Technology Fast 50 programs in the United States and
Canada are automatically entered in the Deloitte & Touche Technology
Fast 500 program, which ranks North America's top 500 fastest growing technology
companies. For more information on the Deloitte & Touche Technology
Fast 50 or Technology Fast 500 programs, visit http://www.fast500.com.
For more information about InnaPhase, visit http://www.innaphase.com.
Applied Biosystems Introduces GeneMapper
v3.0 Software for High Performance Genotyping Applications
Applied Biosystems has announced the release of v3.0 of its industry-standard
GeneMapper software, a powerful, flexible package with allele-calling capability
for large genotyping studies. GeneMapper v3.0 combines the functions of
GeneScan and Genotyper software for a wide variety of research applicaitons,
including SNP validation and screening microsatellite analytic and sizing-only
applications. The new version software can analyze fragment analysis data
from all Applied Biosystems genetic analysis systems. This latest version
of GeneMapper software also offers a complete set of interactive tools to
define new markers and alleles, edit existing markers and allele bins, set
up customized analysis methods, and confirm allele calls quickly and accurately.
The entire data analysis process is automated. Previously, most genotyping
projects required manual examination of almost all allele calls. GeneMapper
software, however substantially reduces the need for data review, virtually
eliminating this bottleneck. For details, visit http://www.appliedbiosystems.com.
Dennis LeTendre Joins Laboratory Expertise
Center as Vice President
Laboratory Expertise Center (LEC) has announced the appointment of Dennis
LeTendre as Vice President for Business Development and Marketing. Mr. LeTendre
received degrees in Criminal Science and Electronic Engineering from the
University of Florida, and recently earned an MBA from Rice University in
Houston, with a specialty in Chemical Manufacturing Management. Mr. LeTendre
held many managerial positions within Perkin Elmer's (now Applied Biosystems)
Laboratory Automation group. His most recent position was president of RTS
Enabling Technology, a laboratory software and automation technology firm.
LEC is a highly specialized laboratory consulting group with a focus on
global and local laboratory automation architecture development and design.
For details, visit http://www.labexpertise.com.
ChemSW Announces Update of NIST/EPA/NIH Mass
Spectral Database with 45,000 More Spectra
ChemSW, Inc. has announced the availability of NIST 02, the new NIST/EPA/NIH
Mass Spectral Database with more than 175,000 spectra and over 147,000 compounds.
This is the largest increase in the history of the database. Every spectrum
has been evaluated to produce the first fully-evaluated database for the
identification of unknown spectra. The database is available in the common
NIST format and versions that are compatible with most manufacturers' data
systems, features multiple query options to match unknown spectra with identifiable
compounds, and provides structure searching with the new NIST 02 Database.
Multiple user libraries can easily be created using Mol files. A built-in
utility enhances the analysis and examination of user data files, and a
special interpreter illustrates the fragmentation of a structure compared
to observed peaks in the mass spectrum. ChemSW is a leading provider of
chemical inventory management systems, MSDS systems and other chemistry
laboratory software and services. For details, visit http://www.chemsw.com.
Agilent Technologies Integrates Spotfire's
Web Services Architecture into its Life Sciences Informatics Solution
Agilent Technologies Inc. and Spotfire Inc. have announced that Agilent
is integrating Spotfire's DecisionSite Posters software application into
the Agilent Synapsia Informatics Workbench. The integration is expected
to allow scientists using Synapsia to easily share analyses, questions and
decisions based on complex data sets across scientific and geographical
boundaries, thereby helping in the hunt for new cures for diseases. Synapsia
allows scientists working in drug discovery to formulate and document insights
from massive quantities of complicated data. Its visual data interaction
tools enable scientists to pinpoint relationships, patterns trends and correlations
hidden within terabytes of heterogeneous genomic, chemical and life-sciences
data. DecisionSite Posters allows teams of scientists using Synapsia to
combine analytical results and domain expertise through the interactive
discovery center. DecisionSite Posters facilitates consensus across distributed
organizations where team members from different disciplines, often using
incompatible technologies, contribute to the discovery process. For details,visit
http://www.spotfire.com or http://www.agilent.com/chem.
Agilent Technologies Obtains License for
Millennium Pharmaceuticals' SpectrumMill Software
Agilent Technologies Inc. has announced that it has obtained a license from
Millennium Pharmaceuticals Inc. that will allow Agilent to exclusively develop
and sell software based on Millennium's SpectrumMill software. SpectrumMill
software is a package of tools developed and used internally at Millennium
for scientists doing protein research for disease and drug discovery. The
agreement also will provide Millennium with early and advanced access to
Agilent products and chemistries for proteomics research. SpectrumMill software
provides scientists with highly advanced tools for analyzing large volumes
of complex mass spectral data. SpectrumMill data can be integrated into
Agilent's recently introduced Synapsia Informatics Workbench software platform.
Millennium will assist in the development and evaluation of future Agilent
proteomics products. Agilent hopes to benefit from Millennium's early evaluation
of its proteomics products in an advanced research setting. For details,
visit http://www.agilent.com/chem.
WireWorks West Announces Bioreactor Automation
Software
WireWorks West, Inc. has announced the release of FermWorks, software that
helps biotechnology and pharmaceutical companies streamline the drug discovery
process by automating experiment control and managing critical process data.
FermWorks addresses the need for laboratory-wide automation and data management
by enabling technicians and researchers to monitor and control a network
of bioreactors and associated instruments, and to dramatically increase
the scale and efficiency at which laboratories can operate. FermWorks allows
researchers to manage groups of bioreactors, and to apply control strategies
to any bioreactor in an experiment. Researchers can quickly redefine configurations,
adapt control methodologies from prior experiments to current processes,
and compare process performance. FermWorks provides remote networked control
and data display to staff within a laboratory or around the world, and is
designed for the central storage of all process and configuration data.
WireWorks West will install FermWorks systems in four San Francisco Bay
Area biotechnology and pharmaceutical organizations during the next six
months. For details, visit http://www.wireworkswest.com.
Labtronics Introduces Next Generation Instrument
Interfacing Software
Labtronics has introduced their new NEXXIS Balance Data System (BDS),
a next generation instrument interfacing software that allows users to create
a secure information network in their laboratory. The NEXXIS BDS is a new
balance automation solution and data management system that provides secure
and documented control over balance applications and balance data management.
It is designed to address issues of data integrity and security and to include
all of the components required for compliance with 21 CFR Part 11. NEXXIS
BDS ensures that SOPs are carried out completely and correctly. A powerful,
high level Process Editor is used to define the SOP process for a weighing
application. The process can include data collection from the balance, communication
with the balance, messages for the analyst, interfacing to LIMS, reporting
requirements, data storage to files or databases, calculations, etc. Each
step of the analysis can be clearly defined and implemented. At run time
the analytical procedure is controlled by the interaction between NEXXIS
BDS, the balance and the analyst. For details, visit http://www.labtronics.com.
SDI Releases 7th Edition of Global Assessment
Report for the Laboratory Life Science & Analytical Instrumentation
Industry
Strategic Direction Inc (SDI) has released the 7th edition of their Global
Assessment Report for the Laboratory Life Science & Analytical Instrumentation
Industry. The report addresses the market demand for all significant scientific
instrument techniques. Each market is forecast by region and product, and
is sectioned out by industry, laboratory function and vendor share. Each
of the more than 60 sections have been expanded to five page formats and
include a number of tables and graphs accompanied by detailed discussion
and explanation of the underlying forces behind the numbers. The report
also include information on industry participants, including profiles of
the top 50 vendors in the overall market. Data on industry indexes and overall
trends, plus a section summarizing the overall global economic scenario
are also included. For details, visit http://www.strategic-directions.com.
McClellan Nominated for FDA Commissioner
President Bush has announced his nomination of Mark McClellan as FDA commissioner.
McClellan, who would fill a post that has been vacant for nearly two years
because of a political standoff over who should fill the slot, is currently
a member of the president's Council of Economic Advisers. McClellan, generally
regarded as the nation's top health policy adviser, is a physician and an
economist. McClellan's nomination so far has the blessing of Sen. Edward
Kennedy (D-Mass.), who is chairman of the committee that will oversee his
confirmation to the post by the Senate. "Dr. McClellan has impressive
credentials both as a physician and as an economist, and I look forward
to learning more about his views on issues critical to the FDA, Kennedy
said just before the announcement was made." A standoff between Bush
and Kennedy has left the agency without a commissioner since the president
took office. McClellan has not worked in any FDA-regulated industry, but
has been a professor at Stanford University and deputy assistant secretary
of the Treasury Department under President Clinton. One problem likely to
plague McClellan, 39, is that he has never managed a large staff. The FDA
has more than 10,000 employees in offices spread across the country. Questions
about McClellan's management skills are likely to come up during his confirmation
hearing before the Health, Education, Labor and Pensions (HELP) Committee.
The hearing is to be scheduled as soon as possible. For details, visit http://www.fda.gov.
FDA Publishes E-Record Maintenance Guidance
The FDA Sept. 5 issued the fourth in a series of draft guidances on the
agency's thinking about how industry should maintain electronic records
in compliance with 21 CFR Part 11. In the document, published in the Sept.
5 Federal Register, the agency outlines two possible approaches to handling
the maintenance of electronic records. The "time capsule" approach
involves preserving an electronic record on the same electronic media and
computer system used to create it. This method has limited practicality
for long-term records maintenance, and likely would only be used as a short-term
solution. The other approach, electronic records migration, involves moving
electronic records from one computing environment to another. Electronic
records may migrate through several successive systems during a records
retention period, but they must continue to conform to regulatory and statutory
requirements. The guidance also advises firms to control factors that might
affect the reliability of electronic records, including data encoded within
an electronic record; metadata for an electronic record; and the processes
of extracting and presenting information in a readable form. The guidance
also recommends the use of periodic testing to make sure records remain
readable. To view the draft guidance, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1539-gdl0001.pdf.
Thermo LabSystems Reaches New Milestone in
Customer Quality Audits
Thermo LabSystems, a leader in laboratory informatics and services, has
reached the significant milestone of hosting one hundred customer quality
assurance audits since it began keeping records in 1992. This total comprises
audits undertaken by customers, as well as prospective customers as part
of their evaluation and selection process. Computer system vendors, such
as Thermo LabSystems, are subject to vendor audits (2nd party audits) by
customers in industries such as pharmaceutical and food production, where
the system operates in a GLP or GAMP regulated environment. These audits,
which are mandated by regulatory authorities, are conducted to gain evidence
that the vendor is designing, testing, supporting, and documenting the computer
system in a controlled manner. For details, visit http://www.thermolabsystems.com
New Toolkits to Assist Validation for Atlas
CDS from Thermo LabSystems
Thermo LabSystems, a leader in laboratory informatics solutions and
services, has released the Validation Toolkit for version 2002 of its Atlas
CDS (Chromatography Data System). The toolkit comprises software and documentation
to provide a valuable resource for the implementation of Atlas in regulated
environments. The new toolkit offers a number of major advances over previous
versions, including a redesigned automated test driver, which has proven
successful as the standard driver across all Thermo LabSystems' software
product validation kits. The automated test driver allows users improved
control over which tests to run as part of their own validation and provide
single mouse-click access to results for review; all within a modern user-friendly
interface. In addition to the automated test driver, the Atlas 2002 Validation
Toolkit includes: Compiled automated test scripts; Manual test scripts for
every automated test in Microsoft Word format; Visual Test source code;
Functional specifications; and, Test approach/Functional Specification Matrix.
The latest version of the Validation Toolkit also contains a comprehensive
set of tests to support customers in the validation of Thermo's DataServer
and A2D instrument data acquisition and control devices, which are supplied
to customers with Atlas CDS. For details, visit http://www.thermolabsystems.com
InnaPhase Signs Technology Agreement with
SGS BioPharma
InnaPhase Corporation, a leading provider of enterprise technology solutions
for life sciences, has announced that SGS BioPharma, a leading contract
research organization, has signed a license agreement to implement InnaPhase's
Watson Laboratory Information Management System (LIMS). This agreement provides
SGS BioPharma with Watson licenses for their Wavre facilities in Belgium
and is scheduled to go into production in September 2002. The Watson LIMS
system is specifically designed to support DMPK/Bioanalytical studies in
drug development while ensuring regulatory compliance with the FDA's 21
CFR Part 11 guidance on electronic records and signatures. Watson has an
established track record of accelerating bioanalysis, sample management
and regulatory compliance in pharmaceutical drug development. "Watson's
flexibility and reliability are critical to the diversity of work that we
are performing within our bioanalytical laboratory," said Bernard Jeanbaptiste,
Head of Bioanalysis at SGS BioPharma. "Strict compliance with 21 CFR
Part 11 and enhanced efficiency in performing daily work for our clients
made Watson a clear choice for SGS BioPharma," he added. For details,
visit http://www.innaphase.com.
CREON·LAB·CONTROL Introduces Q-DIS/WIRELESS
for Wireless Data Entry for Q-DIS/QM LIMS
CREON·LAB·CONTROL, a leader in intelligent analytical data management
technology, has announced the new development of Q-DIS/WIRELESS. Current
trends show that handheld computers and wireless access portals are becoming
increasingly relevant in chemical analysis. They will seamlessly integrate
into corporate information management solutions such as LIMS, electronic
record management, and analytical workflow management tools. This Web technology-based
wireless solution is based on the latest Microsoft .NET and CREON·LAB·CONTROL
Q-DIS/PANDA technology. Q-DIS/WIRELESS supports all handheld computers equipped
with Wireless LAN network adapters compatible to IEEE 802.11b (Wi-Fi) running
on. Data is entered and automatically sent to Q-DIS/WIRELESS server and
from there directly into Q-DIS/QM LIMS or Q-DIS/R Analytical Workflow system.
Q-DIS/WIRELESS interface technology allows integrating the system also into
existing LIMS solutions. The biggest threat to the security of handhelds
today is loss of the device. Therefore, Q-DIS/WIRELESS transfers all information
without intermediate storage on the PDA immediately. The immediate data
transfer is documented by a fully traced data trail until the data is stored
in the final system. The personalized data transfer between the PDA and
Q-DIS/WIRELESS server is protected by a 128bit encryption. Q-DIS/WIRELESS
is 21 CFR Part 11 compliant. For details, visit http://www.creonlabcontrol.com.
ChemSW Introduces New Portable Inventory Manager
Controls Security and Movement of Stock Room Chemicals
ChemSW, Inc. has introduced a new Portable Inventory Manager (PIM) option
for its CIS Chemical Inventory System. The PIM, featuring sophisticated
bar-coding capabilities, is ideal for companies and Universities that need
to track the movement and cost accounting of chemicals from stock rooms.
The system ensures chemical security in addition to automatically generating
invoices to the appropriate cost centers, labs, grants, etc.
"Current events have resulted in heightened awareness of chemical security,
and many organizations have discovered that access to dangerous chemicals
may be too easy," commented Brian Stafford, President of ChemSW. "We
were already developing this system as a 'point-of-sale' tool. Now we're
applying the technology with many companies and Universities to create chemical
security in stock room environments." CIS Pro and the PIM capability
track, on a real-time basis, exactly who is in possession of every chemical
that leaves the stock room. It allows the security and financial responsibility
to move as the actual chemicals are relocated. ChemSW is a leading provider
of chemical inventory management systems, MSDS systems and other chemistry
laboratory software and services. For more information, visit http://www.chemsw.com.
Agilent Technologies Offers New Synapsia Informatics
Literature
Agilent Technologies Inc. has announced publication of literature to support
its recently announced Agilent Synapsia Informatics Workbench. The literature,
comprising a brochure and three datasheets, outlines the features and benefits
of using this new family of software products. The brochure titled, "Agilent
Synapsia Informatics Workbench," (publication number 5988-7532 EN)
provides the reader with a general explanation of the particular features
and benefits of using Synapsia for data integration and analysis. There
is also a sidebar that provides some basic information on the two optional
Synapsia modules: the Chemfocus module and the Statistics module. The two-page
Chemfocus module datasheet (publication number 5988-7622EN) provides an
overview of key features and benefits of the software when used for the
analysis of chemical structure. The Statistics module datasheet (5988-7621EN)
describes key features and benefits when using the module to supplement
and enhance the data capabilities of Synapsia. Also available is a Synapsia
overview datasheet (publication number 5988-7620EN). Free copies of the
literature can be ordered at http://www.agilent.com/chem.
Agilent Technologies Makes It Easier to Run
Third-Party Microarrays on New Microarray Scanner
Agilent Technologies Inc. has introduced the Agilent G2565BA microarray
scanner, which makes it easier for scientists to scan a wider variety of
1" x 3" (25mm x 75mm) glass slide microarrays from third-party
manufacturers as well as from those labs spotting their own microarrays.
This added flexibility demonstrates Agilent's commitment to open systems
gene expression analysis. The new microarray scanner delivers efficient
scanning of most standard varieties of 1" x 3" (25mm x 75mm) glass
slides; simple customization of microarray scan regions for non-Agilent
1" x 3" microarrays; a laser-saver function that can be programmed
to turn on and off according to a given lab's workflow needs; Web-based
monitoring of the status of microarray scanning; and, enhanced instrument
start-up diagnostics software that assesses scanner performance parameters
and provides researchers with a status report prior to scanning. Agilent's
Feature Extraction Software is also included and provides users of Agilent's
catalog and custom microarrays with the simplicity of seamless, automatic
feature extraction and feature look-up. For details, visit http://www.agilent.com/chem.
Zymark Acquires Benelux Distributor Labotec
Zymark Corporation, a leading provider of automation solutions servicing
the life sciences industries, has acquired Labotec NV/SA, a distributor
of Zymark products in the Benelux region. Labotec NV/SA will become a wholly
owned subsidiary and will be renamed Zymark Benelux NV/SA. Zymark acquired
the Teralfene, Belgium-based company to reinforce its commitment to the
European market and increase its direct representation in the region. Jef
Leemans, founder of Labotec, has been appointed managing director of the
subsidiary and Director, European Service and Support. For details, visit
http://www.zymark.com.
FDA Announces Plans to Move Biotech Drug Review
to Drug Center
In a move widely applauded by the biotech and pharmaceutical industries,
the FDA has announced plans to shift review and approval responsibilities
of biotech drugs from the Biologics Center (CBER) to the Drug Center (CDER).
The shift may help erase some of the inconsistencies that exist between
the regulation of drugs and biotech therapies. According to those familiar
with the plans, affected products will include monoclonal antibodies, recombinant
protein therapies, growth factors and cytokines like interferon and interleukin.
CBER will concentrate on its traditional role overseeing vaccines, blood
safety and cutting-edge areas like gene therapy and tissue transplantation.
For details, visit http://www.fda.gov/bbs/topics/NEWS/2002/NEW00834.html.
FDA Draft Guidance Addresses Contamination
Issues of Bioengineered Plants in Drugs
New draft guidance from the FDA stresses that manufacturers must take multiple
steps to prevent cross-contamination during the harvest and processing of
bioengineered plants used in drugs, biologics and medical devices. The draft
guidance, which was published in the Sept. 12 Federal Register, also suggested
inserting a genetic marker to change the color of the plant or modify the
conditions under which it will grow. For details, visit http://www.fda.gov/OHRMS/DOCKETS/98fr/02d-0324-gdl0001.pdf.
FDA Names New Head of Regulatory Affairs
The FDA has appointed John Taylor senior associate commissioner for regulatory
affairs, the same position held by his father for several years in the late
1980s. He replaces Dennis Baker, who has headed the regulatory affairs office
since 1999 and now will head up the FDA's regional field office in Dallas.
In addition, the regulatory affairs director position has been elevated
to a senior associate commissioner post. In that position, Taylor will be
responsible for ensuring that FDA-regulated products comply with the consumer
protection laws and the regulations the agency enforces. He will manage
the FDA's field operations and staff, including approximately 1,000 investigators
and 100 compliance officers in FDA offices around the U.S. Taylor, an attorney,
joined the FDA's Office of the Chief Counsel in 1991 and moved to the Office
of the Commissioner six years later as senior advisor on regulatory affairs.
In 2000, he was named director of the Office of Enforcement in the Office
of Regulatory Affairs. For details, visit http://www.fda.gov/bbs/topics/NEWS/2002/NEW00833.html.
FDA Launches Electronic Daily Briefing
FDA has launched Drug Industry Daily, an electronic daily briefing that
provides coverage of what's happening on Capitol Hill, in the courts and
at the FDA, the FTC, HHS, NIH and other key agencies and decision making
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