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World Kidney Day on the March
By Kevin Davies
It may lack the public profile of Breast Cancer Awareness Month or World AIDS Day, but don't tell that to the International Society of Nephrology (ISN), which last week rolled out a global, internet-driven campaign to "hype" the dangers of hypertension, renal and other vascular diseases.
March 9 has been declared the inaugural World Kidney Day (WKD), and is being marked by dozens of initiatives around the world, from Albania and Australia to Morocco and Uruguay. An editorial - "World Kidney Day: An Idea Whose Time Has Come" - is being jointly published in eight different kidney journals. World Kidney Day is being co-organized by the ISN and the International Federation of Kidney Foundations (IFKF). In the United States, educational efforts are being led by the National Kidney Foundation (NKF). more
DataTrak Acquisition of ClickFind
Part I: EDC Vendor Modernizes Product Line
By Mark D. Uehling
The DataTrak account executive had been optimistic. Even confident. But then the call came. The news was bad. The contract had gone elsewhere.
And who won the business? DataTrak CEO Jeffrey Green heard the name of the victorious vendor: ClickFind. "I said, 'Who the hell are they?' " Green recalls. Soon he rang up ClickFind and started a conversation. Seven months later, DataTrak bought the once-obscure company for $4 million in cash and $14 million in DataTrak stock. more
Part II: Texas Executive Taunts Rivals
By Mark D. Uehling
Some entrepreneurs dream of selling their companies, buying a few sports cars and mansions, and settling into a life of golf. Jim-Bob Ward is different.
Ward just sold ClickFind to Cleveland's DataTrak International. The price: $18 million (in cash and DataTrak stock). From the sound of it, Ward simply cannot wait to get up in the morning as VP of e-clinical development at DataTrak, his new employer. That's because he finally gets to go into hand-to-hand combat against the biggest, toughest names in the industry and see who's got the best technology. more
Bio-IT Briefs
Summaries of the latest industry news.
Study Links Ambien Use to Unconscious Food Forays
According to emerging medical case studies, the sleeping pill Ambien seems to unlock a primitive desire to eat in some patients, causing some to sleepwalk into their kitchens and consume calories ranging into the thousands. Story in The New York Times.
Half a Million to Join U.K.'s BioBank for Life
The world's largest medical experiment will be launched this week in the Cheshire town of Altrincham, when hundreds of volunteers will give blood and DNA to the controversial new genetic database, Biobank. Story in The Guardian.
Drug Clears Clogged Arteries
A cholesterol-lowering drug has for the first time been shown to shrink blockages that cause most heart attacks, indicating such pills may offer the first non-surgical way to start to clear clogged arteries. Story in The Washington Post.
Merck KGaA Seeks to Restore Stature with Bid
Merck KGaA's Ä14.6 billion ($17.4 billion) bid for rival German drug company Schering AG marks a comeback attempt for the Merck family, a centuries-old investor in the pharmaceutical industry that in recent decades has seen its company overshadowed by bigger and more-global rivals. Story in The Wall Street Journal (sub. req.)
| Bio-IT World February 2006 Issue Highlights |
Preventable Vioxx Problems?
By John Russell
Pathway analysis tools might have identified Vioxx's problematic off-target activity much earlier, argue authors of a fascinating review article in Current Opinion in Chemical Biology]. "[M]uch of the relevant pathway regarding this COX-2 inhibitor (refecoxib) side effect was available at the time of the clinical trials in 1999... This is where modern pathway databases can help to organize the scattered but essential pieces of information to facilitate efficient look-up of drug targets involved in multiple critical pathways," write Upinder Bhalla and colleagues from the National Centre for Biological Science, Tata Institute of Fundamental Research, Bangalore, India. more
Pharma's Mixed Response to Trials Database
By Mark D. Uehling
Some readers may have missed a late December 2005 article in the New England Journal of Medicine (NEJM). The article by Deborah Zarin and colleagues examined recent trends in the public registration of clinical trial data in the main U.S. database - clinicaltrials.gov. In 2004, a group of influential medical journal editors threatened to bar publication of clinical trial studies that had not been registered in a suitable public database. A deadline of September 2005 was set. Zarin's article was the first detailed look at pharma's reaction. more
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Upcoming Industry Events
The 2nd Annual Text Analytics Summit 2006 - June 22 - 23, Hilton Back Bay, Boston USA
Following the massively successful Text Mining Summit 2005, the 2nd Annual Text Analytics Summit 2006 will bring together leading-edge developers and tech-savvy users of text analytics technology. Users and developers will meet in order to discuss:latest developments in text analytics technology;leveraging text analytics enterprise-wide;lucrative emerging applications for text analytics; + much more.
Free Ticket Offer
We have 2 free tickets to give away to Bio-IT World Subscribers – simply go to www.textanalyticsnews.com/freeticket/bio to enter the prize draw!
For further info, visit www.textanalyticsnews.com/bio, call Ravi Virpal on +44 (0) 20 7375 7162 or email ravi@textanalyticsnews.com
Life Sciences Conference + Expo - April 3 - 5, Boston, MA
The Life Sciences Conference + Expo features an outstanding program of keynotes, three-day conference tracks, educational workshops, exhibit floor, and award programs and special events. Speakers will discuss the latest technology developments and research breakthroughs on the complete spectrum of topics involved in drug discovery through market delivery. Learn from actual case studies and panel presentations on how the leading pharma and biotech companies utilize IT and informatics to enhance drug process and speed the time to market.
Find out more today at: http://www.lifesciencesexpo.com
Stability Programs - June 8 - 9, Princeton, NJ
https://www.cbinet.com/show_conference.cfm?confCode=HB653
CBI is pleased to announce the 2006 Stability Programs Summit, which features new, elevated content and a distinct focus on pressing stability regulatory requirements. This conference convenes leaders from key regulatory agencies and leading case studies to map out the next steps in meeting various stability testing requirements as set by ICH, FDA, ASEAN, WHO, and EMEA. Attend to learn how to best implement a stability testing program, how to evaluate the tools and technology available and gain insight into the various methods for stability data analysis.
Bio-IT World Best Practices - Call for Entries - Deadline: April 7th
Bio-IT World is now seeking submissions to its 2006 Best Practices Awards Program. This annual Best Practices Awards Program attracts an elite group of life science professionals: executives, entrepreneurs, cutting-edge innovators and others responsible for developing and implementing innovative solutions for streamlining the drug development and clinical trial process. The winners and entrants will be featured in a Special Report published in Bio-IT World, and invited to attend a gala Awards Announcement reception, held during the annual DIA conference.Find out more at www.bio-itworld.com/bestpractices/2006
MIT PROFESSIONAL INSTITUTE - Registration Open
The Massachusetts Institute of Technology is currently accepting registrations for 35 intensive, week-long programs designed especially for professionals. Courses taught on campus by MIT faculty from June through August. Earn a certificate and CEUs. Offerings include biotechnology, chemical engineering, energy, IT, mechanical engineering, nanotechnology, physics, technology policy, system architecture, and other topics of vital interest to today's engineers and scientists. Visit our website to register and view course descriptions. http://web.mit.edu/mitpep/ads/pi-bioit-mar.html
CBI's Drug Development – From Animal Models to Phase I; Pursue Quality Leads by Expediting PK/PD and Efficacy Data Collection -- April 10 - 11, 2006, Philadelphia, PA
Expediting drug development is a major concern for the pharmaceutical industry. Maximizing preclinical and early clinical development not only speeds up the process, but also reduces money wasted on pursuing compounds with little or no potential for approval. The purpose of this event is to bridge the gap between preclinical and Phase I development. High level speakers present crucial solutions ranging from developing new humanized transgenic animal models to designing more efficient Phase I trials. For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com. Visit: https://www.cbinet.com/show_conference.cfm?confCode=HB637
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Digital Signatures and Electronic Information Exchange
By Mollie Shields-Uehling
SAFE-BioPharma Association
A fundamental transformation is occurring in the way healthcare organizations and their business partners exchange information. The industry is rapidly shifting from paper-based to electronic information exchange, which will ultimately create significant cost savings and improve global collaboration.
To achieve seamless electronic information exchange for electronic business transactions, confidential information sharing and electronic funds transfer, a highly secure trust environment is needed-one that depends on an online user identity validation system that is legally enforceable and regulatory compliant. In addition, the system must provide a high level of trust that the party at the other end of the electronic communication is who he or she says he is. To do so, the system requires digital signatures that can be verified and that will stand up in a court of law like notarized wet signatures.
Out of necessity, most healthcare organizations have developed their own independent identity management systems. But at present, they do not work together. The results are significant cost increases and escalating complexity for those involved in the pharmaceutical industry and in patient care. more
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Featured Content
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Case Studies - MAC OS X in Research IT Infrastructures
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Many scientific organizations have adopted Apple's UNIX-based operating system, Mac OS X, as part of their IT infrastructure. They benefit from its streamlined manageability, fewer security headaches and powerful computational capabilities. This white paper profiles four scientific IT organizations from the academic, government and commercial segments who have successfully made Mac OS X part of their mixed-platform computing environments.
DOWNLOAD WHITEPAPER
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Using Laboratory Systems In A Regulated Environment
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Need to ensure your laboratory conforms to predefined quality assurance criteria? Need a better understanding of FDA 21 CFR Part 11?
Get the knowledge here.
Download this presentation offering insight into laboratory system validation procedures, and guidance on dealing with 21 CFR Part 11
DOWNLOAD PRESENTATION
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Structured Product Labeling for Life Sciences - Software Demo from PTC's Arbortext
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Learn how PTC's Arbortext solution will enable you to easily create SPL-compliant submissions. Download this free demo of Arbortext's SPL solution to learn how you can:
· Convert new and existing label content to XML
· Create and maintain narrative content and structured data elements for FDA submission
· Automatically publishing multiple output formats, including regulatory-compliant SPL and PDF for printing and viewing
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The Case For Electronic Laboratory Notebooks
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What you need to know to choose an ELN solution that meets the needs of your organization.
Contents include:
* Cross-disciplinary versus specific ELNS
* Knowledge management and efficiency gains
* Intellectual property protection.
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Briefing On: Electronic Data Capture
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The controversies surrounding EDC are shifting. There is less talk of the risks of using EDC and more attention to the advantages of real-time drug safety. Long-term trends will continue to nudge the industry toward progressively higher use of EDC. Having the easiest tools for clinical sites to use will be a competitive advantage for companies that use EDC skillfully.
READ MORE from BioïIT World's Senior Editor Mark D. Uehling reports on how EDC gets done.
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Reprints and ePrints
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Interested in reprints or electronic copies of articles published in Bio-IT World magazine or one of our electronic newsletters? Contact:
Jen Hartman
Reprint Management Services
(717) 399-1900 Ext. 128
(717) 399-8900 Fax
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Published by Bio-IT World Copyright © 2005 Bio-IT World Inc./International Data Group. All rights reserved. No material may be reproduced electronically or in print without written permission from Bio-IT World Inc., One Speen Street, Framingham, MA 01701. For reprints and/or copyright permission, please contact RMS, 1808 Colonial Village Lane, Lancaster, PA; 17601 (717) 399-1900 ext. 172, or email: rwsmith@reprintbuyer.com.
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