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Sales Contacts
For advertising information contact: Kay O. Christopher
Regional Sales Manager, Ad Sales - New England, Northeastern U.S.
860-693-2991
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| NOTABLE QUOTE |
“Because of the economic impracticality of sequencing hundreds of people in a clinical trial, “the pharma guys are pretty much sitting on the sidelines, waiting for guys like us to come along.” – Complete Genomics CEO Clifford Reid
Read full story at Bio-IT World.com |
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| IN THIS ISSUE |
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Pharsight Purchase Opens Translational Medicine Prospects for Tripos |
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CRFs to Get Digital Signature Capability |
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Sentinel Initiative Boosts FDA Safety Oversight |
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News Briefs |
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MERGERS
Pharsight Purchase Opens Translational Medicine Prospects for Tripos
By Deborah Borfitz
The merger of two brand-name modeling and simulation firms should help bridge the historic divide between drug discovery and clinical development, eliminating some of the costly mistakes pharmaceutical companies make as they usher compounds from the bench to the bedside.
Tripos, a St. Louis, MO-based discovery software company, is about to acquire Pharsight Corp., a Mountain View, CA-based clinical development software company, in a $57 million cash deal that will heighten the focus on translational research and help industry “make better decisions earlier in the overall drug development process,” says Shawn O’Connor, Pharsight’s chairman and CEO. Read more.
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STANDARDS
CRFs to Get Digital Signature Capability
By Deborah Borfitz
The Clinical Data Interchange Standards Consortium (CDISC) is collaborating with the SAFE-BioPharma Association to add digital signature authentication to CDISC’s flagship Operational Data Model (ODM). The expanded capability will make it easier for clinical trial investigators to complete drug safety and case report forms (CRFs), thereby encouraging physicians to participate in further studies, says Landen Bain, the Consortium’s liaison to healthcare.
The SAFE-BioPharma digital signature will be embedded within an ODM-based electronic CRF that will in turn be displayed by the enabling “integration profile” RFD (Retrieve Form for Data Capture). “RFD enables the electronic capture of clinical trial data directly from patients’ electronic health records [EHRs],” says Bain. It has been jointly developed by CDISC and IHE (Integrating the Healthcare Enterprise) over the last three years. Read more.
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DRUG SURVEILLANCE
Sentinel Initiative Boosts FDA Safety Oversight
By Ann Neuer
As part of its strengthening focus on product safety, the Food and Drug Administration (FDA) is rolling out the Sentinel Initiative, a new effort that creates an integrated electronic system known as the Sentinel System for monitoring marketed medical products throughout their entire life cycle.
Rachel Behrman, FDA’s Associate Commissioner for Clinical Programs, explains that the Sentinel System will enable FDA to conduct product safety queries proactively from multiple existing data sources from remote locations, such as electronic health record systems, medical claims databases, and possibly clinical trial databases if they overlap with those of marketed products. “Data sources will be maintained by their owners and will remain behind the firewall of the data owner. We are not creating one big database,” she says. Read more.
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Most-Read Story from Previous Issue
BRIDG Moves Toward Double Layer of Semantics
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News Briefs
- Phase Forward founder, chairman Bleicher leaving company
- Nextrials expands its U.S. sales force
- CRF Inc. strengthens clinical advisory board
- Exco InTouch's electronic patient diary selected by Synairgen
- Invivodata captures symptom relief data in endometriosis trial
- Good Products and Adlib Software partner for regulatory submissions . . . more
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CDER RTF Actions Rise: Sign of Things to Come?
From the U.S. Regulatory Reporter, Sept. 2008 issue
Since the early 1990s, when the user-fee era began, CDER officials have been warning industry that the quality of their initial new drug applications (NDA) must improve if these submissions are to gain access to the review process and, therefore, avoid the dreaded refuse-to-file (RTF) action. These warnings have often been accompanied by agency observations that FDA drug reviewers have been too lenient in accepting inadequate NDA submissions for review.
When they are first submitted, all NDAs are subjected to the so-called “filing review” or “completeness review” by their relevant new drug review divisions. This evaluation ensures that sufficient data and information have been submitted in each section of the NDA to justify “filing” the application—that is, initiating the formal review of the NDA. One of the key goals of the filing review, of course, is to protect limited agency resources (i.e., review staff) from being invested in evaluating incomplete or insufficient NDAs.
Despite warnings of agency officials as well as FDA regulations and at least one older guideline on the topic, the RTF has been a little-used tool over the years. This has been so even during the user-fee era, during which agency officials have often spoken of the importance of complete NDAs in meeting its review time goals and warned of the consequences of incomplete NDAs (i.e., RTFs).
To read the full article, subscribe to the U.S. Regulatory Reporter.
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FEATURED EVENTS
DIA 2nd Annual Clinical Forum: Data Driven Drug Development Decisions October 20-23, 2008 | Ljubljana, Slovenia
Super Computing ~ November 15-21, Austin, TX
Fifth Annual Molecular Imaging Week ~November 17-19, 2008, La Jolla, CA,
The Next Tool for Healthcare Innovation~ Nov 20, 2008 2pm EST A Complimentary Frost & Sullivan eBroadcast
The Association for Laboratory Automation (ALA) presents LabAutomation2009, January 24-28, in Palm Springs, CA.
TEPR+ 2009 - Feb 1-5, 2009 | Palm Springs, CA
Barnett Educational Services
Cambridge Healthtech Events
To have your event featured here, contact Lynn Cloonan for more information.
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| CALL FOR PROPOSALS |
2009 Bio-IT World Conference & Expo
Clinical Research Professionals: We invite you to submit a speaking proposal for consideration by our Advisory Committee for the 7th Annual Bio-IT World Conference & Expo, April 27-29, 2009 at the World Trade Center in Boston, MA.
Track 5: Clinical and Medical Informatics – Will focus on the role of IT solutions, theoretical knowledge and social infrastructure in allowing for efficient gathering and analysis of clinical data. Details here.
Please submit proposals by October 15.
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| FEATURED CONTENT |
Managed Innovation,
Assured Compliance
Developing, executing and managing the transformation, analysis and submission of clinical research data with SAS® Drug Development
sponsored by SAS
Discovery organizations are identifying a lot of promising compounds, but clinical research processes haven't kept pace with timely testing of all those potential therapies. This white paper describes how SAS Drug Development supports true innovation across the clinical trial process.
In this white paper you will learn how to:
~Assemble data to foster better collaboration
~Get up-to-date information during clinical trials
~Make informed decisions earlier in the trial process
Download now
Addressing Life Sciences Constantly Growing Data Challenges Research Environments sponsored by BlueArc
The continued explosion of raw experimental data, the increased use of video, the growingadoption of new data retention practices, and the move to high throughput computational workflows are all placing new demands on the way life sciences organizations store and manage their data.
Download this white paper to learn about:
• Factors driving the data explosion in the life sciences
• New data management issues that must be addressed
• HPC trends that are placing new demands on storage
• Storage solution attributes that address performance, manageability, and energy efficiency. Download now
“Storage for Science – Methods for Managing Large and Rapidly Growing Data Stores in Life Science Research Environments” sponsored by Isilon
Large and rapidly growing stores of file-based and other data are a hallmark of life science research and bioinformatics. Determining how best to manage those data stores has become a significant challenge for Researchers and IT Pros alike. This paper is intended to: Provide guidance on the many storage requirements common to Life Science research; Explain the evolution of modern storage architectures; Summarize the major data storage architectures currently in use. Additionally, it will present the Isilon IQ clustered storage product as a strong and flexible solution to those needs. Download now
Microsoft’s BioIT Alliance
Bio-IT World published a special supplement with support from Microsoft and their Alliance members. The supplement provides insight into the activities of the Alliance and their partners. Click here to access the Supplement PDF.
To have your white paper featured here, contact Lynn Cloonan for more information. |
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| EXCLUSIVE WEBCAST |
Life Science Webcasts from Bio-IT World and Cambridge Healthtech Media Group
Bio-IT World Expo
Video Highlights
Drug Discovery, Development and Commercialization: Evolving Challenges and Opportunities
Joshua Boger, PhD, president and CEO, Vertex Pharmaceuticals Inc., delivers his keynote at the 2008 Bio-IT World Conference & Expo in Boston, April 30, 2008.
View the webcast.
Personalized Genetics: Advancements and Driving Change
Linda Avey, co-founder of 23andMe, delivers her keynote at the 2008 Bio-IT World Conference & Expo in Boston, April 30, 2008.
View the webcast.
The Future of Personal Genomics
A distinguished panel of personal genomics experts discuss the future of personal genomics at the 2008 Bio-IT World Conference & Expo in Boston, April 30, 2008. They include Dietrich Stephan (co-founder, Navigenics); George Church (Harvard Medical School); Jeff Drazen (editor-in-chief, New England Journal Medicine); Fred Ledley (Bentley College); John Halamka (CIO, Harvard Medical School); and Linda Avey (23andMe). Bio-IT World Editor-in-Chief Kevin Davies moderates the discussion.
View the webcast.
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| Contact the Editors |
Contributing Editor Deborah Borfitz covers development planning and protocol design; investigative site selection and management; and patient recruitment and retention.
Contributing Editor Ann Neuer covers project management, operations, and outsourcing, as well as data collection, data management, and electronic data capture. Ann has been writing in the clinical trials sector since 1995. |
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| eCliniqua Archives |
BRIDG Moves Toward Double Layer of Semantics
Sept. 29, 2008
More Archives.
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