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Industry Trends
Clinical Research Off-shoring
By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore. Read more.
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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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| IN THIS ISSUE |
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Lilly: New Operating Model will Speed Tailored Therapies to Market |
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Studies May Soon be Monitored Less Frequently-or From Afar |
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News Briefs |
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PIPELINE MANAGEMENT
Lilly: New Operating Model will Speed Tailored Therapies to Market
By Deb Borfitz
 As of this year, Eli Lilly and Company is converting to a new operating model designed to streamline drug development and better "capture the value" of a record-setting number of new medicines in its pipeline. The enablers include a flexible project management approach, routine use of advanced analytics and adaptive trial designs, and a focus on tailored therapies, says Tom Verhoeven, PhD, senior vice president and co-leader of the Development Center of Excellence.
The fresh approach has integrated all clinical specialties and capabilities necessary to bring innovative medicines to market, says Verhoeven, including the newest functions associated with analytics and medicinal tailoring. "We're not just changing the organizational chart; we're building a system that allows [functional] groups to coordinate activities with each other on a single process map across study phases and even post-approval." Read more.
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STUDY MONITORING
Studies May Soon be Monitored Less Frequently-or From Afar
By Deb Borfitz
A two-year-old question could get answered this year when the Clinical Trials Transformation Initiative (CTTI) publishes a position paper on how best to improve trial monitoring. "The document will be the stance of the public-private partnership's thinking on the matter that could lead to new FDA monitoring guidance, says Mark Behm, compliance advice and assurance regional director at AstraZeneca and member of a CTTI monitoring work stream.
The last significant guidance on monitoring practices was updated by the FDA in 1998, says Behm. In the interim, clinical research has grown into a more complex, multi-national enterprise routinely aided by external service providers and technologies like electronic data capture (EDC) and e-diaries. It has also, from time to time, attracted negative media attention and a sizable up-tick in regulatory enforcement activity, turning FDA inspections and Warning Letters into key shapers of industry thinking about what is and isn't permissible in regards to monitoring. Read more.
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Most-Read Story from Previous Issue
Oracle Clinical Development Analytics Could be Game Changing
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Standard versus Priority Designation Trends 2009: A Look at Prevalence
From the U.S. Regulatory Reporter
As CDER's output of new molecular entity (NME) approvals dipped slightly in 2009, so did the prevalence of priority review designations among the approved drugs. Only 30% of the NMEs cleared by CDER in 2009 had obtained the coveted priority review status, the lowest rate in eight years (since the 29% rate in 2001).
To read the full article, subscribe to the U.S. Regulatory Reporter.
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LIFE SCIENCE JOBS
The University of Washington Department of Genome Sciences is seeking a LINUX SYSTEMS ENGINEERING MANAGER to lead a team in a diverse scientific computing environment that includes multiple HPC systems, petascale storage, and custom application servers. Apply online at UW Hires for req number 61505. http://www.washington.edu/admin/hr/jobs/
To have your job openings featured here, contact Lynn Cloonan for more information.
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SPONSORED LINKS
To have your product or service featured here, contact Lynn Cloonan for more information.
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Insight Pharma Reports 
Inflammatory Disorders: Therapies That Suppress or Balance the Immune Response
Author: Lucy J. Sannes, Ph.D., MBA
The human immune system can go awry, either attacking an individual's body or producing an exaggerated response to a foreign substance that is normally benign. In these situations, immunotherapies are needed to balance or suppress the unwarranted immune response. This report reviews the problems of insufficient efficacy, side effects, and adverse events associated with the small-molecule and biological drugs available today to treat these disorders. Read more .
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FEATURED EVENTS
- Risk Management Free Symposium, March 2, 2010
- Electronic Data in Clinical Trials, March 8-9, 2010, Philadelphia
- eCTD 2010 - One Day Forum, March 10, 2010, Philadelphia
- Summit for Clinical Ops Executives (SCOPE) - March 8-11, 2010 | Philadelphia
- Drug Development Latin America, March 10-11, 2010, Philadelphia
- Bio-IT World Conference & Expo • April 20-22, 2010, World Trade Center •Boston, MA
- Best Practices Awards Dinner and Ceremony | April 21, 2010 | Boston, MA
- The Post -Approval Summit, May 11-12, 2010, Boston,MA
- Beyond Sequencing Strategies for Success, June 22, 2010, San Francisco, CA
- Bio-IT World Web Symposia Series
- Barnett Educational Services
- Cambridge Healthtech Events
To have your event featured here, contact Lynn Cloonan for more information.
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| eCliniqua Reader Survey |
eCliniqua is conducting a brief survey to gather information on the eCliniqua eNewsletter and its companion web site, eCliniqua.com. Access and complete the survey and your name will be entered into a drawing to receive a $10 Starbucks gift card. Thank you in advance for your participation.
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eCTD 2010
March 10, 2010 | Philadelphia |
The inaugural eCTD conference-- hosted by CHI, Bio-IT World, and eCliniqua-- will cover how to achieve efficiency & compliance in electronic formats.
A sampling of featured presentations:
- How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions
- Global Submission Management from Concept to Realization
- Taking eCTDs off the Critical Path to Drug Development
- Electronic Signatures & Regulatory Processes, What Agencies are Saying
View conference details and register today. Mention key code ECL & save $300 off your registration!
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Best Practices Awards Dinner and Ceremony
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Accepting Dinner Reservations!
The Bio-IT World Best Practices Awards Networking Reception and Dinner recognizes individuals and teams for their novel and innovative uses of technology, business strategies, and solutions that will advance drug discovery, development, biomedical research, and clinical trials.
The Awards Dinner is scheduled for Wednesday, April 21, 2010 at the World Trade Center, Boston. Please join us for this special event. Book your dinner reservation(s) today!
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| FEATURED CONTENT |
Curing Life Sciences Data Management  Challenges with Scalable Storage High performance storage systems are a given to meet today's life sciences R&D computational challenges. But with the explosive growth in data produced by next-gen lab equipment, scalability and long-term data management issues must also be addressed. . Download Whitepaper (Sponsored by: Panasas)
StorNext 4.0: Technical Product Brief
Proven in the world's most data intensive industries, Quantum StorNext is a scalable, high-performance file system which allows data sharing across Linux, Mac, Unix, and Windows operating systems and manages data in enterprise storage environments. Download Whitepaper (Sponsored by: Quantum )
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
Moore's Law and the Future of Genome Sequencing
Guest: Jonathan Rothberg, Ph.D., Founder/CEO Ion Torrent Systems; Founder Curagen, 454 Life Sciences, Rain Dance
Editorial inteview conducted by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World with Jonathan Rothberg reflecting on the past decade of his accomplishments and a glimpse at his new project, Ion Torrent Systems. Interview conducted at CHI's Exploring Next Generation Sequencing conference in September 2009. Download Now .
Oxford Nanopore's Third-Generation Sequencing Technology
Guest: John Milton, Ph.D., Vice President Research, Oxford Nanopore Technologies UK
Editorial interview conducted by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World with John Milton that offers insights into Oxford Nanopore's potentially revolutionary new sequencing technology, which marries exonuclease cleavage of DNA and protein nanopores. Interview conducted at CHI's Exploring Next Generation Sequencing conference in September 2009. Download Now .
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