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Bio-IT World Clinical Trials Survey Results 
This brief survey is intend to provide insight into three areas: 
• Key clinical process challenges facing the industry 
• Trends in cloud computing usage and projects growth within the clinical sector 
• Usage of outsources services and projected growth 

Access Survey 

January 23, 2012 
Contact the Editor 
We invite your comments and feedback for this edition of Weekly Update. 

Allison Proffitt 
Managing Editor 


Budget Woes Stall Clinical Trials and Stymie Sites 
Bio-IT World (Feb 20 2012) Trial Design and Logistics 

Imagine buying a new car or a new house but not knowing the price until the papers have already been drawn up and it’s time to sign on the dotted line. According to Christine Pierre, President of RxTrials, that’s exactly the situation investigative sites face as they attempt to negotiate budgets and contracts for clinical trials.

How Does Big Pharma Boost Its Returns? 
Fool.com (Feb 19 2012) Electronic Data Capture (EDC) 
Break it down with the DuPont Formula.
Deadly bird flu studies to stay secret for now: WHO 
reuters.com (Feb 17 2012) Electronic Data Capture (EDC) 
GENEVA/LONDON (Reuters) - Two studies showing how scientists mutated the H5N1 bird flu virus into a form that could cause a deadly human pandemic will be published only after experts fully assess the risks, the World Health Organization (WHO) said on Friday.


Why Bristol-Myers Squibb Could Break Out This Year 
The Motley Fool (Feb 15 2012) Electronic Data Capture (EDC) , Trial Design and Logistics 
Why Bristol-Myers Squibb Could Break Out This Year
How to Successfully Repurpose a Drug 
WSJ Blogs (Feb 14 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics 
As today’s WSJ reports, there is growing interest in running clinical trials that repurpose drugs that have already won FDA approval for another disease.
FDA unveils biosimilars guidance 
Nature Publishing Group (Feb 9 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics 
Move could open the door to cheaper generic versions of biological drugs.
Craig Lipset on the Recruitment Mind Shift 
Applied Clinical Trials (Feb 9 2012) Trial Design and Logistics 
REMOTE is the first-ever ran­domized clinical trial under an in­vestigational new drug (IND) application in which the study is managed entirely us­ing electronic tools and allows subjects to participate in the clinical trial regardless of their proximity to clinical sites. Pfizer’s pi­lot project uses mobile phone and Web-based technology to collect necessary data for the trial, without clinic visits. The trial was announced last June. And this month  ACT, Editor-in-Chief Lisa Henderson talked t
Researchers defend benefits of mutant flu research 
Nature Publishing Group (Jan 25 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics 
A dire lack of global virus surveillance doesn't negate the potential of mutation monitoring, argue two researchers behind the mutant flu research.


Picture Perfect: Imaging in Drug Discovery and Translational Medicine 
Bio-IT World (Feb 7 2012) Market Insights , Trial Design and Logistics 
Bio-IT World | Imaging in drug discovery has been rising to the forefront of conversations more and more recently. Managing editor Allison Proffitt spoke with Ken Kilgore, Director of Immunology Pharmacology at Janssen Research & Development (formerly Centocor Research & Development), a Johnson & Johnson company, about how—and why—imaging’s role is changing in drug discovery.
Dana-Farber lands $10M for cancer research 
Business News (Feb 1 2012) Trial Design and Logistics 
Dana-Farber Cancer Institute has been awarded a $10 million grant rom the Massachusetts Life Sciences Center to support the expansion of its cancer imaging research program, Mass High Tech reports. Funding for the grant comes from the state’s 10-year, $1 billion Life Sciences Initiative. The money will support the establishment of Dana-Farber's Molecular Cancer Imaging Facility, a $20 million research initiative in South Boston to develop new molecular imaging probes. As MHT reports, the imaging facility will expand several of Dana-Farber’s basic and clinical research enterprisesfocused on developing targeted cancer therapies.
Bush Doctrine: The Pharmaceutical Safety Data Problem 
Bio-IT World (Jan 27 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics 
Bio-IT World | The Bush Doctrine: What the industry calls “safety data” covers everything from discovery-oriented in vitro or cell based studies to extensive GLP toxicology study data, voluminous clinical study records, and post-marketing/pharmacovigilance systems. It leads one to wonder: does anyone have informatics systems that allow safety investigators across the pharma enterprise to effectively mine this ocean of information?
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