January 23rd, 2012

CLINICAL NEWS & ANALYSIS

Remedies for Safer Drugs Bio-IT World (Jan 21 2012) Regulatory Issues & Drug Safety Pharmacovigilance experts have an abundance of signal detection tools to sift through large quantities of data seeking causal relationships between adverse events (AEs) and experimental drugs. They also have an assortment of data mining tools capable of finding statistical associations suggestive of problems regarding approved drugs. All this technology is intended to safeguard clinical trial participants, patients, and the reputation of recall-weary drug developers. But drug safety specialists can’t be sure which technology or signal detection method is best.
Medidata: Integrating Infrastructure for Clinical Trials Bio-IT World (Jan 18 2012) Electronic Data Capture (EDC) , Regulatory Issues & Drug Safety ,Trial Design and Logistics Bio-IT World \| Glen de Vries thought he would be teaching biology or chemistry in college, but somewhere en route to a satisfying career in academic research, he got distracted. Bio•IT World chief editor Kevin Davies spoke to de Vries about the progress of Medidata and the state of e-clinical technology in general.
Biodesix Receives New EU and US Patents for Blood-based Oncology Tests businesswire.com (Jan 9 2012) Market Insights Biodesix has announced the issuance of three additional patents which provide intellectual property protection for head and neck tests, lung cancer patient selection, and monitoring.

ELSEWHERE IN THE PRESS

FDA Has (Some) Social Media Advice For Pharma
WSJ Blogs (Jan 9 2012) Regulatory Issues & Drug Safety , Trial Design and Logistics
Last month, the FDA released draft guidance on "responding to unsolicited requests for off-label information about prescription drugs and medical devices."

Knome’s New CEO Signals New Directions in Genome Interpretation
Bio-IT World (Jan 9 2012) Trial Design and Logistics
Bio-IT World | Knome, the first company to offer direct-to-consumer genome analysis, has appointed neurologist and biotech executive Martin Tolar as its new CEO as it seeks to push further into two prime markets for genome interpretation software -- biopharma and clinical genomics.

FDA Releases Social Media Guidelines
Bio-IT World (Jan 9 2012) Regulatory Issues & Drug Safety
News Brief | The Food and Drug Administration has released its guidelines for how pharma companies use social media to respond to questions about off-label use of drugs and devices. But they're still not as comprehensive as many hoped for.

Bristol-Myers buying Inhibitex for $2.5 billion
MarketWatch (Jan 8 2012) Trial Design and Logistics
Bristol-Myers Squibb purchasing Inhibitex, a specialist in hepatitis C treatments, for $2.5 billion

Expect Measurable ROI of Innovation in 2012
Bio-IT World (Jan 5 2012) Trial Design and Logistics
In 2011, biopharma sponsors continued to rely on an increasing number of contract research organizations (CROs) and eClinical technology solutions to support the research of drugs and related devices. Biopharma sponsors’ most precious asset: controlled access to clinical data throughout the course of trials, became more crucial and challenging than ever. Setting the stage for 2012, CROs are now not only responsible for executing studies and helping analyze and evaluate clinical data, but also offering access to data from all trials in one location.

ELSEWHERE IN THE PRESS

Quintiles consolidates patient communities into new Digital Patient unit
pmlive.com (Jan 6 2012) Trial Design and Logistics
Contract research organisation Quintiles has combined its digital patient resources, including two online patient communities, into a single unit. The company’s new Digital Patient unit will bring together MediGuard.org and ClinicalResearch.com to offer its pharma clients a more efficient patient recruitment service.

Lilly projects sharp drop in 2012 profit
reuters.com (Jan 5 2012) Trial Design and Logistics
(Reuters) - Eli Lilly & Co forecast a sharp plunge in profits for 2012, the first full year its top-selling Zyprexa schizophrenia treatment faces generic competition, and its shares fell as much as 3.6 percent.

Flurry Of Cancer Pacts
Chemical & Engineering News (Jan 3 2012) Market Insights
The year 2011 ended with multiple acquisitions and research partnerships through which the drug majors Takeda Pharmaceutical, Merck & Co., Eli Lilly & Co., and AstraZeneca gain access to compounds that biotech firms are developing for the treatment of cancer.

New year, new science
Nature Publishing Group (Jan 2 2012) Trial Design and Logistics
Nature looks ahead to the key findings and events that may emerge in 2012.

Exclusive Webinar

Meeting Compliance Needs through Enhanced Management of Patient Data
Sponsored by: Dell

How can a data center manager best manage the vastly growing volumes of digital patient data? How long must it be stored? And how is this all done while making the data center highly efficient and rapidly available to those who need it? These topics, and others related to improving data center performance and scalability will be addressed through an informative webinar sponsored by Dell Compellent. Please join us for this live event, and participate by asking questions that can help solve some of your data center challenges.

Presenter: Colin Schmugge/Data Center Manager at Radiology, Ltd.

Moderator: Dr. Kevin Davies, Editor-in-Chief, Bio-IT World

Watch Today.