PATIENT SAFETY
SAS Takes Lifecycle View of Patient Safety Data
By Ann Neuer

The pharmaceutical industry and regulatory agencies are sharpening their focus on patient safety through intense efforts to improve the way safety data are collected, analyzed, and interpreted. And there is a long way to go, says Jason Burke, global director of the health and life sciences market segments at SAS. “Today, most organizations do separate analyses for drugs before and after approval. This is a challenge because it may not be obvious how the lifecycle of a drug looks when safety analyses are conducted using separate pre- and post-approval processes and systems,” Burke explains.

A comprehensive lifecycle view of the safety performance of a drug is what is needed to provide a more repeatable, standardized, and auditable approach for exploring safety signals. The FDA is steering the market in this direction with the release of various guidances intended to improve how the agency disseminates safety information, how adverse events are to be reported, and how reviewers are to conduct the clinical safety reviews for the new drug application (NDA) and biologics license application (BLA) review processes. There is also the Sentinel Initiative, launched by the FDA in May to develop a national strategy for monitoring medical product safety, a nod to the emerging science of safety. Read more.

PATIENT RECRUITMENT
Acurian: Bigger Database, Better Results
By Deborah Borfitz

In the U.S., the chief challenge of recruiting patients into clinical trials is not disinterest but “putting information in front of people so they can make a choice,” says Rick Malcolm, CEO of Acurian. It is a task that the Horsham, PA-based patient recruitment firm has clearly mastered after more than a decade in the business.

Over the last three years, Acurian’s opt-in database of self-reported chronic disease sufferers has grown from eight million to more than 50 million patients, and half a million of them have been screened for trial participation, says Malcolm.

The majority of patients were added to the database via exclusive partnerships with a handful of large health data aggregators, says Malcolm. The patients include both survey respondents who opted broadly to receive health information about their medical condition and those who opted specifically for information about clinical trials. The rest of the database is populated with visitors who have registered their interest in trials at the Acurian website. Virtually all patients reside in the U.S. Read more.

Duke Goes with Alphadas for its Early Phase Trials
By Deborah Borfitz

Accurate and timely data collection has always been critical to subject safety in first-in-human clinical trials. It is even more so now that a growing proportion of the Phase I study population are patients with serious medical conditions rather than healthy volunteers.

With that in mind, Duke University Medical Center made a decision earlier this summer to license the electronic data capture software of London-based Logos Technologies. The Alphadas system is especially well designed for the complexities of early phase trials, says Barry Mangum, PharmD, FCP, director of clinical pharmacology for Duke Clinical Research Unit (DCRU) and associate professor of clinical pharmacology at the medical center. “We can understand the safety profile [of compounds] earlier than we ever could have before.” Read more.

LIFE SCIENCE JOBS

Isilon Systems ~ Senior Marketing Communications Manager
Isilon Systems is the worldwide leader in clustered storage systems and software for digital content and unstructured data. We seek an experienced marketing communications professional/writer expert in creating and delivering effective and persuasive business communications. The ideal candidate can think at the strategic and conceptual level and act, simultaneously, as a highly-effective and productive individual contributor. The position is based in Seattle, WA. For additional information click here

Lilly Singapore Center for Drug Discovery (LSCDD) - Associate Director of Informatics,
Lead and mentor a strong team for the Bioinformatics group at the Integrative Computational Sciences (ICS) department at LSCDD towards the development of novel algorithms, data analysis methods and software tools for drug discovery. Work closely with the Software Engineering group at ICS, and collaborate with the Discovery IT organization in Europe and USA. For additional information, or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery (LSCDD)- Senior Bioinformatics Scientist,
Contribute to the development of novel algorithms, data analysis methods and software tools for drug discovery as part of the Integrative Computational Sciences (ICS) department at LSCDD. Work closely with informatics and software engineering peers at ICS, and collaborate with the Discovery IT organization in Europe and USA. The successful candidate will offer hands-on insight and expertise in tailored therapeutic informatics and statistical analyses at the post-genomic era. For additional information, or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery (LSCDD) - Manager, Software Engineering (Integrative Computational Sciences)
Join the Integrative Computational Sciences (ICS) department at Lilly Singapore Centre for Drug Discovery (LSCDD),as Manager Software Engineering. Lead the development of integrated applications to process and visualize data from cutting edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. Masters in Computer Science/Engineering or related discipline, 10+ years post graduation experience , 2 years management experience needed. For a complete job description and requirements or to apply visit: LSCDD

Lilly Singapore Center for Drug Discovery(LSCDD) -Senior Software Engineer,
Join a strong team of software engineers in our Integrative Computational Sciences (ICS) at LSCDD. Collaborate with, and help develop integrated applications to process and visualize data from cutting-edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. The Software Engineering team provides computational tools and tailored software solutions that enable the global effort of Tailored Therapeutics; ‘The Right Drug, at The Right Dose for The Right Patient at The Right Time'. For additional information, or to apply visit: LSCDD

Memorial Sloan-Kettering Cancer Center - Linux Systems Administrator
MSKCC Bioinformatics Core in Manhattan seeks Linux Systems Administrator. Install, configure, update, monitor and troubleshoot HPC cluster, email and web servers. Bachelor's degree and 3 years experience with HPC, network security, Postfix, Apache, Tomcat, Grid Engine, Solaris. Email [email protected] orwww.mskcc.org #015429. EOE/AA

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FEATURED EVENTS

ELNs: Advanced Laboratory Solutions-September 15 - 17 2008 • Crowne Plaza, Brussels, Belgium

Discovery Knowledge & Informatics - September 15 - 17, 2008 • Crowne Plaza, Brussels, Belgium

Multiplexed Genomics Tools: Targeting the Missing Links
Between Health and Disease - September 21-23, 2008 • Providence, RI

Next-Generation Sequencing Data Analysis -September 22-23, 2008 • Providence, RI

DIA 2nd Annual Clinical Forum: Data Driven Drug Development Decisions - October 20-23, 2008 | Ljubljana, Slovenia

Barnett Educational Services, 2008 Schedule

To have your event featured here, contact Lynn Cloonan for more information.