POST-APPROVAL RESEARCH

McClellan Envisions Lifecycle Approach to Drug Surveillance
By Catherine Varmazis

BOSTON | Rising drug development costs and public frustration about major drug recalls highlight the need for an active, post-market drug surveillance system, Mark McClellan told attendees at the recent Post-Approval Summit.

McClellan, former head of the FDA and currently chairman of the Reagan-Udall Foundation, said declining success rates in Phase III clinical trials are not always related to a drug’s effectiveness. Rather, he said, they can be attributed to the costs of following up on questions about the safety of drugs in particular settings, such as tracking down rare side effects, determining the effects of long-term use, and concerns about off-label use. Read more.

SYSTEMS INTEGRATION

Three Levels of Integration for Exco InTouch, Logos Technologies
By Deborah Borfitz

Speedier recruitment drives for Phase I studies is just the first of many benefits that will result from a multi-stage integration project under way between mobile messaging provider Exco InTouch and early-phase electronic data capture (EDC) and site automation specialist Logos Technologies.

The completed integration work allows the recruitment system housed in Alphadas, the electronic universe manned by Logos Technologies, to be tapped for suitable patients based on a protocol’s inclusion and exclusion criteria, explains Giles Wilson, the company’s business and operations director. Those patients are then sent a text message via Atlas, the short messaging service (SMS) tool of Exco InTouch. Patients respond to questions using their mobile phone, and the replies are immediately routed to site recruitment staff through Alphadas. Read more.

COMMENTARY

Using Technology to Get More Benefit from Kinetic and Dynamic Data
By Daniel Weiner, PharSight Corp.

Pharmacokinetic/pharmacodynamic (PK/PD) data managers and scientists involved in early drug development are being squeezed by several trends: an accelerating pipeline of candidate drugs emerging from discovery requiring in vivo PK evaluation; increasing demand for more elaborate and intensive PK/PD evaluations at earlier stages of development; and the FDA’s Critical Path Initiative which is calling for more use of PK/PD modeling.  As a result, leading companies are meeting these challenges by implementing a clinical pharmacology data repository that provides greater standardization and access to data and improves productivity by leveraging the time of scarce scientific talent. Read more.

• CDISC reports attendance increase at European Interchange event 
• City of Hope cancer center goes live using OmniComm EDC solution 
• CRO ACORN adds proprietary oncology-focused data to its information portfolio 
• Clinsys partners with Medidata Solutions through ASPire to Win program 
• Veeda Oncology selects ClinPhone's TrialWorks CTM system 
• Good Products launches clinical technology consulting services ... more 

LIFE SCIENCE JOBS

Friedrich Miescher Institute for Biomedical Research - Part of the Novartis Research Foundation
Basel, Switzerland is looking for a Head of IT Systems & Infrastructure. You will manage a cutting-edge core server and network infrastructure, comprising Linux and Solaris, as well as a robust Windows and Macintosh environment. We look forward to receiving your application: human.resources@fmi.ch. click for more information

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) -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 - Application Analyst
MSKCC Genomics Core seeks an Application Analyst to configure UNIX and Windows systems, maintain LIMS server and install analysis software. Requires a Master’s degree, UNIX experience, and knowledge of a language besides PERL beyond the beginning level. Email Jobops5@mskcc.org or www.mskcc.org #015563. EOE/AA

Memorial Sloan-Kettering Cancer Center - Bioinformatics Engineer MSKCC Bioinformatics Core in Manhattan seeks Bioinformatics Engineer. Design and develop bioinformatics
processing and analysis pipelines for traditional and next-gen sequence data. Consult with, train, and analyze data for researchers. Master's degree and 5 years experience in Bioinformatics software development, sequence assembly, SQL, Perl, Python. Email bic-jobs@cbio.mskcc.org or www.mskcc.org #015415. EOE/AA

Memorial Sloan-Kettering Cancer Center - Linux Systems Administrator - MSKCC Bioinformatics Core in Manhattan seeks Linux Systems Administrator. Install, configure and update OS, databases, software. Monitor and troubleshoot HPC cluster, email and web servers. Master's degree and 5 years experience with HPC, network security, Postfix, Apache, Tomcat, Grid Engine. Email bic-jobs@cbio.mskcc.org or www.mskcc.org #015429. EOE/AA

Paradigm-Sales/Business Development – IT Solutions and Services
Paradigm (www.Paradigminfotech.com) is a global IT services and solutions provider. Paradigm has over 1000 employees and is the recipient INC. 500 and D&T Fast 50 consistently.  Paradigm is looking for SALES / BUSINESS DEVELOPMENT PEOPLE.  Experience: 2-3 years Direct sales experience in Software Solutions or Services including Application development or support and preferably selling to Pharmaceutical, CROs or Health care industries. Location:Columbia, MD,Contact:  Erin Lowman, erin@paradigminfotech.com, 410-872-1008 x 100

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FEATURED EVENTS

Computing Short Courses at MIT - June / July - Cambridge, MA 

2nd Label-Free Protein Array- Latest Advances in Analysis of Macromolecular Interactions,July 3-4th 2008 -Paris- France

Barnett Educational Services, 2008 Schedule

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