Editor’s Note: A Year of Tumult
By John Russell

If you think of the ‘business year’ as an annual race extending from Labor Day to July 4 -  followed by a brief summer pause to reset for the next race – this year the economy trampled all other contenders. Budgets shrank. Clients retrenched. Untouchables weren’t. Whatever your plan of attack was on September 1, by January 1 it wasn’t.

This made for an interesting first year for Predictive Biomedicine. It served as a brutal reminder of the power of the economy over technology. Much of PB’s coverage was caught in the maelstrom. Several stories first presented with rosy expectations, later took unexpected darker turns. Yet the steady advance in predictive approaches to drug discovery and development was also captured in PB coverage. More.

Microsoft Names Les Jordan as BioIT Alliance Director
By Kevin Davies

Microsoft has appointed Les Jordan, industry chief technology strategist for Microsoft’s life sciences team, as the new director of the BioIT Alliance. He succeeds Rudy Potenzone, who recently left Microsoft, leaving some momentary uncertainty in his wake as to the fate of the three-year-old industry consortium. More.

Will Regulated Product Submission (RPS) Trump eCTD?
By Ann Neuer

Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions (Learning to Embrace the eCTD, Bio-IT World May/June 2009), the Food and Drug Administration (FDA) is changing the game. FDA is planning to implement an agency-wide standard known as Regulated Product Submission (RPS) that is expected to replace eCTD. More.

Top Story Last Issue
Remodeling the FDA
By John Russell

Very soon, FDA will restart its End of Phase 2A (EOP2A) meeting program during which sponsors and FDA collaborate often using modeling and simulation (M&S) – pharmacometrics (PM) in FDA parlance – to analyze current data, refine clinical trial design and to inform industry’s critical go/no-go decisions on projects. More.

Short News & Analysis

(Click For Full Briefs)

Entelos Retains Seven Hills Partners
Seven Hills is assisting the Company’s Board of Directors and senior management in evaluating various strategic alternatives..

Ingenuity and Integromics Integration For Genomics Analysis
The companies announced the integration of RealTime StatMiner and Integromics Biomarker Discovery (IBD) for Tibco Spotfire.. 

BioSeek and Merck Serono Extend 2008 Agreement
BioSeek will continue to use its proprietary BioMAP platform to evaluate Merck Serono small molecule compounds and..

LIFE SCIENCE JOBS

Manager, Scientific Computing & Programming (Bioinformatics Manager)
SAIC-Frederick, Inc has an exciting opportunity for a Manager, Scientific Computing & Programming - Core Genoytyping Facility in Gaithersburg, Maryland.  In this role, you will lead the Bioinformatics & Analysis Group.  Master’s or equivalent required.  PhD preferred. Six years experience in development of scientific programs in high-performance computing environment including five years supporting scientific research in computational chemistry, biology, or genetics, & two years supervisory experience.  View complete job posting & apply: www.saic-frederick.com. Position #146945. 

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

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Insight Pharma Reports

Direct-To-Consumer Genetic Testing: Business Prospects in the United States 
Author: Kathie L. Wrick, Ph.D 

Genetic testing has come a long way since the development of the first genetic test in 1963. According to NIH, almost 1,500 genetic tests are now in use. This report focuses on health-related decision making applications of DTC genetic tests and examines various components of this emerging business environment. Read more.

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ClinicalTrialsArena.com, Tuesday 30 June - Wednesday 1 July 2009, Virtual Event

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