Predictive Biomedicine -- Informatics tools and strategies driving decisions 
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We invite your comments and feedback for this edition of Predictive Biomedicine.
 
John Russell
Executive Editor

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IN THIS ISSUE 
Editor’s Note: A Year of Tumult 
Microsoft Names Les Jordan as BioIT Alliance Director 
Will Regulated Product Submission (RPS) Trump eCTD? 
Remodeling the FDA
Short News & Analysis
 
  
 

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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Bioinformatics and Computational Biology: Bottlenecks and Options

PAREXEL Bio/Pharmaceutical R&D Statistical Sourcebook 2009/2010

Bio-IT World 2009 Conference on DVD … Presentations, Posters, and more.

To have your product or service featured here, contact Lynn Cloonan for more information.

 

Insight Pharma Reports

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

Direct-To-Consumer Genetic Testing: Business Prospects in the United StatesGenetic 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.

 

FEATURED EVENTS

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

Bio-IT World Europe Conference co-located with BIOTECHNICA, Oct 6-8, 2009

Barnett Educational Services 

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FEATURED CONTENT

Biomarkers: An Indispensible Addition to the Drug Development Toolkit
Examining the Potential of Biomarkers.  This white paper provides insight from experts in industry and academia, and explores the role of biomarkers as evaluative tools in improving clinical research and the challenges this presents. (Sponsored by Thomson Reuters)


Scientific Data Lifecycle Management: Preparing for Storage in an Uncertain Future
Help your organization maintain control over vast and overwhelming streams of data and prepare for the future of sequencing through this informative paper. Download the paper    (sponsored by BlueArc)

 
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Developing, executing and managing the transformation, analysis and submission of clinical research data with SAS® Drug Development. Download the paper   (sponsored by SAS)

 
What’s Wrong with Biomarkers?
No one doubts biomarkers’ long-term value, but many obstacles remain. Read this in-depth analysis in which distinguished experts examine biomarker challenges, failures, barriers, and need for standards. 
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Protecting Intellectual Property 
In this white paper we explore the issues facing patent creation and defence in the electronic age and discuss the tools and functionality required to protect innovation.  Access the Paper (sponsored by IDBS)

To have your white paper featured here, contact Lynn Cloonan for more information.
EXCLUSIVE WEBCAST

NEW! Life Science Webcasts from Bio-IT World and Cambridge Healthtech Media Group
Life Science Webcasts
NEW!
Chris Dagdigian Talks Trends
At the Bio-IT World Conference & Expo, Chris Dagdigian talked about the old news, breaking news, and future of bio-IT. Get his perspective on what's overhyped and what's worth the buzz. View the webcast.

NEW!
The Future of Personal Genomics
An expert panel candidly discussed the future of personal genomics and what that means for both companies and consumers at the Bio-IT World Expo. Clifford Reid (Complete Genomics), Philip Reilly (3rd Rock Ventures), Dietrich Stephan (Navigenics), Robert Green (Boston University), John Halamka (Harvard Medical School), and Jorge Conde (Knome), give their unique perspectives on how this emerging industry could change medicine. View the webcast.

Boguski's Resounding Health
Mark Boguski is launching a new direct-to-consumer Internet search firm called Resounding Health and he tells Bio-IT World Editor, Kevin Davies, all about it. His goal is to create value-adding process networks to provide the most cost-effective management of chronic diseases in the near future. View the webcast.

Open Source Models for Personalized Medicine
Through the company he founded, CollabRx, Jay Tenenbaum aims to leverage the extraordinary untapped expertise and resources across the industry to empower individual patient health care through personalized research. View the webcast.

P.B. ARCHIVES

View the Predictive Biomedicine newsletter archives here.

Cambridge Healthtech InstitutePublished by Cambridge Healthtech Media Group, division of CHI, Copyright © 2009; All rights reserved. Predictive Biomedicine may not be reproduced, electronically or in print, by any means, mechanical or electronic, in whole or in part, without written permission of Cambridge Healthtech Media Group, 250 First Ave., Suite 300, Needham, MA, 02494. 
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