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What’s Wrong with Biomarkers?

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John Russell
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Remodeling the FDA 
Chris Dagdigian's Plenary Keynote: Bio-IT World Expo '09
IBM's Sunny Forecast for Clinical Cloud Computing 
Network Biology 2.0 Symposium Attracts Prominent Lineup 
Short News & Analysis

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. Significantly, the reason the pilot EOP2A was halted in 2007 wasn't so much to absorb its early lessons, though that was important; it was also because rising demand for PM reviewers on NDA (new drug application) approval decisions meant there simply weren't enough PM resources to go around.  

In a bit more than a decade, pharmacometrics at FDA has grown from a small effort that was regarded with early skepticism and whose activities were mainly restricted to population PK questions into one of the agency's most promising priorities. A small cadre of champions, some immediately recognizable (e.g. Dr. Lawrence Lesko, Director, Office of Clinical Pharmacology) and others toiling quietly in the trenches, have worked steadily inside FDA to prove PM's value and to coax the agency to embrace it. Joga Gobburu (r) leads the effort now. More.

World Pharmaceutical Congress - June 9-11, 2009

Chris Dagdigian's Plenary Keynote


IBM's Sunny Forecast for Clinical Cloud Computing
By Deb Borfitz

An increasing number of the top life science companies are considering a switch from the outright acquisition and customization of e-clinical technologies to establishing and accessing "clinical clouds." Indeed, it may be the only sensible way to access needed software and information as they engage in more collaborations, alliances, and partnerships to weather the "perfect storm of unprecedented challenges" bearing down on their collective bottom line, says Paul Papas, the Americas life sciences leader for IBM Global Business Services. More.


Top Story Last Issue
Network Biology 2.0 Symposium Attracts Prominent Lineup

By John Russell

The roster of speakers at last week's Network Biology 2.0 symposium, sponsored by Gene Network Sciences (GSN) and the Broad Institute and held at the Broad, featured some of the most influential people in systems biology and personalized medicine -- Jim Collins, George Church, Mark Boguski, and Peter Sorger to name but a few. Eric Schadt was scheduled but a last minute conflict caused a switch and he was ably stood in for by his former Merck/Rosetta colleague Jun Zhu. More.


Short News & Analysis

(Click for Full Briefs)

Genedata Launches Expressionist 5.2
Expressionist 5.2 has enhanced capabilities for Mass Spectrometry (MS)-based biomarker discovery..

Definiens Improves Accuracy in Her2/neu Biopsy Scoring
Definiens completed a feasibility study for the evaluation of the Her2/neu protein in breast cancer biopsies..

GE Healthcare launches IN Cell Investigator v1.5
New features of IN Cell Investigator v1.5 facilitate: whole well analysis, the generation of a panoramic image..

GNS Announces Cancer Collaboration with UCSF
GNS and UCSF have already utilized REFS to discover and validate novel mediators of the cell cycle transition..

Genologics, SAS to Integrate Products
GenoLogics and SAS plan to integrate the Geneus lab and data management with the JMP Genomics statistical discovery..
Entelos Proposes Delisting from AIM
Entelos is seeking stockholder approval to cancel the trading of its shares of common stock on the AIM Exchange..

Plectix Introduces Insulin Signaling Tool
Plectix BioSystems introduced Insulin Signaling cBook in Cellucidate, a web-based workspace for cell biology..

(Click for Full Briefs)



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: Position #146945.

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



Electronic Notebook: Streamline experimental IP; capture and re-use data; enhance collaboration.

Learn how you can Accelerate Data Management Application Development 10x 

Secure Web Conferencing-Complimentary Webinar 

Translational Research-Editorial Report

Novoseek, the biomedical search engine based in text mining technology.

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

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.



Advances in Oncology Drug Development: Linking Drug Response Phenotypes to Multiplex Molecular Signatures, Thursday, June 18th, 2009

DIA 45th Annual Meeting, June 21-25, 2009, San Diego, CA
Insight and Innovation: Novel Approaches to Safety Pharmacology and Toxicology in the 21st Century
 - Tuesday, June 23rd, 2009, Tuesday 30 June - Wednesday 1 July 2009, Virtual Event

Barnett Educational Services 

Cambridge Healthtech Events 

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

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Bio-IT World Europe

Bio-IT World Europe builds on the strong success of CHI's U.S. Bio-IT World Conference & Expo, which takes place in Boston each Spring. We are pleased to announce the inaugural European event co-located with BIOTECHNICA -- Europe's No. 1 event in Biotechnology and Life Sciences with a total of 16,000+ participants. 

Bio-IT World Europe will continue uniting life sciences, pharmaceutical, and IT professionals to share ideas and innovation through networking and education.  

Conference Tracks are:  Hardware for the Life Sciences; Bioinformatics for Genomics; IT Software for the Life Sciences; and Data Integration and Knowledge Management.  Download a conference brochure today.

What's Wrong with Biomarkers?What’s Wrong with Biomarkers?
Sponsored by: Definiens

The hype around biomarkers has reached such a fever pitch that it risks provoking a backlash among needed constituencies such as payers, physicians, and patients. No one doubts biomarkers' long-term value, but many obstacles remain, and that time still seems distant. Read this in-depth analysis in which distinguished experts examine biomarker challenges.Access the Paper

Protecting Intellectual Protecting Intellectual Property Property
Sponsored by: IDBS 

Intellectual property (IP) remains one of the most important assets of any commercial entity. Historically, paper has been used to establish, maintain and defend IP, but as industry becomes increasingly digital, new tools must be used to ensure IP protection. In this white paper we explore the issues facing patent creation and defense in the electronic age and discuss the tools and functionality required to protect innovation. Access the Paper 


Scientific Data Lifecycle Management: Preparing for Storage in an Uncertain Future
Sponsored by:BlueArc

Managing vast and overwhelming streams of gene sequencing data today requires ultra-high performance systems and processes. With continued rapid advancement and improvements in gene sequencing, expect tomorrow's instruments to output quantities of genomic information that will dwarf current levels. Help your organization maintain data control and prepare for the future of sequencing through this informative paper that discusses:

The information technology challenges of gene sequencing
"Intelligent" methods for data management and customization
System survival tips... Deciding what data to keep or delete
New tools to keep scientists ahead of impending data torrents. Download the Paper 

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


NEW! Life Science Webcasts from Bio-IT World and Cambridge Healthtech Media Group
Life Science Webcasts
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.?" When the Resounding Health "brain" achieves a critical mass of validated and important connections, "we will have in effect crowdsourced a revolutionary new, e-patient-friendly textbook of personalized medicine and customized care." View the webcast.

Open Source Models for Personalized Medicine
Through the company he founded, CollabRx, Jay "Marty" 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. 

Modeling Caloric Restriction
Using their causal network modeling (CNM) platform, Renee Kenney and her team at Genstruct helped Sirtris Pharmaceuticals model how two of their SIRT1 compounds worked and show that one compound in particular is much more potent at mimicking caloric restriction than resveratrol, an active ingredient in red wine.
 View the webcast. 

Paul Bleicher, Looking Back at Phase Forward
After founding Phase Forward more than a decade ago and serving as Chairman until late last year, Paul Bleicher has had a prime perch from which to observe and drive change in the e-clinical industry. In this exclusive Life Sciences TV Webcast to mark his decision to step down as Chairman last year, Bleicher looks back with Bio-IT World Editor Kevin Davies on a decade of achievement and hints at his next venture in the health care arena.
 View the webcast.


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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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