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Wednesday, February 10, 2010      Email to a Friend  |      Visit us on Twitter 
  ISI's Approach to Tracking Regulatory Requirements 
  Counting Down to Bio-IT World Expo 2010 
  HTG Sets Sights on the FFPE Treasure Chest 
  News & Reports 
  Information On-Demand 

Regulatory Compliance Services 
ISI's Approach to Tracking Regulatory Requirements 

By John Russell 

Given the massive effort required to win regulatory approval for a new drug it is easy to understand the euphoria surrounding agency approval following an NDA submission and perhaps to forgive the sense the hard work is over. But for internal 'regulatory affairs' teams the work not only continues but intensifies. Ensuring compliance with post-marketing requirements is a daunting task for even one approved drug, let alone a portfolio of many. 

Whippany, NJ-based ISI, long a leader in submission software and consultancy services, has for the past few years also pushed into post-marketing services and tools. "The problem is there is all this information about what products are registered, for which markets, what the details for manufacturing are, etc.," says Kate Wilber, director of regulatory services at ISI, "and pharma companies are really having trouble pulling it all together. It's all a question of having theses little bits and pieces of information that are all part of the license approval."   Read more 


Counting Down to Bio-IT World Expo 2010 

We are less than three months away from the kick off to the 2010 Bio-IT World Expo in Boston, being held from April 20-22. All signs point to a brilliant event, with registrations pouring in and exhibitors scrambling for the final few booths. We hope you'll consider joining us. 

Confirmed keynotes include Christoph Westphal, co-founder and CEO of Sirtris Pharmaceuticals and senior VP for external drug discovery at GlaxoSmithKline, which snapped up Sirtris for a cool $700 million last year. 

Read more 

Last Issue's Top Story 
HTG Sets Sights on the FFPE Treasure Chest 

Locked up in the vast quantity of FFPE tissue collected over the years is a treasure trove of genomic information about patients. Now, High Throughput Genomics (HTG), a small company based in Tucson, believes it has the key to unlock that bulging treasure chest and to catapult itself into prominence as a company offering pharmacogenomics (Pgx) and diagnostic services and products.   Read more 



(Click for Full Briefs) 

BC Genomics Partners with Genpathway | Designed to offer whole-genome chromatin immunoprecipitation sequencing (ChIP-Seq) services, the alliance provides researchers investigating gene regulation and genetic pathways with a single source for services supporting genome-wide studies of transcription factor binding, gene transcription and epigenetic events.

Entelos Wins Patent | Simulation specialist Entelos says the methods strengthen the Entelos Metabolism PhysioLab and can improve diagnosis, clinical testing, and personalized treatment.

TTP LabTech Launches New Screening Service | Based around the company's HCS technology, the new service will provide clients with high-content data using cell-based assays for the investigation of various biological phenomena - including cell cycle, RNAi profiling, angiogenesis and signal pathway profiling.

Quotient Bioresearch Debuts New Website | The new website highlights the company's key focus areas of Chemistry and Metabolism, Clinical and Bioanalytical Sciences.

Peakdale Molecular, Pfizer Unveil Chem. Services Group | The new group will employ 50 scientists and provide developmental chemistry services for Pfizer and other pharmaceutical developers.

(Click for Full Briefs) 


StorNext 4.0: Technical Product Brief  
Proven in the world's most data intensive industries, Quantum StorNext is a scalable, high-performance file system which allows data sharing across Linux, Mac, Unix, and Windows operating systems and manages data in enterprise storage environments. Download Whitepaper   (Sponsored by: Quantum ) 

The Key to Life Sciences Data Management: 
Transparent Migration Life sciences organizations face new data management challenges as the volume of research data grows and more data is kept online for longer times. 
 Download Whitepaper (Sponsored by: BlueArc) 

Innovative tool allows Merging & Analyzing  Disparate Data for effective compound prioritization decisions  
Progressive new software has been released that enables discovery scientists to rapidly merge chemical and biological data together for effective compound prioritization decisions and communication among scientific team members.  Learn more by downloading this brief podcast: 

  • Save time 
  • Get the full view of your data 
  • Easily find compounds that meet multiple success criteria 

    Listen to the podcast 


Insight Pharma Reports
Multiplex Assays: Evolving Technologies, Applications, & Future Directions
Author: Ken Rubenstein, Ph.D. 

Multiplex Assays has generated a great deal of excitement in the past 15 years.  This report examines the role of multiplex and multi-analyte biomarker assays in translational medicine.  Read more . 

Industry Trends
The "Net Innovation Trend" and What it Means for Big Pharmas, Biotechs, and Generics 
By Mark P. Mathieu 

Innovation is the key value driver in healthcare. Over the past 8 years, the pharmaceuticals sector has lost a stunning $593 billion (-65%) in market cap while the two sectors with innovation - biotech and med tech - have each added $71 billion (+46%) and $19 billion (+6%) in market cap, respectively.
Read more 



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



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

Contact the Editor 
We invite your comments and feedback. Contact John Russell , Editor 

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