Microdoses of Excitement over AMS, 'Phase 0' Trials
By Mark D. Uehling

How did Speedel, a small Swiss biopharma company, shave off a third of the development timeline and budget for a renin inhibitor for heart disease? How did it confidently pick the best of three compounds to put into clinical trials? One word: microdosing.

Now microdosing has new federal backing. Last month, in January, three years after a similar blessing at the EMEA, the FDA published a final guidance on exploratory investigational new drug (IND) applications. A catchier term is "Phase 0." The FDA defines one such tool as "microdose studies," or human trials in perhaps six patients who receive no more than 100 micrograms and less than 1 percent of a standard dose of a drug under investigation. Based on the strength of microdosing data, regulators will allow radically shortened preclinical programs in some cases. more

Featured Events

2nd Annual Electronic Laboratory Notebooks - February 27-28,Philadelphia, PA

Bio-IT Best Practices Awards - Call for Entries - Early Bird Deadline February 28

PittCon - March 12 - 17, Orlando, FL

CBI's Drug Development – From Animal Models to Phase I; Pursue Quality Leads by Expediting PK/PD and Efficacy Data Collection -- April 10 - 11, 2006, Philadelphia, PA

Gene Therapy and Stem Cells Week, March 8 – 10, 2006, Cambridge, MA

Life Sciences Conference + Expo - April 3 - 5, Boston, MA

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Preventable Vioxx Problems?
By John Russell

Pathway analysis tools might have identified Vioxx's problematic off-target activity much earlier, argue authors of a fascinating review article in Current Opinion in Chemical Biology [1].

"[M]uch of the relevant pathway regarding this COX-2 inhibitor (refecoxib) side effect was available at the time of the clinical trials in 1999... This is where modern pathway databases can help to organize the scattered but essential pieces of information to facilitate efficient look-up of drug targets involved in multiple critical pathways," write Upinder Bhalla and colleagues from the National Centre for Biological Science, Tata Institute of Fundamental Research, Bangalore, India. more

Inside BG Medicine

By John Russell

Think Intel Inside, but instead of microprocessors, think industrial-strength experimental platforms, focused on all things omic, designed and even run by a third party, but living deep inside biopharmaceutical companies. Need high-volume, highly accurate proteomic or metabolomic data? No problem. Need to separate the signal from the noise? Can do. Worried about keeping pace with omic experimental technology? Don't. more

Pharma's Mixed Response to Trials Database
By Mark D. Uehling

With a seasonal shopping virus striking the nation at the usual time, some readers may have missed a late December 2005 article in the New England Journal of Medicine (NEJM). The article by Deborah Zarin and colleagues examined recent trends in the public registration of clinical trial data in the main U.S. database — clinicaltrials.gov. more

Featured Events

Upcoming Industry Events

2nd Annual Electronic Laboratory Notebooks - February 27-28,Philadelphia, PA
www.srinstitute.com/cs358
The premier conference on strategic opportunities for pharmaceutical/biotech companies and other related biotechnology counterparts who have adopted (or plan to adopt) ELN framework and are seeking successful practical solutions in tackling the barriers - such as legal concerns, regulatory fears, cultural change, technological integration and shrinking budgets. This year's format will feature concurrent A.M. pre-conference workshops, followed by a general plenary, then will split into two unique tracks on A) ELN drug discovery/IP and B) using ELN's in a GXP environment. Register by Feb. 20 and mention code ELNBioIT to receive $200 off the standard rate. To register, phone 212-967-0095 or 1-800-599-4950.

Bio-IT World Best Practices - Call for Entries - Early Bird Deadline February 28th
Bio-IT World is now seeking submissions to its 2006 Best Practices Awards Program. This annual Best Practices Awards Program attracts an elite group of life science professionals: executives, entrepreneurs, cutting-edge innovators and others responsible for developing and implementing innovative solutions for streamlining the drug development and clinical trial process. The winners and entrants will be featured in a Special Report published in Bio-IT World, and invited to attend a gala Awards Announcement reception, held during the annual DIA conference.Find out more at www.bio-itworld.com/bestpractices/2006

PittCon - March 12 - 17, Orlando, FL
Pittcon is the premier meeting place for scientists, IT professionals and vendors of instrumentation, LIMS and data management software worldwide. The Conference features technical programs, short courses, and an exposition of laboratory equipment including the "Informatics Zone" where you will find the latest in products and services for the laboratory automation and data management. More information at www.pittcon.org

CBI's Drug Development – From Animal Models to Phase I; Pursue Quality Leads by Expediting PK/PD and Efficacy Data Collection -- April 10 - 11, 2006, Philadelphia, PA
Expediting drug development is a major concern for the pharmaceutical industry. Maximizing preclinical and early clinical development not only speeds up the process, but also reduces money wasted on pursuing compounds with little or no potential for approval. The purpose of this event is to bridge the gap between preclinical and Phase I development. High level speakers present crucial solutions ranging from developing new humanized transgenic animal models to designing more efficient Phase I trials. For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at [email protected]. Visit: https://www.cbinet.com/show_conference.cfm?confCode=HB637

Gene Therapy and Stem Cells Week, March 8 – 10, 2006, Cambridge, MA
CBI's 2nd Conference on Commercializing Stem Cells for Therapeutic Applications, March 9-10, 2006, examines following key issues: - Stem Cell Sourcing and Utility for Therapeutic Applications; - Business Models, Funding Challenges and IP Strategies for the Commercialization of Stem Cells; - Legal, Political and Ethical Issues Affecting Stem Cell Research; - Update on Stem Cells in Cardiac Clinical Trials.Plus! Attend a One-Day Symposium on Gene Therapy Research on March 8, 2006. Register for all three days with special package pricing. For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or visit https://www.cbinet.com/show_conference.cfm?confCode=HB630

Life Sciences Conference + Expo - April 3 - 5, Boston, MA
The Life Sciences Conference + Expo features an outstanding program of keynotes, three-day conference tracks, educational workshops, exhibit floor, and award programs and special events. Speakers will discuss the latest technology developments and research breakthroughs on the complete spectrum of topics involved in drug discovery through market delivery. Learn from actual case studies and panel presentations on how the leading pharma and biotech companies utilize IT and informatics to enhance drug process and speed the time to market.
Find out more today at: http://www.lifesciencesexpo.com