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PROJECT ZERO DELAY ACCELERATES DRUG'S PATH TO CLINICALTRIAL.

Publication: Biotech Business
Publication Date: 01-SEP-09 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
A phase I clinical trial enrolled its first patient only two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human cancer trial, a milestone that normally takes three to six months. Investigators from The University of Texas M. D. Anderson Cancer Center and pharmaceutical company AstraZeneca have reported their work in the Journal of Clinical Oncology.

The joint effort, dubbed Project Zero Delay, is part of a strategic collaboration between the two organizations designed to safely accelerate development of new cancer drugs. In many cases that process takes about 12 years and the cost of bringing a new drug to patients has been estimated at around $1.3 billion. [Ref: J. A. DiMasi and H. G. Grabowski,...

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