Thanks for the links Maui. I have very little doub
Post# of 30066
Posted On: 01/06/2015 2:05:09 AM
Thanks for the links Maui. I have very little doubt that BP will use Lympro, probably not as soon as some would like but they'll want it.
Quote:
Oncology drug development is one of the largest therapeutic areas for pharmaceutical companies. To get a single oncology drug through clinical trials and the FDA approval process, pharmaceutical companies can spend over $1 billion, and the process can take12 to 15 years and require thousands of patient volunteers (Foundation for National Institutes of Health). In addition, clinical trial success rates have been very low: 70% of oncology drugs fail in Phase II and 59% of oncology drugs fail in Phase 3 (Kola, 2004).
A new paradigm is clearly needed. It has been hypothesized and demonstrated that using molecular markers to stratify patients into appropriate clinical trials can improve success rates of trials. While a study analyzing clinical trial drug development in breast cancer from 1998 to 2012 found that only 14% of drugs in clinical development for advanced disease were approved, when patients were selected based on HER2 status, the success rate increased to 23%. Using HER2 status to stratify patients also led to a 27% decrease in costs (Parker, 2012).
Similarly, clinical trial success rates in NSCLC [Non-Small Cell Lung Cancer] during the same time period were six times higher for biomarker-targeted therapies and three times higher for receptor-targeted therapies than for trials that were not molecularly guided. The risk-adjusted cost for NSCLC clinical drug development was estimated to be nearly $2 billion (Parker, 2014).
http://www.n-of-one.com/obrgreen/obr_vol8_issue3.php
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