Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the Continue reading The Weak Correlation Between Antibiotic Action and Mortality
The recently published INSIGHT trial showed that starting HIV therapy earlier rather than later has benefit for patients 1. This should not come as a surprise considering the excellent suppressive power of current triple regimens. The trial which enrolled 4685 Continue reading The Beauty of Science: No Need to Think About Costs When You Live in An Ivory Tower
It was déjà vu all over again, albeit compressed in time: when the race started to replace PegIFN+RBV for the treatment of HCV infection, the learnings from HIV drug development and the lessons with HAART provided an excellent template for quick Continue reading 2014: The Year That Changed The Landscape of HCV Therapy