Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x ’20 initiative got underway. Its goals were spelled out clearly: To ‘Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 ’[3]. It was driven by ID clinicians and by antibiotic developers concerned Continue reading The 10 x ’20 Initiative – A Retrospective
Today we discuss the group of BAFF/APRIL inhibitors, specifically the three TACI mAb constructs that are currently in development. They were tested in a broad gamut of B-cell indications but failed to show efficacy in many. So far, consistent clinical success has been seen only in IgA nephropathy (IgAN), with Continue reading BAFF / APRIL Inhibitors Homing in on IgAN
Companies can stop studies before reaching projected enrollment numbers. It could be a decision based on a planned interim analysis (IA) or it could be for ‘administrative’ reasons. The latter may not indicate that a company has fallen on hard times financially; it could be the result of operational problems Continue reading THE UTILITY OF FUTILITY