Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Aulus Cornelius Celsus wrote his famous book ‘De Medicina’ approximately 2000 years ago. Living in the times of Caesar Augustus, little is known about his persona. We are not even sure whether he was a practicing physician. Many of his books were lost but Volume VIII was rediscovered in the Continue reading New BIOMARKER CONSORTIUM PROs
Statements that have the words ‘FDA’ and ‘flexibility’ in a single sentence need to be approached with some skepticism. Especially if made by the Agency. ‘Flexibility’ always sounds better than ‘less rigidity’. Regulators are tasked with providing a certain sense of consistency or stability in the drug development jungle where Continue reading The New Default: 1 (One) Single Pivotal Trial
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