Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”. He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS
New medical and science journals pop up in our mailbox on a biweekly basis. Offers to join as Editor, solicitation for articles based on past publications, invitations for subject reviews come as unsolicited emails. Medical publication houses, old and new, are expanding, adding more and more subspecialties to their established Continue reading JOURNAL BUSINESS vs EDITORIAL OVERSIGHT
Today’s topic is about the lackluster recruitment of US centers in recent CABP trials. We noticed that Eastern European (EE) centers, specifically from Ukraine, Bulgaria, and Serbia, contribute patients in large numbers, actually making these trials feasible. When sponsors and CROs needed to enroll CABP patients, they could not rely Continue reading CABP TRIAL ENROLLMENT – BUT NOT IN THE USA