Patient recruitment, retention, diversity, & safety are all factors driving the need for radical innovation in clinical research. This need was made painfully apparent during the current COVID-19 pandemic.
We can no longer ‘do the same thing and expect a different result’; it’s time to take giant steps forward.
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Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.