Informa’s closed-door Leadership Summit convenes C-suite stakeholders to stress-test manufacturing and supply strategies under resource nationalism, export controls, and reshoring incentives reshaping ...
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical ...
Understand why the FDA's shift toward single pivotal Phase III trials requires establishing a drug's mechanistic hypothesis ...
Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into ...
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits ...
FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity. This week on ...
Global trial expansion demands front-loaded supply planning and robust infrastructure, rather than reactive logistics once enrollment begins, to protect timelines and investigational product ...
PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.
As cell and gene therapies move from bespoke academic protocols into commercial-scale manufacturing, the raw materials underpinning them are emerging as one of the most consequent ...
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