Bridging the Gap Between Great Science and Drug Development
I'm spending a few days on holiday in beautiful Mallorca. The heat has been so intense this year that it limits what you can do during the day. It ...
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Insights
Scientific and regulatory insights for drug development
Articles and perspectives on DMPK, toxicology, non-clinical safety, regulatory strategy and successful drug development.
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Small molecules are still driving progress on novel targets
I came across an interesting summary in Nature Reviews Drug Discovery looking back at the novel drug targets of 2025. What captured my interest was...
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Drug discovery has become faster. But has decision-making improved?
Over the past decade, the process of drug discovery has changed dramatically. • AI can now generate thousands of new molecules. • Structural b...
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FDA Draft Guidelines on the Use of Quantitative Systems Pharmacology (QSP) Based Dose Selection.
The FDA has just released draft guidance on using Quantitative Systems Pharmacology (QSP)-based dose selection for the minimum anticipated biological effect level (MABEL) in first-in-human trials.
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Translating DMPK Data into Clear Development Strategy
DMPK data are most valuable when they are translated into practical decisions that guide candidate selection, toxicology planning and early clinical development.
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