Latest Articles

  • Extreme Language Ultra-High Potency

    The newest generation of small-molecule therapies bring containment needs well beyond those of conventional HPAPIs. What does this mean for the pharma lexicon – and the pharma landscape? read more

  • Status Of AI Regulation On Drug Development

    As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more

  • An Interview With Brian Morrissey

    In this interview we spoke to Brian Morrissey, General Manager of Gaelic Laboratories, about the strategy behind their acquisition of Athlone Laboratories, and its impact. read more

  • The Human Advantage in ADME Testing

    Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more