Latest Articles

  • 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

  • Executive Q&A - A Strategic Acquisition: Insights and Ideas

    An interview with Brian Morrissey, General Manager of Gaelic Laboratories, which has acquired Athlone Laboratories in a strategic deal that typifies the current pharma M&A landscape and puts all of Ireland’s Beta-Lactam manufacturing capacity under one ownership umbrella. read more

  • Executive Q&A - Early Drug Development

    In this Q&A, we explore early-stage pharmaceutical drug development trends, key scientific and technical challenges, and the role emerging technologies play in enhancing efficiency and quality during early pharmaceutical development. read more

  • An Interview With Andreas Eschbach

    How has AI acceptance evolved in the pharmaceutical sector, and what strategies have been most effective in overcoming resistance to AI adoption? read more