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

  • AI in Pharmacovigilance: Key Takeaways from Boehringer Ingelheim’s Recent Rollout

    In conversation with Pharmaceutical Outsourcing, Claudia Lehman, Head of Global Pharmacovigilance Operations at Boehringer Ingelheim and Lucinda Smith, ArisGlobal’s Chief Safety Product Officer, reflect on some of the lessons learned from Boehringer’s deployment of AI to date in targeted use cases, starting with adverse event case intake and processing. read more

  • From Lunar Orbit to First in Human: The High Stakes of Bold Science

    Much like the literal moonshots now back on the launch calendar, first in human studies are defined by the tension between danger and possibility. They are where bold ideas either earn the right to move forward or are stopped before they can do more harm than good. As an industry, our challenge is to keep reaching for those transformative rewards while taking the risks - scientific, financial, and human - every bit as seriously as a crew strapping in for a flight around the Moon. 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