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

  • Hasty Decisions, Runaway Projects

    Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. 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

  • Quality: The Gold Standard for CDMOs - No Exceptions, No Compromises

    In today’s hyper-competitive pharmaceutical landscape, innovation, speed-to-market and cost control usually take the spotlight when selecting a contract development and manufacturing organization (CDMO). However, underneath all those metrics, a single truth remains: if quality fails, so does everything else. read more