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

  • From Service Provider to Strategic Partner

    As drug development grows more complex and timelines compress, sponsors require CDMO relationships built on integration, flexibility, and shared accountability read more

  • The Operational Foundations That Characterize Regulatory Leaders

    Holding individuals and teams explicitly accountable for data accuracy and quality might seem straightforward, but it is difficult to sustain in practice. read more

  • Rethinking the Oligonucleotide Journey

    The history of oligonucleotide therapeutics illustrates that transformative medical progress occurs when foundational scientific breakthroughs are matched by equally robust advances in development infrastructure. Over the next decade, oligonucleotides are poised to expand their clinical footprint beyond reactive treatment and toward proactive preventive intervention for highly prevalent chronic conditions. read more