Latest Articles

  • 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

  • Five Steps to Smooth Agentic AI Adoption

    In agentic AI-enabled labs, AI goes from individual, one-off applications to comprehensive workflow orchestration. read more

  • An Interview with Rod Ketner, PhD

    Sponsors sometimes optimize too narrowly for the next milestone instead of the full development path. A formulation may be sufficient for an early study but still be poorly positioned for robust scale-up, transfer, or validation. That’s where delays and added costs show up. read more

  • Patient-Centric Drug Delivery

    Across modalities and markets, patient-centric drug delivery is converging on three themes: self-administration at home, integration of drug delivery device platforms earlier in clinical trials, and alignment of formulations with device and human factors requirements. read more