Latest Articles

  • Material-Sparing Strategies for Rapid Development and Scale-Up of Complex Drug Products

    In an industry where complex molecules and first-in-human (FIH) formulations often come with very limited API supply, material-sparing strategies are central to efficient CMC development. 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

  • Horizon Lines: A Quarterly Review of NDAs – July-September 2025

    This quarterly review on New Drug Applications contains data for applications approved during the third quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 48 applications were approved by the FDA during these three months. read more

  • Limitations of Existing Life Science Software - and the Opportunity to Evolve

    ELNs, LIMS and SDMS systems aren’t going away anytime soon. They provide a foundation for doing reliable, collaborative, and impactful science. The key here is that by embracing and adopting new technologies, scientific organizations can protect their existing investments while unlocking new levels of efficiency, collaboration, and discovery - at their own pace and on their own terms. read more