Latest Articles

  • 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

  • How Early Data Drives Better Cell Line Performance

    In the race to bring new biologics to market, development teams are constantly balancing speed, quality, and regulatory expectations. Yet one factor often determines long-term success more than any other: the strength of the data generated in the earliest phases of cell line development. read more

  • 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

  • Under the Spotlight: Agentic AI

    In an interview with Pharmaceutical Outsourcing, ArisGlobal’s Jason Bryant discusses the premise of AI’s next high-profile incarnation, the technology’s potential in late-stage pharma R&D operations, emerging early use cases, and some of the guardrails that need to be in place to ensure trusted, impactful use. read more