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

  • 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

  • Shore to Please

    As this year is coming rapidly to a close, I thought it might be interesting to review the ten biggest announced projects since January: read more

  • Why DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

    After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes. read more