Latest Articles

  • Flexibility as a Core IND Strategy

    With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more

  • We Have More Data Than We Know What to Do With

    Every year brings another round of headlines about pharma “drowning in data.” At this point, that’s less a warning than a permanent weather condition. read more

  • From Data to Tissue

    The national-security regulatory landscape now layers a geopolitical framework onto the data flows, sample logistics, and vendor relationships that make modern clinical research possible. This architecture will not simplify. The DSP’s country-of-concern list may expand, the BIOSECURE Act’s designated-entities list will likely grow, and state legislatures continue adding requirements. read more

  • Horizon Lines: A Quarterly Review of NDAs – April to June 2026

    This quarterly review on New Drug Applications contains data for applications approved for the first time during the second quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. read more