Latest Articles

  • Extreme Language Ultra-High Potency

    The newest generation of small-molecule therapies bring containment needs well beyond those of conventional HPAPIs. What does this mean for the pharma lexicon – and the pharma landscape? read more

  • Should Sponsors Provide Source Document Templates?

    Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more

  • 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

  • Rethinking the Oligonucleotide Journey

    The history of oligonucleotide therapeutics illustrates that transformative medical progress occurs when foundational scientific breakthroughs are matched by equally robust advances in development infrastructure. Over the next decade, oligonucleotides are poised to expand their clinical footprint beyond reactive treatment and toward proactive preventive intervention for highly prevalent chronic conditions. read more