Latest Articles

  • Post-Approval Change Management

    Achieving global approval for a single change may take three to five years, but inefficient lifecycle change management rarely registers as a crisis. 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

  • The Build-vs-Buy Decision About Connected Devices Just Got Easier

    Sponsors making decisions about device programs this year are setting more than just cost expectations for device procurement. They’re deciding whether devices will be a limiting factor on representative data or whether a partner who owns the full device strategy — not just the hardware — can enable broader, more diverse trials than would be possible by going directly to a manufacturer or managing it internally. read more

  • The Tough Decisions

    While there are many drugs to make the end of life easier and less painful, the fundamental problem of deciding when to end life is a topic and a decision few want to address. read more