Latest Articles

  • 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

  • An Interview With Dave Miller, Ph.D.

    Early formulation decisions can make or break a program, yet they’re often made under significant data constraints. What are the most common mistakes sponsors make when they rush that decision, and what does it typically cost them downstream? read more

  • An Interview with Rod Ketner, PhD

    Sponsors sometimes optimize too narrowly for the next milestone instead of the full development path. A formulation may be sufficient for an early study but still be poorly positioned for robust scale-up, transfer, or validation. That’s where delays and added costs show up. read more

  • Patient-Centric Drug Delivery

    Across modalities and markets, patient-centric drug delivery is converging on three themes: self-administration at home, integration of drug delivery device platforms earlier in clinical trials, and alignment of formulations with device and human factors requirements. read more