Latest Articles

  • Safely Scaling Highly Potent API manufacturing

    Ever more drug developers are searching for CDMOs with contamination-limiting capabilities. But how can they know which have these high-potency credentials? 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

  • AI Technologies in Pharmacovigilance

    Leading pharmaceutical companies are predominantly applying AI to case intake and early case processing in PV, where rising Individual Case Safety Reports (ICSRs) volumes and diverse report formats have made manual handling increasingly unsustainable. AI is used to support data intake, extraction, and transformation up to the point where information can be integrated into the safety database, while downstream steps like case assessment and medical review largely remain human-led. 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