Featured Editorial

  1. Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery 5/14/2026

    Cell therapy success depends on a durable implantation environment, making delivery and sustainability central to efficacy and functional outcomes.

  2. Treatment Adherence And Designing Therapeutics To Meet Patient Needs 5/6/2026

    Reformulation improves adherence by reducing pill burden and side effects, enhancing real-world usability and align therapies with diverse patient needs.

  3. Complaints Into Practical Action: Human Factors Drug Delivery 5/5/2026

    Post-market HF are more than a quality metric, they help teams diagnose issues, guide fixes, and improve real-world usability of drug-device products beyond validation.

  4. Human Factors: A Key Factor In Regulatory Approvals 5/5/2026

    In this article, combination product consultant Doug Mead demonstrates the practice and results of using GenAI search tools to conduct precedent research on Human Factors (HF) regulatory considerations. He illuminates query responses related to Complete Response Letters (CRLs), HF study waivers, use errors, critical tasks, and other aspects of FDA approvals for combination products and other delivery devices.

  5. Regulatory Attention To Human Factors: How Much Is There? 5/5/2026

    In this article, Chief Editor Tom von Gunden considers trends in drug delivery likely to drive increased scrutiny around Human Factors {HF) in regulatory submissions and approvals. In an embedded video and transcript from Tom’s conversation with combination products consultant Doug Mead, the two discuss findings from GenAI queries that surfaced FDA precedents on HF-related matters including critical tasks, use errors, and risk mitigation.  

  6. Gaining An Edge In GLP-1 Production 5/5/2026

    The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

  7. Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction 5/4/2026

    Optimized delivery technologies will be central to next-generation therapies, serving as key differentiators for both clinical efficacy and operational feasibility.

  8. Where Drug Delivery Falls Short And What The Industry Should Do Next 4/24/2026

    Next-generation drug delivery pairs science with usability, solving adherence by simplifying treatment, aligning patient behavior, and improving poorly tolerated therapies.

  9. BCS Class IV: Rescuing Hard To Deliver Molecules With Nanoformulation 4/23/2026

    BCS Class IV drugs have low solubility and permeability. Oral nanoparticles can overcome both barriers, offering a more effective and tunable oral delivery strategy.

  10. Patient-Centric Drug Delivery: Do Possible And Preferable Always Align? 4/22/2026

    In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.