Featured Editorial

  1. Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease 5/19/2026

    Autologous intradiscal therapy integrates delivery and biology into one system, highlighting the potential of cell therapies in complex, localized disease environments.

  2. Surgical Therapeutic Design: Key Considerations In Formulation And Delivery 5/18/2026

    Conventional antibiotic prophylaxis often fails to maintain therapeutic levels at the surgical site over time; controlled-release local antibiotics can solve this.

  3. Need A Drug Delivery Conversation Starter? Try Target Product Profile 5/18/2026

    In this article, Chief Editor Tom von Gunden explores the need for and existence of cross-functional communication during drug product development and delivery device selection. He consults industry veterans with experience in various formulation or delivery roles at GSK and Merck. They identify the Target Product Profile (TPP) as the core concept guiding collaboration. 

  4. When Software Becomes Part Of The Medicine 5/15/2026

    Software is no longer just a support tool; it is central to real-world efficacy, transforming combination products by optimizing dosing, adherence, and technique.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.  

  10. 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.