Infusion Drug Delivery Articles

31. What Do Patients Appreciate? Therapeutic Innovation And Accessibility 11/11/2025

    At the PODD 2025 conference, patient advocates telling their own treatment stories focused on innovations in therapies and delivery methods for targeting chronic and rare diseases, leveraging technologies such as gene editing and subcutaneous delivery of complex biologics. In this article, Chief Editor Tom von Gunden carries forward the patient-centric themes of convenience and accessibility.

32. How Can We Develop New Treatments For Patients With Early Breast Cancer? 11/10/2025

    Intensity Therapeutics has developed a new approach to treating cancer — a therapy injected directly into tumors that kills cancer and stimulates a potent anticancer immune response.

33. Drug Delivery Innovation: Getting Advanced Therapies To Patients 11/3/2025

    In this article, Fran DeGrazio recounts the evolution of drug delivery technologies as she underscores the need to innovate in the delivery of advanced therapies. Considering chronic diseases, rare diseases, and difficult-to-reach therapeutic targets, Fran offers suggestions for organizing and readying for the development and delivery of platforms, systems, and devices for next generation treatments, including personalized, precision medicines.

34. 7 Management Strategies For Combination Product Regulatory Success 9/2/2025

    In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success. 

35. Understanding Annex 1 For Sterile Medicinal Products 8/4/2025

    In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training. 

36. New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development 7/3/2025

    The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase. 

37. Drug Delivery Innovation: If You Build It, Will Anyone Care? 7/1/2025

    In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace. 

38. 3 Lesser Known Keys To Effective Biopharma Supplier Engagement 6/4/2025

    In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services. 

39. Tips From A Biomedical Engineer For Medical Device Innovation And Compliance 5/20/2025

    Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

40. Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective 5/1/2025

    In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.