Frankly Fran

1. Drug Delivery Trends From 2025: Top 4 For Momentum Gains In 2026 12/2/2025

   In this article, Fran DeGrazio identifies four notable trends in drug delivery that gained momentum in 2025 and, she predicts, will continue to do so in 2026 and beyond. They are digitalization, sustainability, patient centricity, and the advanced delivery of complex biopharmaceuticals.

2. 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.

3. Drug Delivery Product Strategy: Aligning The Organization For Execution 10/1/2025

   In this article, Fran DeGrazio offers recommendations to biopharmaceutical sponsor companies about best practices for aligning strategic product initiatives with functional area execution. She outlines 5 key considerations, illustrated with the increasingly common market strategy expansion from drug product development to drug-device combination product delivery.

4. 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. 

5. 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. 

6. 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. 

7. 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. 

8. 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.

9. Design Controls For Drug Delivery Devices, Part 1: A Process Primer 4/1/2025

   In this article, Fran DeGrazio underscores the importance of design controls in the development of combination products and other drug delivery devices. She explains foundational concepts and fundamental steps including design inputs and outputs, design verification and validation, design review, and change controls. 

10. Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges 3/4/2025

    In this article, Fran DeGrazio comments on the potential for subcutaneous delivery of drugs and biologics to advance and ease approaches to patient self-administration. Among the drivers and challenges she identifies are geriatric populations, chronic conditions, complex formulations, and drug delivery device selection.