Frankly Fran

1. 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.

2. 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. 

3. 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. 

4. 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. 

5. 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. 

6. 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.

7. 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. 

8. 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.

9. Use-Related Risk Analysis: Considering The FDA Guidance On URRA 2/5/2025

   The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA. 

10. Drug Delivery Outlook: 7 Waves To Ride In 2025 And Beyond 12/30/2024

    With a view of the evolving landscape of health policy and patient needs, Fran DeGrazio identifies seven biopharmaceutical industry trends that should drive innovation and practical implementation in drug delivery. Harmonization, digitization, quality, intelligence, and agility are among the focus areas Fran recommends for forward-thinking biopharmaceutical companies.