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Advancing Innovation Through Essential Drug Delivery Outputs
Session Chair(s)
Rumi Raquel Young, MS
Director, Regulatory Policy
Novo Nordisk, United States
This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.
Learning Objective : Understand the technology landscape for more complex drug delivery combination products, specific patient considerations informing design and clinical risk, and the role of new regulatory tools like Essential Drug Delivery Outputs; Analyze current challenges facing combination products to deliver advanced therapies (Cell & Gene) or biologics including submission expectations (IND, NDA/BLAs), verification, validation, Control Strategy, and post-market changes.
Speaker(s)
Emerging Policies Driving Complex Combination Product Development (EDDO Focus)
James Bertram, PhD, MS, RAC
FDA, United States
Director, Office of Combination Products, OC
Emerging policies driving complex combination product development (How other policies work with EDDO)
Chelsea O'Connell, MS, RAC
Amgen, United States
Director, Global Regulatory Policy & Intelligence
Overview of complex combination product technologies (implantable, on-body) and development challenges
Alan Stevens, MS
Abbvie, United States
Global Head, Complex Devices and Drug Delivery Systems
Patient Perspectives on advanced therapies and use of complex combination products
Stephen Karpen, PharmD
Breakthrough T1D, United States
Senior Director, Regulatory Affairs
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