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#108: Advancing Innovation Through Essential Drug Delivery Outputs
Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-514-L04-P; CME 1.00; RN 1.00

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Recognize 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; Discuss 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.

Chair

Rumi Raquel Young, MS

Speaker

Overview of complex combination product technologies (implantable, on-body) and development challenges
Alan Stevens, MS

Emerging Policies Driving Complex Combination Product Development (EDDO Focus)
James Bertram, PhD, MS, RAC

Emerging Policies Driving Complex Combination Product Development (How other Policies Work with EDDO)
Chelsea O'Connell, MS, RAC

Patient Perspectives on Advanced Therapies and use of Complex Combination Products
Stephen Karpen, PharmD


Speakers
avatar for James Bertram

James Bertram

Director, Office of Combination Products, OC, FDA, United States
James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →
avatar for Stephen Karpen

Stephen Karpen

Senior Director, Regulatory Affairs, Breakthrough T1D, United States
Stephen Karpen, PharmD joined Breakthrough T1D in 2023 and is the Senior Director for Regulatory Affairs. Dr. Karpen is responsible for implementing Breakthrough T1D’s regulatory strategy and works to accelerate the development of T1D therapies by implementing solutions to challenges... Read More →
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently US Lead, Global Regulatory Policy & Intelligence, where she advances strategic regulatory policy goals by engaging with health authorities, industry, professional associations, and other stakeholders across various... Read More →
AS

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States
Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →
avatar for Rumi Young

Rumi Young

Director, Regulatory Policy, Novo Nordisk, United States
Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum |   06: PersonalizedMed-ComboProd-Diagnostics, Forum

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