2024 Combo Logo FDA

Back to agenda

2024 Combo Products Summit Agenda

session

Building Your Combination Product – Taking the Leap from Clinical to Commercial

October 10, 2024 @ 8:10 am

-

9:10 am

Moderators

Rumi Young, Director, Regulatory Policy, Novo Nordisk

Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly

Speakers

Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA
Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health,(CDRH), FDA
Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck
Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices, AbbVie

At the early stages of drug development, sponsors may not have a final finished combination product configuration in mind and may rely on standalone devices (syringes, infusion pumps, etc.,) or more simple presentations (pre-filled syringes) to support early-phase clinical studies. As a result, there may be challenges when sponsors want to bridge to more complex commercial presentations and have to meet new evidence expectations from the agency. Therefore, how do you select your investigational device(s)? What are critical clinical or device design considerations to enable a successful bridging approach and commercial final finished combination product? This panel will explore regulatory and technical expectations for investigational delivery devices at each phase, and how sponsors can prepare a strong development and bridging approach to support their final commercial presentation.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

Newsletter

Stay in the know about upcoming events and breaking news from the collaborative.

Subscribe

ContACT

Have questions about our events or how to get involved with one of our committees or workgroups?

Get in touch

© 2024 AFDO/RAPS Healthcare Products Collaborative