2024 Combo Products Summit Agenda
session
Building Your Combination Product – Taking the Leap From Clinical to Commercial
October 10, 2024 @ 8:10 am
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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
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.