Challenges of Supplier & Partner Relationships

Thursday, November 13, 2025

3:55 PM - 4:55 PM East Coast USA Time

Moderator(s)

Jason Lipman

Senior Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi

Speaker(s)

Jennifer Brennan

Associate Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi
Meenakshi Gupta

Associate Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi
Hrishikesh Khatav

Global Regulatory Lead - NPD Wearable Injectors and Innovation
Becton Dickinson & Co
Gwendolyn Payne

Director, Regulatory Affairs
Enable Injections

A device supplier and a pharmaceutical company will present a combined use drug-device case study to illustrate the two sides of global regulatory challenges and how to navigate through these challenges in a development partnership. A panel discussion among industry representatives will follow; they will exchange thoughts concerning similar challenges pertaining to relationships with supplier-owned medical devices that are not co-developed. The intent is to build awareness of anticipated challenges and risks related to industry partnerships, so they can plan accordingly. Topics during this session will include identifying R&R, sharing of documents/DHF and other sensitive information, collaborating on submissions (and submission strategies), identifying/navigating global regulatory pathways, plus legal manufacturer considerations and labeling development.