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2024 Combo Products Summit Agenda


Innovative Combination Products for the Next Generation of Medicine

October 10, 2024 @ 11:20 am


12:20 pm


James Wabby, Head, Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie


Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc.
Anjali Gupta, Director Regulatory Affairs – Cell Therapy Device Development, NovoNordisk
Andrea Gray, Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER), FDA
Alex Lyness, Business Development Director – Drug Delivery, TTP PIc
Jerzy Wojcik, VP Regulatory and Quality Services, Edgeone Medical (CDMO)

Combined advanced therapies and complex delivery technologies are emerging as innovative medical products due to their contribution to advancing medical care, and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions who require consistent treatment with daily injections or weekly procedures and who have unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.

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.


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