Speaker List

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Names Organization City State Country

California
Gupta, Nish
Regulatory Group Director, Devices and Combination Products
Genentech
California, United States
Soo, Chin-Wei (he/him/his)
Vice President, Global Regulatory Head, Devices and Combination Products
Genentech/Roche
California, United States
District of Columbia
Duncan, Katie (she/her/hers)
Director, CMC Policy and Advocacy
GSK
District of Columbia, United States
Florida
Neadle, Susan (she/her/hers)
Principal Consultant & President
Combination Products Consulting Services, LLC
Florida, United States
Maryland
Boam, Ashley (she/her/hers)
Director, Office of Policy for Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER)
FDA (Virtual)
Maryland, United States
Massachusetts
Brennan, Jennifer
Associate Director, Global Regulatory Affairs, Devices and Combination Products
Sanofi
Massachusetts, United States
North Carolina
Clemmons, Susan
Associate Director, CMC Devices
GSK
North Carolina, United States
Not Applicable
Chesworth, Tim (he/him/his)
Global Head, Medical Device Regulatory Affairs
Novartis
Not Applicable