This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Delivered as a Hybrid Event from September 20-30, 2021
Live Digital Agenda Runs 11am-3pm EST from Sept 28-30Boston Convention and Exhibition Center

Michele Duggan
Senior Manager, North America Regulatory Affairs at Thermo Fisher Scientific


Michele Duggan is Senior Manager, Regulatory Affairs of the North America Regulatory Affairs function in the Pharma Services Group at Thermo Fisher Scientific. Prior to joining Thermo Fisher Scientific, she worked for a clinical research organization for over 17 years, where she provided chemistry, manufacturing, and controls (CMC) regulatory consulting to biotechnology and pharmaceutical companies. Her broad regulatory experience includes authoring global CMC dossiers and developing CMC regulatory strategies for all stages of the product lifecycle for monoclonal antibodies, cytokines, and other therapeutic proteins.

Agenda Sessions

  • Entering first-in-human clinical trials: considerations for a robust regulatory CMC package