Melis Ayse Coraggio

Melis Coraggio is a Consultant in the FDA & Life Science practice group at King & Spalding LLP. She works closely with clients in navigating the pre-market tobacco product application and review processes and advises in the tobacco and nicotine space, including pre-market tobacco product applications (PMTAs), Substantial Equivalence Reports (SEs), Exemption Requests (EXRs), and provides strategies to assist in facilitating stakeholder engagement.

Prior to King & Spalding, Melis was a Regulatory Review Scientist at FDA’s Center for Tobacco Products’ Office of Science from 2015-2023 where she held roles as a Regulatory Health Project Manager and, primarily, as a Chemistry Reviewer. During that time, she was instrumental in drafting the Center’s first published Product Standard to limit the quantity of nicotine in cigarettes and certain other combusted tobacco products. Among her accomplishments, she was involved in drafting of the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products” Guidance which she presented at 2022 Tobacco Science Research Conference to industry and other tobacco stakeholders as well as served on the Q&A panel.

Before joining the tobacco and nicotine space, Melis spent nine years as a Scientific Researcher at Genentech, Inc.’s Division of Drug Metabolism and Pharmacokinetics performing analytical method development, method validation, and quantitative bioanalysis of small molecule pharmaceuticals for drug discovery and development. During her tenure, she specialized in beta testing of new mass spectrometry instrumentation in collaboration with Thermo Fisher Scientific and presented data at various stakeholder meetings.

Melis holds a Master of Science in Biotechnology with a focus in Molecular Biology from Northeastern University and a Bachelor of Science in Biochemistry with a minor in Biological Sciences from the University of Delaware.