Senior Vice President, Global Regulatory Affairs
Adlai Nortye USA Inc.
New Hope, Pennsylvania
Vicki Demby is currently a SVP, Global Regulatory Affairs, at Adlai Nortye USA, Inc. Starting out her career, Vicki was the section manager for the in vitro transporters group at GlaxoSmithKline, providing in vitro support for the discovery and registration of clinical drug candidates, before transitioning into the regulatory space many years ago (and her first love will always be DMPK). Vicki is an experienced Regulatory Affairs professional holding regulatory roles of increasing responsibility at Bristol-Myers Squibb, GlaxoSmithKline and Merck in various therapeutic areas including oncology, cardio-renal, metabolic, neurology, cell and gene therapy and immunology. She has managed global regulatory approvals for Januvia, Janumet and Marizev and Keytruda indications (unresectable malignant melanoma in Japan; the first Keytruda indication in China; the first adjuvant indication for Keytruda in US, EU, AU, and Japan; and accelerated approval of Merkel cell carcinoma in the US). Vicki was the 2020 AAPS chairman of the regulatory sciences community and currently teaches regulatory affairs graduate level courses at George Washington University. Vicki received her B.Sc. in Biochemistry from the University of Vermont, and her Ph.D. in Pharmacology and Toxicology from the University of Kansas.
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Monday, October 21, 2024
7:30 AM – 9:00 AM MT