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Seminar luncheon

Unique Clinical Pharmacology & Biopharmaceutics Properties of Vyxeos: Development of a Nano-scale Fixed-ratio Cytarabine/Daunorubicin Liposomal Formulation for Acute Myeloid Leukemia


Speakers: Qi Wang, PhD, Senior Director, Jazz Pharmaceuticals
Organizers: Tracy Chen
Date: 2017-09-13
Time: 11:00-13:30 Pacific Time
Registration fee: (USD): Food: $0.
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date: (6)CMIC, Inc.; KCAS Bio; Pharmaron; Taiho Oncology Inc; Waters Corporation; XenoTech
Registration: http://www.PBSS.org
Registration deadline:2017-09-12  (it will close sooner if the seating cap is reached)


About the Speakers

Jackie Gibbons, Ph.D,  is currently Head of Clinical Pharmacology at Jazz Pharmaceuticals, an international biopharmaceutical company with marketed products and development programs in the areas of sleep and hematology/oncology. She earned a BS in Biology from UC Berkeley and a PhD in Toxicology at Cornell University, where she studied cytochrome P-450 enzyme systems. Jackie has worked in the field of drug metabolism and pharmacokinetics for more than 25 years, and her former companies include Chiron, Bayer, and Medivation. She will be speaking on Vyxeos, a nano-scale liposomal formulation of a fixed 5:1 molar ratio of the antineoplastic agents, cytarabine and daunorubicin. In 2016, FDA granted breakthrough therapy designation for the use of Vyxeos in treating of acute myeloid leukemia, and Jazz submitted an NDA in March 2017. Jackie led the clinical pharmacology and biopharmaceutics portions of the NDA and will describe how the unique biopharmaceutics properties of Vyxeos affect its tissue distribution, pharmacokinetics, and exposure-response.


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