Ying Ou
Executive Director at Beigene
Based in San Francisco, United States
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Seniority
Director
Department
General Business & Management
Location
San Francisco
Industry
Biotechnology Research
Company size
2.3K
Contact information
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y•••••••@beigene.com
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Background
About Ying Ou
Over 20 years of drug development and regulatory experience with core expertise in clinical pharmacology (CP), pharmacokinetics/pharmacodynamics (PK/PD), Physiologically-based Pharmacokinetics (PBPK) modeling & simulations and translational science, contributing to approvals of 6 medicines (biologics or small molecules) in oncology, infectious and CNS disease indications, including:(1) Brukinsa® (zanubrutinib, BTK inhibitor for multiple B-cell malignancies)(2) Kyprolis® (carfilzomib, small molecule for multiple myeloma)(3) Albiglutide (biologics for diabetes, GSK)(4) Raxibacumab (monoclonal antibody for anthrax)(5) JURNISTA® (OROS® Hydromorphone, J&J)(6) One-day DURAGESIC patch (fentanyl transdermal system for pain, J&J) o Regulatory Affairs Certification Board (RAC) o Vice Chair and Chair, 2018-2020, Early Development and Drug Safety Community (EDDS), American Society for Clinical Pharmacology & Therapeutics (ASCPT) o Scientific Program Committee, 2014-2017; Session chair for multiple symposiums, ASCPT o Authors of numerous regulatory documents (IND and NDA/MAA filing) • Recipient of numerous corporate awards and other professional/community awards: o BeiGene- multiple Awards, 2018-2022 o Top Overall ASCPT Advocate Award, 2020 o Onyx/Amgen and J&J -> 10 times Bravo awards, 2004-2007; 2013-2017 o Toastmasters International Humorous Speech, 1st place, Area A1, Area B4, Division B, 2022
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