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Latest Update : 2024 / 10 / 24
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Platform for Research and Inspiration in Regulatory Science
About Us
Sherry Ku (顧曼芹)
Current position
- President, 顧德諮詢有限公司, Taiwan (2013-current)
Academic degree
- Doctor of Philosophy, Major in Pharmaceutics and Pharmaceutical Chemistry, Minor in Pharmacology, College of Pharmacy, The Ohio State University, USA
- Bachelor of Science in Pharmacy, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan
Experience
- Chairman of the Board, President, CEO Savior Lifetec Corporation, Taiwan (2014-2019)
- President / Director of the Board, RuenHuei Biopharmaceuticals Inc., Taiwan (2012-2014)
- President and CSO of TWi Pharmaceuticals Inc., and President of Twi Biotech, Taiwan (2010-2012)
- Head of Early Pharmaceutical Development Department, Wyeth Inc., USA
- Vice President, New Jersey State Pharmaceutical Association, USA
- President, Physical Pharmacy and Biopharmaceuticals, American Association of Pharmaceutical Scientists (AAPS), USA
- Committee Member, United States Pharmacopeial USP Convention, USA
- Committee Member, Biotechnology Industry Strategy, Executive Yuan, Taiwan
- Advisor, Taiwan Food and Drug Administration, Taiwan
- Committee Member, Resident Companies Application Review Committee, BioHub Taiwan, National Biotechnology Research Park, Academia Sinica, Taiwan
- Advisor, Ministry of Economic Affairs, Taiwan
- Advisor, Biotechnology Development Center & Drug Commercialization Center
- Counselor, Institute of Biomedical Sciences, Academia Sinica, Taiwan
- Director, Biochemical Technology Education Foundation
- Director, Taiwan Pharmaceutical Manufacture and Development Association
Achievement
- Developed more than 170 new drugs, with 85 Investigational New Drug (IND) applications and 9 listed drugs, including Suprax, Zosyn/Tazocin, Zebeta, Isovorin, Thioplex, Sonata, Tygacil, Bosutinib, and Neratinib in Wyeth/Pfizer.
- Completed 6 Abbreviated New Drug Application (ANDA), including 3 Paragraph IV application, and 6 new drug developments, including 3 biologics, within the 18-month working period in TWi Pharmaceuticals Inc.
- Meropenem and Ertapenem injection global product licenses in US ANDA / EU MA in Savior Lifetec Corporation.
Research subjects
- Pharmaceutical Market Research
- Regulatory Filing in the US and EU
- Clinical Drug Research
- Clinical Pharmacology
- Preclinical Drug Development
- Pharmacology and Toxicology
- Pharmacokinetics and Drug Metabolism
- Physical Pharmacy and Biopharmaceuticals
- Bioavailability Enhancement
- Crystallinity, Polymorphism and Salt Selection
- Analytical and Bioanalytical Method Development
- Quality Control and Quality Assurance
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