Shunchi Wu
Pre-clinical Research Director at Gongwin Biopharm Holdings Co.,Ltd- Claim this Profile
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Bio
Experience
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Gongwinbiopharm 共信醫藥PTS
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Taiwan
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Biotechnology Research
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1 - 100 Employee
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Pre-clinical Research Director
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Nov 2017 - Present
Preclinical drug development including drug MOA/Efficacy/PK/Tox/TK studies. Preclinical in-house in vitro and in vivo studies. Preclinical CRO evaluation, study plans and management. Module 4 (preclinical part) of investigator brochure preparation. Meeting with regulatory authority including pre-IND, EOP I, EOP II and pre-NDA. For the regulatory authority requirements to plan and conduct the suitable studies including repeated tox., impurities safety, in vitro DDIs and in vitro ADME studies. New drug evaluation and license-in process. New patents application, OA and maintenance. Creative projects finding and developing. Scientific studies through academic cooperation for publications. Pet clinical plans and case report forms writing and preparation. Supporting of the medical and marketing department function. Show less
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RD Associate Director
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Aug 2017 - Oct 2017
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Manager, Products R&D Department
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Aug 2015 - Aug 2017
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Scientist
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Apr 2012 - Aug 2015
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Associate Scientist
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Aug 2011 - Apr 2012
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Postdoctoral Research Fellow
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Oct 2010 - Jul 2011
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Chang Gung University
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Research Services
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400 - 500 Employee
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Postdoctoral Research Fellow
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Oct 2009 - Oct 2010
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Education
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國立臺灣大學
Ph.D., Institute of Biochemistry and Molecular Biology -
國立臺灣大學
M. S., Institute of Biochemical Sciences -
臺北醫學大學
B. S., School of Nutrition and Health Sciences