Experience

Sinew Pharma

• Taiwan
• Biotechnology Research
• 1 - 100 Employee

• Director of Business Development

  • Aug 2023 - Present

• Business Development Science Lead

  • May 2023 - Aug 2023


TWi Biotechnology
• Taiwan
• Biotechnology Research
• 1 - 100 Employee
• Medical Reserach Manager

  • Jul 2021 - Apr 2023


Genovate Biotechnology Co. Ltd.

• Biotechnology Research
• 1 - 100 Employee

• Sr. Project Supervisor

  • Jul 2019 - Jun 2021

  ● Participated in and completed a pre-IND meeting with US FDA for a 505b2 product in a therapeutic area of immunology/dermatology through literature review, summarization, identification of questions to FDA and collaboration with a contracted regulatory agent for preparation of regulatory documents ● Participated in a device clinical study of neurodegenerative disease to be conducted in Australia: - Assisted in reviewing CRO agreement - Assisted in reviewing clinical documents including protocol, IB, ICF and study-specific parts of eCRF - Provided scientific inputs as well as identified/contacted resources/vendors worldwide for preparation of study initiation, e.g., obtaining licenses of questionnaires for study endpoints and vendors for biomarker analyses ● Collected information for a potential indication of an orphan drug and presented it as an internal report and a slide deck Show less



TaiRx Inc.

• Canada
• Software Development
• 1 - 100 Employee

• Research Scientist

  • May 2015 - Jun 2019

  ● Assigned to fulfill company’s needs in a position to be in charge of non-clinical Pharmacology studies, through identifying suitable CROs, and communicating for protocol designing, progress monitoring and report writing/reviewing ● Participated in regulatory activities of 3 new drug development programs, totally for 3 INDs (Phase I, II, III) & 1 NDA in US or Taiwan: - Assisted in protocol design, writing and reviewing - Assisted in IND package preparation: writing for both non-clinical (sections of Toxicology, Biology and Pharmacology) and clinical sections (Efficacy and Safety sections) - Conducted a bridging study evaluation and successfully brought an NCE-2 product to NDA in Taiwan Show less


美國加州大學戴維斯分校
• Postdoctoral Fellow

  • Aug 2011 - Apr 2015