Mark Tsai
Associate Director, Combination Product Development @Otsuka Pharmaceutical Companies (U.S.)
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WORK HISTORY
Associate Director, Combination Product Development @Otsuka Pharmaceutical Companies (U.S.)
Princeton, NJ, US
EDUCATION
University of California, Irvine - The Paul Merage School of Business
M.B.A.
University of California, San Diego
B.S.
SKILLS
ABOUT MARK TSAI
With over 20 plus years of combination products and surgical device experience, I offer device development in biopharmaceutical and medical device industries.Competencies* New Product Development and Technical Program Management: Product Concept to Commercialization* Drug Products: Cell Suspensions, Monoclonal Antibodies, Drug Suspensions, Silicone Oil for Ophthalmic Injection* Drug Delivery Platforms: intrathecal drug port/catheter system, Autoinjectors, Prefilled Syringes and subretinal microfluidic drug delivery* Device Industry: intrathecal, ophthalmic, cardiovascular surgical devices and cell-based drug delivery system* Device Types: single-use and reusable devices, implantables, combination products, Class II and devices* Risk Management Process per EN ISO 14971* Design Control (Design Input, Output, Design V&V, Transfer)* Human Factors Studies* Clinical Plan (Class II and Devices)* Clinical Evaluation (CER) Management
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