Management

Amy Huang

General Manager


Ms. Huang joins OBI, Inc. after a distinguished career at GlaxoSmithKline, where she was Vice President and Regional Director responsible for all commercial operations in China and Hong Kong. Ms. Huang is an inspirational leader and successful executive with numerous awards and achievements, including Outstanding Pharmaceutical Manager (Taiwan) and GSK´s Inspirational Leadership Award (2005).

Since the merger of Glaxo Wellcome and SmithKline Beecham in 2001, she presided over record country performances during a turbulent period of regulation in Taiwan's pharmaceutical industry. During her tenure as Managing Director of SmithKline Beecham Taiwan, she oversaw the launches of novel products, such as Engerix B, Tagamet, Augmentin, Avandia, and Seretide, representing some of the most successful.

Cheng-Der (Tony) Yu

Chief Scientific Officer


Dr. Yu is a pharmaceutical scientist with over 35 years of R&D and general management experience in the pharmaceutical industry. Prior to joining OBI, Dr. Yu was the General Manager and Chief Scientific Officer at Microbio, Inc. He was Senior VP at the University Pharmaceuticals of Maryland. During his 14-year tenure at Bristol-Myers Squibb, which preceded his career at UPM, he participated in numerous IND and NDA filings, as well as numerous product launches. He holds 7 patents in the areas of drug delivery and product stability and has published over 35 peer reviewed scientific papers and book chapters. He was a recipient of the American Pharmaceutical Association's Ebert Prize Award, shortly after he finished his Ph.D. in Pharmaceutics from the University of Michigan. Dr. Yu earned a Pharm.D. from the University of Florida and holds a B.S. degree in Pharmacy from National Taiwan University.

Max Chan

Chief Operating Officer


Mr. Chan is a seasoned executive with over 24 years of multinational experience and a long track-record of achievement. He was formerly the CFO of Taiwan-listed JHL Biotech (TPEx: 6540) and TaiGen Biotech (TPEx: 4157) as well as US-listed Himax Technologies (NASDAQ: HIMX). Mr Chan's prior background was that of an investment professional, including stints at Intel Capital and China Development Industry Bank. Mr Chan hold a Masters of Science in Business Administration degree from the University of Illinois at Urbana-Champaign as well as an MBA in Finance and a B.S. degree in Civil Engineering from National Taiwan University.

Richard Tseng

Vice President of Compliance


Dr. Tseng has over 30 years of experience in quality control/quality assurance, material/production management, and pharmaceutical plant construction. Also he is familiar with Taiwan and US PICS/cGMP regulations. Dr. Tseng had worked in American Cyanamid, American Home Products, and Nu Skin and served as a technical director and global quality control senior director, respectively. He obtained PH. D. degree in Clinical Chemistry from Cleveland State University.

Cristina Chang MD, PhD

Vice President, Global Medical and Clinical Development


Doctor Chang is a Medical Doctor trained overseas in Internal Medicine and Gastroenterology/Hepatology Surgery in the oncology field with years of clinical practice. She has a track record work in Clinical Development and Medical Affairs in the global pharmaceutical industry for the Asia Pacific region. Dr. Chang has extensive knowledge of Cancer/Disease biology and Clinical Study. Her experience from Leading companies like Celgene, Sanofi-Aventis, Abbott Laboratories, AstraZeneca, Novartis and Sandoz mainly covers strategic and regulatory planning and Clinical studies execution through the whole life cycle management of a compound, scientific and communication excellence (Prelaunch and Launch readiness including customers management) and promotional compliance to international standards. Dr. Chang is a dynamic bio-pharmaceutical professional with a proven track record of business critical achievements in Oncology (in lung, breast, gastroenterology, prostate/ovary, renal, hepatocellular carcinoma, Hematology/Immuno-Oncology and Transplantation) and other areas like vaccines with Sanofi Pasteur and OTC products. She is a visionary and effective result-driven leader in a dynamically changing environment to achieve business impact.

Sophia Lee

Vice President, Statistic & Biometrics


Dr. Lee has 20 years experiences in Biostatistics, in which 15 years in Biogen and 5 years in Center for Biostatistics in AIDS Research, Harvard School of Public Health. Dr. Lee has solid experience leading and overseeing statistical activities in drug development to ensure integrity and quality of clinical projects including regulatory submissions, clinical development plans, protocol designs and development, clinical study reports, statistical analysis plans, and statistical analyses for labels and publications. Dr. Lee’s area of expertise were in immunology, cardiology, neurology, and AIDS therapeutic areas. Dr. Lee is also an expert in SAS and other statistical programing.Dr. Lee obtained her Ph.D. in Biostatistics from Boston University in USA, and Master of Science in Statistics from University of Wisconsin – Madison in USA, and Bachelor of Science in Mathematics from National Tsing-Hua University in Taiwan.

Jiann-Shiun Lai

Sr. Director, R&D Lab


Dr. Lai has over 20 years of R&D experiences in the development of biological drugs, especially the therapeutic monoclonal antibodies. Prior to joining OBI, he was the Advisor of Department of Industrial Technology, Ministry of Economic Affairs, sketching out the roadmap for antibody drug development and overseeing Technology Development Programs of organizations and biotech companies for MOEA. During his stay in Development Center for Biotechnology, preceding his work at MOEA, he had successfully discovered, developed and licensed out two antibody drugs. Besides, he also established and supervised an antibody engineering team in DCB. Prior to this, Dr. Lai was a principle investigator in Academia Sinica more than nine years. During that period of time, his work focused on the understanding of the mechanism of VDJ recombination of immunoglobulin genes. Dr. Lai accomplished his postdoctoral training at MIT and received his Ph.D. degree from a joint program of SUNY Stony Brook and Cold Spring Harbor Laboratory.

Mitch Che

Chief Operating Officer (USA)


Mitch Che joins OBI Pharma USA Inc. as Chief Operating Officer where he brings over twenty years’ operational and technical expertise spanning the pharmaceutical, telecom, and transportation and logistics industries. Prior to joining OBI Pharma USA Inc., Mitch was Vice President of Facilities, Operations and Procurement for Optimer Pharmaceuticals. Previously, Mitch held positions at AT&T and BP, as well as managing his own executive consulting firm. He is responsible for the development and management of OBI Pharma USA’s operating plans, results, strategic US operations and global IT supporting R&D, clinical and business development plans. Mitch has a B.S. degree in Geochemistry from Brown University and an M.S. degree from the University of California, Berkeley.

Kevin P Poulos

Chief Commerical Officer (USA)


Kevin has over twenty years of senior management experience in various strategic commercial and business development functions both internationally and the United States with Optimer, Wyeth, Rhone-Poulenc Rorer and SmithKline Beecham. Prior to joining OBI Pharma, Inc., he was the President of KPP Biopharmaceutical Commercial Consulting and the Chief Commercial Officer at Optimer Pharmaceuticals. During his career, Kevin oversaw the international and US commercial launches of many innovative pharmaceutical products including Dificid®, Zyvox®, Synercid®, Zagam®, Zosyn®/Tazocin® and Timentin®. He received his B.S. degree in Business Administration from Old Dominion University.

David Hallinan

Global RA VP (USA)


Dr. Hallinan has over 25 years of operational and regulatory affairs experience across a range of therapeutic areas. Prior to joining OBI, David was VP Regulatory Affairs at Idenix Pharmaceuticals, and VP Regulatory Affairs and Quality Assurance at Parexel International. He holds a Ph.D. in Pharmacology and a B.Sc. in Biochemistry from University College, Dublin, Ireland.