Amador Bioscience Appoints Dr. Howard Yuwen as Senior Vice President of Global Regulatory Affairs

Pleasanton, Calif.: Amador Bioscience, a full-service CRO with global expertise in translational research and clinical development, announces the appointment of Dr. Howard Yuwen to Senior Vice President of Global Regulatory Affairs, reporting to Xiaomin Chen, MBA, COO of Amador Bioscience.  
 

Dr. Yuwen has rich experience in drug administration and regulations in China, the United States, and Europe. In his new role, Dr. Yuwen will lead Amador’s global regulatory affairs team providing expertise for clients from IND-enabling to IND to NDA/BLA/MAA, and providing strong regulatory support for drugs to enter the global market.  

"Dr. Yuwen has extensive experience and extraordinary leadership in global drug regulations,” Chen said. “He is very strategic, and we are confident he will take Amador’s global pharmaceutical affairs services and capabilities to new places.” 

Amador Bioscience’s regulatory affairs business includes domestic and overseas translational and clinical pharmacology, bioanalysis and biomarkers, and clinical development teams with extensive experience. With a quality management system that meets international standards and uses the team's rich negotiation experience with regulatory authorities in various countries, it successfully provides global pharmaceutical companies with technology, regulatory strategy and consulting, clinical development planning, registration pathway, and regulatory negotiations.  

At present, Amador Bioscience has established teams in the United States, Europe, and China, and has successfully completed more than 210 market entry applications (NDA, BLA, and MAA). Its customer base ranges from top biotechnology start-ups to multinational pharmaceutical companies.  

"Amador Biotech is a science-focused CRO with a scientific and rigorous attitude, efficient execution ability, and a high-quality team full of enthusiasm,” said Dr. Yuwen. “It's an honor to be a part of it.” 

Dr. Yuwen has more than 30 years of experience in drug administration and regulation at international pharmaceutical companies. He has held senior management positions at biopharmaceutical companies across the world including Worg Pharmaceuticals in China, Alexion in the United States, Shire (now Takeda Pharmaceutical Company) in the United Kingdom, and Elan Pharmaceuticals (now Perrigo) in Ireland. Dr. Yuwen's drug administration experience includes senior positions at the Center for Biological Product Evaluation of the U.S. Food and Drug Administration (FDA) and Fogarty International Fellow of the National Institutes of Health.  

Dr. Yuwen holds a Ph.D. from the Chinese Academy of Preventive Medicine, a bachelor's and master's degree in medicine from Xi'an Jiaotong University, attended the Kellogg School of Management at Northwestern University, and received leadership skills training at the Center for Creative Leadership.  

Dr. Bing Wang, Chairman and CEO of Amador Bioscience said, "Dr. Yuwen has been focusing on quality systems, drug regulations, clinical research and other fields for more than 30 years Amador Biologics' strategic positioning to bridge global drug development is a good fit. It is believed that Dr. Yuwen will lead the rapid development and growth of the regulatory affairs team.”