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- Guangbin Peng
- Vice President, Biometrics ,Tigermed Consulting Co., Ltd.
- Guangbin Peng , Vice President, Biometrics of Tigermed, is responsible for Tigermed Biometrics US operation (Biostatistics, Statistical programming and data management) and business development. Graduated from Iowa State University with M.S in biology/statistics and MBA from Purdue University Krannert School of Management. Over 15 years’ experience in biostatistics and clinical research with focuses on oncology and CNS therapeutics areas, supported multiple regulatory submissions to US FDA, EMA and PMDA.
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- Rodrigo Estacio
- Growth & Emerging Markets Regulatory Lead, Takeda
- Rodrigo is a Growth & Emerging Markets Regulatory Affairs Lead at Takeda with more than 17 years of experience in Regulatory Strategy. Rodrigo successfully lead cross-functional teams in developing regulatory and development strategies for China and other 38 Countries. Recent accomplishments involved successful Health Authority interactions with CDE/NMPA as well as CTA submissions and approvals under the new guidelines. Rodrigo is also the Policy Lead for the Growth & Emerging Markets, being responsible to closely monitor the evolution of the regulatory landscape in China.
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- Xiang Yang Yu, Ph.D.
- Program Manager, Accellient Partners
- Dr. Xiang Yang Yu has been an independent consultant as Director of Preclinical Development at Acurx Pharmaceuticals since June 2018. She has been a Program Manager at Accellient Partners with responsibilities for API and drug product CMC manufacture as well as for regulatory writing/filings including FDA IND and European IMPD submissions/amendments/annual reports. She has also been involved in managing CMC in multiple clinical trials from Phase I to Phase III in multiple therapeutic areas since 2014. Prior to that, she was a principal investigator at Ironwood Pharmaceuticals where she was involved in drug discovery and development programs in multiple therapeutic areas as well as efficiently and strategically managed external drug discovery and development collaborations in the US, Europe and Asia. Prior to joining Ironwood, Dr. Yu was Director of Medicinal Chemistry at Epix Pharmaceuticals leading successful drug discovery programs. She was the chemistry project leader for S1P program licensed to Amgen for highly potent, selective and orally active agents for autoimmune diseases leading to $20 million upfront payment and $307 million milestone payment in a record 9 months. Dr. Yu was also a chemistry project leader for a GSK collaborative discovery program which resulted in $5.5 million upfront payment in 7 months. Before joining Epix, she led multiple anti-infectious programs at Activbiotics and Cubist Pharmaceuticals. She obtained her MS and Ph.D. degree in Organic Chemistry from Florida State University. She received her undergraduate degree from East China University of Science & Technology in Shanghai. Dr. Yu is a Board Director and President of the Chinese American BioMedical Association (CABA) since 2014 (a 501(C)(3) not-for-profit professional organization. She was the President of CABA - (2013-2014). She is currently a Co-chair in MassBio Forum at MassBio and a BayHelix member.
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- Dr. Dan Zhang
- Executive Chairman of Fountain Medical Development Ltd.
- Dr. Dan Zhang is the Executive Chairman of Fountain Medical Development Ltd, a clinical CRO with 1700 employees operating in China, Hong Kong, Taiwan, South Korea, Japan, UK, India, Philippines, Armenia & USA. Dr. Zhang was the Head of Clinical Development and was the Head of Safety Assessment at Sigma-Tau Research Inc-leading Italian Pharmaceutical Company, He was the vice president at the Quintiles Transnational Corp., and Chairman of Quintiles Medical Development (Shanghai) Company Ltd., Dr. Zhang is a member of grant review committee for National Drug Development Fund of China, and is also a consultant for the China Food and Drug Administration (CFDA). He is a member of ICH E19 Expert Working Group. He is also chairing the committee of Pharmaceutical R&D, China Pharmaceutical Industry Research and Development Association. Dr. Zhang is also a senior consultant for the Chinese Academy of Medical Sciences and Peking Union Medical College. He was a member of the Overseas Expert Committee on New Drug R&D for the Ministry of Science and Technology of China. Dr. Zhang was the former board of directors for the Sino-American Pharmaceutical Association (SAPA) and was the former president of Chinese Biopharmaceutical Association-USA (CBA). Dr. Zhang is chairing the government relationship committee of Bayhelix-an organization hosting senior executives from life-science organizations in USA and China. Dr. Zhang received his pre-med training from Peking University and received M.D. from Peking Union Medical College. He then went to the Harvard School of Public Health and received MPH in health policy and management. Then he went to the Wharton Business School of the University of Pennsylvania, where he obtained his master’s degree in healthcare management in 1998
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- Pingkuan Zhang, M.D.
- Senior Medical Director, Takeda Oncology R&D
- Dr. Pingkuan Zhang obtained her medical degree at Fudan University, Shanghai, China and was a licensed physician before joining industry in 2003. She worked for Sanofi, AstraZeneca and GSK in medical and R&D roles in China with increasing responsibility before moving to US as medical director for global pivotal studies at GSK in 2014. She designed and delivered life cycle management studies for the China and Asian regional unmet medical needs, and led the delivery of global pivotal studies. She successfully achieved line extension of global compounds in China, as well as new drug registration in US and Europe. She is currently Senior Medical Director, working for Takeda Oncology R&D, based in Boston.
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