Shen Xiao 肖申

肖申博士现任礼邦制药首席科学官,负责公司新药的临床前开发和全球药物注册,并协同首席医学官推进公司新药的临床开发工作。之前曾任海森生物医药有限公司首席医学官,思路迪医药的首席战略官和首席医学官。肖申博士曾在美国食品药物监督管理局(FDA)担任药理,毒理的非临床高级审评员负责内分泌,代谢疾病新药的非临床审评,和临床高级审评员负责心、肾、血管疾病新药的临床审评。在近二十年的 FDA工作生涯中,负责审评了数百个新药开发(IND)的各个阶段,跨度从临床前期、临床各期、及上市后的药物疗效、安全跟踪、随访;做为临床评审员和/或综合评审小组负责人负责审批了十几个新药的上市工作。其间曾在 FDA 医疗器械审评中心(CDRH),负责多个相关医疗设备的审评、审批(IDE510kPMA)。

加入 FDA 之前,曾作为内科临床主治医生、博士研究助理和博士后有十多年的临床工作和实验室研究经验,包括各类普通内科疾病诊治、抗生素临床药代动力学的研究、细胞信号传导的研究等。其间除了曾获国家科技进步三等奖一项,全军科技进步二等奖一项外,还获得 FDA,美国生理协会(APS),国际肾脏病协会(ISN),日本透析和人工脏器协会的多项奖励。

Be responsible for the setting of company’s R/D product pipelines, non-clinical and clinical product development, and global regulatory affairs. Previously, he served as the Chief Medical Officer at Hasten Biopharmaceutical Co, Ltd, and the Chief Medical Officer and Chief Strategy Officer at 3D Medicines Inc for taking the full responsibilities of company’s clinical product development and global regulatory affairs.  

Before that, Dr. Xiao worked in the US FDA as a senior medical officer and was responsible for the clinical review of new drugs in the areas of Cardiovascular, renal, diabetes, obesity and some other endocrine and metabolic diseases. During his nearly 20-year career at the FDA, he reviewed several hundreds of Investigational New Drug (IND) applications across various stages, including preclinical, clinical phases, and post-marketing drug efficacy and safety tracking, and follow-up. As a clinical reviewer and/or multiple discipline team leader, he approved over a dozen of NDAs/BLAs. He also worked at the FDA’s Center for Devices and Radiological Health (CDRH), where he reviewed and approved multiple medical devices (IDE, 510K, PMA). 

Prior to FDA, as an attending physician in Nephrology in China and research fellow in US, he had over a decade of clinical practice and laboratory research experience. His experience includes diagnosing and treating a variety of general internal medicine diseases, renal diseases, conducting the clinical pharmacokinetics studies for different antibiotics, and studying cell signaling pathways. During this time, he was awarded numerous honors including the China National Scientific and Technological Third Award,  and many other awards from the FDA, the American Physiological Society (APS), the International Society of Nephrology (ISN), and the Japanese Society for Dialysis Therapy and Artificial Organs (JSDAO). 

Angela Yu 于琳

Angela graduated with a Master of Science degree from the University of Hertfordshire in the UK. She held a clinical supply position at the Medical Department of Boehringer Ingelheim, where she gained comprehensive understanding of clinical supply demands and market pricing structures. Subsequently, she joined the RTG division of Medtronic, contributing to the localization and implementation of factory establishment for the group. In 2019, Angela joined Harbour BioMed, where she assisted in and advanced the initiation of oncology clinical trials overseas, successfully communicating and engaging with clinical suppliers across Europe, the United States, and Hong Kong. Currently, she serves as the Head of Clinical Supply for  Huadong, supporting the company in establishing a supplier management system and overseeing related supplier bidding processes

Angela毕业于英国赫特福德大学理学硕士学位,在勃林格殷格瀚医学部担任临床供应商职位,在充分学习了临床供应商需求,市场价格梯度后加入了美敦力RTG事业部,协助集团完成本地化建厂的落地,在2019年时Angela加入和铂医药,协助并推动肿瘤海外临床的试验的开展,并在欧洲,美国和香港都完成了临床供应商的沟通与接洽。目前其担任中美华东临床供应商负责人,协助公司完成供应商管理体系搭建及相关供应商招投标工作 

Fiona Xing 邢新苗

Fiona Xing is currently serving as the Head of Clinical Supply Chain at Brii Bioservices (Beijing) Co., Ltd. She entered the pharmaceutical industry in 2005 and worked at Servier, Allergan, Bayer R&D Center and Merck Serono R&D Center, mainly engaged in local and global clinical trial supply chain coordination and management. ​

Fiona Xing holds a master‘s degree in microbiology from Shandong University and an MBA degree from Sofia University in the United States. In addition, Fiona Xing has obtained professional Project Management (PMP) and Program Management (PgMP) certification from the American Project Management Institute.

邢新苗目前任职于腾盛博药医药技术(北京)有限公司,担任临床供应链负责人。她从2005年进入医药行业,先后任职于施维雅,艾尔建,拜耳研发中心,默克雪兰诺研发中心,主要从事中国以及全球临床试验供应链协调和管理工作。​

邢新苗拥有山东大学微生物学专业硕士学位,并获得美国索菲亚大学MBA学位。 此外,邢新苗持有美国项目管理协会的专业项目管理和项目集管理认证。

 

Siwei Li 李四维

Dr. Siwei Li, Director of DMPK at Degron Therapeutics. Dr. Li earned his B.S. in Biotechnology from Nanjing University in 2008 and received his Ph.D. in Chemistry from the University of Cincinnati (USA) in 2014. Then he served as postdoctoral research fellow at the University of Michigan College of Pharmacy and also obtained a professional certificate in Data Science from Stanford University. With over 10 years of experience in drug discovery and development, Dr. Li has held key positions including Director of AI Pharmacology at an AI Drug Discovery biotech company, Senior Principal Investigator at BeiGene, and Research Scientist at a Silicon Valley precision medicine company. He is also recognized as an Elsevier Outstanding Reviewer for Food Chemistry journal. His research focuses on small molecule non-clinical pharmacokinetics, Model-Informed Drug Discovery (MIDD): PKPD and AI model development and application in drug discovery and development, Bioanalytical technology development and application, AI-driven proteomics and metabolomics research. Dr. Li has contributed to 10+ drug discovery programs and led/participated in non-clinical PK studies supporting multiple China-US IND filings. To date, he has published over 20 papers in internationally renowned journals and filed 1 patent application.

李四维博士,达歌生物药代动力学总监。2008年毕业于南京大学生物技术专业本科,2014年获美国辛辛那提大学化学博士学位。随后在美国密西根大学药学院从事博士后研究,并获斯坦福大学数据科学职业认证。李博士拥有10余年的药物研发经验,曾先后担任AI制药公司AI药理总监、百济神州高级主任研究员及美国硅谷精准医学公司研究科学家。同时,他还是爱思唯尔《Food Chemistry》期刊的杰出审稿人。李博士的研究方向聚焦于小分子非临床药代动力学研究;模型引导的药物研发(MIDD): PKPD模型和AI模型在药物研发中开发和应用;生物分析技术开发与应用。他还在AI赋能蛋白质组学及代谢组学研究方向拥有多年实践经验。曾参与10余个新药研发项目,并主导参与多个中美IND申报相关的非临床药代动力学研究工作。迄今在国际知名期刊发表论文20余篇及申请专利1项。

 

Megan Qin 秦飞

Megan Qin has over 15 years of experience in the healthcare industry and is a PMI-certified Project Management Professional specializing in clinical research project management, clinical pathway planning, clinical operations, and innovative intelligent solutions. She has held positions at world-renowned healthcare companies including Roche Medical, Bard Medical (BD), BI (Boehringer Ingelheim), and Stryker Neurovascular, where she served as the Head of Clinical Affairs for China, accumulating extensive knowledge and hands-on experience in GCP (Good Clinical Practice) for drugs and medical devices. She is particularly passionate about innovative medical devices, optimizing clinical data applications, and implementing project management risk controls.
Currently, she also holds roles as Committee Member of Medical Device Clinical Trial Quality Management Committee-China Association of Rehabilitation of Disabled Persons and Working Group Member of DIA Real-World Evidence Research Group.

秦飞拥有超过15年的医疗行业经验,PMI认证项目管理专家,专注于临床研究领域项目管理,临床路径规划,临床运营及创新智能化解决方案。她曾就职于罗氏制药、巴德医疗(碧迪医疗)、BI(勃林格殷格翰)以及史赛克医疗等世界知名医疗企业,曾担任中国区临床事务负责人,积累了丰富的药物及医疗器械GCP的知识和实践经验,在创新医疗器械、优化临床数据的应用,实施项目管理风险管控等方面尤其热衷。现兼任中国残疾人康复协会-医疗器械临床试验质量管理专业委员会委员,DIA真实世界研究工作组成员。