本次ISPE中国供应链分委会,将聚焦上述临床供应链领域的核心点,邀请行业资深专家参讲和讨论。欢迎行业伙伴们积极参与、交流,为提升中国临床供应链的行业品牌度共同努力。
高腾医药 CEOISPE 中国制药供应链分委会主席
CBA-GP中国区联络人临床运营负责人,高级总监,英矽智能
凯复医药临床运营副总裁
Takeda副总监,临床供应链运营
琚珏刚先生,目前在英矽智能担任临床运营负责人,管理所有临床研究项目从策略到运营交付的各种事宜,并涵盖人员/预算/流程等各方面的管理。在加入英矽智能之前,琚珏刚先生曾在原力生命担任全球临床运营负责人,在岸阔医药担任产品开发策略和临床开发负责人,以及在昆拓/艾昆玮担任临床战略规划负责人。在此之前,琚珏刚先生曾在阿斯利康、安进/昆泰、诺华/昆泰和法码康担任过多项职务,涉及从全球临床研究的管理到研究中心的运营管理工作。琚珏刚先生毕业于上海交通大学,拥有科学学士和硕士学位。
• Johnny Ju, currently as the Head of clinical operations in Insilico, responsible for clinical study projects from strategy to operational delivery, also covering the management of people / budget / process / etc. Before joining in Insilico, Johnny had been the Global Clinical Operations Head in Ionova, Head of Product Development Strategy and Clinical Development in OnQuality, and Head of Clinical Strategy Planning in KunTuo/Quintiles. Even before, Johnny had taken multiple roles from Global clinical study management to site level operational management in AstraZeneca, Amgen/Quintiles, Novartis/Quintiles and Pharmacons. Johnny was graduated from Shanghai Jiao Tong University, with Bachelor and Master Degrees of Science.
北京大学医学部流行病与卫生统计学硕士。拥有10年以上国际项目管理经验和10年+Biotech公司创新药研发工作经验。熟悉药物研发临床前研究、IND申报和临床开发等工作,包括临床开发计划、临床试验方案制定;数据管理、统计分析、药物安全管理等领域,领导完成了多个在中国、美国和澳大利亚开展的I/II期临床试验,参与多个化合物中、美、澳新药临床试验IND申请和pre-IND沟通交流工作以及临床前研究工作。现负责凯复医药全球临床运营和法规注册工作。
Mrs. Wang received her Master of Epidemiology and Health Statistics from Peking University Health Science Center. With over 10 years of Global project management experience in China CDC and Damien Foundation Belgium and more than 10 years of innovative drug research and development experience in Biotech companies. She has been involved in preclinical research and development, IND application, and clinical operations, including data management, statistical analysis, and drug safety management. Mrs. Wang has led the completion of multiple Phase I and Phase II clinical trials in China, Australia, and the United States, and participated in the IND applications and pre- IND preparations, as well as preclinical researches for a variety of new drugs in China, Australia, and the United States. Currently she is in charge of the global clinical operations and regulatory affairs of Keythera Bio-Pharmaceuticals.
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