Early drug development, bridging the gaps across ocean

weiwei99

活动内容：

Dr. Zhu has over 20 years of clinical development experience and has led the design and execution of multiple pivotal clinical trials of important novel investigational drugs, such as tyrosine kinase inhibitors (SUTENT®), rank ligand antibody (XGEVA™), PEGylated Recombinant Human Hyaluronidase (PEGPH20) and other mechanistically innovative drugs including HDAC inhibitor and JAK inhibitors. In this workshop, Dr. Zhu will share her invaluable knowledge on drug development and clinical trial experience both in US and in China.

Speaker Bio

Dr. Huan Joy Zhu obtained her M.D. degree from Beijing Medical University and her Ph.D in biochemistry from Georgia Institute of Technology. Since her graduation from Georgia Institute of Technology in1992, Dr. Zhu has worked in several pharmaceutical and biotech companies in the US and have devoted her professional career in developing new therapies to help patients in need. She served multiple positions with increasing responsibilities in the past 24 years, with the most recent roles as chief medical officer at Zenith Epigenetics Corp and S*Bio Pte Ltd., Vice president at Bavarian Nordic, Halozyme therapeutics. with strong focus in oncology and ophthalmology.

In her earlier career, at CIBA Vision/Novartis Joy worked on two New Drug Applications which led two successful ophthalmic drug approvals by the FDA: Zaditor®, in 1999 and Rescula®, in 2000. At SUGEN/Pfizer, Dr. Zhu’s leadership and her expertise in clinical development led the approval of SUTENT® (sunitinib malate) in 2007 for the treatment of metastatic renal cell carcinoma.

At AMGEN, Dr. Zhu was the first Chinese American physician to be appointed as the Global Development Leader and was directly in charge of developing strategies for Denosumab oncology clinical program in 2003. Denosumab had the highest priority in the pipeline at the time at Amgen. Dr. Zhu’s leadership, dedication, and experience ultimately led to the approval of XGEVA™ for skeletal-related events prevention in patients with bone metastases from solid tumors; for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Recently Dr. Zhu started her own consulting business to provide her expertise to multiple start up companies in China. She bridges the gaps between China and US and helps a number of China based companies filed INDs in US. She also develops the overall oncology drug development strategies for companies, as well as provides resources for development functions such as regulatory, project management, CMC, DMPK, and clinical operation. She also provides due diligent support for licensing opportunities.

祝欢1987 年从北京医科大学获得医学学士学位, 1992 年在美国佐治亚理工学院获得生物化学博士学位。自从1992 年佐治亚理工学院毕业后, 祝博士先后在美国多家国际医药技术公司任职。她在过去25 年中担任越来越重要的职位, 参与了许多重大科研项目。曾担任的职位包括高级主管、首席医疗官和医学总裁, 主攻眼科和肿瘤领域的新药研发。

在视康/诺华, 祝欢作为临床科学家, 参与了两个美国FDA新药申请并获批: 1999 年批准用于治疗过敏的Zaditor®, 和2000 年批准用于治疗青光眼的Rescula®。在SUGEN /辉瑞, 祝博士担任临床研发主任, 直接领导开发SUTENT®(索坦/苹果酸舒尼替尼)。此药于2007 年被FDA 批准用于治疗转移性肾细胞癌, 在当时是最前卫的靶向治疗新药, 也是肾癌治疗史上20 年来的第一个新药突破。

在安进(AMGEN), 祝博士是公司里第一位成为全球临床开发负责人的中国人, 直接负责XGEVA™(狄诺塞麦)的全球临床开发。当时, 狄诺塞麦是安进公司最重要的战略方向。祝博士带领团队为XGEVA™ 获得FDA 批准用于以下适应症: 用于实体瘤骨转移患者，预防中骨折相关事件的发生; 用于成人患者及骨骼成熟的青少年患者，治疗手术无法切除的或手术切除会带来严重病症的骨巨细胞瘤(GCTB); 用于经双膦酸盐治疗的晚期癌症患者，治疗恶性肿瘤高钙血症(HCM)。在强生, 祝博士代表西海岸生物公司参与总公司的全盘科研计划和预算。近十年来, 祝博士先后担任了4 家中小型生物公司的医学总裁, 主管全公司肿瘤药研发项目。

最近祝博士创办了自己的咨询业务, 给多个中国的初创企业提供她的专长服务。她缩短了中国和美国之间新药研发的差距，并帮助许多中国企业完成在美国的新药研发申报。她还提供多种推动企业发展的服务, 包括监管策划、项目管理、CMC、DMPK 和临床操作的整个肿瘤药物发展战略等。对于有意向引进知识产权的企业，她可以在尽职调查过程中提供帮助。


时间：Sun, August 27, 2017
2:30 PM – 4:30 PM PDT

地点：SV 1898 Group, Inc
4699 Old Ironsides Drive, Suite 150
Santa Clara, CA 95054
United States


链接：https://www.eventbrite.com/e/ear ... tickets-36903969767