标题: Early drug development, bridging the gaps across ocean [打印本页] 作者: weiwei99 时间: 2017-8-15 23:18 标题: Early drug development, bridging the gaps across ocean 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.