发布时间:
2017
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11
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27
点击次数:
0
Positions：
President
Company：
3DBiopharm
个人简介：
3D Medicines is a leading precision medicine company focused on cancer in China with 350 employees. The 3Ds stand for Diagnosis, Data, and Drug development, representing our integrated business in cancer precision diagnosis, genomic big-data analysis, and oncology drug development. In the past six years, 3D Medicines has worked with 200 top hospitals and performed over 7,000 genomic tests on cancer patients’ tumor tissue and blood samples using NGS and dPCR. At the same time, our company developed and established over 1,500 patient-derived cancer cell-lines (PDC) and 150 patient-derived xenograft (PDX) models from patients’ tumor tissues, rendering us the ability to screen drug candidates using hundreds of PDCs. With the integrated in-house genomic database, potential genomic-based biomarkers can be identified and validated in large PDC cell line panel and proof-of-concept in PDX models. Biomarkers will be used in all clinical trials for patient stratification, thus increasing the chance of success for our drug development program. Our drug development pipelines include a global first subcutaneous injection single domain PDL1 antibody, KN035, which is currently in Phase I trials in both US， Japan，and China. KN035 is a truly differentiated immunotherapy agent with some unique characteristics, such as, single domain structure for good stability at room temperature, small molecular weight for fast penetration into tumor tissue, optimal formulation for good bioavailability in subcutaneous injection, lower immunogenicity for better safety, easy to use for better patient compliance, and much lower manufacture and distribution cost. Prior to 3DMed, Dr. Gong served as VP of Drug Development and Regulatory Affairs of Beigene, CEO of BL Pharma, and CTO of JOINN Laboratories. From 1998 to 2008, Dr. Gong worked at US FDA as Reviewer, he conducted primary and critical reviews of numerous IND and NDA applications for both small molecules and biologics. Dr. Gong is member of the Drug Safety Evaluation Committee of the Chinese Pharmaceutical Association, Council member of AAALAC and Tongxieyi Club, and members of editorial board of Chinese Journal of New Drugs, and Progress in Pharmaceutical Sciences. Dr. Gong received his Ph.D. in Toxicology from New York University in 1996 and a medical degree from Beijing Medical College in 1984.