[summit person] Gong Zhaolong: exploring the new trend of FDA drug approval

Dr Gong Zhaolong once worked as a new drug reviewer in the drug review center (CDER) of the U.S Food and Drug Administration (USFDA), and served as the pre clinical chief reviewer of many widely concerned new drugs, such as Crestor, PPAR and DPP4, CB1 and so on In the past 20 years, Dr Gong has participated in new drug research and development from different perspectives such as FDA, cro and new drug R & D enterprises He has accumulated rich experience in strategic planning of new drug global development, non clinical and clinical trial scheme design, GLP regulation management, project selection and drug resistance evaluation in new drug research and development, coordinated promotion of non clinical and clinical trials, and risk evaluation in project promotion On September 24-25, Dr Gong will attend the 2016 China Pharmaceutical R & D Innovation Summit and the press conference of the top 100 pharmaceutical enterprises' R & D strength, which is directed by the China Pharmaceutical University, hosted by the pharmaceutical intelligence elite club and hosted by the pharmaceutical intelligence network, as a special guest to explore the new trend of FDA drug approval with all colleagues Gong Zhaolong, former senior drug review expert of FDA, thought of CEO of Dee Pharmaceutical Technology Co., Ltd "after a hundred years of development and accumulation, the FDA of the United States has formed a relatively mature drug review and approval system, which has formulated corresponding approval standards for new drugs, improved new drugs, generic drugs and biological similar drugs, to a certain extent, ensuring the safety and effectiveness of drugs on the market." "In recent years, the FDA has launched a series of new systems, including the establishment of a number of fast review and approval channels, which greatly improves the approval efficiency and shortens the approval time," Gong said "With the implementation of the precision medicine program, FDA has launched a series of new reform measures, using the most advanced scientific and technological means to guide clinical trials, to ensure that personalized drugs urgently needed in clinical can be approved for marketing as soon as possible Especially in the field of tumor therapy, the maturity and development of immunotherapy has brought new hope for human beings to defeat tumor, and the combination of precision medicine and immunotherapy will become the direction of tumor therapy in the future " Dr Gong said so Dr Gong Zhaolong graduated from Beijing Medical College (now the medical department of Peking University) in 1984, received his doctorate in toxicology from New York University (NYU) in 1996, and engaged in postdoctoral research at the National Institutes of Health (NIH) from 1996 to 1998 From 1998 to 2008, he worked as a new drug reviewer in the drug review center (CDER) of the U.S Food and Drug Administration (USFDA) He has been the pre clinical chief reviewer of many widely concerned new drugs, such as Crestor, PPAR and DPP4, CB1 and so on In the past decade, he has completed hundreds of new drug review reports, covering all fields of new drug research and development, including pharmacology, PK / PD , ADME, toxicology, etc In the past ten years, he has accumulated a lot of experience in new drug research and development He has a comprehensive understanding of the whole process of new drug research and development, drug approval standards, drug development laws and various management norms In 2008, Dr Gong returned to China and served as the chief technical officer of Zhaoyan new drug research center He fully participated in and actively promoted the company's internationalization process, making Zhaoyan become a cro organization with dual GLP qualifications of China's SFDA and the U.S FDA and international AAALAC certification, and promoted many domestic projects to enter the clinical development stage through FDA review In 2012, Dr Gong successively served as CEO of Laibo Pharmaceutical Co., Ltd and vice president of Baiji Shenzhou new drug development and drug administration, and participated in and promoted three innovative drugs of Baiji to enter the stage of clinical development and foreign equity transfer Dr Gong is currently a member of the pharmaceutical clinical research committee of China pharmaceutical innovation promotion association, the editorial board of China new drug journal, the editorial board of pharmaceutical progress journal, the Council member of AAALAC (International Laboratory Animal assessment and Accreditation Committee) and the director of freehand club He is also the CEO of mindI Pharmaceutical Technology Co., Ltd MindI has the largest PDC new drug development platform for liver cancer in the world, and has the ability to carry out drug response research on hundreds of tumor patient cell lines in the preclinical stage, and through the analysis of a large number of tumor cell genome big data, to find effective targets and biomarkers, so as to greatly improve the success rate of clinical development of high-tech drugs The world's first new generation of PDL1 antibody, an innovative tumor immunotherapy drug developed by mindI, has submitted its clinical application to the US FDA and China food and drug administration, and entered clinical research within this year In the past 20 years, Dr Gong has participated in new drug research and development from different perspectives such as FDA, cro and new drug R & D enterprises He has accumulated rich experience in strategic planning of new drug global development, non clinical and clinical trial scheme design, GLP regulation management, project selection and drug resistance evaluation in new drug research and development, coordinated promotion of non clinical and clinical trials, and risk evaluation in project promotion On September 24-25, at the "2016 China Pharmaceutical R & D Innovation Summit and top 100 pharmaceutical enterprise R & D strength list conference" hosted by the pharmaceutical intelligence elite club and under the guidance of the China Pharmaceutical University, and hosted by the pharmaceutical intelligence network, Dr Gong will attend as a special guest to explore the new trend of FDA drug approval with all colleagues We are looking forward to it How about you? 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