Lecture Topic 1: Application Progress and Regulatory Strategies and Challenges of Organoids and Organ-on-Chip Technology

Introduction to the speaker

      Qu Zhe, Deputy director (in charge) of the Pathology Office of the Institute of Safety Assessment of the China National Medical Products Administration, a non-clinical drug (GLP) inspector of the State Food and Drug Administration, a member of the Toxic Pathology Professional Committee of the Chinese Society of Toxicology, a certified pathologist of the Veterinary Pathologist Branch of the Chinese Veterinary Association, and an expert in the field of innovative drug research and development in the National Science and Technology Expert Database. Mainly engaged in drug preclinical safety evaluation research, drug toxicity pathology evaluation, research on new technologies and methods for in vitro neurotoxicity evaluation, construction of national toxicity pathology image database and development of pathology AI-assisted diagnosis models, etc. He has published more than 70 academic papers, more than ten of which are included in SCI, and participated in the editing and publication of 13 monographs. Won the second prize of Beijing Science and Technology Award, the second prize of Chinese Pharmaceutical Association Science and Technology Award, etc. 。

Modern organoid chip technology has developed by leaps and bounds in the fields of disease modeling, toxicology research, drug screening and personalized medicine, and has entered a period of accelerated multi-technology integration and clinical translation. However, it still faces translation problems such as standardization, reproducibility and large-scale application. This lecture focuses on the supervision and standardization practices of new methods (NAMs) such as organoids/organ chips by European, American, Chinese and international organizations. It deeply explores the core challenges and collaborative innovation paths of technology from laboratories to regulatory acceptance, and explains the research progress of the performance evaluation, quality standards and joint verification series of various types of organoids and organ chips under the practical paradigm of "platform construction + topic research + joint verification", aiming to connect the entire chain of "industry-university-research and supervision" collaborative innovation system for organoids and organ-chip technology.

Wang Xixian, Leader of the instrument engineering team of the Single Cell Center of Qingdao Institute of Bioenergy and Processes, Chinese Academy of Sciences, Taishan Scholar Young Expert of Shandong Province, and member of the Youth Promotion Association of the Chinese Academy of Sciences. Committed to the development and engineering of single cell analysis/sorting methodology platforms based on microfluidics and single-cell Raman spectroscopy technology, he developed the world's first high-throughput Raman flow cell sorter and achieved industrialization. He has presided over more than 10 key research and development plan projects of the Ministry of Science and Technology and National Natural Science Foundation of China. He has published more than 30 papers in international journals such as PNAS, Science Advances, and Nature Communications, and has authorized 7 invention patents.

Cell and gene therapy (CGT) products have the characteristics of high value, strong timeliness and complex cell matrix. The traditional culture method sterility test takes about 14 days, and the risk release sterility test still takes 7 days, which is difficult to meet the needs of rapid product release and clinical medication. This lecture will introduce the direct detection system of single-cell bacteria with dielectrophoresis-multiphase flow collaborative separation as the front end and image recognition and Raman fingerprint as the core. It will focus on the efficient separation and enrichment of low-abundance contaminating bacteria, multi-modal rapid identification and instrument development. The lecture will also share the team’s preliminary exploration in image recognition and Raman model construction, and discuss the application value of this technology in biopharmaceutical quality control.