Nonclinical Evaluation Studies of Cellular and Gene Therapy Products

Dr Quanjun Wang is CEO and Chief Scientist of the Safe Medical Research Institute and Vice President of the Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences. He is a Distinguished Professor at the Hefei Institutes of Physical Science, Chinese Academy of Sciences; Adjunct Doctoral Supervisor, School of Pharmacy, East China Normal UniversityDr Wang has over 20 years of experience in innovative drug R&D and nonclinical safety evaluation. He has published 140+ peer-reviewed papers and authored/co-authored eight monographs in toxicology and regulatory science. He golds 20+ patents in drug evaluation methodologies Dr Qingli Wang is Chief Pharmacist and Senior Reviewer at the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA). Dr. Wang joined the CDE in 2002 and has since specialized in the evaluation of drug safety studies. Currently serving as Director of the Department of Pharmacology and Toxicology at the CDE, he leads technical reviews for pharmacological and toxicological studies of drugs and spearheads the development of China’s technical guidance system for non-clinical drug research.Concurrently, he holds the position of Chair of the Drug Toxicology Committee at the Chinese Pharmacological Society Professor Xingchao Geng a Research Professor and Director of the National Center for Safety Evaluation of Drugs at the National Institutes for Food and Drug Control (NIFDC), China. Dr. Geng serves concurrently as: Chair of the Drug Safety Evaluation Research Committee, Chinese Pharmaceutical Association, National GLP Inspector and National Expert for New Drug Evaluation. With over 20 years of experience in drug safety evaluation research, he has directed preclinical safety assessments for more than 200 domestic and international new drug candidates

• 1. Overview of cell and gene therapy products2. Safety risks of cell and gene therapy products3. Regulatory frameworks for cell and gene therapy products4. Quality control of cell and gene therapy products5. Nonclinical toxicology studies6. Advances in in vivo animal models for evaluation7. Organoid and organ-on-chip models for evaluation8. Evaluation of delivery systems9. Immunogenicity assessment10. Pharmacokinetics studies and evaluation11. Tumorigenicity/oncogenicity assessment12. Integration site analysis and off-target assessment13. Nonclinical evaluation of stem cell products14. Nonclinical evaluation of car-t cell products15. Nonclinical evaluation of oncolytic viruses16. Nonclinical evaluation of gene editing products17. Nonclinical evaluation of nucleic acid drugs18. Nonclinical evaluation of extracellular vesicle therapies19. Nonclinical evaluation of red cell therapeutics20. Nonclinical evaluation of combination therapies21. On-site GLP inspection for registration Abbreviations