Description: Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks systematically explores the nonclinical evaluation of Cell and Gene Therapies (CGT) products, emphasizing risk mitigation and innovation. The book provides comprehensive coverage, including 20+ chapters spanning preclinical toxicology, pharmacokinetics, and novel evaluation models. It is the first book to integrate organ-on-chip models into CGT evaluation, reflecting FDA/NMPA modernization initiatives. It includes practical guidance on addressing CRISPR off-target effects, immunogenicity, and long-term carcinogenicity risks.
Brief description:
Dr Quanjun Wang is CEO and CSO of the Saifu Laboratory 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 University
Dr 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