Nonclinical Safety Assessment of Advanced Therapeutic Products and Application of Novel Evaluation Approaches

Dr. Jinhua Lu is the co-founder and chief scientist of TriArm Therapeutics. Before joining TriArm, he served as an expert reviewer at the Office of Advanced Medical Products of the U.S. FDA, responsible for reviewing cell and gene therapy products, medical devices, and combination products. Dr. Lu is a widely recognized expert in the field of cell and gene therapy and has co-authored several FDA guidance documents. He has also served on the Scientific Advisory Board of the FDA's Oncology Center of Excellence and received the FDA's Excellence in Regulatory Science Award, among other honors.

Lu Jinhua has been engaged in biopharmaceutical research and development for over twenty-five years. Prior to working at the FDA, he served as a senior scientist, department head, and consultant for both government and the biopharmaceutical industry, focusing on the development of viral vectors and viral vaccines for cancer treatment, and leading multiple projects into clinical trials. He has extensive experience in strategic planning, project management, process and assay method development, formulation, and regulatory compliance.