Dr. Bo Fu is the head of the Statistics and Programming Department at Astellas China. He has previously served as a TA/Franchise head or project leader at multinational pharmaceutical companies such as Merck, AbbVie, and Sanofi, focusing on innovative drug development.
Dr. Fu has successfully brought drugs and vaccines to market in major countries and regions across various fields, including vaccines, oncology, infectious diseases, immunology, gene and cell therapy. His research primarily focuses on adaptive clinical trial design, benefit-risk assessment of pharmaceuticals, and real-world data. He has published over fifty papers and book chapters.
As an expert representative of IFPMA, Dr. Fu has contributed to the revision and drafting of the clinical trial guidance document E6R3 Annex2 within the ICH international expert group. He is also involved as steering committee member or lead in national and international professional organizations, including the DIA, RDPAC, ICSA, ASA-Biopharma Section Regulatory-Industry Statistics, and ACSE.
Session objectives:
