Dr. Sun has an extensive background as a regulatory reviewer at the U.S. FDA, where he reviewed numerous INDs/NDAs and achieved groundbreaking regulatory approvals, including single-phase 3 clinical studies and modeling and simulation techniques for new drugs. He also played a pivotal role in developing seven regulatory guidance documents for various aspects of pharmaceutical research.
Over the past 15 years, Dr. Sun has led a team in achieving a historic milestone by developing the first-ever multi-herbal drug product, which has completed its clinical phase III development and is poised for NDA submission in the United States. This achievement has the potential to revolutionize herbal drug development and open new avenues for addressing unmet clinical needs.
Dr. Sun's contributions to public policy have been recognized with numerous FDA research grants, the FDA Francis Safety Award, and The Commissioner's Special Citation Awards, underscoring his significant impact on the field of regulatory medicine.
