Profile

Dr. Jun Yang has over 25 years of experience in drug development in both the regulatory agency (US FDA) and the pharmaceutical industry. He specializes in regulatory strategies, clinical development strategies, clinical pharmacology, and PK/PD applications. Dr. Yang obtained his Ph.D. in pharmaceutical sciences from the Ohio State University. Dr. Yang obtained his Master degree from The University of Tennessee focusing on biostatistical modeling using SAS. Dr. Yang spent two years as a Pharmacometrics fellow at Pfizer-SUNY Buffalo strategic alliance. During his 9-year tenure at the FDA, Dr. Yang reviewed more than 1000 new IND submissions and approved more than 30 NDAs/BLAs as a clinical pharmacology/pharmacometrics reviewer.
After leaving the FDA in 2016, Dr. Yang was executive Director and vice president in the pharmaceutical industry, heading the Translational Medicine and Global Regulatory Affairs department. He was the founder and CEO at JP Global Pharma. Dr. Yang has rich experience guiding and advising lean and efficient preclinical and clinical strategies at various R&D stages. He also has extensive hands-on experience in PK/PD M&S and model-informed drug development (MIDD) using different statistical software. He has helped more than 100 IND/NDA submissions from 2016-2023. Dr. Yang assisted more than 30 pharmaceutical companies in addressing dose optimization for oncology drugs (Project Optimus) from 2020 to 2023.