Terry Tai

Biography

Dr. Tai has more than 10 years of experience in regulatory science as a medical reviewer and consultant at the Taiwanese CDE. In the role of a senior medical reviewer/IND review team leader, Dr. Tai has reviewed more than 200 IND cases and was instrumental in developing multiple TFDA draft guidance documents for new drug development. As the Director of Consultation Center, he had provided scientific and strategic leadership to a multidisciplinary (CMC/PT/PK/Clinical/Stat.) regulatory consultation team consisted of senior reviewers and senior project managers that offered integrated consultation services to new drug development pipelines from pharmaceutical industries/research institutes. Additionally, Dr. Tai had been designated as the principal investigator/co-PI in multiple government-sponsored programs, such as the TFDA-sponsored Program to facilitate “Cross-strait Cooperation Agreement on Medicine and Public Health Affairs”. Specifically, he led the collaboration between the TFDA/CDE and CFDA-CDE to execute the “Cross-strait Collaborative Platform on Technical Review of Drug” and provided “Mainland China Regulatory Consultation Service” to domestic pharmaceutical companies interested in submitting a CTA/NDA/ANDA to the CFDA.   

Research Interest

 biochemistry