Korea Health Industry Development Institute Recruits 'Overseas Pharmaceutical Expert' Park Joon-tae as Standing Consultant

The Ministry of Health and Welfare and the Korea Health Industry Development Institute announced on the 3rd that they have appointed Jun Tae Park, a standing consultant and an expert in regulatory affairs and Good Manufacturing Practice (GMP) for pharmaceuticals from the U.S. Food and Drug Administration (FDA), as an overseas pharmaceutical expert at the institute on the 1st to support domestic pharmaceutical companies' entry into the U.S. market through new drug development.

Consultant Park earned a Ph.D. in the United States and has accumulated nearly 30 years of experience in the U.S. regulatory affairs and Chemistry, Manufacturing, and Controls (CMC) field. After working at the FDA, he was responsible for CMC development for FDA approvals at the U.S. Department of Defense and U.S. biotech ventures, making him an expert with extensive experience and knowledge in pharmaceutical regulatory affairs and manufacturing quality processes.

During his 11 years at the FDA from 2006 to 2017, he served as a reviewer for Investigational New Drug (IND) applications and Biologics License Applications (BLA) in the CMC field, handling clinical and product approvals for cell therapies including monoclonal antibodies, antibody-drug conjugates (ADC), and exosomes. Subsequently, he held positions such as Vice President of New Drug Regulatory Affairs at Helixmith and Chief Technology Officer (CTO) at Ilias Biologics.

Consultant Park stated, “Because biopharmaceuticals have complex production and manufacturing processes, it is important to establish CMC plans from the early stages to increase the probability of successful development.” He added, “With the recent increase in demand from domestic companies aiming to enter the U.S. market through the development of biopharmaceuticals such as cell and gene therapies (CGT) and microbiomes, I am pleased to provide practical support to domestic companies based on my extensive experience in the CMC field and as an FDA reviewer.”

Consultant Park will provide customized on-site consulting on CMC development strategies, FDA meetings, and BLA preparation to support domestic pharmaceutical companies’ entry into the U.S. market. Companies wishing to receive consulting can apply through the institute’s pharmaceutical industry information portal, and the service will be provided free of charge.

This content was produced with the assistance of AI translation services.