PROFILE

이형주 대표

Early Phase Regulatory Affairs for Rare Disease Drug Development

This presentation is intended to introduce regulatory program and activities planning for rare disease drug development in the US, which include orphan drug designation, IND submission, and regulatory expedited programs such as fast track designation.

KCRN Research

EDUCATION

MS in Bioscience Regulatory Affairs, Johns Hopkins University, 2005 – 2007
MS in Agricultural Biotechnology, Seoul National University, 1999 – 2001
BS in Animal Science, Konkuk University, 1992 - 1999

PROFESSIONAL EXPERIENCE

KCRN Research, Inc., CEO & Founder, 2012 to current
Hanall Pharmaceutical International, Inc. Associate Director of Clinical and Regulatory Operations, 2010 to 2012
Rexahn Pharmaceuticals, Inc. Project Manager of Clinical and Regulatory Operations, 2006 to 2010
5 years laboratory experiences, 2001 to 2005

RESEARCH ACTIVITIES & OTHERS

Planning Tips for US IND Filing and Early Phase Clinical Trial, Client Seminar, QuBEST Bio, Suwon, Korea, May 13, 2025
Understanding and Practical Aspects of US Regulatory Affairs and Clinical Trials in Early Phase Drug Development, 2024 Fall International Convention of the Pharmaceutical Society of Korea (PSK), Seoul, Korea, October 23, 2024
Good Information to Know in Planning Early Phase Regulatory and Clinical Projects in US, 2023 Client Appreciation Day of KCRN Research and QuBEST BIO, Yongin, Korea, November 19, 2023
Practical Aspects of Early Phase Regulatory Affairs and Clinical Trials in the US, 2022 Korea Bio Investment Conference, The Korea Economic Daily, Seoul, Korea, July 12, 2022
Practical Aspects of Early Phase Regulatory Affairs in the US, KIOSC Training, March 31, 2021
Practical Aspects of Conducting Early Phase Clinical Trials in the US, KIOSC Training, October 20, 2020
Introductory Seminars for US Clinical and Regulatory Operations, The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), May 19 and Jun 23, 2020