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

M.S., Bioscience Regulatory Affairs, Johns Hopkins University, Baltimore, MD, 2007
§ M.S., Agricultural Biotechnology, Seoul National University, Seoul, Korea, 2001
§ B.S., Animal Science, Kon-Kuk University, Seoul, Korea, 1999

PROFESSIONAL EMPLOYMENT

May 2012 - Present / CEO & Founder and Sr. Regulatory & Project Manager
KCRN Research, Inc., Germantown, MD
Develop and manage KCRN Research
Oversee clinical and regulatory projects on early phase drug development
Oct 2013 – Present / GPKOL (Global Pharma Key Opinion Leader) – Clinical Trials and Regulatory
Korea Health Industry Development Institute
Consult clinical and regulatory needs from Korean applicants
Apr 2010 - Apr 2012 / Associate Director, Clinical Regulatory Affairs, HPI, Inc., Rockville, MD
Managed multiple clinical projects as a sponsor project manager
Monitored clinical sites
Served as the internal RA representative for multiple clinical projects

PRESENTATIONS & PUBLICATIONS

Understanding CRO Activities in Early Phase Clinical Trial, 2019 KAPAL (Korean-American
Professional Association in Life Sciences) Annual Conference, Rockville, MD, November 7-8, 2019
n Understanding US Regulatory Affairs and Clinical Trials in Early Phase Drug Development, Clinical
Research Science Expert Course for Cutting-edge Drug Development, Advanced Course for
Pharmaceutical Medicine, Seoul National University, Seoul, Korea, October 11-12 2018
n Understanding US Clinical Trials in Early Phase Drug Development: Practical Aspects, 2014 KASBP
Spring Symposium, Korean American Society in Biotech and Pharmaceuticals (KASBP), Edison, NJ,
June 6-7, 2014
KCRN Research, Inc. 1 April 2024
Confidential 3
§ Understanding US Clinical Trials in Early Phase Drug Development: Practical Aspects, Hugh Lee,
The 11th Osong International Bio-Symposium, Ochang, Chung Chung Buk Province, Korea,
September 18, 2012
§ Invasion and intracellular survival of a stn (Salmonella enterotoxin gene) mutant of Salmonella
typhimurium, Lee H.J.; Yim S.Y.; Ryu S.R.; Annual Meeting of Korean Society of Microbiology,
2000