Updated: Nov 8
오는 11월4일에 제 9 회 카팔 온에어 웨비나를 개최합니다. 이번 온에어웨비나는 보건산업 진흥원 미국지사 (KHIDI-US)와 함께 공동개최하는 웨비나 시리즈 #4 이기도 합니다.
이번 웨비나에서는 미국 FDA에서 20년의 심사 여러 Guidance에 경험을 가지고 계신 정상목 박사님께서 발표를 해주십니다.
Clinical Development 'R' us
Clinical development has been the significant challenge for drug developers due to a low likelihood of success (e.g., 9.6% from Phase I for all developmental candidates*). Regulatory sciences and strategies become increasingly critical pillars in building clinical development plan for any successful new drug development.
In this presentation, roles of regulatory sciences and strategies in the clinical development will be elaborated.
* Clinical development success rate 2006-2015, BIO Industry Analysis
About the presenter:
Sang Mok Chung, Ph.D.
Vice President of Regulatory Affairs
LG Chem Life Sciences Innovation Center, Cambridge, MA
Dr. Chung has dedicated his professional development at building expertise in regulatory science* of drug development. Dr. Chung has extensively reviewed regulatory submissions such as Investigational New Drug, New Drug Application or Biologic License Application from clinical pharmacology perspectives as part of multidisciplinary team. Dr. Chung’s review experiences cover conventional small molecules, peptides, oligonucleotides, biologics and biosimilars. Dr. Chung has therapeutic backgrounds in the areas of diabetes, lipid disorders, obesity and endocrinology (e.g., growth hormone deficiency, Cushing’s disease, or thyroid hormone) with further expansion in many other diseases (e.g., pulmonary and rheumatology), which can indicate for conventional or rare diseases. Dr. Chung has actively participated in regulatory researches as PI or co-PI, and presenting those results at scientific meetings. Dr. Chung has given lectures related the clinical development to colleges and universities.
Dr. Chung earned Ph.D. in Pharmacokinetics, College of Pharmacy, University of Illinois at Chicago.