2021 KAPAL–KHIDI Bio & Health Webinar Series는 한미생명과학인 협회 (KAPAL)와 KHIDI 미국지사 웨비나 시리즈입니다.
Topic Title: 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.
KWiSE (Korean-American Women in Science and Engineering)의 NIH지부 (회장, 김동연 박사)와 Washington DC 지부 (회장, Jinyoung Barnaby 박사) 에서 Korea Foundation의 후원으로 COVID-19을 주제로 온라인으로 한미 공동 포럼을 주최하고 있습니다. 이번 네번째 포럼은 한국시간으로10월 1일 오전 9시반부터 11시까지 진행될 예정입니다. (미국동부시간 9월 30일 저녁 8:30-10시). 포럼의 주제는 “Monoclonal Antibodies as Therapeutics against SARS-CoV-2: From Development to Regulatory Approval” 입니다.
백신이 이미 개발되어 일반인에게 보급되고 있는 시점이지만 백신 접종후에도 시간이 경과하면서 점차 재감염의 가능성이 높아지는 지금의 상황을 고려할때 항체를 이용한 치료제 개발은 매우 시급하고 적절한 문제가 아닐 수 없습니다. 그러한 면에서 이번 포럼은 과학계를 포함하여 일반인에게도 어필하는 주제라고 생각합니다.
이번 포럼의 연사로는 셀트리온의 부사장님인 이수영 박사님과 미국 식품의약청 (FDA) 에서 team leader로 재직하시는 최수영 박사님 두분을 초청하였습니다. 이수영 박사님은 “Neutralizing Effect of CT-P59 Against SARS-CoV-2 Variants” 라는 주제로, 그리고 최수영 박사님은 “Monoclonal Antibodies Targeting SARS-CoV-2”라는 주제로 심도있고 유익한 강연을 해주실 예정입니다.
이번 포럼은 미국 FDA에 계시는 신양미 박사님이 좌장을 맡아 주시고, 미국 국립보건연구원(NIH) 에서 근무하시는 지영미 박사님의 사회로 진행될 예정입니다. 더 자세한 내용을 보시려면 첨부한 포럼 포스터와 프로그램을 참고하시기 바랍니다.
KSEA(Korean-American Scientists and Engineers Association) is hosting its 3rdInnovation and Entrepreneurship Symposium (IES)during the US-Korea Conference on December 15 – 18, 2021 at the Hyatt Regency Orange County, Garden Grove, CA. The symposium seeks to provide a cooperative environment for current and future aspiring entrepreneurs in the US and Korea to network with high-profile entrepreneurs and investors, listen to the stories of those who have successfully exited their companies, and learn about the best practices of startups, from protecting your intellectual property and assets to securing funding from venture capitalists and government agencies. The symposium program and additional information can be viewed on the UKCwebsiteand from the attached program overview.
For budding entrepreneurs, come pitch to potential investors at the Startup Pitch Competition about how your solution seeks to improve the synergy between the US and Korea. We invite all entrepreneurial-minded American and Korean professionals to attend the IES during UKC 2021 and learn about growing cross-border business opportunities in the US and Korea today. About ten competition finalists will go head-to-head to compete for various awards, including cash awards. Additional details, including eligibility requirements and timeline, can be found here and from the attached program overview and the flyer.
Interested in competing? Apply at https://bit.ly/3jQzJ64by Friday, October 1, 2021, 11:59 EDT.
We invite all entrepreneurial-minded professionals and students to attend the IES during UKC 2021 and learn about the continually growing cross-border partnership opportunities in the US and Korea.
Thank you.
Byungkyu Brian Park, UKC 2021 Chair and KSEA President
Woo Il Lee, UKC 2021 Co-Chair and KOFST President
IES Organizing Committee Co-Chairs
Kyeong Ho Yang (Chair, KITEE) IL Minn (Co-Chair, Competition, Johns Hopkins University) Jeho Park (Co-Chair, Program, Claremont McKenna College) Kwangrog Kim (Co-Chair, Entrepreneurship, Primer Sazze Partners)
