14:00-14:30 생체 분자영상을 이용한 바이오의약품의 비임상 분포 평가
박현수 박사 (서울대학교)
14:30-15:00 항체-약물 중합체의 유효성/안전성 평가 관련 글로벌 연구 및 규제동향
이병일 박사 (㈜LG화학)
15:00-15:30 항체-약물 중합체의 특성 및 약물동태학적 특성 분석을 위한 기반기술 개발
진종화 박사 (오송첨단의료산업진흥재단)
15:30-16:00
Break
16:00-18:00
Part 2 : 살생물제의 안전성평가 및 관리
좌장 : 박용주 교수 (경성대학교)
16:00-16:30 화학제품안전법 이행을 위한 살생물제 승인 규정의 이해
이재우 연구사 (국립환경과학원)
16:30-17:00 살생물제 구제제류의 효과·효능 시험방법 개발 및 평가
탁준형 교수 (서울대학교)
17:00-17:30 화학제품안전법상 살생물제의 독성시험 개요
엄현수 소장 (안전성평가솔루션(주))
17:30-18:00 중대재해처벌법 이해 및 대응
김경윤 전문위원 (노무법인 더원)
18:00-18:10
총평 및 폐회사
2022 춘계 국제심포지움
2022 KSOT/KEMS Toxicology Workshop & Spring International Symposium
일 시 : May 13 (Friday), 2022, In-Person & Virtual
주 제 : Current Issues in Biotherapeutics (바이오의약품 안전성 연구의 최신 동향)
May 13 (Friday), 2022
09:30-9:50
Welcome Remarks
Dr. Young-Jin Chun (President of KSOT, Chung-Ang University)
Dr. Kyung Won Seo (Director General, National Institute of Food and Drug Safety Evaluation)
Dr. Eun Ju Jeong (President of Korea Institute of Toxicology)
09:50-10:30
Plenary Lecture I
Chairperson: Dr. Hyung Sik Kim (Sungkyunkwan University)
Key Concepts in Nonclinical Safety Assessment of Antisense Oligonucleotides (ASOs)
Dr. Tae-Won Kim (IONIS Pharmaceuticals, USA)
10:30-10:40
Break / Exhibition Visiting
10:40-12:10
Session 1
The Development of mRNA Vaccine and Its Side Effects
Chairperson: Dr. Ki Taek Nam (Yonsei University)
10:40-11:10 mRNA Vaccine and Its Adverse Effect
Dr. Jae-Hwan Nam (The Catholic University of Korea)
11:10-11:40 Clinical Significance of mRNA COVID-19 Vaccine Adverse Reactions
Dr. Jacob Lee (Hallym University Kangnam Sacred Heart Hospital)
11:40-12:10 Myocarditis: A Serious Complication of mRNA Vaccine for COVID-19
Dr. Eun Seok Jeon (Samsung Medical Center/Sungkyunkwan University)
12:10-13:30
Exhibition Visiting / Council Meeting
13:30-14:10
Plenary Lecture II
Chairperson: Dr. Tae Cheon Jeong (Yeungnam University)
Intratracheal Therapy Using Oligodeoxynucleotides and/or Genetically Modified Lactic Acid Bacteria-derived Biological Molecules
Dr. Takashi Sato (Shinshu University, Japan)
14:10-15:40
Session 2
Advanced Biologics – Safety and Efficacy Issues in Preclinical and Clinical Study
Chairperson: Dr. Kyung-Min Lim (Ewha Womans University)
14:10-14:40 Forefront of In Vivo Genome Editing for Vision
Dr. Jeong Hun Kim (Seoul National University Hospital)
14:40-15:10 Current Status of CAR-T, Its Pros and Cons
Dr. Hyoung Jin Kang (Seoul National University Hospital)
15:10-15:40 Clinical Development of Olinvacimab and Other Novel Therapeutics
Dr. Jin-San Yoo (PharmAbcine)
15:40-16:00
Break / Exhibition Visiting
16:00-17:30
Session 3
(KIT Session) Preclinical Trial Evaluation and Guidelines for Biopharmaceutical Development
Chairperson: Dr. Ki-Suk Kim (Korea Institute of Toxicology)
16:00-16:30 PBMC-humanized Mouse Models for Efficacy Evaluation of Immuno-oncology Drugs
Dr. Jong Soon Kang (Korea Research Institute of Bioscience and Biotechnology)
16:30-17:00 Preclinical Safety Aspects of MSC-derived Extracellular Vesicles in Drug Development
Dr. Kyoung-Sik Moon (Korea Institute of Toxicology)
17:00-17:30 Considerations on Non-clinical Assessment of Biologics
Dr. Kyoung Suk Choi (Ministry of Food and Drug Safety)
17:30-17:40
Closing Remarks
General Information
2022 KSOT/KEMS Toxicology Workshop & Spring International Symposium
Date : May. 12 (Thu) ~ 13 (Fri), 2022 In-Person & Virtual Venue : Samsung Convention Center, Seoul National University, Seoul, Korea Title : Current Issues in Biotherapeutics