독물학자의 관점에서의 항암제 개발
항암제 분야가 성장하면서 제약회사는 빠르고 민첩하게 생명을 구하는 치료제를 개발하고 생산해야 한다는 압박을 받고 있습니다. 항암제 시장 파이프라인의 약 42%를 경구제*가 차지하고 있으며 항암제는 일반적으로 고효능 의약품으로 분류되기 때문에 다양한 취급 및 안전 전략이 필요합니다. 이 웨비나에서 다음 주제에 대한 독물학자 Joe Galati의 설명을 들을 수 있습니다.
- 고활성 저분자 평가 기준
- 독성 결합 시스템
- 고활성에서 저활성으로 분자 다운그레이드
- 안전 및 취급 전략
*출처: IQVIA- Global MIDAS Edition Includes antineoplastic agents (L01) and endocrine therapy (L02)- 248 molecules, OSD includes: tablets, ODT, capsules
Joe Galati
Thermo Fisher Scientific Global Toxicology Services 선임 이사(SD)
Bio: Dr. Joe Galati is the Senior Director of Global Toxicology Services and has 20 years of experience in the pharmaceutical industry, in the field of occupational toxicology and patient/product safety. Involved in evaluating the toxicity of compounds (active pharmaceutical ingredients, intermediates, contaminants, etc.) in order to assign appropriate toxicity categorizations/bands, determine low potency versus high potency, and develop occupational exposure limits for worker safety, as well as threshold of toxicological concern/permitted daily exposure/acceptable daily exposure values for patient safety. Also involved in identifying whether the handling of compounds complies with the requirements for Good Manufacturing Practice in a multi-product facility and advising on potential drug product quality/regulatory concerns, such as cytotoxic, cytostatic, hormone, sensitizer, and others. A full member of the U.S. Society of Toxicology, as well as the Society of Toxicology of Canada, with a Ph.D. in Pharmacology and Molecular Toxicology from the University of Toronto. Also, an author of several peer-reviewed publications, and a presenter at various international scientific meetings, conferences, and universities, in North America and Europe.
Thermo Fisher Scientific Global Toxicology Services 선임 이사(SD)
Bio: Dr. Joe Galati is the Senior Director of Global Toxicology Services and has 20 years of experience in the pharmaceutical industry, in the field of occupational toxicology and patient/product safety. Involved in evaluating the toxicity of compounds (active pharmaceutical ingredients, intermediates, contaminants, etc.) in order to assign appropriate toxicity categorizations/bands, determine low potency versus high potency, and develop occupational exposure limits for worker safety, as well as threshold of toxicological concern/permitted daily exposure/acceptable daily exposure values for patient safety. Also involved in identifying whether the handling of compounds complies with the requirements for Good Manufacturing Practice in a multi-product facility and advising on potential drug product quality/regulatory concerns, such as cytotoxic, cytostatic, hormone, sensitizer, and others. A full member of the U.S. Society of Toxicology, as well as the Society of Toxicology of Canada, with a Ph.D. in Pharmacology and Molecular Toxicology from the University of Toronto. Also, an author of several peer-reviewed publications, and a presenter at various international scientific meetings, conferences, and universities, in North America and Europe.
