报告人：李福民 博士
报告题目： The Essential Role of Bioanalysis in Support of Drug Development: Small Molecules, Biotherapeutics, and Gene/Cell Therapies
时间：2018年11月6日（星期二）上午 10:00
地点：厦门大学翔安校区药学院426报告厅
邀请人：张晓坤 教授
报告人简介：Dr. Fumin Li has more than 20 years’ experience in analytical chemistry and 13 years’ experience in the pharmaceutical contract research organization (CRO) industry with a focus on regulated bioanalysis and fit-for-purpose biomarker bioanalysis of small molecules and biotherapeutics using LC-MS based technologies. Dr. Li is the Associate Director/Scientific Head, R&D and Discovery, for PPD Bioanalytical Laboratory in Middleton WI, USA. PPD is a leading global CRO, providing drug development, lifecycle management and laboratory services with offices in >47 countries and > 20,000 professionals worldwide. Dr. Li provides oversight for the scientific conducts of the bioanalytical department of >100 staff supporting numerous IND, NDA, and ANDA filings. Dr. Li leads and builds an industry first-class R&D team of more than 20 scientists to support over 100 clients, from small biotechnology to major pharmaceutical companies. Dr. Li has demonstrated track record of success in strategic directions, scientific excellence, signature client services and business growth.
报告摘要：The presentation will have a brief introduction to drug development, bioanalysis, and the new frontiers of bioanalysis in support of development of new and complex modalities. Focus will be placed in LC-MS based bioanalysis. Examples and/or case studies will be presented appropriately in the context of bioanalysis of small molecules, biomolecules, and gene/cell therapies. Biomarkers are increasingly used to understand biological target engagement, efficacy, dose-response relationship and PK/PD modelling. Development and fit-for-purpose biomarker validation will be discussed. Despite the enormous progress toward development of innovative drugs, generic drugs are indispensable in improving the health of world’s major populations. The critical role of bioanalysis in support of generic drug development will be covered.
