6月29日“绿色制药前沿论坛”第十二讲预告

　　题目：Botanical Products &Biologics -Something Old and Something New for Regulatory Science
　　　　　植物药和生物药：监管科学的老革命与新问题
　　主讲人：HaiAn Zheng 副教授 （美国阿尔巴尼药学与健康科学学院）
　　时间：6月29日（星期一）13:30
　　地点：协同创新大楼1006
　　
　　讲座内容简介：Regulatory Science is the science of developing new tools, standards and approaches to assess the safety, efficacy,quality and performance of products, according to US FDA’s definition. The recent advancementsof Regulatory Science have ledto a few exciting clinical breakthroughs, such as the new pathways and approvals of biosimilars in Europe and the US. However, many challenges remain with regulatory, ethical, economic, and scientific (REES) dilemmas, especially for mixtures and complex drug products, such as peptides, proteins, nanomedicines, and traditional botanical products.Biologics and botanicals are both complex products derived from living resources. Despite many differences, we may utilize similar regulatory strategies to control their pharmaceutical quality, thus ensure their safety and efficacy for patients. As a mixture, botanicals are often bbin电子 effective and safe clinically, while protein or peptide therapeutics usually present as mixtures of different derivatives/impurities or ensembles of different conformations. Therefore,we proposed 4-D Quality by Design (QbD)with the fourth time dimension of dynamics and kinetics, which is enabled by continuum-scale characterization (CSC) at atomic, molecular, nano-, micro- and product levels. This approach can be made possible upon the scientific foundation and recent progresses of biophysics, physicochemical characterizations and computational simulation, as well as knowledge integration by informatics. This talk will lay out the overall strategies, recent technical resolutions and couple of case studies.

　　主讲人简介：HaiAn Zheng is an Associate Professor of Pharmaceutical Sciences at Albany College of Pharmacy and Health Sciences in Albany, New York, where he teaches and leads pharmaceutics, regulatory science, biotechnology and related curriculum. Trained as a pharmacist and pharmaceutical scientist, he obtained expertise and skills through his previous industrial and academia appointments. His research is focused on formulation, characterization, delivery, development, quality evaluation and product design of therapeutic proteins and peptides, botanicals and other complex products. His group is integrating technologies and methodologies from multiple disciplines to provide new solutions to quality control, reveal mechanism of actions, and enable product design. Also, Dr Zheng has been actively contributing to professional organizations, such as American Association of Pharmaceutical Scientists (AAPS) and American Association of Colleges of Pharmacy (AACP). He was elected as the Chair of the AAPS Northeast Regional Annual Meeting (2010), a member of AAPS Membership and Group Coordination Committee (2011-14), a delegate of AACP faculty council (2012), and the Chair-elect for AACP Graduate Education Special Interest Group (2015). Dr Zheng credited Shanghai Medical University School of Pharmacy(now merged with Fudan University) for launching his career with Bachelor of Pharmacy. He obtained a MS of Chemistry from State University of New York, and completed his PhD of Pharmaceutical Science at University of Connecticut.

　　讲座面向全校开放，欢迎各学院教师、研究生、本科生等踊跃参加。