Sandra Suarez Sharp, PhD. |
Dr. Suarez Sharp is currently a Master Biopharmaceutics reviewer at the Division of Biopharmaceutics/ Office of New Drug Products/OPQ supporting all therapeutic areas. Some of her responsibilities in this office include the secondary/tertiary review of submissions containing Biopharmaceutics information such as dissolution, biowaivers, IVIVCs, multivariate models for RTRT, physiologically based PK-biopharmaceutics models in support of drug product quality, and mentoring new reviewers. She joined the FDA in 1999 as a Clinical Pharmacology and Biopharmaceutics reviewer in the Office of Clinical Pharmacology. Prior to this, she spent two years at UNC Chapel Hill as a postdoctoral fellow in the area of drug delivery to the lungs. Dr. Suarez Sharp holds a Ph.D. in Pharmaceutical Sciences from University of Florida and a bachelor’s degree in Industrial Pharmaceutical Chemistry from Mexico.
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Dr. Diane J. Burgess |
Dr. Burgess received her B.Sc. degree in Pharmacy from the University of Strathclyde, U.K. (1979) and her Ph.D. in Pharmaceutics from the University of London, U.K. (1984). She was a postdoctoral fellow at the Universities of Nottingham, U.K. (1984-1985) and North Carolina (1985). Dr. Burgess joined the faculty at the University of Illinois at Chicago in 1986 as Assistant and then Associate Professor and moved to the University of Connecticut in 1993. She was promoted to Professor in 1999, and in 2009 she was appointed Board of Trustees Distinguished Professor of Pharmaceutics at the University of Connecticut.
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王亚敏 |
王亚敏,1991年于北京医科大学药学院获学士学位,1994年7月于军事医学科学院毒物药物研究所获药剂学硕士学位,毕业后从事药物制剂开发工作,1995年8月至1996年10月作为访问学者 赴日本富山医科药科大学附属医院药剂部从事靶向给药制剂的研究。1999年7月至今在局药品审评中心工作,承担抗感染、呼吸、放射、内分泌、五官、皮科等适应症药品药学专业审评工作及项目负责人工作,参加多项技术指导原则的起草工作,在学术期刊发表文章近三十余篇。现任化药药学一部高级审评员,2017年5月任化药药学一部副部长。
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宁保明博士 |
宁保明 博士,中国食品药品检定研究院研究员。WHO国际化学对照品审评专家、国家药典委员会委员、科技部重大专项审评专家、新药审评专家。美国药典中文版编委、中国药典英文版编委、美国药典委员会及欧洲药典委员会访问学者。中国药科大学、烟台大学硕士研究生指导教师。从事化学药品质量研究、标准物质、缓控释制剂体外质量与体内相关性研究、吸入制剂质控技术研究工作。
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Feng Qian, Ph.D. Professor |
Dr. Feng Qian received his Ph.D. in Biomedical Engineering from Case Western Reserve University (OH, USA) in 2003, and his BS/MS (1998) from the Department of Materials Science and Engineering, Tsinghua University, Beijing. Dr. Feng Qian joined the School of Pharmaceutical Sciences, Tsinghua University (Beijing, China) in August 2012. Prior to that, Dr. Feng Qian held positions of Research Investigator, Senior Research Investigator, and Principal Scientist in the Department of Drug Product Science and Technology at Bristol-Myers Squibb Company (New Brunswick, NJ, USA) from 2003 to 2012, when he was responsible for clinical formulation development, drug delivery research, external research collaboration/technology assessment, etc. Dr. Qian is an author of over 50 peer reviewed papers, ~20 patents/patent applications, and a book chapter. Dr. Qian also serves as a member of the Editorial Advisory Board (EAB) of Molecular Pharmaceutics, Journal of Pharmaceutical Sciences and AAPS PharmSciTech. Dr. Qian received “Chemistry Leadership Award” from BMS in 2008, and “Janssen Investigator Award” in 2014 and 2015.
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Nikoletta Fotaki, Pharmacist, MSc, PhD |
Dr Nikoletta Fotaki is a Pharmacist, with an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. She participated in several research projects in the School of Pharmacy of the National and Kapodistrian University of Athens and in Hoffman La Roche (Pharmaceutical and Analytical R&D, New Jersey, USA) before her academic appointment at the University of Bath. She has also worked in the National Organisation for Medicines in Greece. She is a reviewer and scientific advisor of several scientific journals, a Deputy Editor for AAPS Open and member of the editorial board of Dissolution Technologies and DiePharmazie. She is an Associate Fellow of the Higher Education Academy and has been involved in the evaluation of several research proposals. She is also an Adjunct Associate Professor in the University of Waterloo (Canada) and a visiting Lecturer in King’s College London. She is the past chair of the IVRDT Focus Group of AAPS. |
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刘镇博士 |
刘镇博士,默克公司首席研究员,于2004年获得哥伦比亚大学化学工程专业博士学位。他的博士研究工作主要集中在聚合物物理和材料表征方面,开发具有新颖性能的纳米粒子/聚合物复合材料。 毕业于哥伦比亚大学后,刘博士加入默克公司制剂科学部,从事药物晶型的鉴定和筛选以支持制剂开发,研究药物在制剂中的相变以优化制剂组成和工艺。 近年来,刘博士的兴趣集中在开发先进的成像表征工具和方法,如高分辨率三维成像和光谱成像,对制剂结构进行分析,以建立对配方过程 - 产品性能 - 药物释放相互影响的基本理解, 这是开发长效肠胃外制剂(LAP)等新型药物输送系统的关键。
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张戍昂博士 |
Shawn Zhang is founder and managing partner of DigiM Solution LLC. Shawn graduated from Rutgers University with a Ph.D. in Computational Physics and a minor in Computer Engineering. Before starting Boston-based DigiM, Shawn held senior positions at Ansys and Thermo Fisher Scientific, and played instrumental roles in research, development and business growth. With a talented team passionate about the combined power of imaging and numerical simulation, Shawn leads DigiM (www.digimsolution.com) to becoming the pioneer in microstructure science for drug and drug delivery system applications. DigiM designed, developed, and funded I2S Enterprise Image Data Management System, an artificial intelligence computing cloud, which is online for commercial subscription, with adoptions from S&P 500 customers.
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Dr. Johannes Krmer |
Dr. Krmer is the founder and managing director of the “PHAST group” with sites in Germany, France, and Switzerland. Since 1987, he is working in the field of dosage form performance testing. He obtained his states diploma in pharmacy from Frankfurt University. After specializing in pharmaceutical analysis, he obtained his Ph.D. in pharmaceutical technology and biopharmacy from Heidelberg University. Dr. Krmer is an elected member of the USP Dosage Forms Expert Committee. With the International Pharmaceutical Federation (FIP) he is member of the Focus Group on Dissolution/In Vitro Release Performance Testing. He is a member of the American Association of Pharmaceutical Scientists, the Biopharmaceutics Group within APV (International Association for Pharmaceutical Technology), and the Deutsche Pharmazeutische Gesellschaft (DPhG). His scientific interest is focused on IVIVC-based (in vitro in vivo correlations) in vitro performance testing method-development for pharmaceutical dosage forms, with special regard to stability problems. He is the author of several publications and several book chapters as well as coeditor of a book on dissolution testing.
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Dr. Xujin Lu |
Dr. Xujin Lu is a Research Fellow at Bristol-Myers Squibb Company in the department of Drug Product Science and Technology. With more than 27 years of experience in the pharmaceutical industry focused on research and development, Dr. Lu has involved in a broad range of functions and made key contributions to the development of a number of pharmaceutical products. Dr. Lu currently focus on drug release and dissolution, use of in-vitro biorelevant testing for formulation development, pre-formulation studies, and biopharmaceutics risk assessment. Dr. Lu is active members of AAPS, ACS, SAS, and Coblentz Society, a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS (2013 - 2015). Dr. Lu also serves in the USP Expert Panel on New Advancements in Product Performance Testing, and the Editorial Advisory Board of Dissolution Technologies journal. Dr. Lu received his Ph.D. in Analytical Chemistry from the University of Georgia at Athens, GA. He also received a M.S. in Analytical Chemistry from Chinese Academy of Sciences at Dalian Institute of Chemical Physics. Prior to joining BMS, he completed a postdoctoral fellowship in the University of Illinois at Champaign-Urbana.
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Samir Haddouchi |
Prior to joining SPS Pharma Services in 2005, Samir spent more than 10 years in the pharmaceutical industry.As a chemist, he started working on the analytical development of agrochemical compounds at Sandoz Agro in the region of Basel (Switzerland).During the Novartis merger, he moved to Orléans (France) in 1998 to join the analytical group in the technical development department where he became responsible for dissolution.
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李又欣博士 |
李又欣博士,绿叶制药集团有限公司全球研发总裁;科技部“长效缓控释及靶向技术国家重点实验室”主任,吉林大学、烟台大学教授、博士生导师。中组部“”创新人才特聘专家,山东省泰山学者。
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Date
May 31, 2019-June 1, 2019
Online Registration Deadline
May 29, 2019
On-site Registration Dates
May 30, 2019