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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.

 

Sandra Suarez博士是美国FDA药品审评中心生物等效评审三部生物药剂学代理负责人,佛罗里达大学博士学位,1999年起加入FDA临床药理办公室,目前是新药审评办公室生物药剂学部门的主审及代理负责人,负责与治疗相关的技术审评。



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.

Dr. Burgess has been active in teaching, research and service throughout her career. Her students have recognized her with the Outstanding Teacher of the Year Award (2005 and 1992). She received the 2009 Distinguished Service award from the University of Connecticut, School of Pharmacy. In 2010, she became the first recipient of the CRSI (Controlled Release Society, India Chapter) fellowship award for outstanding contributions in drug delivery research. Dr. Burgess is the 2011 recipient of the Nagai APSJ International Women Scientist Research Achievement Award. Dr. Burgess also received the 2013 AAPS IPEC Ralph Shangraw Memorial Award for her outstanding research in the area of pharmaceutical excipients. In 2014, Dr. Burgess was recognized for her exceptional commitment in CRS, and was selected as the recipient of the Distinguished Service Award. She has over 130 refereed publications. She is the editor of two books. She has given over 330 research presentations, over 170 invited lectures, and 12 keynote addresses at major international scientific meetings; Dr. Burgess has served as major advisor for four M.S. and 18 Ph.D. graduates as well as 12 post-doctoral fellows. She is currently directing the research of eight Ph.D. students and one post-doctoral fellow.

Dr. Burgess is a fellow of AAPS (American Association of Pharmaceutical Scientists) and of AIMBE (American Institute for Medical Biological Engineering). She served as elected President of AAPS in 2002 and CRS (Controlled Release Society) in 2009. She is a member of the USP Biopharmaceutics Expert committee and the USP Advisory Panel on Injectables. Dr. Burgess is editor of the International Journal of Pharmaceutics (2009 – to date). She was an editor for AAPSPharmSci (1999 - 2005) and editor of the Journal of Drug Delivery Science and Technology (2003 - 2008). Dr. Burgess serves on the editorial boards of seven international journals. Dr. Burgess has severed on NIH study sections on Drug Delivery and Biomedical engineering, Drug Delivery and Drug Discovery, Gene and Drug Delivery, and Nanomedicene as well as many special study sections for NIDA, NIDDK and NCI (2001- to date). In 2001 she undertook a sabbatical at the Office of Testing and Research at CDER, FDA. She consults for pharmaceutical, food, cosmetic and other industries.

 

1979年Burgess博士于英国斯特拉斯克莱德大学获得药学学士学位。 1984年获得英国伦敦大学的药剂学博士,并获得英国诺丁汉大学(1984-1985)和北卡罗来纳大学(1985)的博士后研究员。 其后,Burgess博士于1986年加入伊利诺伊大学芝加哥分校担任助理教授和副教授,并于1993年转任康涅狄格大学。1999年升任教授,2009年被任命为康涅狄格大学药剂学专业董事会特聘教授。
Burgess博士一直活跃于教学,研究和服务工作。1992年和2005年被学生认可,获取年度杰出教师奖。2009年,她获得了康涅狄格大学药学院颁发的杰出服务奖。 2010年,她成为CRSI(受控释放协会,印度分会)奖学金的第一个获奖者,表彰她在药物输送研究方面做出了杰出贡献。 Burgess博士是2011年Nagai APSJ国际女科学家研究成就奖的获得者。 Burgess博士还因其在药用辅料领域的杰出研究而获得2013 AAPS IPEC Ralph Shangraw纪念奖。 2014年,Burgess博士因其在CRS中的杰出贡献而获得认可,并被选为杰出服务奖的获得者。她共发表130多篇论文,编辑两本著作。她在主要的国际科学会议上发表了330多篇研究报告,170多个邀请讲座和主持了12个主题研讨会。Burgess博士曾担任过4个硕士,18博士以及12名博士后研究员导师。她目前正在指导8位博士的研究和一名博士后研究员的研究工作。

Burgess博士是AAPS(美国药物科学家协会)和AIMBE(美国医学生物工程研究所)的研究员。她于2002年担任AAPS的当选主席,并于2009年担任CRS(控制释放协会)的成员。她是USP生物药剂学专家委员会和USP注射剂咨询小组的成员。 Burgess博士是国际药剂学杂志(2009年至今)的编辑。她是AAPS药物科学杂志(1999-2005)的编辑和药物传递科学与技术杂志(2003-2008)的编辑。 Burgess博士是七种国际期刊的编辑委员会成员。 2001年至今,Burgess博士从事NIH关于药物输送和生物医学工程,药物输送和药物发现,基因和药物输送以及纳米医药的研究部分,以及NIDA,NIDDK和NCI的许多专业领域研究。 2001年,她在FDA的CDER测试和研究办公室任职,为制药,食品,化妆品和其他行业提供咨询。

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。

 


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。
作为主要负责人或技术专家参与国家科技重大专项、仿制药一致性评价、国家药典委员会标准提高等科研课题十余项。发表论著和译著10余部。发表论文50篇。
北京大学医学部(原北京医科大学)理学学士、理学硕士;中国药科大学理学博士
1992-1996 北京医科大学实验药厂、药学院物理化学教研室助教。

1999年- 中检院化学药品室(期间2013年4月-2014年6月,在福建省药品检验所挂职任副所长)。

 


Feng Qian, Ph.D. Professor
School of Pharmaceutical Sciences, Tsinghua University,Beijing, China

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.
Dr. Qian’s current research interests include 1). Physical pharmaceutics, such as solubility enhancement of poorly water soluble drugs using amorphous or nano-crystalline technologies; high concentration protein (mAb, etc.) solutions. 2). Novel therapeutics against cancer, in particularly, pancreatic cancer. The lab is closely collaborating with major pharmaceutical companies such as Bristol-Myers Squibb, Johnson & Johnson, Bayer, etc., on several research areas.


钱锋博士本科、硕士毕业于清华大学材料科学与工程系。 2003年于美国Case Western Reserve University获得生物医学工程博士学位。2003年4月起就职于美国制药企业Bristol-Myers Squibb Company(百时美-施贵宝公司),历任研究员(Research Investigator),资深研究员(Senior Research Investigator),和主任科学家(Principal Scientist),从事药剂学和药物成品的科研,开发,项目管理,和学术界合作等工作。2012年入选中组部千人计划(青年类),加入清华大学医学院药学系(现药学院),从事药物制剂和给药系统研究工作,同时担任药学院副院长。 在工业界工作期间,钱锋博士的工作涉及20多个新药(包括化学和生物药物)的研发,其中包括主持多项一期到三期的新药临床药剂开发,以及多项新药产品的项目管理工作。同时,钱锋博士负责开发和评估新型药剂技术平台,支持新技术在产品上的应用。在新型药物制剂领域,钱锋博士已申请~20多项美国/中国专利,成功将多个创新候选药物带入不同阶段的临床试验。钱锋博士已发表~50余篇学术论文,是Molecular Pharmaceutics, Journal of Pharmaceutical Science, AAPS PharmSciTech 等期刊的Editorial Advisory Board 成员,中国药学会纳米药物专业委员会委员。


Nikoletta Fotaki, Pharmacist, MSc, PhD
Reader in Pharmaceutics, University of Bath, UK

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.
Dr Fotaki’s expertise and research are focused on PBPK modeling, drug absorption, development of in vitro screening tools and associated software for predicting absorption and in vivo performance in normal populations and in special populations (i.e. paediatrics, disease states), pharmacometrics, personalized medicine, biorelevant solubility and dissolution methods, dissolution imaging, development of in vitro-in vivo correlations and relations, formulation development, animal models for the prediction of absorption, methods for reduction/ refinement/ replacement of animal experimentation, biowaivers, dissolution testing, design of BA/BE studies.



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。

 


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.

 

张戍昂,数姆科技的创始人和首席执行官。张戍昂博士毕业于Rutgers新泽西州立大学,师从世界著名的非线性物理学家,”孤力子”的发现者Norman J. Zabusky教授。曾任包括FEI, VSG, Ansys在内的多家国际知名电子显微技术或仿真软件公司的软件研发, 应用和销售高级管理人员,并繁忙的管理工作之余发表了百余篇高水平学术论文。张戍昂早年就读于哈尔滨工程大学徐玉茹院士门下,是863水下智能机器人数字模拟软件与水下虚拟现实系统的核心研发成员。张博士有着丰富管理和销售经验,并精通工程数值模拟,三维成像,图像处理,可视化,建模等多个三维纳米领域的关键技术。2014年创办的数姆科技,已成为缓释药物工程、页岩勘探开发、和纳米材料表征与优化方面的世界权威。数姆自行设计,研发并投资的I2S智能图像云计算平台为已投入商业运营并为多家世界500强企业采用。

 

 

Dr. Johannes Krmer
CEO, PHAST GmbH, Germany

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.

 

Johannes Krmer博士是“PHAST集团”的创始人兼首席执行官。1987年起,他一直从事制剂性能试验的研究。
他从法兰克福大学获得药学专业的国家文凭并专门从事药物分析工作,后获得海德堡大学制药技术和生物药学方向的博士学位。
Krmer博士是USP药剂专业委员、国际药学联合会溶出/体外释放性能试验聚焦小组成员。他还是AAPS、国际制药技术协会(APV)生物药剂学小组、德国制药公司协会(DPhG)的成员。他的科研重心是基于体内外相关性的药物制剂体外试验方法特别是与稳定性相关的研究,参编多部与溶出试验相关的专著。

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.

 

吕旭进 博士, 百时美施贵宝公司(BMS)药品科学技术部高级研究员(Research Fellow)。加入BMS 27年来专注于药剂研发和药物分析技术的建立与应用,为公司的IND/NDA申请和药品上市做出重要贡献。吕博目前的研究领域包括药物释放、溶出以及处方研究和处方前研究中生物相关的体外试验和药学风险评估。吕博是美国药学家协会,美国化学会,应用光谱学会, 科布论茨学会会员,并任AAPS体外释放和溶出技术(IVRDT)聚焦组前主席(2013-2015)。目前担任USP药品性能测试专家组成员,以及Dissolution Technologies 期刊的编委。

吕博在美国乔治亚大学获得分析化学博士,中国科学院大连化学物理研究所分析化学硕士,伊利诺伊大学-厄巴纳香槟博士后。

 


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.
In 2005, he resigned from Novartis to create SPS Pharma Services in Clermont Ferrand which is the first and only CRO specialized in Dissolution and Release Testing.Since then, Samir manages SPS facility and is in charge of projects management.
In April 2013, SPS Pharma Services moved to a new larger facility in Orleans (France) in order to ensure better efficiency and provide a broader range of services to its clients, including cGMP routine testing.The facility has been successfully inspected by US FDA and is registered as Pharmaceutical Establishment for both US and Europe.
Fields of interest and expertise: analytical development (LC), in vitro dissolution and release testing (all techniques from USP1 to USP7), in vitro-in vivo correlations (IVIVC), formulation development, laboratory automation.

Samir is regularly invited as speaker in international conferences as well as expert for various organizations (scientific societies and Health Authorities).

 

Samir Haddouchi现任法国SPS制药服务公司总经理兼技术负责人,经常受邀作为国际学术会议或协会的演讲嘉宾,分享他们团队在溶出测试方面的技术和经验。
Samir Haddouchi在加入SPS之前,曾在制药行业工作了10余年。期间,曾在瑞士巴塞尔的山德士农用化学部门从事分析工作。在山德士与诺华合并之后,于1998年在法国奥尔良的诺华分析部门工作,开始负责与溶出度相关的质量分析研究。
2005年,Samir从诺华离职,在法国克莱蒙-费朗创立了SPS制药服务公司,这是世界首家专业溶出度和释放度测试技术服务CRO公司。2013年4月,为了提高工作效率和完善客户服务系统,SPS公司搬迁到法国奥尔良,为客户提供一系列的技术合同服务,包括符合cGMP要求的日常测试工作。目前,SPS公司已经获得FDA的认可,注册成为符合欧盟和美国法规要求的制药服务公司。

SPS公司的技术服务领域包含:分析方法的开发(LC),体外溶出度和释放度测试(美国药典1法至7法),体内外相关性研究(IVIVC),处方开发,实验室自动化。

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“千人计划”创新人才特聘专家,山东省泰山学者。
李又欣博士于1988年在北京大学获得博士学位。1991年4月,获德国洪堡奖学金,到德国药学技术与生物药学研究所从事新制剂研发相关工作;1994年1月,应聘于德国HOECHST公司(现赛诺菲公司)作为资深研究员;1998年3月开始,在德国SCHWARZ PHARMA制药公司任化学部高级主管及项目主管。自加盟绿叶制药集团后,现任全球研发总裁,负责绿叶制药创新药物的研究与开发。
李又欣博士主要从事新药及新型释药技术的研究,主持或参入开发的治疗帕金森氏症的新药Neupro、治疗尿失禁的新药Toviaz以及治疗癫痫的新药Vimpat都已在全球上市。回国后带领绿叶制药技术创新团队建立并完善了长效及缓控释技术、脂质体与靶向给药技术、透皮释药技术、新型化合物以及抗体技术等五个平台,拥有长效和靶向制剂国家重点实验室。中国产品线共有在研新药项目37个,其中6个新药在中国、美国、欧洲同步开展临床研究,其中四个产品在中美或欧洲申报上市。李又欣博士拥有十余项发明专利,还在国际权威刊物发表论文60余篇,被同行引用5000余次。


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