第五届国际药用辅料中国大会演讲嘉宾介绍（一）

Adrian Bone

Adrian Bone graduated in Pharmacy from the University of London after which he had a career of more than 35 years in the pharmaceutical industry both in the UK and internationally. He held senior positions in several functions, primarily in quality assurance overseeing manufacturing and supply operations for medicines. Currently, Adrian works in an advisory capacity to IPEC Europe and the IPEC Federation, assisting these associations in their goals to exchange good practices and to develop harmonized standards for pharmaceutical excipients.

Adrian Bone毕业于伦敦大学药学院，之后在英国和其他国家有35年多的工作经验。 他在许多方面担任高级职位，主要是药品生产质量保证和供应链。目前Adrian担任IPEC欧洲和IPEC联盟的顾问，协助协会开展良好操作规程的交流，制定药用辅料协调标准。

 

David R. Schoneker

David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets.

Schoneker先生负责协调卡乐康全球范围内的法规事务和原材料的评估。他获得尤西纽斯学院的学士学位和维拉诺瓦大学的化学硕士学位。在卡乐康公司担任法规部职位之前是全球质量保证部总监。他于1977至今一直在卡乐康公司工作。Schoneker先生活跃于多个专业协会，如美国药学科学家协会、医生质量报告倡议组织、美国质量协会、美国癌症协会、美国分析化学师协会，以及特拉华谷色谱论坛等。他还加入许多行业协会，如：国际药用辅料协会（IPEC）、色素制造商国际协会（IACM）、营养学理事会（CRN）和食品技术研究所（IFT）。Schoneker先生是IPEC美国（2007-2009）的前任主席。在任职期间，他积极参与促进制定辅料药品生产质量管理规范（GMP），以及有助于提高全球供应链安全性的相关指导方针。Schoneker先生经常担任ExcipientFest的演讲人。

 

Janeen Skutnik-Wilkinson

Ms. Skutnik is the Head of Quality Intelligence and Compendial Affairs at Biogen. In this role she is responsible for Review of regulations and guidances, globally that impact Biogen as well as many external engagement activities. Her former positions include: Vice President of Health Sciences at DBA, .Director /Team Leader of Quality & Regulatory Policy at Pfizer, responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues. She has over 20 years’ experience and expertise in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch.

Skutnik-Wilkinson女士，获康涅狄格大学的理科学士学位，IPEC美国的选举主席。担任Biogen公司质量情报和药典事务负责人，负责法规和指南审查。过去曾担任DBA健康科学副总裁，辉瑞质量与监管政策主任/团队负责人，IPEC联盟主席、IPEC药典评阅/协调工作组的主席、ICH Q3D元素杂质的专家委员会成员、PhRMA药典联络小组主席等职务。在药典、质量及法规政策方面，她有着超过20年的工作经验。她曾担任过各种职责包括文档、变更控制、分析方法验证、以及产品发布等。

 

Patricia Rafidison

Patricia has several years of experience in the pharmaceutical industry as a qualified person, quality manager, regulatory affairs, and involved in pharmaceutical development. She is active in a number of trade associations such as IPEC (International Pharmaceutical Excipient Council) since 1992, and is the current IPEC Federation President. Patricia contributed to numerous articles on pharmaceutical raw materials, and IPEC guidelines. She is a pivotal member of several excipient-related expert networks for Quality and Regulatory standards, including WHO. She is a member-elect of the French National Academy.

帕特里夏·拉菲迪森，IPEC联盟主席，药学博士，在制药行业有数年的经验，历任质量员、质量经理、监管事务，并参与制药开发。 自1992年以来，她积极参加了一些行业协会，如国际药用辅料协会，参与许多有关药物原料和IPEC指南方面的文章，是包括世卫组织在内的几个与辅料相关的质量和监管标准专家网络的关键成员。

 

Susanne Keitel

Susanne Keitel is a licensed pharmacist with a Ph.D. in pharmaceutical technology. Following ten years in the pharmaceutical industry, she held variatious senior positions at the Federal Institute for Drugs and Medical Devices (BfArM), Germany. Since October 2007, Susanne Keitel has held the post of Director of the European Directorate for the Quality of Medicine & HealthCare (EDQM), Council of Europe in Strasbourg.

Susanne Keitel获药品技术博士学位, 执业药师。在制药业界有十年的工作经验，随后她在德国联邦药物和医疗器械研究所（BfArM）担任多项高级职务。自2007年10月起，Susanne Keitel担任斯特拉斯堡欧洲议会欧洲药品质量管理局司长。

 

Priscilla Zawislak

Priscilla is the current Chair of IPEC-Americas and has been a member of IPEC Americas committees since 2001 and a member of the IPEC Americas Executive Committee. She is also the Vice-President of the IPEC Federation. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives.

Priscilla，获特拉华大学获得生物科学与化学学士学位，是IPEC美国的现任主席，自2001年起成为IPEC美国的成员，担任IPEC美国执委会成员。她也是IPEC联盟的副主席。 10多年参与国际食品添加剂委员会和纤维素衍生物贸易协会的工作。 目前，Priscilla是陶氏食品，制药和医疗解决方案业务的全球监管事务经理，负责赋形剂，API和食品添加剂的法规事务，此前还担任亚什兰公司的药物和营养业务全球监管事务经理，负责食品添加剂和赋形剂产品的合规以及FMC生物聚合物质量经理。

 

 

顾景凯

顾景凯，药物分析博士，吉林大学唐敖庆特聘教授，博士生导师；吉林大学药物代谢研究中心主任。 主要从事药物与高分子辅料分析、药物代谢动力学和基于DMPK的前体药物设计研究工作；兼任吉林大学分子酶学工程教育部重点实验室、理论化学国家重点实验室教授，美国化学会会员，国家药品审评中心评审专家，Xenobiotica, Journal of Pharmaceutical Analysis、“药学学报”、“中国临床药理学报”、“中国药理学通报”编委，是国际和国内多个药学领域主流杂志的审稿人。

 

赵孝斌

毕业于俄亥俄州立大学获药剂学博士，2007年就职于Abbott，2010年受聘于美国食品药品监督管理局（FDA）药审中心（CDER）任资深审评员，主管仿制药审批，重点审查多肽、脂质体等复杂药物制剂的CMC一致性评价及其cGMP质量系统， 并参与了FDA的纳米药物法规指南专家工作组，制订了多项脂质体相关药物的标准。任职FDA之前主要从事肿瘤药物、单克隆抗体药物、纳米给药技术的研究，在脂质体药物制剂、人源化抗体免疫治疗，siRNA给药系统等领域开展了前沿性的工作。2014年创建The White Oak Group LLC（白橡树医药咨询有限公司）。