2019 Speakers & Panellists

  • Piet Christiaens

    Dr. Piet Christiaens

    Scientific Director Nelson Labs NV

    Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories.

    From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers).

    From 2001 onwards, Mr. Christiaens held the position of Scientific Director at Toxikon Europe where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries.

    Currently Mr. Christiaens oversees all laboratory operations at Nelson Labs NV and is also giving support to the European business development. 

  • Dr. Zhenxia Du

    Professor, Center of Analytical Chemistry and Testing Beijing University of Chemical Technology, China

    1997.8-Current: Center of Analytical Chemistry and Testing, Beijing University of Chemical Technology.

    Dr. Du’s strength is in the development of methods for GC/MS, SFC-MS and LC-MS applied to food safety, environment safety, medicines and polymer materials.  She also is extremely experienced in spectral analysis using IR, NMR and MS approaches for structural deduction. Through solving many difficult problem for many enterprises, she has established good cooperation with many companies, such as the Chinese academy of inspection and quarantine, State Grid Company of China, Tongfang NUCTECH Co. Ltd, Beijing Tong Ren Tang Chinese Medicine Co. Ltd. and many universities. 

    As visiting scholar, Dr. DU has studied at Purdue University in the United States in 2012. At the same time, Dr. Du began a cooperation with Waters Corporation and established the polymer additives library (more than 300 kinds of material) which commonly used in plastic packaging materials. Based on the additive polymer library, the method to identify main leachables-polymer additives in medical products was developed by ultra-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry (UPLC-QTOF MS) and realized the rapid screening extractables and leachables. As a director  or  participants of the National Science-technology Support Plan Projects, National nature Science Foundation, philanthropic projects supported by the General Administration of Quality Supervision, Inspection and Quarantine(GAQSIQ) and other projects from the enterprises. Dr. Du has public more than 80 papers in Analytical Chemistry, Journal of Chromatography A, Journal of Hazardous Materials, Food Chemistry, so on. About packaging materials compatibility research, Dr. DU published 8 relating dissertations.

  • Michael Ebert

    Sr. Engineering Manager, Technical Fellow, Bakken Fellow Medtronic, USA

    Michael Ebert is an engineering expert leader with 35+ years working experience at Medtronic.  He is a Medtronic Bakken fellow, the highest technical honor and recognition at Medtronic, for his substantial technical contributions to the business units, the corporation and the biomedical device industry. Especially, Mike’s technical leadership in researching, developing, implementing and integrating the biological safety of medical devices into the development and postmarket monitoring processes have resulted in numerous successful clearance/approvals and the launch of Medtronic products globally.

  • Dr. Andrew Feilden

    Chemistry Operations Director Smithers Rapra

    Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011 and was appointed Chemistry Operations Director in October 2012. He specializes in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. Andrew previously worked at AstraZeneca for 12 years, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University.

  • Queenie Gai

    Extractable Lab Supervisor – BioReliance Validation Services, China Merck, China

    Queenie Gai received her M.S. in Analytical Chemistry from East China University of Science and Technology. She joined Merck in 2013 and now serves as E&L Lab Supervisor in Merck BioReliance Validation Lab.  BioReliance Validation lab is responsible for Merck’s overall strategy and execution of E&L studies supporting the development and application of SUS. Queenie is responsible for leading local team to provide extractables validation services on single use system to global customers.  She also coordinates global E&L projects and E&L test method development and validation.  

  • Ted Heise

    Vice President, Regulatory & Clinical Services MED Institute, USA

    Theodore (Ted) Heise has over 25 years of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory & Clinical Services at MED Institute.  In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.

     

    Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University.   He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.  

    For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices.  He currently serves as convenor of TC 194/WG 14.  As convenor, Dr. Heise is leading the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.

  • Luo Hongyu

    Senior Scientist Baxter Healthcare Company, China

    She has more than 20 years experiences in technical assessment and safety evaluation for medical devices and pharmaceutical packages industry. Before joining Baxter, as the director of Chemistry department in CFDA Jinan Quality Supervision and Inspection Center for Medical Devices, Shandong Province. 

    Led drafting a number of national and industrial standards on medical devices and pharmaceutical packages. Coauthored and published 4 professional books as well as more than ten articles.

    Served as member of WG14 in ISO/TC 194 Biological Evaluation of Medical Devices; Committee member of National Standardization Technical Committee on Implants for Surgery; Expert of National Science & Technology Ministry.

    骆红宇

    苏州百特医疗用品有限公司研发中心高级科学家。工程应用技术研究员。从事药品包装和医疗器械安全性评价及实验研究20多年,曾任CFDA济南药品包装材料检验中心化学室主任。主持或参与完成多项科技部重点研发项目、国家药典委项目等。完成药品包装及医疗器械国家、行业及协会标准项目数十项,参与编写相关专著4部。

    现任国际标准化组织ISO/TC194第14工作组(医疗器械化学表征)工作组委员、全国外科植入物标准化技术委员会委员、国家科技部在库专家。

  • Kathy Huang

    R&D Manager Becton Dickinson Medical Devices (Shanghai) Co. Ltd., China

    Kathy joined BD as R&D manager of Analytical Chemistry Lab.  She is responsible for Extractable& Leachable research for pre-filled syringe products and medical device; YBB test and materials identification to support internal partner and external customer.

    Prior to joining BD, Kathy worked at Baxter R&D centre. She worked for new packaging material development and doing extractable and leachable research for them. Kathy received Ph.D. in Physical Chemistry from Institute of Chemistry, Chinese Academy of Sciences, Beijing.

  • Dr. Dennis Jenke

    Chief Executive Scientist Triad Scientific Solutions, UK

    Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples. 

  • Zhang Li

    Senior Engineer CFDA Hangzhou Medical Device Testing Center, China

    Biography to follow...

  • Keaton Nahan, Ph.D.

    ORISE Fellow at Center for Devices and Radiological Health U.S. FDA

    Keaton Nahan, Ph.D. is a postdoctoral fellow at the Center for Devices and Radiological Health of the US Food and Drug Administration. His work in the Division of Biology, Chemistry, and Materials Science addresses analytical methodology in biocompatibility evaluation of medical devices. Dr. Nahan received his doctorate in analytical chemistry from University of Cincinnati in 2017.
     

  • Dr. Daniel Norwood

    Executive Partner SCIO Analytical & Senior Consultant at Smithers Rapra, UK

    Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis.  In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development.  Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.  

    Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing.  He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.

  • Chen Ping

    Head of R&D Department Haichang Contact Lens Co. Ltd., China

    He graduated from East China University of Science and Technology in 1991

    From 1996-2014 he worked in quality assurance department of Haichang  Contact Lens Co., Ltd. Responsible for raw material testing, product quality control and quality certification.

    From2014 until present he has been working as Head of R & D department of Haichang  Contact Lens Co., Ltd.

    He is responsible for product development and registration, contact lens material and extraction solution composition research.

  • Zhengjian Qi

    Professor and Doctoral Supervisor School of Chemistry and Chemical Engineering, Southeast University, China

    Dr. Zhengjian Qi is professor and doctoral supervisor of School of Chemistry and Chemical Engineering, Southeast University. She earned her B.S. in Chemistry from Nanjing University in 1986, and her Ph.D. in Physics & Chemistry of Materials from Southeast University in 2009. Her research fields including optoelectronic functional materials, fluorescence or phosphorescence complexes, silicone-based functional materials and polymer-based electroluminescent materials and devices.

    Prof. Qi has hosted and completed many national and provincial research projects, such as the National Natural Science Foundation of China, Subprojects of national science and technology support, Jiangsu province science and technology support, National science and technology research project and Jiangsu province natural science foundation of China, and so on. Currently, the under study projects including Jiangsu province science and technology achievements transformation projects, National major scientific instruments and equipment development projects and Enterprises entrust projects etc.. Prof. Qi has published more than 50 papers, obtained 7 invention patents.

    Prof. Qi has obtained three times the talent training object of “333” project in Juangsu province, one time third prize of Jiangsu province science and technology progress, “Luneng award”, “Harmony of science and technology award”, and the first prize of “education foundation research grants” in southeast university.

  • Nikhil Sahotra 博士

    材料排放市场专员 Markes International, UK

    Dr. Sahotra got his BSc in Chemistry from the University of Central Lancashire, followed by MSc in Drug Chemistry from Newcastle University. In 2018 he completed his PhD in organic chemistry. Since then he has been working for Markes International, specialist in thermal desorption technology. His current job involves the sampling and analysis of air borne chemical from products and materials.

    Sahotra博士在中央兰开夏大学获得化学学士学位,之后在纽卡斯尔大学获得药物化学硕士学位。 2018年,他完成了有机化学博士学位。 从那时起,他一直在为热解吸技术专家Markes International工作。 他目前的工作内容包括从产品和材料中取样和分析空气中携带的化学物质。

  • Sandi Schaible

    Senior Director, Analytical Chemistry and Regulatory Toxicology WuXi AppTec, USA

    With over 25 years’ experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing.

  • Sharlene Dai

    Sr. Principal Toxicologist Medtronic, USA

    Sharlene is a toxicology subject matter lead at Medtronic Restorative Therapies Group, responsible for the biological safety evaluation and toxicology risk assessment through the life cycle of a wide variety of medical devices and applications globally, especially implantable devices and drug device combination products.   She is a US delegate and an international expert of the ISO 10993/TC 194 Working Groups and a member of ASTM F04 committee.  Sharlene holds BSE in Biomedical Engineering from Southeast University, MD in Clinical Medicine from Nanjing Medical University, and Ph.D. in Neuroscience and postdoc in Pharmacology/Toxicology from Michigan State University.  She is also a board certified toxicologist (D.A.B.T.) and holds a regulatory affairs certificate (RAC) at U.S.

  • Dr. Sherry Parker

    Toxicology Director WuXi AppTec, USA

    Dr. Parker has over 20 years of toxicology and medical device experience, and is an expert in analytical, pharmacological, and toxicological evaluations of medical devices and combination products. After receiving her Ph.D. in Molecular and Cellular Pharmacology from the University of Miami, Dr. Parker worked as a toxicologist for the US EPA, RTI International, OrbusNeich Medical, and Fresenius Medical Care. In her current position as WuXi AppTec’s Senior Director of Toxicology, Dr. Parker provides manufacturers with guidance on global regulatory and technical requirements and testing program design.

    In May 2019, Dr. Parker was appointed to a three-year term as co-chair of the Advancing Safety in Health Technology / Biological Evaluation (AAMI/BE) Committee. In addition, she is currently an internationally recognized ISO expert and a U.S. Delegate for TC 194, the technical committee for ISO 10993, and is the President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology.

  • Carsten Worsøe

    Carsten Worsøe

    Principal Scientist Extractables and Leachables Novo Nordisk

    Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.

  • Weichun (Wes) Yang

    Senior Manager Baxter, China

    Wes joined Baxter in December 2015 as Sr. Scientist II and manager of Suzhou extractable and leachable team at Baxter Suzhou R&D center. Wes’s major responsibilities include leading the Suzhou E&L team to support new product development and launch; maintenance of current products; collaborating with key internal and external partners to achieve operational excellence; future technical direction and capability of the team.

    Prior to Baxter, Wes was the analytical lab manager at Kemin Industries in Des Moines, IA. Before that, Wes worked few years as research associate at University of California, Riverside.

    Wes received his B.S. in Chemistry from Zhejiang University and Ph. D. in Analytical Chemistry from Brigham Young University. Wes published over 30 papers in peer-reviewed journals including Analytical Chemistry and Lab on a Chip.

  • Lynn Yao

    Scientific Affairs Manager, China 科技事务经理,中国 West Pharmaceutical Packaging (China) Co., Ltd. 西氏医药包装(中国)有限公司

    Lynn currently serves as Scientific Affairs Manager (China) in West Pharmaceutical Packaging (China) Co., Ltd., in her role, Lynn helps to review and analyze the industry development as well as the regulatory changes in China for injectable and offer scientific advice.

    Lynn joined West as a Technical Support Engineer, providing technical support in mainland China. Before joining West, Lynn worked in a technical support supervisor role with a company dealing with biochemical and microbiological reagents after she graduated from University with a Master degree in Biochemical Engineering.

    姚雪凌,现供职于西氏医药包装(中国)有限公司,作为科技事务经理(中国),帮助分析行业和市场的发展以及中国注射剂法规的变化,提供科学性建议。

    姚雪凌起初作为技术支持工程师加入西氏,向中国大陆区客户提供技术支持。她在加入西氏之前,在获得获得生物化工硕士学位后,作为技术支持部门主管在一家生物化学和微生物试剂公司工作。

     

  • Xiaoxia Ye

    Manager Huadong Medicine Co., Ltd., China

    She has been working as a Principal Scientist from July 2018 at Kun  Pharmaceutical Technology (Hangzhou) Co., Ltd., Hangzhou, China. She led led extractables/leachables studies for pharmaceutical packaging material and drug delivery system as well as led drug quality studies.

    Senior Research Scientist I,   03/2016-06/2018

    Baxter Healthcare International Inc., Suzhou, China

    Led extractables/leachables studies for pharmaceutical packaging material and drug delivery system

    Technical Specialist II – Research,  01/2015-12/2015

    Trican Well Service, Calgary, Canada

    Conducted petroleum-related product development

    Mass Spectrometry Analyst,  05/2013-08/2014

    Mass Spectrometry Facility, University of Alberta, Canada

    Operated, maintained and troubleshot analytical chemistry instrumentations, including LC/MS/MS, GC/MS, MALDI-MS, etc.
    Performed qualitative and quantitative analysis of small and large molecule samples

    Postdoctoral Fellow,   03/2012-04/2013

    Department of Laboratory Medicine and Pathology, University of Alberta, Canada

    Provided lab support to Canadian Institutes of Health Research funded lymphoma project

     

    Education

    Ph.D in Analytical Chemistry                                       09/2006-02/2012

    University of Alberta, Edmonton, Canada

    Bachelor in Analytical Chemistry                                    09/2002-09/2006                                

    Zhejiang University, China

     

  • Fangfang Zhang

    Senior Engineer, Deputy Director of Analysis Department Shanghai Food and Drug Packaging Material Control Center, China

    Fangfang has nearly 16 years experiences in the compatibility of food and pharmaceutical packaging material and work as senior engineer and deputy director of Analysis department in Shanghai Food and Drug Packaging Material Control Center.

    She has been engaged in the research of quality standards and method development of food and pharmaceutical packaging materials, and is good at the design of experimental scheme. Familiar with the quality standards, guidance and regulations of container closure system, she participated in quality standards development and published and participated in more than 10 professional papers, with one invention patent and one utility model patent. In 2016, she went to Extractable and Leachable laboratory in Illinois for advanced study.

    张芳芳,上海市食品药品包装材料测试所高级工程师,检验部门副主任。在食品、药品包装材料相容性研究领域工作16年,从事食品、药品包装材料质量标准研究、方法开发工作,擅长相容性研究方案的设计等。熟悉各国食包材、药包材质量标准、指导原则、法规等。参与多项食包材、药包材、药用辅料质量标准制修订,发表及参与专业论文10余篇,拥有发明专利1项、参与实用新型专利1项。2016年曾赴美国可提取物浸出物实验室进修。

  • Yi Zhang

    Laboratory Director Guangzhou BrunsLab Co., Ltd., China

    Yi Zhang is a Deputy Director in BrunsLab. She has 14 years experiences in developing analytical methods for drug substance and drug products, and responsible for E/L laboratory building and operation started in 2010. As the principle scientist, she currently leads E/L programs in packaging systems for pharmaceutical products and in disposable components for manufacturing process, and has engaged in hundreds of testing on drug product container closure evaluation as well as single-use component qualification. In additional, she is also senior technical manager in R&D Group of Consumables Management Association Guangdong and supports the new products development for memberships.