Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on extractables and leachables (E&L). I have been in the field since 2001. I began my E&L career extracting and analyzing flavor compounds from soy protein. In 2005 I began to work with pMDI container closure systems. Currently manage the E&L activities at RTP and support other R&D groups within AstraZeneca. A member of the Materials Working Group within ELSIE and Knowledge Base sub-team I have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and bio-compatibility. I have a Ph.D. in Physics from the University of Wyoming.
Fu Peilin, R&D center director, Shenyang Sinqi Pharmaceutical Co.,Ltd., Ph.D of pharmaceutical analysis, Shenyang Pharmaceutical University; Master’s supervisor, China Medical University; Pharmaceutical analysis expert, China Medicine Education Association; China youth May 4th Medal; Person in charge of public platform for science and technology services of "compatibility of pharmaceutical products and packaging research", Shenyang Bureau of Science and Technology; Specializing in the compatibility of pharmaceutical products and packaging materials; Co-edited the first book in China — “Theory and Practice of Compatibility of Pharmaceutical Products and Packaging”.
Xie YangGuo majored in medicinal chemistry and received his medical Ph.D dgree from Shanghai Jiaotong University in 2019. In the same period, he joined Shanghai Henlius Biotechnology Co., Ltd. as the Senior Supervisor E&L Formulation Analysis, mainly engaged in E & L study of container closure system and single use system in biopharmaceutics. He was familiar with analytical techniques including LC-QTOF, LC-QQQ, GC-MS, HPLC and ICP-MS. In addition, he was in charge of E&L method development of several projects and published 2 related papers.
Weipu biomedical R&D and laboratory services Technical expert of compatibility research
Ms. Chang graduated from Tongji University, focus on analysis and detection, with 8 years of experience in compatibility research of drug packaging materials, components and appliances, and elemental impurities. Ms. Chang is familiar with the guiding principles and regulatory requirements related to compatibility research at home and abroad, such as USP1663/1664、665/1665、PQRI、BPOG、ICHM7、ICHQ3、Four domestic compatibility guidelines and so on.
Ms. Chang participated in and was responsible for more than 2000 compatibility research projects, participated in and took charge of nearly 200 projects successfully declared at home and abroad, familiar with the technical requirements for review and approval at home and abroad, combining rich research strategy experience with advanced LCMSMS, GCMS, ICPMS and other technical platforms, service customers include Beisheng Research, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, Changchun Biotech, Yichang Humanwell, Guilin Nanyao, etc
Weichun Yang, is currently Sr Director of Analytical Service Unit at STA Pharmaceutical Co. Weichun has over 20 years of analytical chemistry experience in the pharmaceutical, environmental, food/feed, and chemical industries. Authored over 30 publications in related areas and participated in several books preparation. Weichun received his Ph. D. from Brigham Young University.
Work for many years in building BPOG datas and E&L research of Filter and Single use system, I has a lot of experience in method build, unknow identification and quantification, Safety assessment based on TTC and PDE. Combined with many years in project management of validation, I familiar with the challenge in E&L research and NDA of customer and dedicate in providing scientifical validation service which meet regulation and customer requirement.
Mr. Hovery Yin holds master’s degree of analytical chemistry from East China University of Science and Technology, has nearly 10 years of analytical R&D experience in biopharma industry. Familiar with the global regulations and technical guidance of E&L study, has rich practical experience in E&L study which has completed hundreds of drug packaging, process plastic components and medical device E&L projects. He has participated in several times of NMPA on-site audit, familiar with the quality requirements of the laboratory management system.
He is currently the E&L Project Manager in Sartorius Confidence® Validation Services. He is responsible for technical support of validation and project management for Single-Use System (SUS). Prior to Sartorius, he worked for United States Pharmacopeia as Scientist to develop analytical methods for pharmacopoeia standards and then had role as Technical Manager of Extractables & Leachables in NSF International.
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.
Master of Analytical Chemistry, He has worked for a long time in the Provincial Institute of drug control and authoritative international third-party testing institutions; and deeply engaged in the field of pharmacy, materials and consumer goods testing for over 20 years, with experienced chromatography, mass spectrometry and spectral detection technologies. he is familiar with pharmaceuticals R&D, registration regulations and application requirements. At present, he is responsible for the compatibility research of drugs, packaging materials, production components, SUS and medical devices.
Ewa is a Project Manager at the Smithers Medical Device Testing Chemistry laboratory in Shawbury, UK. Ewa holds a Masters of Science degree in Food Technology – Human Nutrition and Consumer Sciences. She has previous experience working in Food Industry, specialising in new product development and participating in launching hundreds of products from concept to shelf. She has since focused her attention on project management and completed certifications in PRINCE2, AgilePM and Change Management. Currently she oversees a number of E&L studies and analytical projects and works with a variety of clients from the pharmaceutical industry.
James Vergis, Ph.D. is a Director of Science, Research & Innovation at the law firm of Faegre Drinker Biddle and Reath, LLP and is a member of the firm’s Life Sciences Consortium Management Team and Government and Regulatory Affairs Practice Group. As one of the consulting professionals within the law firm, Jamie provides scientific and strategic consulting services to individual clients and various Pharmaceutical and Biotechnology consortia such as Allotrope Foundation, Enabling Technologies Consortium (ETC), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). As a scientist whose work has touched on various fields of study, Jamie is passionate about helping clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes.
Jamie has a B.S. in biochemistry with a minor in computer science from SUNY Geneseo and a Ph.D. in molecular biophysics and biochemistry from Yale University.
Melisa is a Senior Associate Scientist in the Environmental and Occupational Toxicology group within Nonclinical Safety & Pathobiology at Gilead. Her responsibilities include providing toxicological support and authoring health-based risk assessments to support product quality and occupational toxicology programs. Regarding extractable and leachable assessments at Gilead, she conducts the toxicological assessments of identified extractables and leachables for components in the manufacture, storage, and use of pharmaceuticals. Melisa has 10+ years of experience in the pharmaceutical industry. She is a member of the Extractables and Leachable Safety Information Exchange Consortium and currently co-chairs the Safety Working Group. Melisa received her Bachelor of Science degree at UC Berkeley in Molecular Toxicology and her Master of Science degree at UC Santa Cruz in Environmental toxicology.
Xiaoyuan Shi has many years of experience in using mass spectrometer and developing methods. At present, mainly responsible for the technical support work of drug genotoxic impurities and package material E&L in SCIEX, providing customers with timely and effective analysis methods and solutions.
Xueping Xu has been worked in drug and medical device pre-clinical safety evaluation for more than 10 years. 100 + toxicological risk assessment and biological evaluation projects for medical device products including cardiovascular, orthopedic, dialysis and breathing gas pathway devices, successfully assist clients to get the NMPA, FDA and CE approvals.
Xiaoxia Ye is the manager of trace impurity investigation lab at Huadong Medicine. She is responsible for E/L and trace-impurity-related studies for pharmaceutical products. Xiaoxia Ye obtained Ph.D. degree from University of Alberta and has more than 15 years’ experience in chemical characterization using mass spectrometry.
• Senior Scientist 2013 - present, Baxter Healthcare Cor. (Suzhou R&D)
• 15+ years experiences in analytical chemistry including using chromatography with mass spectrometry, structure elucidation, method development and validation, etc.
• Deeply involved in E&L assessment, structure elucidation for unknowns, analytical method development and validation for targeted compounds, etc.
Wenjing Zhao is a senior scientist of Medtronic Technology Center in Greater China. She works in MTC as the chemistry SME and the MOC SME. She is responsible for Chemical Characterization and material safe work for the whole MTC projects. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 10 years. She is good at chemical synthesis and analysis, Polymer chemistry, and material chemical characterization.
Yang Chao, the Biological Evaluation Senior Engineer at the Product Safety Department in Mindray, is responsible for the biocompatibility evaluation of the company's Endoscope Instruments and the verification research of reusable instruments' reprocessing. He is also responsible for the test and verification of the ISO18562 series(PM、VOCs and E&L) for the gas monitoring module of the monitor. With 15 years of experience in testing and verification in the medical device industry, Yang is a Reviewer in the biomedical field of Shenzhen Science and Technology Innovation Comm as well. Prior to Mindray, he worked at the Beijing Institute of Medical Device Testing, with the title of senior engineer.