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.
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.
Weichun Yang, is currently the Director of ADQC department at STA Pharmaceutical Co., and led a group of scientists to provide analytical service support. Prior to STA, Weichun was Sr. Manager at Baxter Suzhou R&D Center and held various positions for several organizations. 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.
Mr. Yang Xiaojun joined Shanghai WEIPU Chemical Technology Service Co., Ltd. in 2018 as the technical director of compatibility study, responsible for the operation of the compatibility study team. He has been in the field of compatibility research since the first guideline for compatibility of plastic packaging materials were issued in 2012. In the past ten years, he wasdedicated to the compatibility study of various in-process components, packaging materials and drug delivery devices in the whole life cycle of drugs, with more than 1000 compatibility project application experience. In addition, he has participated in the drafting of guiding principles for compatibility study of chemicals drugs and elastomers. He has unique experience and skills in the field of compatibility and can provide customized compatibility study solutions for customers.
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”.
Lin Chunxin has over 8 years of E&L project operation experience, handling more than 1000 varieties of E&L projects. He is familiar with domestic and overseas regulations, and has accumulated extractables and leachables research skills.
Cuicui Zhu, Hangzhou Cobetter Validation Center Manager, has been engaged in analytical method development and validation work for more than 3 years in a well-known pharmaceutical company. At present, she has been engaged in filtration process validation research for nearly 10 years, and has provided filtration process validation (chemical compatibility and E&L study services) for more than 4,000 products of nearly 1,000 pharmaceutical companies. She has in-depth research and rich practical experience in the regulatory requirements, risk assessment, analysis and toxicological assessment of SUS E&L.
Carol manages the the team of E&L study and toxicological risk assessment in Shanghai Henlius Biotech. Obtained Ph.D. in Analytical Chemistry from Chinese Academic of Science, she has over 10 years’ experience on method development, small molecular identification, pharmaceuticals & polymer Characterization.
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.
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Lee M. Nagao, Ph.D., is a Senior Director of Science, Regulation and Policy at the law firm of Faegre, Drinker, Biddle and Reath, LLP, and is a member of the Firm’s Life Sciences Consortium Management and Regulatory Affairs Practice Group. The Group works extensively with pharmaceutical, biopharmaceutical and medical device companies on a range of scientific and regulatory collaborations and provides strategic and regulatory guidance to individual life sciences companies. Lee plays a lead role serving scientific and regulatory consortia including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). Lee has extensively published and presented on many aspects of pharmaceutical development including supply chain, CMC, and translational sciences. She has represented various industry groups before regulatory and scientific agencies and organizations in the US, Europe and Asia, including the FDA, EMA, China NIFDC, Chinese Pharmacopoeia, ANVISA, Taiwan CDE, Japan PMDA, and USP.
Wei holds a master degree in Cell Biology from Peking Union Medical School and a Ph.D degree in Toxicology from University of Kentucky.
She joined Medtronic in 2017 and currently is a Principal Scientist at Medtronic Technology Center in Shanghai, China. This role focuses on the biocompatibility evaluation for medical devices and materials across multiple Medtronic’s business units for purposes of product registration and safety assurance.
Dongdi Sun is the director of chemistry lab which mainly provides customized chemistry testing services, including chemical characterization of medical devices materials, drug packaging materials compatibility study, target compounds method development & validation and testing. Dongdi Sun obtained Ph.D. in chemistry from Mississippi State University in the United States. He has 11 years’ research experience in analytical chemistry including 5 years of research experience in chemical characterization of medical devices and drug packaging material compatibility study. In 2019, he won the honorary titles of "doctor of entrepreneurship and innovation of Jiangsu Province" and "high level talents of science and technology innovation and entrepreneurship of Soochow".
Coming soon...
Michael manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009.
Michael has uses his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.). Michael’s team supports a diverse range of clients and industries requiring the support of analytical experts working within a cGMP and ISO17025:2017 environment.
Prior to joining Smithers, Michael worked in the validation department for one of the largest Single Use System suppliers and previous to that at a petrochemical organisation.
Michael has a BSc in Chemistry, and is a Member of the Royal society of Chemistry (MRSC).
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.
Qian Kejun is a senior application chemist in Waters. With over 15 years of experience in LC and MS, she helped many customers set up standard methods. She has led teams members helping customers to build E&L library and develop E&L analysis workflow. Kejun has introduced UNIFI E&L workflow for many customers.
Yi Zhang has 16 years experiences in developing analytical methods for drug products, and was responsible for E/L laboratory building and operation from 2010. As the principle scientist, she currently leads E/L study programs in packaging systems for pharmaceutical products and in disposable components for manufacturing process, and has engaged in hundreds of compatibility testing on drug packaging. In additional, she is also senior researcher of Guangdong Academy of Sciences Drug Preclinical Evaluation Center and supports the new products development for industries.
