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.
Dr. Leshuai Zhang obtained his PhD from North Carolina State University in 2010, where he studied skin toxicology. After graduation, Dr. Zhang joined the Center for Drug Evaluation and Research, US FDA as a Research Fellow where he received drug reviewer training for drug evaluation and investigated the mechanisms of drug induced toxicity. In 2012, Dr. Zhang joined Nanotechnology Innovation Center in Kansas State University as a research assistant professor, focusing on hepatotoxicity of food additives and nanomaterials. Since 2014, he joined Soochow University as a professor, currently working on nano-immunotherapy and hepatotoxicity evaluation of nanomaterials using 3D liver models. He has published over 40 SCI papers in toxicology, pharmacology and nanomedicine area with more than 1500 citations. He holds internationally certified/registered toxicologist including DABT, ERT, UKRT and DCST.
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.
Cheney has over 10 years of CRO business experience and over 8 years of Extractables and Leachables study expertise.
Cheney has Master's degree in biopharmaceuticals, and he is one of the drafters of the technical part of the China CDE’s Extractables and Leachables study gudiance "Technical Guidelines for the Study of the Compatibility of Chemical drugs and Elastomer Seals (Trial)" and has promoted the process of domestic research on the extractables and leachables study of in-process components. He has over 10 years of experience in third-party testing services and 8 years of packaging material E&L regulations and testing experience. He’s familiar with domestic and foreign drug-related laws, regulations and technical standards, master a variety of analytical technical equipment and testing methods; familiar with cGMP good practices, and help domestic companies submit files to regulatory authorities. In terms of E&L study of pharmaceutical packaging materials, he has handled over 1,500 projects, and has accumulated a wealth of extract and extract research skills.
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".
Zhai Zhichen, Director of the IBMD-TC (Guangdong Institute of Advanced Biomaterials and Medical Devices, Testing Center); Standing member of the Regenerative Medicine Translational Group of the Restorative Surgery Professional Committee, Chinese Society Association of Rehabilitation Medicine; Member of the Biomaterials Biological Evaluation Branch of the Chinese Society for Biomaterials. He is mainly engaged in basic and applied research in the fields of biomaterials/medical devices, stem cells, and regenerative medicine; evaluation and development of safety and effectiveness testing methods for medical devices and stem cells; medical device regulatory science research, etc. He has published 15 scientific papers in international peer-reviewed journals, such as Matter, Cell Death & Disease, Theranostics, Scientific Reports, etc., and applied & authorized 4 patents.
Alex Wang is a highly experienced analytical scientist who is mainly responsible for the E&L study and registration support of many drug packaging and/or delivery systems at Fresenius Medical Care. Alex has more than 10 years of experience in drug packaging and drug delivery system, single used system, disposable components, device compatibility study and elemental impurity study, genotoxic testing method development, method validation. With such profound practices, he has accumulated a deep understanding of both domestic and international E&L regulations and guidelines.
Member of the expert database of the Medical Device Branch of China Association for the Promotion of Quality and Safety of Food and Drug Enterprises
Member of the expert database of Suzhou Medical Device Industry Association
Mr. Wang Heng is currently the senior technical director of WEIPU Medical Devices Division, a member of the first batch of expert databases of the Medical Devices Branch of the China Food and Drug Enterprise Quality and Safety Promotion Association, and a member of the expert database of the Suzhou Medical Device Industry Association. He led the establishment of the million-level spectral database. He has extensive practical project experience in chemical characterization of medical devices, drug compatibility studies, in vitro degradation tests, and various physical and chemical property testing.
The laboratory team he leads has served more than 1,000 medical device manufacturers, the vast majority of which are high-risk medical device manufacturers. Assisted in the successful completion of NMPA , FDA and CE registration applications for a variety of high-risk medical devices such as orthopedic implants, cardiovascular implants, neurosurgery interventional devices, ophthalmic implants, blood purification consumables, and infusion equipment.
Jan Baeten received his Ph.D. from the faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. After his academic career as a post-doctoral researcher, he joined Nelson Labs in 2015 as R&D scientist, focusing on innovations in analytical services for the pharmaceutical and medical device industries. Driven by his technical expertise in chromatography and mass spectrometry, Jan works on the development of new analytical solutions, strategies and data processing flows. In his role of technical advisor, he also gives support to business development. Jan is also active in the structure elucidation team working on identification of unknowns.
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”.
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.
Dr. Lei Zhang is the Senior Director of Analysis at Shanghai Henlius Biotech, Inc. With 20+ years of experience in analytical and biopharmaceutical quality research, he has held positions at prestigious organizations such as the Mass Spectrometry Center at the Shanghai Institute of Organic Medicine, Agilent (GC/LC-FTMS Department), GE (Shanghai R&D Center, AIMS Department), and Sunshine Guojian (Shanghai) Co., Ltd.
Dr. Zhang's expertise lies in the analysis of chromatography, mass spectrometry, and electrophoresis. He specializes in quality research on therapeutic proteins and specification setup and control strategy at various stages of the process development and production of biological drugs. His research focuses on the structure elucidation, purity & impurities, and E&L (Extractables and Leachables) studies, ensuring the safety and efficacy of biopharmaceutical products.
Xiaozhen Cheng, graduated from Ocean University of China, majored in pharmaceutical chemistry, Master. Be engaged in pharmaceutical industry for nearly 20 years and be focused on E/L for 12 years. Currently. in charge of an E/L group as a manager in Baxter RD China. Be familiar with the regulatory requirement, guidelines and best practice for E/L. have experienced hundreds of E/L projects, those including pharmaceutical package (plastic container closure system, Vial+rubber container system, components, rubber). Medical device (single use infusion set, auxiliary tubing, dialyzer), manufacturing process components (hose, O-ring, filter). Test method, unknown identification, regulatory requirement enhancement are always the challenge for E/L. Welcome to discuss the solution to those challenge.
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.
Jia Min, Boo is the Technology Manager for Asia Pacific from West Pharmaceutical Services. She is based in the Singapore office. She joined West as a Technical Account Specialist in Technical Customer Services (TCS) and later progressed to the role of Senior Technical Account Specialist. In her TCS role, she provides technical support to pharmaceutical companies in the AP region through product recommendations, technical trainings and consultations to ensure smooth and easy uptake of West’s wide product portfolio for customers' drug product applications. As Technology Manager, in addition to providing TCS support to customers in Australia, she works closely with relevant stakeholders to develop in-depth knowledge of industry and technology. By understanding the technical regulatory requirements, she transforms these into scientific insights for customers and the industry. Additionally, she is also managing the AP Technical Services Lab, which mainly supports West internal projects. Jia Min holds a Bachelor degree in Material Science Engineering from Nanyang Technological University in Singapore.
Chris Waine is a toxicologist with 10 years of experience in human health hazard and risk assessment of chemicals. Along with his work on extractables and leachables, he specialises in the evaluation of pharmaceutical impurities, submissions under the EU REACH Regulation and the application of (Q)SAR models for toxicology. He is a member of the BSI and ISO Technical Committees relating to ISO 10993 on the biological evaluation of medical devices.
Dr. Long is the Director of Analysis and Testing in Shenzhen Smoore Technology Limited (Http://www.smooretech.com), which is one of the global leading company in field of atomization. He got his PhD in Analytical Chemistry in Technical University of Denmark and has worked as the Visiting Scholar in University of the Balearic Islands, Spain. His working experience covers governmental organization, university, Fortune Global 500 etc., as Associate Professor in Shanghai Jiaotong university, Chemical Lab Manager in Saint-Gobain Research (Shanghai) Co., Ltd. China Technical Center manager in Atotech, subsidiary of Total. His academic background includes twice sub-project leader in “The National Key Fundamental Research 973 Program of China” and project leader in “National Natural Science Foundation of China, General Program of 2008”, more than 20 international scientific publications, including 2 papers in the journal Analytical Chemistry, as well as manuscript reviewer in the international journals such as Analytica Chimica Acta etc.
Jason set up Maven E&L in 2019 to provide expert advice in the area of extractables and leachables, after working for GSK in the area of E&L since the mid 1990’s where he held roles of increasing seniority providing support to E&L across many modalities and product types. Jason is a scientific advisor to ELSIE and publishes blogs and article on E&L with a focus on risk based management of leachables.