Key Moments from the 2024 Extractables & Leachables Asia Event:
Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than four decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding)
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.
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.
Wenjing Zhao is a biological technical manager in Fresenius Medical Care and has the responsibility for biocompatibility and chemical characterization of medical device, as well as the compatibility of drug-packaging materials. She worked in Medtronic as senior scientist in charge of medical devices of Chemical Characterization and Materials of Concern for 7 years. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 12 years. She is good at Medical Device Chemical Characterization, Materials of Concern, and Polymer science.
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.
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".
Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than four decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding)
Xuzhuo Chen, Technical Manager at Mid-Link Group, brings over 15 years of experience in physicochemical analysis. With a solid background in analytical chemistry, he’s well-versed in instrumental analysis and developing chemical methods. He has a strong track record in applying physicochemical analysis techniques effectively and planning tailored solutions.
Xiaolong Rong , Technical director of Chemistry Laboratory at WuXi AppTec Medical Device Testing Center. He has more than 10 years of research experience in pharmaceutical packaging material drug compatibility and medical device chemical characterization. He has extensive relevant experience in high-risk device such as surgical implants, cardiovascular interventional devices, neurology and neurosurgery implants, dialysis, anesthesia and respiratory devices, as well as drug-device combinations. In addition, he is familiar with the regulatory requirements of major global markets. Before joining WuXi AppTec, he served successively at Baxter Global R&D Center and BD R&D Center, where he was responsible for the drug compatibility of packaging materials and the chemical characterization of medical devices.
Berk Oktem is a Chemist and Toxicologist at US FDA’s Center for Devices and Radiological Health, Office of Orthopedic Devices. He serves as a lead or technical expert for pre-market reviews and conducted research focused on extractables, leachables analysis, small molecule identification and analysis, polymer degradation and proteomics for more than 20 years. He received his Ph.D. in Analytical Chemistry from the University of Delaware, performed post-doctoral research at Johns Hopkins School of Medicine and also spent 10 years in private sector as research and applications scientist in product development of chemical analysis systems prior to joining FDA.
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.
Jie Liang is a researcher/doctoral director at the College of Biomedical Engineering/National Engineering Research Center for Biomaterials （NERCB）, Sichuan University, and vice president of the Institute of Regulatory Science for Medical Devices, Sichuan University, Director of the Sichuan Testing Center for Biomaterials and Medical Devices. Her main research areas focus on new bioactive tissue regeneration and repair materials, tissue engineering product development and application technology, biomaterials and medical device testing and evaluation technology and methodology.
Main academic part-time jobs: director of the Chinese Society for Biomaterials, vice chairman of the regenerative medicine materials branch, member of the National Medical Devices Standardization Technical Committee (SAC/TC248 (vice-chairman), SAC/TC99, SAC/TC110/SC3), member of the Medical Device Classification Technical Specialized Committee of the State Drug Administration.
