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.
Kok Li Kwang is the Director of Scientific Affairs and Technical Services for Asia Pacific at West Pharmaceutical Services. She leads a team of technical professionals to support pharmaceutical manufacturers in the Asia Pacific region in their injectable drug packaging needs, including material characterization of packaging and analytical solutions. She works closely with her team to identify changing industry dynamics and offer efficient and holistic packaging solutions to enable customers to meet the increasingly stringent drug product requirements. Driving customer satisfaction and contributing towards patient safety are her key focus areas. Kok Li holds a Bachelor’s degree in Chemical Engineering from the National University of Singapore and has more than 18 years of experience in the pharmaceutical and medical diagnostic industry.
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".
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.
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).
