Chief Executive Scientistat
Triad Scientific Solutions, UK
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.
Principal Scientist Extractables and Leachablesat
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 got his master degree from East China University of Science and Technology with major in Analytical Chemistry, had 8 years of analytical R&D experiences in biopharma industry. He is currently the Extractables/Leachables Project Specialist in Sartorius Validation Services department. 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 Convention as Analytical Scientist to develop analytical methods for Pharmacopoeia monograph and then had role as Technical Manager of Extractables & Leachables in NSF International.
Technical Director of Biomedical Technology Centerat
Shanghai WEIPU Chemical Technology Service Co., Ltd.
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.
Medtronic Technology Center – Greater China
Wenjing Zhao is the chemistry scientist of Medtronic Technology Center in Greater China. She is responsible for the Chemical Characterization work for the whole MTC medical devices. She graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and medical device for 10 years. She is good at chemical synthesis, chemical analysis and chemical characterization, and she is also familiar with Macromolecular chemistry.
former U.S. FDA (retired)
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.
Scientific Affairs Manager, China at
West Pharmaceutical Packaging (China) Co., Ltd.
Lynn currently serves as Scientific Affairs Manager (China) in West Pharmaceutical Packaging (China) Co., Ltd., in her role, Lynn helps to review and analyze the industry development as well as the regulatory changes in China for injectable and offer scientific advice.
Lynn joined West as a Technical Support Engineer, providing technical support in mainland China. Before joining West, Lynn worked in a technical support supervisor role with a company dealing with biochemical and microbiological reagents after she graduated from University with a Master degree in Biochemical Engineering.
Dr. Daniel Norwood joined SCIO Analytical as Executive Partner in June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis. In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development. Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute.
Dr. Norwood is an internationally recognized expert in the field of E&L assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on E&Ls in inhalation drug products. He is also a member of the PQRI Working Group on E&Ls in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on E&Ls.
Director of Chemistry Laboratory, Medical Device Testing Centerat
WuXi AppTec (Suzhou) Co., Ltd
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".