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E&L China 2020 Advisory Board

The members bring together years of knowledge and experience from working across the supply chain.

  • Ronald Brown

    Toxicologist former U.S. FDA (retired)

    Ron Brown is a board-certified toxicologist who recently retired from the US FDA Center for Devices and Radiological Health.   At FDA, his research efforts focused on the developing new methods to assess the risk posed by patient exposure to extractable and leachable compounds released from medical device materials.   He is active in both domestic and international standards committees related to the biocompatibility of medical devices.  Until recently, he served as the co-chair of the US TAG for TC194 (Biological Evaluation of Medical Devices) and as convener of ISO/TC194/WG11 (Allowable Limits for Leachable Substances).  Ron is a founding member and former president of the Medical Device Specialty Section of the Society of Toxicology.  He previously held leadership roles in the Society for Risk Analysis and the Association of Government Toxicologists.  Prior to joining FDA, he was a Senior Associate at the ILSI Risk Science Institute in Washington, DC.

  • Baiba Cabovska

    Senior Manager Waters Technologies, USA

    Baiba Cabovska currently is a Senior Manager in Chemical Materials Business Operations for Waters Technologies based in Milford, MA. She is responsible for customer collaborations and addressing customer needs in materials characterization with a special focus on extractables and migration testing.

    Prior to joining Waters, Baiba worked at Mannkind Corporation doing analytical development for insulin based products as well as extractables testing for a dry powder inhalation device. 

  • Dongdi Sun

    Director of Chemistry Laboratory, Medical Device Testing Center 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".

  • Kathy Huang

    R&D Manager Becton Dickinson Medical Devices (Shanghai) Co. Ltd., China

    Kathy joined BD as R&D manager of Analytical Chemistry Lab.  She is responsible for Extractable& Leachable research for pre-filled syringe products and medical device; YBB test and materials identification to support internal partner and external customer.

    Prior to joining BD, Kathy worked at Baxter R&D centre. She worked for new packaging material development and doing extractable and leachable research for them. Kathy received Ph.D. in Physical Chemistry from Institute of Chemistry, Chinese Academy of Sciences, Beijing.

  • Dr. Dennis Jenke

    Chief Executive Scientist 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. 

  • Dr. Daniel Norwood

    Executive Partner Feinberg Norwood & Associates Pharma Consulting

    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 leachables and extractables assessment in pharmaceutical development and manufacturing.  He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables 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 extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.

  • Carsten Worsøe

    Carsten Worsøe

    Principal Scientist Extractables and Leachables Novo Nordisk

    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.

  • Xiaojun Yang

    Technical Director of Biomedical Technology Center 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.

  • Lynn Yao

    Scientific Affairs Manager, China 科技事务经理,中国 West Pharmaceutical Packaging (China) Co., Ltd. 西氏医药包装(中国)有限公司

    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.

    姚雪凌,现供职于西氏医药包装(中国)有限公司,作为科技事务经理(中国),帮助分析行业和市场的发展以及中国注射剂法规的变化,提供科学性建议。

    姚雪凌起初作为技术支持工程师加入西氏,向中国大陆区客户提供技术支持。她在加入西氏之前,在获得获得生物化工硕士学位后,作为技术支持部门主管在一家生物化学和微生物试剂公司工作。