E&L China 2019 Advisory Board
The members bring together years of knowledge and experience from working across the supply chain.
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 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.
Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011 and was appointed Chemistry Operations Director in October 2012. He specializes in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. Andrew previously worked at AstraZeneca for 12 years, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University.
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 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 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.
Dr. Parker has over 19 years of toxicology and medical device research experience, and is an expert in the biological evaluation and toxicological risk assessment of medical devices and combination products. Dr. Parker graduated with a Doctorate Degree in Molecular and Cellular Pharmacology at University of Miami, has since obtained toxicology experience in academia, government, contract research and medical device industries. In her current position, she is the Toxicology Director at Fresenius Medical Care working in global research and development. Dr. Parker is a US Delegate in multiple AAMI working groups for ISO/TC194 (the technical committee for ISO 10993), and is an international ISO expert on three working groups (WG 1, 11, and 15). She is the current Vice-President (2018-2019) and soon to be President (2019-2020) for the Medical Device and Combination Products Specialty Section, of the Society of Toxicology.
Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.
Wes joined Baxter in December 2015 as Sr. Scientist II and manager of Suzhou extractable and leachable team at Baxter Suzhou R&D center. Wes’s major responsibilities include leading the Suzhou E&L team to support new product development and launch; maintenance of current products; collaborating with key internal and external partners to achieve operational excellence; future technical direction and capability of the team.
Prior to Baxter, Wes was the analytical lab manager at Kemin Industries in Des Moines, IA. Before that, Wes worked few years as research associate at University of California, Riverside.
Wes received his B.S. in Chemistry from Zhejiang University and Ph. D. in Analytical Chemistry from Brigham Young University. Wes published over 30 papers in peer-reviewed journals including Analytical Chemistry and Lab on a Chip.
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.