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. 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.
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.
Nick is a Principal Scientist at Hall Analytical Laboratories responsible for providing technical support to new and existing pharma, med device and ENDs customers in the field of extractables and leachables. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections.
Prior to joining Hall, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas including inhalation, topical and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval.
Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. He is an industry recognized expert in Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.
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.
As general manager, Paul is responsible for the Smithers Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers Rapra’s existing analytical and physical testing laboratories.
Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation. He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.
Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services. He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck.
Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University. He also served his country in the United States Army.
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.
