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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.
Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and over the last 12 years has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E.
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.
Aspen Research Corporation is a premier contract research organization that provides analytical services and materials R&D. Our ISO 17025 accreditation and GLP program enable the company to be at the forefront of extractable and leachable studies, food contact notification studies, method development and pre-clinical support studies. Aspen partners with biotech, pharmaceutical and medical device industries to deliver the support that is needed for product development and regulatory submission.
Jordi Labs specializes in the analysis of medical devices, pharmaceutical packaging and food contact applications. We have the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by more than 4 decades of analytical experience and state of the art instrumentation. Our lab is ISO 17025:2017 accredited and we offer cGMP compliant services when required.
Dr. David A Weil, is a master level scientist working for Agilent technologies since 2004, located in Wood Dale, IL. David Is married to his amazing with Naomi and has three older sons.
David’s research is focused on the application of high resolution mass spectrometry coupled with multidimensional separations techniques (GC, LC, and 2DLC, SFC, Ion Mobility) and advanced data mining software tools for multi-omics applications, in particular untargeted metabolomics linked back to changes in biochemical pathways. David is also the global technical leader for Agilent’s Extractable and Leachable analysis project, having developed an accurate mass database and MS/MS library for common E/L compounds. He is active in many collaborations with experts in the E/L field (e.g. Eli Lilly, BD, West Pharma, 3M, Jordi Labs, GE Healthcare, Eurofins, PPD) investigating how new technologies, software and workflows can advance the E/L. Prior to joining Agilent, Dr. Weil was the group leader of the 3M’s Corporate Research Analytical mass spectrometry group (1990-2004) responsible for characterization of extractable/leachable impurities present from a wide variety of drug delivery products including Meter Dose Inhalers, Transdermal Patches, Injectable products and Nasal/oral Sprays packaging
David received his Ph.D. from the University of Minnesota (1984) and Post Doc with Professor Charles Wilkins developing the precursor to MALDI.
Biography coming soon
Bryan Katzenmeyer has over 10+ years of experience specializing in mass spectrometry and separation techniques for the characterization of materials, polymers, monomers, and small molecules as well as increasing leadership roles within technical organizations. He currently oversees the Americas Materials Science business marketing segment for Waters Corporation. The Materials Science business market focuses on polymers, fine and specialty chemicals, extractables/leachables, medical device testing, cosmetics and personal care products, fuel/energy, and agrochemicals. Prior to joining Waters, Bryan was an Analytical Group Leader and Senior Scientist at Valspar (now part of Sherwin-Williams). While here he managed the liquid chromatography and mass spectrometry team focused on developing and validating analytical methodologies to characterize extractables and leachables, resins, oligomers, monomers, and other small molecules in packaging coatings for the food and beverage industries. Bryan received his Ph.D. in Polymer/Analytical Chemistry at The University of Akron working under Distinguished Professor Chrys Wesdemiotis. Here, he researched interfacing liquid chromatography and ion mobility separation with multi-dimensional mass spectrometry for the structural characterization of polymeric materials. He also obtained a M.S. in Chemistry from the University of Wisconsin-Madison and a B.S. in Chemistry from Penn State University.
Dr. Dujuan Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Fairfield New Jersey facility as well as the global leader amongst the three centers of excellence for E&L testing. Before joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers and technical session chairs. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.
Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University. She has authored more than 15 high-impart journal publications with more than 300 citations. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
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.
Bio Coming Soon
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