May 2025
Washington D.C
Since 2006, Smithers Extractables & Leachables USA conference has been supporting the advancements in the E&L industry while keeping the industry informed on new regulations and testing protocols. This event assembles E&L experts to discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, and more. Attendees network, build beneficial relationships, and hear diverse perspectives on issues facing the E&L industry both domestically and globally.
Smithers Medical Device Testing is a leading authority for extractables and leachables studies, with experts who have a proven track record of developing and delivering comprehensive E&L test plans. The partnership between Smithers E&L laboratories and events combines expert technical knowledge and market intelligence on emerging needs from which the whole industry benefits.
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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.
Jan Baeten received his Ph.D. from the faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. After his academic career as a post-doctoral researcher, he joined Nelson Labs in 2015 as R&D scientist, focusing on innovations in analytical services for the pharmaceutical and medical device industries. Driven by his technical expertise in chromatography and mass spectrometry, Jan works on the development of new analytical solutions, strategies and data processing flows. In his role of technical advisor, he also gives support to business development. Jan is also active in the structure elucidation team working on identification of unknowns.
Crystal has supported process qualification, aseptic processing, and filling for a range of commercial biological products. She started her career in the most conventional vaccine programs (tetanus-diphtheria, smallpox) and advanced to process characterization and qualification for novel viral products and finally cell therapy. The opportunity to improve the safety of cell and gene therapy products, whether by material suitability testing, procedural improvements in processing and handling critical products, or focused risk assessment, are all exciting ways for her to contribute to the lexicon of CGT. She works within the bluebird bio Manufacturing Sciences and Technology group to directly support production and quality initiatives around the aseptic processing and finishing steps for the final products.
Dr. Jennifer Ator is a board-certified Principal Toxicologist, Risk Assessor, and Project Manager who earned her Ph.D. in Toxicology and M.H.S. in Environmental Health Sciences from Johns Hopkins University. Dr. Ator prepares, reviews, and manages quantitative human health risk assessments, exposure assessments, product and ingredient safety assessments, and regulatory compliance evaluations for a diverse range of substances within a variety of national and international regulatory contexts, including food allergens, food additives, medical devices, consumer/household products, personal care products/cosmetics, pharmaceuticals, and dietary supplements, among others. Recent work has focused on development of quantitative exposure assessment methodologies to augment core competencies such as Proposition 65, medical device, and personal care product regulatory compliance assessments as well as consumer product safety evaluations.
Experienced Professional in Formulation AR&D, E&L Studies, Glass Delamination Studies, Tech Ops.
Experience handling Project Management & Tech Transfer with a demonstrated history of working in the pharmaceuticals industry in Injectable and Ophthalmic formulations. Skilled in all Hyphenated techniques like LCMS, GCMS, ICP-MS besides HPLC, GC and Good Laboratory Practice (GLP), Method development and Validations, GMP, . Strong research professional with a Doctor of Philosophy (Ph.D.) focused in Analytical Chemistry from Acharya Nagarjuna University, Guntur.
Crystal D’Silva is a subject matter expert in medical device safety at Baxter International and based in Brussels, Belgium. She frequently represents industry expertise in external fora, and she is actively involved in standard development as an expert in the ISO/TC 194 Biological and Clinical Evaluation of Medical Devices technical committee. She is also a European Registered Toxicologist (ERT) and a member of the European Society of Toxicology In Vitro (ESTIV) and the Belgian Society of Toxicology and Ecotoxicology (BELTOX). She has a PhD in Medical Biophysics from the University of Toronto in collaboration with the Princess Margaret Cancer Centre and the Hospital for Sick Children (Ontario, Canada).
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Aspen Research Laboratories is a contract research organization that is known for superior understanding of materials science, and analytical testing. Our ISO 17025 accredited laboratory offers materials characterization, method development, design and execution of extractables and leachables studies, and challenge testing for recycled plastics intended for use in food contact. Our experienced and highly qualified team of scientists collaborates with pharmaceutical, medical device manufacturers, single use suppliers, packaging companies and many other industries to solve challenges and expedite product development.
Element is little more than a decade old, but can trace its origins back to 1827. With roots based in industrial testing and measurement in the Victorian era, Element businesses have been involved in materials and product testing that gave the world the Model T ford, put Concorde into the skies and has helped keep Venice afloat.
Element was formed in 2010, after a management buy-out of the testing division of the Netherlands-based Stork Engineering Group, backed by 3i Group plc. Starting with 860 people in 27 laboratories, the Group has grown dramatically in the last ten years, as many organisations have moved their testing requirements to specialist providers.
Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than four decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding)
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 Element Materials Technology responsible for providing technical support to new and existing pharma, med device and consumer products customers in the field of extractables and leachables. He has over 15 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections. Nick is the Extractables and Leachable expert on the British Standards Institute (BSI) and European Standards Committee (CEN) for electronic cigarettes & E-liquids. Nick has presented on a number of different E&L related topics internationally and has developed and run pre-conference workshops on E&L assessment at a number of international conferences.
Prior to joining Element Materials Technology, 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.
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.
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.
