May 18-19, 2026
Washington, D.C.
Experts From Johnson & Johnson, Pfizer, Bausch + Lomb, Eli Lilly, Philips and MORE
Will contribute to this two-day event focusing on:
Chris Houston is a Research Fellow at Bausch + Lomb with 25 years of experience as an analytical chemist in the pharmaceutical and medical device industries. He started his career at Pharmacia & Upjohn (later Pharmacia, then Pfizer) in Kalamazoo, MI as an analytical scientist focused on chromatographic method development and extractables and leachables (E&L) in ophthalmic drug products. He joined Bausch + Lomb at the Rochester site in 2006 as head of the centralized mass spectrometry facility. During this time, he created and managed a successful E&L program for ophthalmic pharmaceuticals and served as a member of the PQRI Working Group on E&L in Parenteral and Ophthalmic Drug Products. Chris has also held roles as an E&L consultant, director of a contract analytical laboratory, and in QA. He currently leads Bausch + Lomb’s Pharmaceutical Development-Chemistry group. He holds a B.S. degree in Chemistry from the University of Michigan-Flint and a PhD in Analytical Chemistry with a Biochemistry minor from Indiana University.
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.
Ewan Pickard is a Technical Specialist with more than 13 years of experience in the field of Extractables and Leachables. He holds an MSci in Chemistry from the University of Nottingham.
Throughout his career, Ewan has worked across a broad range of E&L roles, designing and executing studies and operating a wide variety of analytical instrumentation and techniques. In his current role at Smithers, he splits his time between LC MS data analysis and the design of leachables methods and studies.
Dr. Xiaoling (Sharlene) Dai is a subject matter expert and leader in toxicology and biological safety risk evaluation for medical devices across the product lifecycle, supporting global regulatory submissions. She is currently a Senior Principal Toxicologist at Abbott and previously served as a Distinguished Toxicologist and Technical Fellow at Medtronic. Dr. Dai specializes in drug device combination and implantable medical devices, with deep expertise in exposure driven toxicological risk assessment and risk based biological safety evaluation. She is an internationally recognized expert and serves as a U.S. delegate to ISO TC 194 Working Groups, contributing to the development of global standards in medical device biocompatibility and toxicology. Dr. Dai has published 15 peer reviewed publications and one book chapter and delivered 43 scientific presentations at conferences focusing on medical device biological safety and toxicology. Dr. Dai received her B.S.E. in Biomedical Engineering from Southeast University (China), M.D. in Clinical Medicine from Nanjing Medical University (China), and Ph.D. in Neuroscience, followed by postdoctoral training in Pharmacology and Toxicology, from Michigan State University. She is a board certified toxicologist (DABT) since 2012 and holds a Regulatory Affairs Certification (RAC) since 2010.
Sainath Babu is a Senior Regulatory Toxicologist at MED Institute, Indiana, specializing in biocompatibility evaluations and extractables and leachables studies for medical devices and combination products. He holds dual board certifications from the American Board of Toxicology and as a European Registered Toxicologist. Previously, he served as a toxicologist at the Texas Commission on Environmental Quality. With over 15 years of experience across academia, government, and industry, Sainath earned his PhD in Environmental Toxicology from Southern University and A & M College, Baton Rouge, and has contributed to numerous publications, book chapters, and conference proceedings.
James O. Mullis –Principal Scientist/Program Lead, Thermo Fisher Scientific, Inc, 8551 Research Way, Suite 90 Middleton WI 53572-4664 James has worked in the Pharmaceutical and Medical Device area for over 35 years. He has had diverse technical and managerial roles spanning Pharmaceutical Development, Medical Device Manufacture/Testing and Contract Laboratory Services. James’s expertise includes design of Extractable and Leachable controlled extraction studies, in-use studies, method development/validation, stability and specification setting for release components. He has worked with inhalation, parenteral, and ophthalmic drug products to successfully produce many FDA approved pharmaceuticals. He has worked with the recent version of ISO 10993-18 for medical device chemical characterization for a wide range of medical devices. James is Chairman of the IPAC-RS Materials Working Group. He served on the Organizing Committee for IPAC-RS Supplier Forum. Helped to draft the IPAC-RS “Recommended Baseline Requirements for Materials Used in OINDP”. He served on the USP Expert Panel Member for USP <1664>, “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems”.
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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.
Gad Consulting Services (GCS) has been providing expert toxicology services to pharmaceutical and medical device companies for over 30 years. We have experience with drugs, devices, and combination products in numerous therapeutic areas, throughout all stages of development and for those already on the market. GCS is proud to offer toxicology and biocompatibility support tailored to meet the specific needs of our clients. Consulting services include:
· Regulatory strategy development; design of full non-clinical and biocompatibility testing programs;
· Medical device gap assessments, biological evaluations, change assessments, bioequivalence determinations
· Study placement and monitoring, report review and preparation, lab audits;
· IND writing, preparation, and filing
· Interaction with regulators, including response to deficiencies without previous project involvement;
Our team has extensive experience in toxicological risk assessment (TRA) methods including the estimation of acceptable exposure limits, and the application of (Q)SAR methodology. Gad Consulting is well-known for the quality and consistent regulatory acceptance of our reports on:
· TRA of medical device extractables, leachables, and volatile organic substances (ISO 10993, ISO 18562)
· TRA of drug packaging and manufacturing equipment extractables and leachables (ICH Q3)
· Qualification of impurities, degradants, residual solvents, and excipients (ICH Q3)
· Mutagenicity evaluation and calculation of compound specific limits, including nitrosamines (ICH M7, (Q)SAR)
Why Choose Nelson Laboratories
Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.
Companies choose Nelson Laboratories for our:
See how we can help you mitigate risk, be first to market, and succeed with your customers.
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.
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.
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.
What is Extractables and Leachables US?
Since 2006, Smithers Extractables & Leachables USA conference has been supporting the advancements in the E&L industry while keeping the supply chain informed on new regulations and testing protocols. This event assembles E&L experts to discuss compliance, case studies, testing, regulations, biocompatibility, data and best practices.
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Why the E&L Industry?
Smithers Medical Device Testing is a leading authority on extractables and leachables with experts who have a proven track record of developing comprehensive E&L test plans. The partnership between Smithers E&L laboratories and Smithers events division ensures we have a timely agenda and key stakeholders attending.
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