Tuesday May 20- Wednesday May 21, 2025
Alexandria, VA
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.
This year's program features:
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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Dr. Ravi Kiran Kaja is a distinguished researcher and dedicated scientist with a Ph.D. in Analytical Chemistry and over 20 years of experience in Pharmaceutical Analytical Research (FAR&D). His career is fuelled by a steadfast commitment to enhancing patient outcomes through innovative pharmaceutical solutions.
Dr. Kaja's expertise spans Complex formulation characterization, Extractable & Leachable (E&L) studies, Pharmaceutical Manufacturing, and Science and Technology (MS&T) as well as Technology Transfer. He believes that collaboration and knowledge sharing are key to advancing the industry.
Beyond his professional endeavours, Dr. Kaja is passionate about mentoring young scientists and engaging in community outreach to inspire the next generation of researchers. His unwavering dedication to both his work and the broader scientific community has earned him respect and admiration in the field.
Diego holds a degree in Chemistry and a Masters in Organic Chemistry with a focus on Mass Spectrometry. Through working as a research scientist in a research institute for 6 years, Diego gained experience in supporting the chemical and pharmaceutical industry by advising and solving problems at a chemical level. Diego then joined the pharmaceutical industry as an Analytical Development Specialist, supporting the drug development process in areas such as degradation and stability studies, elemental impurities and extractables/leachables risk assessment, method development and providing scientific input to strategic decisions. Since then, Diego has gained a thorough understanding of regulatory guidelines and has also worked as a consultant to apply his experience. Currently Diego is part of the Global Alliances team at Lhasa Limited – the parent company of Consult Lhasa – and leads the API degradation profile, drug-excipient compatibility, risk of extractables and leachables, and elemental impurities risk assessment services teams at Consult Lhasa.
James has worked in the Pharmaceutical and Medical Device area for over 30 years. He has had diverse technical and managerial roles spanning Pharmaceutical Development, Medical Device Manufacture/Testing and Contract Laboratory Services. His employers include GSK, Boehringer Ingelheim Pharmaceuticals, Catalent Pharma Solutions, Nelson Laboratories and Thermo Fisher Scientific. 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. James is Co-Chairman of the IPAC-RS Materials Working Group. He has served on the Organizing Committee for IPAC-RS Supplier Forum and USP Expert Panel Member for USP <1664>, “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems”. In addition, he has over 15 presentations and 5 publications in the field of Extractables and Leachables.
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.
Jeff has over twenty years of experience in the pharmaceutical industry supporting E&L and analytical chemistry programs. Jeff currently manages a team of eight E&L study directors in North America, Europe, and Asia; provides leadership to develop and maintain regulatory strategies for various products; and leads efforts to use modern MS techniques to identify and quantify E&L compounds.
Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.
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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.
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.
