Agenda Released! View the 2022 Presentations!
View the Agenda >>>
April 5 - April 7, 2022
Arlington, Virginia & Online
Since 2006 Smithers’ Extractables & Leachables USA conference has offered a unique opportunity for E&L experts to gather and 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 in both the US and globally, delivering high level insight into the market and global landscape. Join The Mailing List to get the latest updates!
Smithers MSE (Materials Science and Engineering) 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, insight into emerging needs, and market intelligence into a collaboration from which the whole industry benefits.
 |
 |
 |
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.
Bio coming soon!
I am a seasoned scientist with a diverse background in chemistry and material sciences. Currently I focus my efforts on using chemistry in the evaluation of medical device biocompatibility. My academic work has focused on synthesis and characterization of biomimetic materials, fabrication of microscale devices, and photonics. I have a professional interest in both technical and popular science writing, which has produced over 30 peer reviewed scientific articles and hundreds of blog articles.
At Nelson Labs I draw on my chemistry and materials experience as well as my research acumen to create solutions for sponsors with interesting and challenging problems facing the assessment of their devices.
Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry and Regulatory Toxicology departments based in St Paul, Minnesota supporting manufacturers of pharmaceuticals, medical devices and combination products. With over 30 years’ analytical experience and over 10 years specializing in international support for extractable and leachable studies, including Toxicological Risk Assessments and Safety Assessments, Sandi and her team have supported thousands of products. Ms. Schaible is also an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Dr. Cartledge is an associate research scientist with the extractables and leachables group at PPD® Laboratories in Middleton, Wisconsin. In 4 years at PPD, he has performed extractables and leachables studies including routine stability testing, controlled extraction studies, method development and validation, and medical device studies. He has successfully executed many programs leading to drug product approval by the FDA.
Robert Malick is a Principal Research Scientist II in Operations Science & Technology Combination Products with AbbVie. He started his 30th year at AbbVie/Abbott having joined after receiving his Ph.D. in Analytical Chemistry from the University of Cincinnati. Robert has been active in extractable & leachables since 2006 for dosing devices and container closure systems ranging from metered dose inhalers to implantable devices. He has spoken at several conferences, chaired industry working sessions and has several publications in the E&L field. Robert is active with industry consortia including ELSIE (Extractables and Leachables Safety Information Exchange), currently serving as Co-Chair of the Materials Safety Working Group and representing AbbVie on the ELSIE Board of Directors.
PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.
The dedicated and highly specialized extractables and leachables (E&L) team in the PPD® Laboratories GMP lab has more than 15 years of experience providing full-program support for all aspects of E&L studies, including overall study design/consulting, container/closure selection as well as manufacturing process qualification and validation. Our E&L team and toxicology experts work with clients to make informed decisions on which extractable compounds will be monitored as leachables in long-term stability studies, development of extractable and leachable methods, leachable stability testing, batch extractables testing and USP compendia testing support.
Twitter: @PPDCRO
From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions. Waters Corporation is the world's leading specialty measurement company focused on improving human health and well-being through the application of high-value analytical technologies and industry leading scientific expertise.
For more than sixty years, Waters has continually pioneered chromatography, mass spectrometry and thermal analysis innovations under a variety of brands including Waters, TA Instruments, ERA, VICAM, and Andrew Alliance. Whether it’s discovering new pharmaceuticals, assuring the safety of the world’s food and water supplies, or ensuring the integrity of a chemical entity in production, we are constantly working with our thousands of customers to change the world.
With a global workforce of more than 7,400 employees, Waters operates in 35 countries, including 14 manufacturing facilities and with products available in more than 100 countries. Our diverse organization is well-positioned to Deliver Benefit through innovations that enhance human health and well-being.
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.
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.
