Our 2026 agenda is here! See what's in store from the FDA, Pfizer, Eli Lilly, Philips, Bausch + Lomb, Takeda, Johnson & Johnson, NAMSA, Baxter, Abbvie and MORE below.
To download a PDF version of the agenda, click here
Please note: Sessions or speakers denoted with * or "tbc" are subject to change.
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.
Betsy is a senior principal scientist in Pfizer Research & Development providing expertise and leadership to Pfizer’s Global Extractable & Leachable Network. Betsy supports E&L studies, conducts risk assessments, as well as implements E&L control, characterization, and regulatory strategies. Additionally, she collaborates with manufacturing, packaging and device, toxicology for development of biotherapeutics and vaccines to ensure product quality and patient safety.
Yemin is a Sr. Principal Research Scientist in Analytical R&D at AbbVie. Since she joined Abbott/AbbVie in 2008, Yemin has contributed to numerous projects from FIH to commercial approval, including solid oral, liquid oral, and parenteral liquid dosage forms. She is the co-chair of the IQ Consortium Pediatric Working Group, a member of IQ Analytical Leadership Group, and a member of ELSIE Materials Information Working Group.
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”.
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.
Gyorgy Vas has over 25 years of experience in scientific research, pharmaceutical and medical device product development, and laboratory management. Over 15 years was spent in a cGMP environment, where that scientific expertise was applied to solve problems related to finished pharmaceutical products and medical devices. In his current position, he is advising regulatory filing strategy for multiple clients, and his group provides solutions for mitigate deficiency letters. He is serving as an internal scientific consultant to the laboratory operations, evaluating new analytical techniques, software products for extractables and leachables testing. As part of his current role he is involved to evaluate and implement non-routine analytical instrumentations and methods for cGMP use. He published more than 20 analytical papers, related to various activities, including sample preparation, trace level method validation, molecular imaging, structure elucidation, and E&L testing. Those scientific publications papers have been cited more than 3000 times over the years.
Samuel Odebamowo is a Senior Application Scientist at Lhasa Limited and a former FDA computational toxicologist. He specializes in the application, interpretation, and regulatory acceptance of (Q)SAR models and in silico frameworks for chemical safety assessment. In his role, Samuel plays a key part in translating complex regulatory requirements, such as ICH M7, S1B, and Q3E, into practical, reproducible toxicological workflows that support confident decision making. He also contributes to scientific engagement activities and cross industry collaborations aimed at improving the use of predictive toxicology in regulatory settings. He holds an M.S. in Environmental Toxicology from New York University and is committed to advancing next-generation risk assessment (NGRA) methodologies across the life sciences.
Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. Dr. Johnson has co-authored several peer-reviewed publications and book chapters describing the implementation of in silico approaches and methodologies for gaining confidence in in silico predictions. Her work expands into novel application of in silico approaches and supporting the advancement of alternative methods. She is particularly interested in the application of computational tools to support toxicological evaluations; for example, in the assessment of extractables and leachables.
Erica L. Dahl, Ph.D., DABT is a Senior Managing Toxicologist for SafeBridge and has over 25 years’ experience in pharmacology and toxicology as a researcher, study director, and consultant. She has expertise in occupational toxicology, hazard assessment of potent pharmaceuticals, genetic toxicology, and product quality, including hazard assessments of potential contaminants identified in Extractables and Leachables studies. She is certified by the American Board of Toxicology and holds a Ph.D. in Molecular and Environmental Toxicology from the University of Wisconsin
Josh received his BA in Chemistry from Boston University in 2013, and his PhD in Chemistry from the University of Pennsylvania in 2020. He joined Takeda Pharmaceutical Company in 2020 as part of the Global Material Qualification team in Manufacturing Sciences and Analytical Technology supporting the organization’s manufacturing and pharmaceutical sciences network. Josh helps to harmonize processes to streamline the material qualification process, centralize knowledge, and develop digital tools to help automate workflows. Prior to joining Takeda, Josh has also worked as a QC Chemist, and as a project management consultant for clinical trials focusing on central nervous system disorders.
Dr. Erica Rogers is a board-certified toxicologist and Senior Toxicologist II at Gad Consulting Services, where she has worked since 2017. She earned her Bachelor of Science in Chemistry from Florida A&M University and completed both her Master’s and Ph.D. in Pharmacology and Toxicology at the University of Louisville. Her graduate research investigated how curcumin modulates BPDE-induced DNA damage, with a focus on mechanisms of genotoxicity and cellular protection. In 2024, she earned the Diplomate of the American Board of Toxicology (DABT) credential and is a full member of the Society of Toxicology (SOT) and the American College of Toxicology (ACT).
Dr. Rogers specializes in toxicological risk assessments of extractables and leachables (E&L) in accordance with ISO 10993 guidance; evaluation of volatile organic substances (VOS) and other constituents detected in inhalation medical devices per ISO 18562; permissible daily exposure (PDE) determinations for pharmaceuticals using available data and read-across methodologies; application of (Q)SAR approaches for assessing mutagenic impurities in alignment with ICH M7; and evaluation of nitrosamine formation and establishment of acceptable intake levels.
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.
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Frances (Fran) Sexton is an Advisor in TS/MS Network Materials Management (Monoclonal) within Network TS/MS at Eli Lilly and Company, providing technical oversight of raw materials and excipients used in global biologics manufacturing. Her work focuses on material qualification, supplier change management, and lifecycle control, with particular emphasis on extractables and leachables risk assessment driven by material composition, sourcing changes, and evolving regulatory expectations. Frances supports cross network alignment of risk based E&L evaluation and documentation to ensure materials remain technically and regulatorily fit for use throughout the product lifecycle, aligned with global best practices.
Dr. Cheng is a Principal Scientist and Working Group Leader at Johnson & Johnson Innovative Medicine, where she leads the global program on single-use systems risk management. Her work focuses on developing risk assessment frameworks to ensure drug product quality and patient safety for biopharmaceutical applications. She earned her PhD in Materials Science and Engineering from University of Florida.
Stephen C. Bady is a Principal Scientist in Technical Services / Manufacturing Sciences at Eli Lilly, where he provides global technical support for extractables and leachables in parenteral manufacturing. His work includes qualifying product contact materials, conducting risk assessments and compatibility studies, and supporting regulatory submissions and audits. Stephen brings prior experience from startup and R&D leadership roles, where he developed drug delivery and biomaterials technologies and authored quality systems supporting FDA filings. He holds MS and BS degrees in Materials Science and Engineering from Drexel University, with expertise spanning biomaterials, polymers, advanced materials characterization, and E&L risk management.
Accomplished leader with nearly three decades of experience guiding global product development from initial concept through market launch. Specializes in developing regulatory science tools that deliver impactful solutions for regulatory and industry stakeholders. Known for fostering strong cross-functional relationships and translating scientific expertise into practical business solutions that drive measurable results. Skilled at connecting technical and commercial perspectives to advance medical device innovation strategically, while empowering teams to deliver sustained impact and breakthrough solutions. Dr. Nawaby is currently responsible for the chemical characterization team at FDA – Center for Devices and Radiological Health (CDRH). She received her BA.Sc. (Cum Laude) and MA.Sc. in Chemical Engineering from University of Ottawa (CAN), Ph.D. in Physical Chemistry from Carleton University (CAN), MBA from University of Texas at Austin – McCombs Schools of Business (USA).
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers). From 2001 onwards, Dr. Christiaens holds the position of Scientific Director at Nelson Labs (formerly Toxikon Europe) where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of extractable and leachables and developing state-of-the-art analytical methodologies. In the last decade, Dr. Christiaens has been a speaker on the subject of “extractables and leachables” at over 150 Conferences and since 2014 he has been engaged in the (2-day) E/L training courses that are hosted by PDA across the Globe. In his current role at Nelson Labs Europe, Mr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.
Denver is a recognized expert in biocompatibility and toxicological risk assessment, with specialization in medical devices containing gas pathways. He currently leads a multidisciplinary biocompatibility and toxicology team at Philips, supporting global product development and regulatory strategy across a diverse portfolio of respiratory devices. Denver has extensive experience in E&L testing and is a subject matter expert in the ISO 18562 series for the biological evaluation of medical device gas pathways. He has led numerous programs assessing volatile organic compounds (VOCs), semi-volatile compounds, and particulate matter, applying risk-based toxicological evaluations to ensure patient safety and regulatory compliance. His work integrates analytical chemistry, toxicology, and systems engineering to support complex decision-making across the product lifecycle. He holds a PhD in Bioengineering from the University of Pittsburgh and a BS in Chemical and Biomedical Engineering from Carnegie Mellon University.
Miki Giffin is a Principal Toxicologist and Biocompatibility subject matter expert at Medtronic where she executes biological evaluations and toxicological risk assessments for a multitude of medical devices while primarily supporting Neurovascular type devices. Miki has received bachelor’s degrees from both Utah State University and Weber State University and a master’s degree from the University of Utah. She has built her career specializing in the hemocompatibility of medical devices and toxicology. She participates as a voting member of multiple AAMI working groups and in the Society of Toxicology. She is actively involved in research, mentoring, and advocacy to expand the knowledge of toxicology and hemocompatibility within the medical device field.
Dr. Street is a Senior Principal Toxicologist and Biocompatibility subject matter expert as well as Technical Fellow at Medtronic, where they lead strategy execution of biological evaluations and conduct toxicological risk assessments for a wide array of medical devices. They received a doctorate in toxicology from North Carolina State University and have built a career focusing on bridging the gaps between industry and regulatory agencies. Dr. Street serves as an ISO/TC 194 U.S. Expert and AAMI Co-Chair for working group 18, shaping international standards to advance biocompatibility assessment methodologies. They are also a published author actively involved in research and advocacy efforts to modernize medical device safety evaluations with patient-focused assessments.
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.
