The 2023 agenda has been announced! Take a look at the program, which features expert speakers from SGS, the FDA, Intertek, Solvias, Novo Nordisk, GSK, PPD, SafeBridge, Sartorius, and more, covering important industry topics such as medical devices, tox evaluation, material selection, single use, study designs, and more!
The new International Organization for Standardization ISO 10993-17: Toxicological Risk Assessment of Medical Device Constituents is essential for the evaluation of toxicological hazards of extractable/leachable chemicals detected in from medical device extracts. The new ISO 10993-17 is currently in the final draft phase and vastly different to the first version which was published in 2002 and last revised in 2012. The document is now in its final draft phase and thought to be published at the end of this summer. Along with the major changes presented in the new standard, more toxicological evaluation tools are offered to decrease the burden of assessing the toxicological risk of chemicals extracted from medical devices. This presentation will provide a brief overview of the new standard and also evaluate the potential impacts to chemical characterization for medical devices (ISO 10993-18).
Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.
Lina Burman holds a PhD in Polymer Technology with focus on evaluation of migration and degradation behavior of polymeric materials and has worked for over 15 years within the medical device industry with biological evaluations and toxicological risk assessments. Lina is currently Senior Scientific Officer at Limulus Bio and in that role, as well as for the last 5+ years, she works as consultant with a broad range of class I to III devices, sold in EU, US and global markets, and as training instructor. Lina is an active member of the ISO/TC 194 biological and clinical evaluation of medical devices technical committee (since 2006) and has been involved as nominated expert in the development of the ISO 18562 standard series for biological evaluations of breathing gas pathways from its inception. Lina organizes the conference Biocompatibility Matters and the popular Limulus Bio Coffee Break discussion forum with the aim of promoting the importance of having robust science behind regulation. Lina is also a member of the Swedish Toxicology Society and the Swedish Pharmaceutical Society.
Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas of interest include medical device and pharmaceutical nonclinical program design and implementation, investigative toxicology, risk assessment of extractable & leachable compounds from medical devices, and regulatory interactions.
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.
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.
Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics.
From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects.
Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.
Eric Hill joined Boston Analytical in 2014 as Director of the Extractables & Leachables laboratory. Prior to Boston Analytical, Eric spent 15 years at a contract analytical laboratory in various roles including Analytical Scientist, Business Development Manager, Business Manager, and finally President. Eric has an extensive background in polymer material characterization, and contributes to industry groups and technical conferences in the E&L space.
Listed, are a few of the many publications and presentations he has conducted:
• Response Factor Variation Study of Internal Standards for Semi-Quantitation of Extractables and Leachables
• using LC-MS, Smithers Rapra Extractables and Leachables Europe Conference, 2019
• Characterization of Extractable Species from Polypropylene Microplates, SLAS TECHNOLOGY: Translating Life
• Sciences Innovation, 2018
• Organic−Inorganic Polyamidoamine (PAMAM) Dendrimer−Polyhedral Oligosilsesquioxane (POSS) Nanohybrids, Macromolecules,
He holds a bachelor’s degree in chemistry from the University of Michigan, a master’s degree in analytical chemistry from Central Michigan University, and an M.B.A. from the University of Michigan
Sven Hackbusch is a Senior Application Scientist at Thermo Fisher Scientific, responsible for the development of LC/MS applications related to small molecule structural elucidation in collaboration with customers in the Pharma/Biopharma markets. He joined Thermo Fisher Scientific in 2017 as an Application Scientist in the LC/MS product demonstration laboratory, focusing on untargeted small molecule applications using Thermo Scientific Orbitrap technology.
Sven holds a Ph.D. in Pharmaceutical and Chemical Sciences from the University of the Pacific in Stockton, CA, USA and a B.Sc. in Chemistry from the Justus Liebig Universität in Gießen, Germany.
Karl studied organic chemistry with a Ph.D in 1988 and has been using hyphenated GC/MS and LC/MS equipment since 1985. He worked for main 3 MS manufacturers as application chemist or product manager from 1990 – 2008, using quadruples, triple quadrupole and Q-ToFs. Since 2009, he is leading the Solvias E&L team in Switzerland, using multiple HRAM-LC/MS/MS systems (Q-Exactive Orbitrap) and GC/MS Triple quadrupoles. In 2021, his team has started using HRAM-GC/MS instead of quadrupoles – to further increase ID rates in E&L studies, ideally to 100%. Since 2023, Karl’s main interest is the integration of Solvias Swiss based E&L team with the US based team of Solvias LLC (former Chemic Laboratories, Boston, USA).
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.
Marine LEPOUTRE currently holds the position of Global Subject Matter Expert in Extractable & Leachable at GSK Vaccines and is responsible for aligning all GSK Vaccines sites with current regulatory requirements. Before this position, in his role of process expert for Belgium site, she leads process validation as homogeneity, holding time, lifetime and lyophilisation. Marine is a Chemical Process Engineer with a master’s degree in Chemistry from CPE Lyon in France.
Dr. Roberto Menzel graduated from FSU University Jena and holds a Ph.D. in Chemistry. He started his career as an assistant editor in the natural science book section at Wiley followed by a position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech where he is heading the internal analytical laboratory and Extractables group. The main working areas are material and product qualification studies for single-use (SU) systems and components for the biopharmaceutical industry. He authored several articles on the characterization of plastics and SU devices regarding extractable compounds.
With over 25 years' experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec's Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing. Ms. Schaible received her Bachelors of Science in Chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA and ISO regulated laboratories. Ms. Schaible provides technical guidance and testing program design, and is an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Sam started his career as an R&D chemist formulating coating formulations with the same additives that he now spends his time detecting and identifying in the extractables and leachables industry. Sam has a vast expertise in overcoming the analytical challenges that can present themselves when performing E&L data analysis. He manages an exceptional team of liquid chromatographers at VR Analytical, an E&L industry leader.
Eric is a Senior Scientist with the Extractables and Leachables department at PPD, a part of Thermo Fisher Scientific. He recently received his Masters of Engineering in Polymer Engineering from the University of Wisconsin - Madison and also holds undergraduate degrees in Chemistry and Applied Mathematics. When out of the office, Eric enjoys new music, photography, and Madison's craft breweries, amongst many other interests.
James Vergis, Ph.D. is a Principal at the law firm of Faegre Drinker Biddle and Reath, LLP and is a member of the firm’s Life Sciences Consortium Management Team and Government and Regulatory Affairs Practice Group. As one of the consulting professionals within the law firm, Jamie provides scientific and strategic consulting services to individual clients and various Pharmaceutical and Biotechnology consortia such as Allotrope Foundation, Enabling Technologies Consortium (ETC), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). As a scientist whose work has touched on various fields of study, Jamie is passionate about helping clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes.
Jamie has a B.S. in biochemistry with a minor in computer science from SUNY Geneseo and a Ph.D. in molecular biophysics and biochemistry from Yale University.
Dr. Saylor has been a staff member at the US Food and Drug Administration for the past 17 years in the Division of Biology, Chemistry and Materials Science (DBCMS) within the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH). At the USFDA, he has pursued research in the area of theoretical and computational materials science applied to medical device applications. These efforts have focused on the dynamics of medical device material systems and tissue interactions at multiple length scales: atomistic/molecular, microstructural, and device scales. This research has addressed a variety of premarket and postmarket issues for medical devices, including the impact of manufacturing changes and tissue composition on the performance of controlled drug release systems, the release and retention of nickel in patients implanted with nickel-containing alloy devices, and patient exposure to potentially toxic additives in biomedical plastics.
Dr. Cohen is a board certified toxicologist and Principal at the consulting firm Gradient. With expertise in computational toxicology and human health risk assessment, Dr. Cohen's primary responsibilities include non-clinical safety assessments of medical device and pharmaceutical components, regulatory compliance assessments, cancer risk assessment, and physiologically based pharmacokinetic modeling. Before joining Gradient, Dr. Cohen earned his doctoral degree at the Harvard School of Public Health, applying in vitro cellular models to study the fate, transport and toxicity of nanoparticles in the lung. He has authored over twenty high impact peer-reviewed articles and one patent, and presented his work to academic and general audiences.
Mac is a Managing Toxicologist for SafeBridge Regulatory Life Sciences Group and has over 16 years’ experience in pharmacology and toxicology as a researcher, study monitor, and consultant. He has been involved in the toxicological assessment extractable and leachable studies since 2010. Mac is certified by the American Board of Toxicology and holds a D.V.M. from the North Carolina State University, College of Veterinary Medicine
Charlie Modlin is an Application Scientist with Lhasa Limited based out of Charlotte, North Carolina. Charlie has been with Lhasa for four years, and specializes in skin sensitization, carcinogenicity, read across assessments and oligonucleotide safety.
Charlie greatly enjoys traveling and speaking on the topics of in silico tools, the science of skin sensitization, and predictive toxicology. In his free time he enjoys playing with his dog, cat and chickens.
Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. She is interested in the application of in silico tools for the analysis of various toxicological endpoints such as skin sensitization, irritation and corrosion as well as endocrine disruption. Her publications include case studies on the application of a framework which allows for transparent and reproducible in silico assessments with an assignment of reliability and confidence. An extension of this work is exploring how to more broadly apply in silico tools towards non-traditional applications.