Our 2025 agenda is coming soon! Until then view our 2024 agenda below and sign up for the mailing list to be the first to know about the 2025 program.
Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Advanced Structural Characterization, Trace Analysis, Extractables/Leachables and Elemental Impurities team. With over 38 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 26 years in the Pharmaceutical Industry. He is a member of the USP Packaging and Distribution Expert Committee, Vice Chair for the PQRI (Product Quality Research Institute) Development Technical Committee, PhRMA Topic Lead for the ICH Q3E Expert Working Group, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, Board of Directors for the ELSIE Consortium, Chair for the SPIE Defense and Commercial Sensing Conference and member of the AAPS Impurities Steering Committee. His research interests include the development of advanced mass spectrometry-based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally and compositionally diverse chemical entities. He also leads multidisciplinary efforts to advance ultrarapid threat detection and development, manufacture and deployment of pharmaceutical countermeasures for catastrophic (e.g. pandemic, environmental disaster, etc.) unanticipated medical needs and point-of-use patient therapies.
I completed my PhD in Analytical Chemistry at the end of 2019 and began working for Smithers in January 2020 as a Senior Analyst, specializing in LC-MS analysis. My PhD involved developing methods for metabonomic studies using high resolution LC-MS analysis. In May 2021 I became Principal Scientist and alongside other responsibilities I now use my previous method development and LC-MS experience to develop and validate methods for leachables studies in an E&L environment.
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.
Jan Baeten received his Ph.D. from the faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. After his academic career as a post-doctoral researcher, he joined Nelson Labs in 2015 as R&D scientist, focusing on innovations in analytical services for the pharmaceutical and medical device industries. Driven by his technical expertise in chromatography and mass spectrometry, Jan works on the development of new analytical solutions, strategies and data processing flows. In his role of technical advisor, he also gives support to business development. Jan is also active in the structure elucidation team working on identification of unknowns.
I am a recognized leader in the field of biomaterials with a strong background in polymer synthesis, modification, formulation, fabrication, and characterization. In addition, I am skilled in the characterization of biomedical materials and drug delivery products following ICH, USP, ISO, ASTM, FDA, and CMC guidance/regulations. Combining experience in both industry and academia, I have a proven capacity to lead with an ability to work independently or as part of internal and external collaborations.
-520-240.jpg?ext=.jpg)
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.
Dr. Nicole Soucy is the Director of Global Toxicology and Biocompatibility in the Preclinical Sciences Department at Boston Scientific. She has nearly 20 years of experience as a toxicologist and risk assessor for products regulated as medical devices, pharmaceuticals, and cosmetics. In her current role, Nicole built and now leads a team of 42 scientists to ensure all products developed and manufactured by Boston Scientific meet or exceed global regulatory requirements for the biological safety evaluation of medical devices - a key safety input for regulatory approval in all regions. In her prior role, Nicole provided technical support, leadership, and guidance to a team of scientists supporting 3M Health Care Business Group, a diverse group of businesses developing and commercializing active pharmaceutical ingredients, drug delivery systems, medical devices, combination products, and cosmetics.
Anthony (Tony) Ragheb is Vice President for Global Research, Testing, Biocompatibility and Toxicology for Cook Medical, and adjunct assistant professor of Biomedical Engineering at Purdue University. His experience includes over 30 years in medical device research, team leadership throughout the total product life cycle, and teaching, and he is an author on over 20 peer-reviewed publications and an inventor on over 60 patents. His current responsibilities include global leadership for biocompatibility, toxicology, material science and engineering testing for Cook Medical, including ISO17025- and FDA/ASCA-accredited in vitro testing laboratories, and GLP-compliant in vivo testing and histopathology laboratories. He also serves as convenor for ISO/TC 150 SC2/WG3, and is active in AAMI, including the US TAG to ISO/TC 194, as well as with AdvaMed and MDMA.
Rodrigo Feliciano currently leads the EU E&L and Materials Science team at Baxter International, and is based in Belgium. Rodrigo has over 15 years of experience in analytical chemistry. Rodrigo obtained his PharmD degree from the University of Lisbon, Portugal in 2003 and a has a PhD in Food Science from the University of Wisconsin-Madison. He was a postdoctoral fellow in the University of Düsseldorf, Germany working in the field of non-targeted metabolomics and authored 33 peer-reviewed manuscripts. He is a national member of the ISO/TC 194 WG and a Fulbright alumnus.
Crystal D’Silva is a subject matter expert in medical device safety at Baxter International and based in Brussels, Belgium. She frequently represents industry expertise in external fora, and she is actively involved in standard development as an expert in the ISO/TC 194 Biological and Clinical Evaluation of Medical Devices technical committee. She is also a European Registered Toxicologist (ERT) and a member of the European Society of Toxicology In Vitro (ESTIV) and the Belgian Society of Toxicology and Ecotoxicology (BELTOX). She has a PhD in Medical Biophysics from the University of Toronto in collaboration with the Princess Margaret Cancer Centre and the Hospital for Sick Children (Ontario, Canada).
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.
I am an analytical chemist with 15+ years of experience working exclusively in a cGMP environment with a wide range of pharmaceutical products. My main area of expertise, and the focus of my career the past eight years, has been the evaluation of drug – packaging/delivery system compatibility for developmental pharmaceutical products. In this area I work extensively with mass spectrometry, both GC/MS and LC/MS, for qualitative identification of unknown substances as well as trace level quantitative analysis. Additionally, I have had extensive experience with the development of chromatographic and mass spectrometric methods, validation of these methods by IHC guidelines and execution of sample analysis throughout my career.
Experienced Professional in Formulation AR&D, E&L Studies, Glass Delamination Studies, Tech Ops.
Experience handling Project Management & Tech Transfer with a demonstrated history of working in the pharmaceuticals industry in Injectable and Ophthalmic formulations. Skilled in all Hyphenated techniques like LCMS, GCMS, ICP-MS besides HPLC, GC and Good Laboratory Practice (GLP), Method development and Validations, GMP, . Strong research professional with a Doctor of Philosophy (Ph.D.) focused in Analytical Chemistry from Acharya Nagarjuna University, Guntur.
Chemist with expertise in unknown compound analysis, extractables & leachables, GC-MS, LC-MS and ICP-MS. Proficient with maintenance and troubleshooting of GC-MS, ICP-MS and general laboratory equipment. Improved process during Kaizen event decreasing hands on time by 25% on testing by reducing non value added steps. Team player focused on efficiency and transparency, who fosters open communication.
Speaker Bio: Currently: Principal Investigator at U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (Maryland, USA). Research work: head of laboratory studying mechanisms of blood coagulation, in particular, related to treatment of Hemophilia A. Regulatory work: review of biological drug products’ quality-related information (protein-, gene therapy- and cell therapy-based products) in INDs, BLAs and supplements to approved products. This involves review of analytical assessment of extractables and leachables (E&L) due to previous experience in development of GC- and ICP-MS -based methods for analysis of small organic compounds and trace elements in biological tissue, relevant to the E&L assessment. Previous employments: J. H. Holland Laboratory of the American Red Cross (Rockville, MD), 1998-2004; University of Maryland School of Medicine (Baltimore, MD), 2004-2006; Armed Forces Institute of Pathology, Walter Reed Army Medical Center (Washington, DC), 2006-2008. Education: BS/MS in Biochemistry - 1982, Moscow State University, USSR. PhD in Molecular Biology - 1998, Engelhard Institute of Molecular Biology, Russian Academy of Sciences, Moscow.
Bio coming soon!
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.
I’m currently the E&L Technology Manager at West. Over the course of my 20 years of industry experience, I have held various analytical lab and lab management positions mostly in E&L, but also in QC and CCI. I’ve previously worked as a director at Boston Analytical, a lab supervisor at GSK, and a senior chemist at Eurofins. I hold a bachelor’s degree in chemistry and a master’s degree in data analytics both from Penn State.
Dr. Jennifer Ator is a board-certified Principal Toxicologist, Risk Assessor, and Project Manager who earned her Ph.D. in Toxicology and M.H.S. in Environmental Health Sciences from Johns Hopkins University. Dr. Ator prepares, reviews, and manages quantitative human health risk assessments, exposure assessments, product and ingredient safety assessments, and regulatory compliance evaluations for a diverse range of substances within a variety of national and international regulatory contexts, including food allergens, food additives, medical devices, consumer/household products, personal care products/cosmetics, pharmaceuticals, and dietary supplements, among others. Recent work has focused on development of quantitative exposure assessment methodologies to augment core competencies such as Proposition 65, medical device, and personal care product regulatory compliance assessments as well as consumer product safety evaluations.
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.
Born: 10.09.1981 in Piekary Śląskie, Poland
Alicja is currently employed at the Octapharma where she is responsible for material qualification at corporate level including chemical safety assessment of polymerc processing, packaging, and administration materials and the planning and supervision of extractables and leachables studies.
Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich, Germany.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.
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.
