Principal Scientist Extractables and Leachablesat
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.
Risk Science Consortium, LLC & US FDA (Retired)
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.
Dr. Martin Wåhlander
Senior Specialist - Materials and Coatingsat
Martin Wåhlander is Senior Specialist of Materials and Coatings at Alfa Laval in Sweden. Since 2018, he has been working as the Subject Matter Expert in the Department of Single-Use Separators. Martin has a Ph.D. in Fibre and Polymer Science from the Royal Institute of Technology, Stockholm. Since 2008, he has been working and has collaborated globally with focus on polymeric materials, coatings and composites at Alfa Laval, ABB Corporate Research (Sweden), the University of Tokyo (Japan), the University of Manchester (UK), and Universität Duisburg-Essen (Germany). Martin has more than 10 peer-reviewed publications and is a member of the Royal Society of Chemistry (RSC).
Global Risk Assessment Services Toxicologist, Drug Safety Research & Developmentat
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.
Thomas Egert is a research scientist at Boehringer Ingelheim, Germany. Dedicated to analytical chemistry for 20+ years, his current role includes responsibility for materials selection and E&L qualification as well as analytical troubleshooting during packaging development.
Thomas is an active member of the Extractables and Leachables Safety Information Exchange Consortium (ELSIE) and the PQRI Parenteral and Ophthalmic Drug Product (PODP) – E&L Working Group. While contributing to several industry seminars in the field of pharmaceutical packaging, his special interest is devoted to predictive physico-chemical models for mass transfer from primary contact materials into pharmaceuticals.
Prior to joining Boehringer Ingelheim, Thomas held various positions in the field of organic trace analysis at an analytical service provider. Thomas holds a diploma in chemical engineering and a master’s degree in bio- and pharmaceutical analysis.
Senior Director, Analytical Chemistry and Regulatory Toxicologyat
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 Armin Hauk
Sartorius Stedim Biotech GmbH
Armin is Principal Scientist at Sartorius BPS, supporting the E&L activities in R&D and PD. Before that he had various positions at Ciba, Ciba Speciality Chemicals and Intertek C&P, as lab head, consultant and qualified person (QP). Armin is lecturer and trainer in E&L conferences and seminars. He is member of the ELSIE- and BPOG-supplier group and delegate in the Pharmacopeia expert group 16 of the EDQM.
Experienced Sales Engineer passionated by collaborating with researchers to find the solutions to their analytical challenges with a demonstrated history of working in the (bio) pharma and biotechnology industry. Skilled in Liquid Chromatography-Mass Spectrometry (LC-MS), Protein Chemistry, Medical Devices, Spectroscopy, and Laboratory Automation. Strong sales professional with a Master focused in biochemistry and a Master in Economics from Catholic University of Leuven.
Managing Director & Principal Consultantat
Maven E&L Ltd.
Jason set up Maven E&L in 2019 to provide expert advice in the area of extractables and leachables, after working for GSK in the area of E&L since the mid 1990’s where he held roles of increasing seniority providing support to E&L across many modalities and product types. Jason is a scientific advisor to ELSIE and publishes blogs and article on E&L with a focus on risk based management of leachables.
Market Development Manager, Pharma/CRO (MS & CE) and Aftermarket, EMEAIat
Ferran obtained his PhD in Pharmaceutical Sciences at the University of Barcelona in 2005 and has been involved with mass spectrometry ever since. He has worked for SCIEX for 15 years holding different positions in sales, marketing and business development covering the EMEAI region. During this time, Ferran has been working closely with customers in the pharmaceutical industry to deepen his understanding of the market and user needs and help deliver the right solutions at the right time.
Robert E. Malick
Principal Research Scientist II, Combination Products, Operations Science & Technologyat
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.
Global Quality Expertat
Etienne MICHEL currently holds the position of Global Quality Expert at GSK Vaccines, with an oversight of several expertise areas such as Extractables & Leachables, Cleaning, Bulk processes, Homogeneity and Chemical compatibility. Before that, in his role as Global Cleaning Expert, he led the development and implementation of new cleaning strategies within GSK. Etienne is a Civil Chemistry Engineer with a master degree in Environmental Sciences and Management from the Université Catholique de Louvain-la-Neuve in Belgium.
Dr. Christina Reufsteck
TUV SUD Product Service GmbH
Christina studied Biology and graduated at the University of Cologne. Then she moved to the German Cancer Research Center in Heidelberg, where she worked in cancer research, and received her PhD. Afterwards, she joined BioMedimplant, an accredited biocompatibility test laboratory in Hannover. There she conducted studies of cytotoxicity, hemocompatibitity and implantation according to the ISO 10993 series. Since 2014, she is working as an expert at the notified body TÜV SÜD Product Service GmbH in Munich and assesses the manufacturers’ technical documentation with focus on biocompatibility. Christina is a member of the German working committee for ISO/TC 194 (Biological and clinical evaluation of medical devices).
Senior Scientific Directorat
Eurofins Medical Device Testing
Paolo Pescio is a European Registered Toxicologist with an M.S. in Applied Toxicology and Biomedical Engineering. He has over 15 years of experience in biological evaluation of medical devices with a successful background as Study Director and Test Facility Manager. He is Senior Scientific Director in Eurofins Medical Device Testing Europe, member of ISO TC194 and CEN TC 206 and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna. He is a former Healthcare Engineering HAS consultant for EU Commission.
Christopher T. Houston, PhD
Senior Principal Scientist & Group Leaderat
Bausch + Lomb
Chris Houston has 22 years of experience as an analytical chemist in the pharmaceutical and medical device industries. He started his career at Pharmacia & Upjohn (later Pharmacia, then Pfizer) in Kalamazoo, MI as an analytical scientist focused on chromatographic method development and extractables and leachables (E&L) in ophthalmic drug products. He joined Bausch & Lomb in 2006 as head of the centralized mass spectrometry facility, becoming a founding member and eventual leader of a multidisciplinary spectroscopic structure elucidation group. During this time, he created and managed a successful E&L program for ophthalmic pharmaceuticals and served as a member of the PQRI Working Group on E&L in Parenteral and Ophthalmic Drug Products. Chris has also held roles as an E&L consultant, director of a contract analytical laboratory, and in QA. He currently leads Bausch & Lomb’s Pharmaceutical Development-Chemistry group. He holds a B.S. degree in Chemistry from the University of Michigan-Flint and a PhD in Analytical Chemistry with a Biochemistry minor from Indiana University.
Dr. Thomas Broschard
Head of Chemical Toxicologyat
Thomas Broschard is a senior toxicologist at Merck’s Chemical and Preclinical Safety Department in Darmstadt, Germany. He studied food chemistry and environmental toxicology at the University of Kaiserslautern from 1985 to 1990. He received his PhD in 1995 from the German Cancer Research Center (DKFZ), where he investigated mechanisms of chemical mutagenesis and carcinogenesis. From 1995 to 1997, he continued his research on this topic as a postdoctoral fellow at the Ecole Supérieure de Biotechnologie in Strasbourg, France. In 1998, he started his career as a regulatory toxicologist in the chemical and pharmaceutical industry. Since 2000, he held several positions at Merck’s Toxicology/Chemical and Preclinical Safety Department. In his current position he is heading the Chemical Toxicology Group that is responsible for the global registration of industrial chemicals, the establishment of substance-specific threshold values (OEL, PDE) and the risk assessment of impurities in drug products with a focus on leachables and extractables. He is very active in the Extractables and Leachables Safety Information Exchange (ELSIE) consortium where he co-chaired the Safety Working Group from 2014 to 2016.
Nelson Labs Europe
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.
Dr. Bettine Boltres
Principal Scientific Affairs, Packaging & Delivery Systemsat
West Pharmeceutical Services Deutschland GmbH & Co KG
As Principal Scientific Affairs, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging and wrote the book "When Glass Meets Pharma".
Since January 2019 she is member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. Since 2015 Bettine is also an active member of the USP Packaging and Distribution Expert Committee as well as the European Pharmacopoeia Commission Group of Experts 16 (elastomers) and the GLS Working Party (glass) and the ISO TC76/WG 4 on elastomers.
Dr. Andrew Feilden
European E&L Strategic Directorat
Dr Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and technical thought leadership activities.
Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written a number of papers and publications and is the inventor of 2 patents.
He has a degree and D Phil from the university of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
Heike Schäfer-Grebe obtained a diploma and Ph.D. in biochemistry at the Ruhr University Bochum, Germany. She completed a Ph.D. and a Postdoc in the group of Prof. H.E. Meyer on the analysis of posttranslational modifications in eye lens proteins using electrophoretic and LC/MS methods, and a two-year Postdoc at Agroscope Liebefeld Posieux, Switzerland, focusing on proteomics and metabolomics analysis of flavor-producing bacteria in cheese, before joining Thermo Fisher Scientific in 2008 as an application chemist for LC/MS methods. Heike joined the Solvias Extractables and Leachables Team in 2015.
Ulli Hohenester studied chemistry at the University of Marburg, Germany. He subsequently obtained a Ph.D. in analytical chemistry at the University of Münster, Germany; the subject of his thesis was to address phosphorylated amino acid in proteins by LC/MS. He then spent four years working on the identification of metabolites for several research facilities in France (CEA, Saclay; UPMC Sorbonne, Paris; INRA, Clermont-Ferrand). Ulli joined the Solvias Extractables and Leachables Team in 2018.
Global Subject Matter Expert, Extractables & Leachablesat
Marine LEPOUTRE currently holds the position of Global Subject Matter Expert at GSK Vaccines and is responsible for aligning all GSK Vaccines sites with current regulatory requirements. Before this position, in her role as process expert for the Belgian site, she led process validation, homogeneity, holding time, lifetime and lyophilisation. Marine is a Chemical Process Engineer from CPE Lyon in France.
David M. Saylor, Ph.D.
Research Materials Engineer, Division of Biology, Chemistry, and Materials Scienceat
US Food and Drug Administration
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.
Senior Scientist, PDS-CMCA-SFC-Trace Analysis and E&Lat
Petra obtained a PhD in analytical chemistry from the VU University in Amsterdam, The Netherlands. She is currently working in GSKs Trace Analysis Extractables & Leachables team based in Stevenage, United Kingdom. She is a project manager of extractable and leachable studies and her work focusses on extractable and leachable risk assessments within biopharma and cell and gene therapy. She is an active member of the ELSIE consortium and involved in harmonising approaches for extractable and leachable testing.
Alicja Sobańtka, PhD
Corporate Material Qualification – Manufacturing Science & Technologyat
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.
Manager of Project Management - E&L and Chemical Analysisat
Michael manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009.
Michael has uses his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.). Michael’s team supports a diverse range of clients and industries requiring the support of analytical experts working within a cGMP and ISO17025:2017 environment.
Prior to joining Smithers, Michael worked in the validation department for one of the largest Single Use System suppliers and previous to that at a petrochemical organisation.
Michael has a BSc in Chemistry, and is a Member of the Royal society of Chemistry (MRSC).