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2020 Advisory Board

  • Ronald Brown

    Toxicologist former U.S. FDA (retired)

    Ron Brown is a board-certified toxicologist who recently retired from the US FDA Center for Devices and Radiological Health.   At FDA, his research efforts focused on the developing new methods to assess the risk posed by patient exposure to extractable and leachable compounds released from medical device materials.   He is active in both domestic and international standards committees related to the biocompatibility of medical devices.  Until recently, he served as the co-chair of the US TAG for TC194 (Biological Evaluation of Medical Devices) and as convener of ISO/TC194/WG11 (Allowable Limits for Leachable Substances).  Ron is a founding member and former president of the Medical Device Specialty Section of the Society of Toxicology.  He previously held leadership roles in the Society for Risk Analysis and the Association of Government Toxicologists.  Prior to joining FDA, he was a Senior Associate at the ILSI Risk Science Institute in Washington, DC.

  • Thomas Egert

    Analytical Development Boehringer Ingelheim Pharmaceuticals, Germany

    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.

  • Nicolas Gallois

    Analytical Senior Scientist Sanofi

    I graduated a Ph. D. in analytical chemistry in 2008 at Ecole Nationale de Chimie de Paris (Chimie ParisTech nowaday).

    After a short experience in the petrochemical industry, I worked for 7 years for Aptar Pharma, Injectables division (formerly Stelmi) and started to be involved in the field of Extractables and Leachables studies. I acquired there a good experience on rubber extractables.

    I then joined Sanofi at the beginning of 2017 as Analytical Senior Scientist. I am in charge of the analytical chemistry activities within a group that is dedicated to the evaluation of primary container for parenteral drug products. Today my main activity is the E&L field, mainly for Prefilled syringes. I am also involved in other activities, like Container Closure Integrity testing.

  • Julie Henrotte

    Quality System EtO Sterilization and Validation Expert Terumo Europe

    Chemist by training, she was working for the past 10 years in the GSK Vaccines incoming material qualification related domains, her main responsibility included the creation the SUS and Primary Container validation standard approach to be applied directly to all the company manufacturing sites while following several qualification and implementation project for single use bags and connectors and vaccine primary packaging and delivery system.  Main objectives was robustness of the qualification package supporting the use of incoming material along-side harmonization and standardization. She is now in charge of the E&L expertise since beginning of 2018, her current role includes responsibility to set the E&L testing requirement at the right level into the company and management of the expertise across the organisation.

  • Dr. Margot Reth

    Global Analytical Development F. Hoffmann-La Roche AG

    Margot Reth is responsible for the E&L laboratory at F. Hoffmann-La Roche in Basel (Switzerland).

    Dedicated to analytical chemistry for 15+ years, her current role includes responsibility for the E&L investigation of primary packaging and single-use process equipment as well as for material related analytical trouble shooting. As E&L subject matter expert Margot is involved in risk assessments and in the implementation of global strategies for E&L testing for development and commercial projects.

    Prior to joining F. Hoffmann-La Roche, Margot held various positions in the field of organic trace analysis and E&L testing at Ciba Speciality Chemicals, BASF, and at the analytical service provider Intertek.

    Margot holds a state exam in food chemistry and has a PhD in mass spectrometry.

  • Alicja Sobantka

    Corporate Operational Excellence and Support Octapharma

    Alicja is currently employed at the Octapharma Pharmazeutika Produktionsges.m.b.H. where she is responsible for material qualification at corporate level. She performs extractables and leachables assessments including 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. In 2015 she won the award “Allocation d´installation scientifique pour jeunes chercheurs”, which is offered on an annual basis by Rennes Métropole. 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.

    After completion of undergraduate studies in food chemistry and toxicology at the Technical University in Kaiserslautern Alicja graduated in chemical engineering with the focus on process engineering and polymer technology at the University of Applied Sciences in Kaiserslautern. She holds a PhD in environmental engineering from the Vienna University of Technology in Austria.

    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 employs more than 6,200 people worldwide to support the treatment of patients in 105 countries with products across three therapeutic areas: critical care, haematology (coagulation disorders), immunotherapy (immune disorders). Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.  

  • Dr Reinhard Stidl

    Senior Toxicologist Safetree Consulting

    Reinhard Stidl is a chemist and toxicologist by training and started his career as a toxicologist at Baxter in 2007. During his time at Baxter, Baxalta and Shire, he was leading the group Toxicological Risk Assessments, responsible for the safety assessment of impurities (incl. E&L), excipients, chemical modifications of APIs, as well as specification limits based on safety data for parenteral drug products for global manufacturing sites. Since 2018 he works as independent toxicology consultant.

  • Dr. Cheryl Stults

    Principal C&M Technical Consulting

    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

    Carsten Worsøe

    Principal Scientist Extractables and Leachables Novo Nordisk

    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.