2018 Advisory Board

  • Thomas Egert

    Analytical Development Boehringer Ingelheim Pharmaceuticals

    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.

  • Dr. Andrew Feilden

    Chemistry Operations Director Smithers Rapra

    Andrew Feilden joined Smithers Rapra as a Principal Consultant in June 2011 and was appointed Chemistry Operations Director in October 2012. He specializes in extractable and leachable testing and the selection and assessment of materials for medical and pharmaceutical applications. Andrew previously worked at AstraZeneca for 12 years, leading their extractable and leachable testing. He has been working in the field of trace analysis using hyphenated techniques such as GC-MS and LC-MS for over 12 years. Whilst at AstraZeneca he was an active member of industry working groups, the IPAC-RS container closure group and he was the co-chair of ELSIE material group. Andrew gained a degree and D.Phil from York University.

  • 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

    Manager Extractable & Leachable GSK

    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.

  • 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.

  • 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.