2019 Advisory Board

  • Ronald Brown

    Toxicologist 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

    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.

  • 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.

  • Cheryl Stults 博士

    负责人 C&M Technical Consulting

    Stults 博士是 C & M Technical Consulting, LLC 公司的负责人,该公司与各种本地公司和国际公司合作,旨在推进注射产品和吸入产品的发展。Stults主要关注设备和包装材料的分析和特性,以进行材料的选择、鉴别和控制。她拥有密歇根州立大学分析化学博士学位和阿奎纳斯学院管理学硕士学位。她之前担任的职务包括:Novartis Pharmaceuticals Corporation 高级研究院、旧金山州立大学助理研究教授,以及 Johnson & Johnson 下属公司质量助理。Stults是《萃取物及溶出物手册》(Leachables and Extractables Handbook) (Wiley 2012) 的联合主编,并且一直是萃取物及溶出物安全信息交换(Extractables and Leachables Safety Information Exchange,简称 ELSIE)和国际药用气雾剂监管与科学联盟(International Pharmaceutical Aerosol Consortium on Regulation and Science,简称 IPAC-RS)两大联合机构的董事会成员。她一直积极参与 ELSIE 试点协议研究和数据库开发,并曾带领 IPAC-RS 工作小组开发 OINDP 材料基线要求、萃取物及溶出物开发模式和化学品风险评估工具,同时还继续作为 IPAC-RS 科学顾问参与全球外展服务以及材料相关活动。Stults 博士目前是 USP 包装和分销专家委员会成员,致力于编写和修订材料相关的章节。

  • 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.