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.
Analytical Senior Scientistat
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.
Dr. Cheryl Stults
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.
Manager of Project Managementat
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).
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. Margot Reth
Global Analytical Developmentat
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.
former U.S. 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.
Quality System EtO Sterilization and Validation Expertat
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.
Corporate Operational Excellence and Supportat
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.
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.