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.
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA
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.
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.
Jack is a technical specialist with substantial experience of the pharma sector. Within the last 5 years his main emphasis has been on small molecule analysis, specialising in high performance liquid chromatography (HPLC) and high performance liquid chromatography coupled with mass spectrometry (HPLC-MS).
Alfred works in Cytiva’s extractables and leachables lab focused on testing polymeric materials and components used in the manufacturing of biopharmaceutical drug substances and products. He has a special interest in LC-MS and identification of unknowns, using high resolving mass spetrometry. Alfred is a Pharmacist and holds a PhD in Pharmaceutical Science, Analytical Pharmaceutical Chemistry from Uppsala University.
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.
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.
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.
Dr. Elizabeth Martin is a European Registered Toxicologist and gained her PhD at the University of Wales, Swansea in the field of DNA damage and repair. She then joined the Medical Research Council Toxicology Unit, and led a research group focused on assessing the importance and consequences of DNA damage, and the use of DNA adducts as markers for predicting carcinogenic risk. In 2001, Dr. Martin joined AstraZeneca as a Genetic Toxicologist, and subsequently moved into a role as a Project Toxicologist in 2008, working projects across multiple therapy areas. Currently based in Cambridge, UK, Dr. Martin is a Project Toxicologist for late stage and marketed products, and is also the lead for the safety assessment of impurities and Extractable & Leachables.
Dr. Cohen is a board certified toxicologist at the scientific consulting firm Gradient, with specialties in computational toxicology and human health risk assessment. At Gradient, his primary responsibilities include chemical hazard and risk assessment, consumer product safety evaluation, and non-clinical safety assessments of medical device and pharmaceutical components. Before joining Gradient, Dr. Cohen earned his doctoral degree at the Harvard School of Public Health, applying mathematical models to study the fate, transport and toxicity of nanoparticles in the lung and liquid suspensions used for in vitro toxicity screening. He has authored 23 publications including peer-reviewed articles, book chapters, and one patent, and presented his work to academic and general audiences. Dr. Cohen holds a Visiting Scientist appointment at the Harvard T. H. Chan School of Public Health where he researches the applications and human health implications of nanomaterials across the life cycle of nano-enabled products.
Ashley Hellenbrand is an Associate Research Scientist with the extractable and leachables group at PPD® Laboratories in Athlone, Ireland.
After studying Chemical Engineering and Business Management, Cecile Balloffet joined Clariant in 2006. After being an area sales manager, Cecile joined the team of newly formed Healthcare Polymers Solutions segment which focuses on enhancing and protecting healthcare products. She initiates and manages new business developments in Western Europe.
Chris Smalley is retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations
Dr. Stanard is currently the Director, EHS Product Stewardship at Ultragenyx and previously lead Global Occupational & Quality Toxicology at AstraZeneca. Dr. Stanard has over 20 years of experience in the biopharmaceutical industry covering a broad spectrum of responsibilities in the drug development process within R&D, clinical and commercial manufacturing operations. During this time, his primary focus has been on hazard identification and hazard/risk assessment, including occupational exposure limits and derivation of permitted daily exposure values for extractables and leachables, APIs, intermediates and impurities. Dr. Stanard received his PhD in toxicology from Colorado State University and an MPH in toxicology from San Diego State University. He is certified by the American Board of Toxicology. Dr. Stanard is an active member of the Extractables and Leachables Safety Information Exchange (ELSIE), serving as the co-chair of the Safety Working Group and member of the Executive Committee and Board of Directors.
After studying molecular biology at the Bielefeld University and graduating with a PhD in genetics and molecular biology in 2005, Dr. Steven Watt was granted a position as assistant professor at the department of proteome and metabolome research. There he was in charge of a mass spectrometry service unit, dealing with proteome and metabolome projects. In 2009 he joined Thermo Fisher Scientific as an instructor for scientific and pharmaceutical mass spectrometry applications. In his current position as a business development manager at A&M STABTEST he is involved in customer relations, marketing and the development of new analytical services in the field of pharmaceutical analysis. At A&M STABTEST he is also acting as scientific advisor for the Bioassay group, which performs ELISA and cell-based bioassays.
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.
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 of Eurofins Medical Device Testing Europe, Healthcare Engineering HAS consultant for EU Commission and adjunct professor in “Regulatory aspects in toxicology - Legislation in European Union” at the University of Milan. Paolo is also a Former member of ISO TC194 and CEN TC206 groups and Chairman of the Italian Mirror Committee.
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).
Karl Abele obtained a M.Sc. and Ph.D. in chemistry at the Ruhr University in Bochum, Germany. He is an expert in the fields of mass spectrometry and separation technology for small molecules and worked for several years as application specialist for three MS manufacturers. In 2010 he joined Solvias, where is currently leading the Extractables and Leachables team within the Specialized Expert Analytical Solution Unit.
