Dr. Ader is co-founder and Technical Director of SafeBridge Consultants, Inc., the premier resource for high level risk assessment, safety, health and environmental support to the biopharmaceutical industry. Dr. Ader has over 20 years of experience in extractables and leachables and 30 years of experience in the pharmaceutical and chemical industry including working for the past 27 years at SafeBridge. He received a Ph.D. in Industrial Health (Toxicology) from the University of Michigan and an M.S. in Industrial Hygiene from Temple University.
Mohinish Sahai, PhD, MBA, is a Group Leader for Extractable and Leachables within PPD (Part of Thermo Fisher scienfic) at Athlone, Ireland. He has about 16 years of experience in the pharmaceucal industry from various roles within Analycal method development, validaons , Extractable and Leachables. In the following years he had developed his experse parcularly in Extractables and Leachables(E&L), Nitrosamine tesng and genotoxic impuries evaluaons. At PPD, Athlone Ireland site , he leads the E&L group and work extensively on E&L studies for Parenteral products, Manufacturing process components assessment, OINDP’s and other inhalaon and different formulaons CCS.
He holds a Doctorate in chemistry and a master’s degree in management. He is a Black belt in Lean Six Sigma.
Jure Hren is a Senior Expert Science & Technology in the technical development of Biologics at Novartis in Slovenia. In his current role he is focusing on E&L assessments and other E&L related activities, required for ensuring safety and regulatory compliance. He holds a PhD in Organic Chemistry from the University of Ljubljana and also specializes in understanding the aspect of polymers and their additives as contact materials, used for manufacturing, storage and administration of pharmaceutical products. Jure has extensive experience in analytical chemistry in the pharmaceutical industry, having worked in the analytical development for more than a decade. In his previous roles he was predominantly focused on structure elucidation and quantification of small molecule impurities, encompassing a wide variety of pharmaceutical products.
Graduated in 2010 in Veterinary Medicine at the University of Padua, Margherita Monico has also obtained a Master’s degree in Biotechnology for Business at CUOA Business School.
In Mérieux NutriSciences since 2019, Margherita is one of the Science Center Project Managers dedicated to designing and supervising Extractables & Leachables studies, and also provides customized courses and webinars on the subject.
Daniele Ubbiali holds a degree in Industrial Biotechnology from Milano-Bicocca University. After graduating, he moved to Germany to pursue a PhD in Proteomics at the University of Halle-Wittenberg. Following his doctoral studies, he returned to Milan and joined Eurofins, where he has been working for nearly three years in the field of Extractables and Leachables. He published two first name papers on high impact factor journals.
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, TX (US) where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-polymers (Kraton Polymers). From 2001 onwards, Dr. Christiaens holds the position of Scientific Director at Nelson Labs (formerly Toxikon Europe) where he developed analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of extractable and leachables and developing state-of-the-art analytical methodologies. In the last decade, Dr. Christiaens has been a speaker on the subject of “extractables and leachables” at over 150 Conferences and since 2014 he has been engaged in the (2-day) E/L training courses that are hosted by PDA across the Globe. In his current role at Nelson Labs Europe, Mr. Christiaens supports the Strategy and Global Business Development for Extractables and Leachables Service Offerings for Pharmaceutical and Medical Applications.
Ferran obtained his PhD in Pharmaceutical Sciences at the University of Barcelona in 2005 and has been involved with mass spectrometry ever since. He has worked for SCIEX for 15 years holding different positions in sales, marketing and business development covering the EMEAI region. During this time, Ferran has been working closely with customers in the pharmaceutical industry to deepen his understanding of the market and user needs and help deliver the right solutions at the right time.
Dr. Valeria Mazzoni, graduated in Industrial Biotechnology in 2015 at the University of Milan Bicocca, working for 2 years as a researcher at the same university. She obtained a master's degree in food quality in 2016 and has been working in Neotron since 2017, gaining experience in the R&D and packaging department (food and Pharma). From 2024 is the head of the E&L Unit of Neotron.
Dr. Roberto Menzel graduated from FSU University Jena and holds a Ph.D. in Chemistry. He began his career as an assistant editor in the natural science book section at Wiley, followed by a position as a group leader for organic trace analysis in the environmental analytical division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech, where he led the internal analytical laboratory and Extractables group for 10 years. His main areas of work included material and product qualification studies for single-use (SU) systems and components for the biopharmaceutical industry. Recently, Roberto took over the role of product manager for microcarriers and biopreservation solutions in the Advanced Therapy Unit at Sartorius. He has authored several articles on the characterization of plastics and SU devices concerning extractable compounds and is a regular speaker at industry conferences, sharing his expertise and insights on material studies and advanced therapy solutions.
Alessio Mastrovito is a research scientist part of the Vantive E&L EU team. After his MSc in Industrial Chemistry at Bologna University, he worked as Analytical Chemist at a third-party lab conducting chemical testing on a wide range of medical devices, focusing on chemical characterization and ethylene oxide sterilization residuals analysis (according to ISO 10993 parts 7 and 18). He joined Vantive in 2021 as E&L SME, being key figure within a number of sustaining product and MDR remediation activities, acquiring experience on many products of the PD, HD and Acute portfolio.
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Sr. Principal Scientist in the Compendial Science Group-General Chapters. He works with 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 in 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.
Muneeba Khalid is a biochemical scientist with over 10 years of experience in cell biology, bioprocess engineering, microfluidics and single use systems. She holds a PhD completed at both the National University of Sciences and Technology, Pakistan and the Johns Hopkins University, USA. Muneeba’s scientific work and publications have had a significant impact on the scientific community, and she hopes to continue contributing to science while working at Regeneron. In her free time, she likes baking, hiking, gardening and interior designing.
With over 15 years' experience in analytical chemistry, Diane's current role includes responsibility for E&L testing of primary packaging and disposable process equipment, as well as material-related analytical troubleshooting. As an E&L subject matter expert, Diane is involved in risk assessments and the implementation of global E&L testing strategies for development and commercial projects. Prior to joining F. Hoffmann-La Roche, Diane obtained a PhD in Mass Spectrometry and held various positions in academic laboratories and pharmaceutical companies, always in the field of organic trace analysis by mass spectrometry.
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.
Rodrigo Feliciano is currently serving as a Senior Principal Scientist at Johnson & Johnson, based in Belgium. As an E&L SME, he specializes in implementing regulatory strategies for complex drug-device combination products.
With 20 years of experience in analytical chemistry—7 of which are dedicated to E&L and related regulatory frameworks—Rodrigo has developed a strong background in chromatography and mass spectrometry.
He holds a PharmD from the University of Lisbon, Portugal, which he earned in 2003, and he completed his PhD in Food Science at the University of Wisconsin-Madison. Following that, he had the opportunity to finish a postdoctoral fellowship at the University of Düsseldorf, Germany, where he focused on developing -SPE for non-targeted metabolomics using high-resolution mass spectrometry. Throughout his academic career, Rodrigo has authored 33 peer-reviewed articles.
Rodrigo has been an active member of the ELSIE community and has represented Belgium as a national member of the ISO/TC 194 WG for the past 6 years, concentrating primarily on ISO 10993-1,-12 and -18. Additionally, he is a Fulbright alumnus.
Dr. Alina Martirosyan is experienced in non-clinical evaluation of medical devices and pharmaceuticals, and is a Biocompatibility subject matter expert at B. Braun Melsungen AG (Germany). As part of the biological risk assessment of medical devices she is planning, coordinating and managing the biocompatibility studies, performs toxicological evaluation and risk assessment of chemical constituents, dealing with notified bodies and national agencies. She holds a PhD degree in Biochemistry, is a European Registered Toxicologist (ERT), Delegate of American Board of Toxicology (DABT), and is acting as an expert in ISO/TC 194 for the ‘Biological and clinical evaluation of medical devices’.
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.
Chris Waine is a toxicologist with 12 years of experience in human health hazard and risk assessment of chemicals. Along with his work on extractables and leachables, he specialises in the evaluation of pharmaceutical impurities, submissions under the EU REACH Regulation and the application of (Q)SAR models for toxicology. He is a member of the BSI and ISO Technical Committees relating to ISO 10993 on the biological evaluation of medical devices.
Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. Dr. Johnson has co-authored several peer-reviewed publications and book chapters describing the implementation of in silico approaches and methodologies for gaining confidence in in silico predictions. Her work expands into novel application of in silico approaches and supporting the advancement of alternative methods. She is particularly interested in the application of computational tools to support toxicological evaluations; for example, in the assessment of extractables and leachables.
Julia Martins has a strong academic and professional background in toxicological sciences, having earned a PhD in the field. Her expertise in analytical chemistry is supported by her master's degree, further strengthening her scientific foundation. Julia's extensive experience as a toxicologist in the pharmaceutical industry in Brazil has solidified her proficiency in toxicological assessments. Over the years, she has gained in-depth knowledge of regulatory guidelines and the evaluation of multiple toxicity endpoints within the context of toxicological risk assessments. Julia is currently a Scientist at Lhasa Limited where she contributes to the development of computational solutions for impurity assessment and read-across methodologies, including extractables and leachables (E&L) safety assessment.