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).
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James M. Vergis, Ph.D. is a Principal with Faegre Drinker Biddle & Reath LLP and a member of the firm’s Consortium Management Team. He provides scientific, strategic, and operational leadership to a range of pharmaceutical, biotechnology, and nonprofit collaborations, including the Extractables and Leachables Safety Information Exchange (ELSIE), Allotrope Foundation, Enabling Technologies Consortium (ETC), and the IQ Consortium. In this role, he works with industry leaders to advance precompetitive research, develop data-sharing initiatives, establish governance frameworks, and drive adoption of emerging technologies that support scientific innovation. Dr. Vergis has extensive experience building collaborative programs that bring together industry, academia, regulators, and technology providers to address complex challenges in drug development and product quality. He holds a B.S. in Biochemistry with a minor in Computer Science from SUNY Geneseo and a Ph.D. in Molecular Biophysics and Biochemistry from Yale University.
Minh Khoa Ta holds a strong academic background in computational chemistry, with published research focusing on molecular modelling and data driven approaches to chemical systems. Currently, he is working in the Extractables & Leachables (E&L) group at Resolian, UK. Minh Khoa remains strongly interested in applying computational and in silico methods to solve practical challenges in industry. His aim is to bridge fundamental computational chemistry with real world E&L and materials related problems, contributing to more efficient and predictive risk assessment strategies.
Dr Nazli Ozdemir is Founder and Director of Gulsine Ltd, a London-based computational materials and digital analytics company specialising in materials ageing, degradation prediction, and regulatory validation. She leads development of the A2P2-AI platform for predictive polymer degradation modelling and is a UK partner in the Innovate UK Eureka REFLOW project on polymer recycling and lifecycle assessment.
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.
Betsy is a senior principal scientist in Pfizer Research & Development providing expertise and leadership to Pfizer’s Global Extractable & Leachable Network. Betsy supports E&L studies, conducts risk assessments, as well as implements E&L control, characterization, and regulatory strategies. Additionally, she collaborates with manufacturing, packaging and device, toxicology for development of biotherapeutics and vaccines to ensure product quality and patient safety.
Dr Aidan Sexton is a Senior Principal Scientist in Material Sciences at Biotherapeutics Development & Supply (BTDS), Janssen. His expertise is focused on the application and innovation of polymeric single use systems in pharmaceutical production. Prior to this, he worked in various roles in Manufacturing Science and Technologies, Validation, Engineering and Quality Assurance for a variety of pharmaceutical manufacturers (large and small). His experience over 24 years in the industry includes small volume parenteral fill finish, API manufacture and biopharmaceutical manufacturing.
He is an active participant in various industry groups with respect to the use of polymeric SUSs (BioPhroum) and lectures at master’s degree level in University College Cork (MEngSc Pharmaceutical and Biopharmaceutical Engineering).
Prior to this Aidan performed research in heterogeneous catalysts concentrating on the valorification of natural gas and membrane catalysis.
Maximilian Bossong is a Material Specialist at Sartorius, where he leads material qualification and technology transfer activities focused on the compatibility of raw materials and packaging components for cell culture reagents. He has expertise in extractables and leachables (E&L), analytical chemistry, and material risk assessment. During his PhD research, he investigated the fate and distribution of leachables in biologics manufacturing using experimental studies, advanced analytics, and predictive modelling, contributing to improved understanding of material-related risks and mitigation strategies.
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’.
Rick has 20+ years of experience working in the pharmaceutical industry, from large pharmaceutical and consumer health companies such as GSK and Haleon to small scale startups. Rick’s internationally recognised scientific expertise and personal contacts in the extractables and leachables field is the driving force behind Extractus Ltd. Having built GSK’s (and later Haleon’s) extractables and leachables team from the ground up, Rick has a deep understanding of our clients’ requirements, from both scientific and regulatory standpoints. Having been the shepherd guiding internal GSK and Haleon product owners through the extractables and leachables process, including choosing the most suitable contractors to carry out the work, Rick is well versed within the E&L world, and garners great respect and confidence from our clients and other leaders in the field.
Julia Vincenz is an MSAT Specialist at VTU Engineering, where she has worked since September 2018. She holds an MSc in Biopharmaceutical Quality Management and brings over 10 years of GMP experience, with expertise in process and cleaning validation. For more than six years, Julia has specialized in extractables and leachables (E&L) topics, supporting the development and compliance of pharmaceutical manufacturing processes.
: 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 Diane 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, Diane get a PhD in mass spectrometry and held various positions in Academic labs or Pharmaceutical companies in the field of organic trace analysis by mass spectrometry.
Susanne Becker did her Ph.D. at the University of Konstanz in Analytical Chemistry. After seven years’ experience in the pharmaceutical industry at Aeropharm and Baxter, she joined Intertek (Schweiz) AG in April 2016, where she is working as Project leader in E&L and since 2021 as Head of Extractables and Leachables Labs.
Nina Macho graduated in nutritional sciences at the University of Vienna, and in toxicology at the Medical University of Vienna. After investigating dietary factors which protect against DNA damage at the Cancer Research Institute of Vienna, she worked in the field of ecotoxicology at the Austrian Institute of Technology. In 2013 she joined the Department of Pharmacology and Toxicology at Octapharma, where she is responsible for toxicological risk assessment of impurities in biopharmaceutical products. Since 2023, Nina is board member of the ELSIE Consortium and participating in several toxicological working groups.
Tine Hardeman studied Polymer Chemistry at the University of Leuven and received her MSc in 2013. She acquired a PhD for her dissertation on the controlled synthesis of conjugated polymers in 2017.
After gaining further R&D experience at Kaneka Belgium, Tine started her career at Datwyler in 2018 as Manager Material Development. In this role, she is working on the development of new rubber formulations, raw material management, and helping customers with rubber compound-related questions, among other things. Additionally, she has been focusing on the field of Extractables & Leachables.
Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics.
From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects.
Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.
