Dr. Elizabeth Martin is currently based in Cambridge, UK and is a Senior Director at AstraZeneca with the joint role of Project Toxicologist and Strategic Impurities Toxicology Lead. She is a European Registered Toxicologist. Dr. Martin gained her PhD at the University of Wales, before joining the Medical Research Council Toxicology Unit where she led a research group focused on assessing the consequences of DNA damage and their use in predicting carcinogenic risk. Dr. Martin joined AstraZeneca in 2001 and in her current role supports the portfolio with the safety assessment of impurities, including the risk assessment of Extractables & Leachables.

James Vergis, PhD, is a principal at the law firm of Faegre Drinker Biddle and Reath, LLP, and is a member of the firm’s life sciences consortium management team and government and regulatory affairs practice group. As one of the consulting professionals within the law firm, Jamie provides scientific and strategic consulting services to individual clients and various pharmaceutical and biotechnology consortia such as Allotrope Foundation, Enabling Technologies Consortium (ETC), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). As a scientist whose work has touched on various fields of study, Jamie is passionate about helping clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes.

Jamie has a BS in biochemistry with a minor in computer science from SUNY Geneseo and a PhD in molecular biophysics and biochemistry from Yale University.

Jessica Marques obtained a master's degree in biochemistry from the University of Aveiro, Portugal. She has been working at GSK Stevenage, United Kingdom, as part of the trace analysis, E&L team for over two years. Her work focusses on E&L risk assessments within biopharma and cell and gene therapy and trace level analysis to support control and assessment of mutagenic impurities.

As principal of scientific affairs for Europe, Ana Kuschel is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. She also bridges scientific information through industry outreach. This is complementing her previous role as manager for material development, where she worked with existing, and on the development of new, rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.

Dr. Roberto Menzel graduated from FSU Jena (Germany) and holds a PhD in chemistry. He started his career as an assistant editor in the natural science book section at Wiley followed by a position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech, where he is heading the internal analytical laboratory and extractables group. The main working areas are material and product qualification studies for single-use (SU) systems and components for the biopharmaceutical industry. He authored several articles on the characterisation of plastics and SU devices regarding extractable compounds.

Dr. Carla Landolfi has about 25 years of experience in toxicology field gained in the pharmaceutical industry, eight of them as manager to a toxicology group. She has solid knowledge in the development of safety programs for pharmaceuticals, cosmetics, food supplements, medical devices, biocides, and other consumer products.

Carla has broad experience with regulatory national and international guidelines and rules (ICH/EMA/FDA/GLP/ISO) and she has been the main or co-author of several papers and posters, published in peer-reviewed journals. She's also a professor at university masters as well as a founding editor of Archives of Clinical Toxicology.

Mike Ludlow is science lead for the analytical and materials science division within Drug Development Solutions (formerly LGC). He is an analytical chemist with over 25 years’ experience in chromatographic and spectroscopic techniques, specialising in the area of extractable and leachable testing and impurity characterisation.

In his current position, Mike provides technical support to operational and commercial colleagues and to an extensive client base, primarily focussed on the pharmaceutical and consumer healthcare sectors. He has presented at numerous international events on topics including extractables and leachables, genotoxic impurity analysis, and experimental design.

Mike is currently on the Register of Specialists for the UK Government Office of Product Safety and Standards (OPSS). He previously worked for ICI Chemicals and Polymers division where he was responsible for the NMR area providing support to the research function at Runcorn in the UK.

Mike holds a BSc Hons in applied chemistry, an MSc in analytical chemistry, and an MBA from Warwick Business School.

With over 30 years’ experience, Sandi Schaible is responsible for oversight and direction of WuXi AppTec’s analytical chemistry and regulatory toxicology departments in St Paul, Minnesota, USA. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterisation and target analysis testing, method development, and method validation, as well as completing risk assessments and biological evaluations.

Sandi received her bachelor's in chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental, and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA, and ISO regulated laboratories. She provides technical guidance and testing program design, and is an international and US delegate for TC 194, the technical committee for ISO 10993.

Dr. Jianwei Li is currently the principal E&L consultant and chemistry writer at Chemical Characterization Solutions LLC. He worked at Medtronic, a leading global medical device company, for nearly 16 years as a technical fellow and subject matter expert in chemical characterisation. He also worked in the pharmaceutical industry for eight years. Over the course of his nearly 23-year industry career, he has published extensively in the areas of analytical chemistry with nearly 50 publications and four patents and has frequently served as a scientific reviewer for over 10 international journals.

He received his PhD in analytical chemistry from Purdue University, USA, and did his postdoctoral research at the University of Minnesota, USA.

Nick Morley is a principal scientist at Element Materials Technology responsible for providing technical support to new and existing pharma, med device, and consumer products for customers in the field of extractables and leachables. He has over 15 years of experience in the field of E&L, both in large pharma and at a CRO. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments, and authoring E&L regulatory sections. Nick is the E&L expert on the British Standards Institute (BSI) and European Standards Committee (CEN) for electronic cigarettes and e-liquids. Nick has presented on a number of different E&L related topics internationally and has developed and run pre-conference workshops on E&L assessment at a number of international conferences.

Prior to joining Element Material Technology, Nick spent over 10 years at GSK in the field of E&L. During this time, he worked on a range of therapeutic areas including inhalation, topical, and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality, and regulatory approval. Whilst at GSK, Nick was a member on one of the ELSIE (Extractable and Leachables Safety Information Exchange) working groups.