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.

Trish Parris 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, E&L, and contamination risk assessments. In recent years, Trish participated in the ICH M7 working group to develop appendix 3 and co-authored the 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.

James Vergis, PhD, is a director of science, research, and innovation 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.

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.

Markus Obkircher is director of R&D, heading Merck’s reference materials and proficiency testing division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials under ISO/IEC 17025 and ISO 17034 double accreditation. Prior to this position he was R&D manager in Buchs, Switzerland, with a strong focus on synthesis, characterisation, and certification of reference materials. He joined Merck/Sigma-Aldrich eight years ago after heading the development unit for a custom API manufacturer. He completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, and further holds an executive MBA degree from the University of Zurich.

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 in the areas of E&L evaluation, chemical characterisation, biocompatibility, and compatibility of drug-device combination products. He worked at Medtronic for nearly 16 years as a chemistry subject matter expert and technical fellow. In this role at Medtronic, he worked with a team of analytical chemistry, toxicology, and biology professionals whose primary responsibility includes the application of diverse analytical strategies and methods for the discovery, identification, and quantification of trace constituents in drug-device combination products and medical devices. Foremost among these activities was the initiation and establishment of one of the best analytical laboratories to perform the drug product E&L analysis and medical device chemical characterisation. He also worked for 3M for eight years in its pharmaceutical business. Over the course of his nearly 23-year industry career, he has published extensively in the areas of analytical chemistry with nearly 45 publications and served as frequent scientific reviewers 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.