Andrew Teasdale, PhD, is a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca’s impurity advisory group. Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published a book addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control,’ (Wiley and Son) and is soon to publish as editor a book focussed on practical implementation of ICH quality guidelines.

Tom van Wijk is a senior scientist with 20 years of experience in pharmaceutical analysis. He is working at Solvay Pharmaceuticals in early and late phase chemical and pharmaceutical development and currently supporting established marketed products at Abbott Healthcare Products in the analytical science and technology department. He specializes in small molecule impurity profiling, mass spectrometry, and method development for the active materials as well as the formulated products. One of his key interests is developing applications and strategies to control trace levels of potential mutagenic impurities in pharmaceutical products. He received his Ph.D. from the faculty of pharmaceutical sciences at the Utrecht University in November 2016.

Larry Wigman is an analytical chemist by training with his doctorate from Duke University under the direction of the late Charles Lochmuller. He has held various positions in pharmaceutical development including: senior re­search scientist at Pfizer, manager at Mylan, associate director at Sano, prin­cipal consultant at Regulitics LLC; and, most recently principal scientific man­ager of the small molecule analytical chemistry and quality control (SMACQC) Group at Genentech. Larry joined the relatively new SMACQC Group to lead the analytical develop of small molecule therapeutics. He was attracted by Genentech’s exceptionally strong discovery biology initiative and ability to translate these discoveries into drugs that make a difference.

Dr. Lutz Müller is a project leader in toxicology with F. Hoffmann-La Roche in Basel, Switzerland. The focus of his work is on projects in R&D in therapeutic areas such as nervous system, cardiovascular, inflammation, immunology, on­cology and rare diseases. These are spanning small molecules, peptides, anti­sense molecules and biologicals. In terms of scientific expertise, genotoxicity, impurities, carcinogenicity, immunotoxicity, in vitro systems, risk assessment, regulatory toxicology are his primary reference areas. Dr. Müller has been involved in the ICH guideline process since its inception in the early nineties of the last century. As disease therapeutic area liaison for NORD (Neuroscience, Rare Diseases, Ophthalmology) in pharma research and early development (Roche pRED), Dr. Lutz Müller supports the overall strategy of the company in developing new medicines in these areas. Scientific publication record: More than 100 original publications in peer reviewed journals and various book chapters. Organiser/lecturer of/on multiple international meetings and workshops.

Fenghe received his Ph.D. in physical chemistry from the Chinese Academy of Sciences and a B.S. degree in chemistry from Shandong University, China. He has been with Boehringer Ingelheim Pharmaceuticals Inc. for 16 years and currently is a senior research fellow in the department of material and ana­lytical sciences. His primary responsibility involves analytical development of small molecule entities which includes providing leadership in impurity eluci­dation and mutagenic impurity risk assessment and control. He is the current organiser of the GTI Advisory Council within the company. Prior to BI, Fenghe had several academic assignments including, mass spectrometry lab manager, department of chemistry, Northwestern University; associate professor, Na­tional Center of Biomedical Analysis of China.

Alexander Amberg performed his doctoral studies at the department of toxicology and pharmacology at the University of Wuerzburg (Germany) and obtained his PhD in biochemical toxicology in 2000. In 2001, he joined the early and exploratory safety group of Sanofi, and in this position has been responsible for in silico/computational toxicology analysis globally at Sanofi. Since 2007, he has been registered as a European registered toxicologist (ERT) after getting his examination of Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are development of new in silico prediction models for different toxicity endpoints and data management of in-house data in combination with publicly available toxicity data, to support drug development in research and development. For this he is also a member of different internal expert advisory groups as well as external initiatives, like the IMI eTOX consortium (for toxicity data sharing and development of new expert systems for in silico toxicity prediction), the IMI SafeSciMET education program and others. With respect to genotoxic impurities (GTIs), he was actively involved in the preparation of the white paper for the use of in silico systems in the scope of ICH M7 and other publications regarding GTIs. Internally, he is member of the task force to support the in-house implementation of ICH M7.

Raphael (Raphy) Nudelman is a chemical toxicologist with over 20 years of industry experience. He holds a PhD in organic chemistry from the Weizmann Institute of Science and completed postdoctoral research at the US Air Force Research Lab and Duke University Medical Center. At Teva Pharmaceutical Industries, Raphy held various roles, including in the medicinal chemistry department, the patent department, the non-clinical safety department, and as the Impurity Expert of the company. His expertise spans impurity and excipient qualification in drug substances and drug products, with a recent focus on risk assessment of nitrosamine impurities in pharmaceuticals. Raphy retired from Teva in September 2024 and founded Nudelman ChemTox Consulting, where he continues to provide consulting services in the pharmaceutical impurity qualification field.

Dr. Roustem Saiakhov first joined MultiCASE in 2000 as a computational scientist. He was quickly promoted to the positions of Vice President of Research and Development, Chief Operating Officer, and has served as the company’s President since 2012. Dr. Saiakhov is a Native of Russia. In 1991, he was awarded a Ph.D. through the Kazan State University, the third oldest university of the Russian Federation. There, he studied the quantitative structure-activity relationship of complex element organic compounds with advisors Professor Vladimir Galkin and Professor Rafael Cherkasov. In 1995, Dr. Saiakhov joined Professor Michalski’s group at the Polish Academy of Science as a postdoctoral chemist. He relocated to the United States in 1997, joining Dr. Gilles Klopman’s group at Case Western Reserve University as a postdoctoral scientist. With over 25 years of experience in teaching and research, his expertise includes cheminformatics, molecular modeling, QSAR, organic and computational chemistry, and computational toxicology. Dr. Saiakhov also performs expert review on behalf of MultiCASE through its risk assessment and safety consulting services. He has been the principal investigator on numerous grant projects and has over 120 scientific publications and presentations.

After studies in cell biology and genetics at the Free University of Brussels (1987), Jacques Van Gompel was appointed a position as research assistant within the department of experimental pathology at the University Hospital (AZ-VUB). There, he performed research on the morphology, genetics and immunology of diabetes mellitus type I. After that he joined the Janssen Research Foundation in 1992. Until February 2000, he was study director for the bacterial and mammalian gene mutation assays within the department of genetic and in vitro toxicology. Meanwhile, he also obtained his PhD at the Free University of Brussels on the topic of “Development, Evaluation and Implementation of Acute and Chronic in vitro Exposure Methods in Applied Genetic Toxicology”. From 1995-2000 he successfully completed two European community-funded projects in the area of hepatotoxicity and perfusion culture. From February 2000 until April 2001, he was responsible for the genetic toxicology profiling within the newly formed department of exploratory development. In May 2001, he became group leader within the ADME/TOX department of Johnson & Johnson Pharmaceutical Research & Development. Next to the functional responsibility for the genotoxicity screening activities he is ADME/TOX representative for discovery projects in the areas of CNS, oncology and HIV from hit-to-lead until delivery into the preclinical development organisation. In June 2005, he became head of the department of genetic and in vitro toxicology within the global preclinical development organisation. Furthermore, the department has end-to-end responsibilities within Janssen Pharmaceutica from hit-to-lead until brand support. for high throughput genotoxicity screening and genotoxic impurities, cleaning validation, PbOEL and others. Currently the department of genetic toxicology is embedded in the mechanistic and investigative toxicology department. Jacques is a member of the global impurity steering team and the genotox review committee at Janssen/J&J.

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience En­gineering at the University of Leuven (Belgium) in 2012. She started at Toxikon Europe in 2013 as study director at the Extractables & Leach­ables Department, focusing on Injectables and Parenterals and in 2014 she became responsible for the chemical characterization testing for the medical device industry. Today, she is Department Head Pharma Services at Toxikon Europe.

Catrin Hasselgren has a background in the pharmaceutical industry, having spent 12 years at AstraZeneca working in computational toxicology with her last position being associate director of computational ADME and safety. After a short stop at the University of New Mexico followed by founding her own consultancy company, she is now also senior principal scientist at Leadscope.

Dr. David Snodin has a B.S. in chemistry at Imperial College, London; a Ph.D. from Bristol University in organic chemistry. He has subsequent M.Sc. quali­fications in chemical analysis, toxicology (University of Surrey) and applied statistics. His career spans over 35 years in regulatory toxicology including: food industry, MHRA (Expert Preclinical Assessor and UK representative on the CHMP Safety Working Party); vice president – nonclinical at PAREXEL International Drug Development Consulting; independent consultant since 2010, specialising in general nonclinical consulting with a particular interest in impurity qualification. His recent publications are focused on regulatory risk assessments.

Patrick Reichl is currently member of the group, Toxicological Risk Assessment at Shire. Patrick holds a Master’s degree in Genetics and Toxicology. In his Ph.D. thesis, he investigated novel therapeutic targets in hepatocellular carci­noma. Patrick joined Baxalta (now part of Shire) in 2015 and currently works as Sr. professional. His areas of expertise include in silico toxicology as well as safety assessments related to oncology products, genotoxic and elemental impurities as well as environmental risk assessments.