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.

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. Lutz Mueller started his career with moving into genetic toxicology in 1981 when starting to work on his Diploma in biology. This means that he has accrued in the meantime about 40 years of experience in safety assessment of medicines. From 1989 on, he has been the head of the department of Mutagenesis and Carcinogenesis at the Federal Institute for Drugs and Medical Devices in Berlin, Germany. In 2000, he moved into industry to create a group of entrepreneurs working on “In silico Safety and Metabolism” at Novartis in Basel. While at Novartis, he began to realize the power of working with project leader responsibilities in Oncology. In late 2004, he moved to F. Hoffmann-La Roche into the role of a toxicology project leader and has ever increased his area of expertise in toxicology and safety assessment ever since. Small molecules, antisense modalities, biologics and vector-based gene therapy products for new medicines for human disease, he has worked on them all. He has also served as liason between safety assessment and research at Roche for neuroscience, ophthalmology and rare diseases establishing and tightening the close relationships between research and development in drug discovery. While he has contributed at Roche to move many molecules into man and further along the clinical development phase even into approval, the big reward came in Mid 2020 with the approval for the world’s first small molecule mRNA splice modifier, risdiplam. He has been a major driving force behind the fast R&D process on this medicine named Evrysdi to help patients with spinal muscular atrophy. Lutz Mueller is currently chairing the corporate Translational Safety Committee of Roche’s Pharma Research and Early Development function. His internal and external reputation is evidently documented with the title of “distinguished scientist” and supported by his contribution to more than 100 peer reviewed publications and book chapters. Moreover, he left his mark in the international contribution in the ICH guideline process since 1991, the inception of the ICH process. Still today, he is representing EFPIA on ICH M7, the “mutagenic impurities” guideline. He also earned his reputation being a frequent presenter at international conferences.

Rok Grahek received his BSc in chemistry and his PhD in science from the University of Ljubljana, Slovenia.

In 1986, Rok was employed in R&D in Lek Pharmaceuticals d.d. Slovenia.

As a researcher he started with GC and after a few years HPLC and MS became his main area of interest in connection with impurities in drugs. Trace analysis of impurities (genotoxic impurities, synthetic tracers, nitrosamines) with LC-MS and GC-MS is an important area of Rok’s research. For the past 25 years, Rok has been leading a group or researchers dealing mainly with impurity profiles, impurities isolation, identification, and trace analytics.

Rok is an author or co-author of nearly 40 patents and scientific papers and more than 50 scientific conference contributions.

Michelle Kenyon, MA, is a research fellow in the Toxicology Impurity Risk Management group at Pfizer. Michelle has over 30 years of experience in the pharmaceutical industry as a genetic toxicologist with a focus for more than 20 years on the risk assessment and management of impurities. She leads a toxicology team responsible for Pfizer’s in silico mutagenicity assessments and co-leads a cross functional team that establishes acceptable intakes for nitrosamines in the portfolio. Michelle also represents Drug Safety as the co-lead of a cross-discipline team at Pfizer that provides development and commercial teams advice on safety and quality aspects of impurity control. She has also developed expertise in extractable and leachable and contaminant risk. Michelle’s expertise is recognised externally where she has worked collaboratively in cross industry groups, including the International Consortium for Innovation and Quality (IQ) DruSafe Impurities workgroup and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Impurities Management Workgroup where she has respectively been co-leading and leading subgroups that have recently published manuscripts related to non-mutagenic impurity management. She is also a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3C Guideline for Residual Solvents expert work group. Michelle has authored more than 25 peer-reviewed manuscripts relating to various impurity topics.

Mark Harrison, PhD, is an associate principal scientist in trace analysis and external advocacy at AstraZeneca. Mark has over 30 years’ experience in the pharmaceutical and biochemical industries as an analytical chemist working within trace analysis and mass spectrometry specialisms. He currently co-chairs the IQ nitrosamine analytical advisory group. Mark has published over 20 papers relating to trace analysis, mutagenic impurities, and other impurity-related matters and has also been a speaker at many international conferences. He is actively involved in industry expert groups, including the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), having previously co-chaired the latter’s nitrite working group. Mark recently contributed to the book published by Andy Teasdale addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control’, (Wiley and Son).

Mayur Mitra is an American board-certified toxicologist and currently serves as a Distinguished Scientist - Toxicologist within Safety Assessment at Genentech Inc. As part of his role he serves as the Therapy Area Lead for Genentech’s Oncology portfolio and as a Cross-functional Drug Development Team Lead. Previously, Mayur was employed as a Toxicologist at Bristol-Myers Squibb. Mayur received a PhD in Toxicology from the University of Louisiana at Monroe and a postdoctoral fellowship at the Washington University School of Medicine in St. Louis. Mayur is well published and has authored 25+ peer reviewed articles and book chapters.

Dr. Marko Trampuž works as a scientist in the early development department in Sandoz Development Centre Slovenia, Lek Pharmaceuticals d.d. He obtained his MPharm degree in 2015 and PhD in chemical sciences in 2019 at the University of Ljubljana in Slovenia. His PhD research work focussed on particle engineering, polymorphism, and mathematical modelling of chemical processes, particularly crystallisation. After completing his PhD, he worked as a medicinal chemist at drug discovery and development platform in SciLifeLab in Stockholm, Sweden, specialising in drug discovery of novel drugs for psychiatric, autoimmune, and oncological disorders. Since joining Lek Pharmaceuticals d.d. in 2021, his main responsibilities have been the development of novel analytical approaches for N-nitrosamine impurities and complex APIs, utilising his skills in synthetic organic chemistry and various spectroscopic methods.

Dr. Carla Landolfi graduated in chemistry and pharmaceutical technology from Rome University. She has more than 20 years of experience in the toxicology field gained in the pharmaceutical industry, 10 of them as manager to the toxicology group. She's the main or co-author of several papers and posters, has published in peer-reviewed journals, and she's an invited speaker at international conferences as well as the founding editor of archives of clinical toxicology. In 2020, she founded the ToxHub, a consultancy company specialised in toxicological risk assessment and regulatory toxicology.

Dr. Paulo Eliandro da Silva Junior is a pharmacist-biochemist (USP) with a master's and PhD in medicinal chemistry, synthesis and drug discovery (FCFRP-USP, University of East Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). Paulo's experience in the pharmaceutical industry started in 2013 as a trainee at Novartis, Horsham, UK, in the global discovery chemistry department. After that Paulo worked mainly in regulatory affairs, quality audits, and drug product and drug substance development with focus on impurities control, including E&L, mutagenic impurities, such as nitrosamines, in his own consulting company, Integra Consultancy. Paulo also is a founder of another company, BIND, which is a startup for synthesis and characterisation of analytical standard for development processes, and teaches postgraduate courses that cover various pharmaceutical topics.

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.

George Johnson is an associate professor of genetic toxicology at Swansea University. He has expertise in the quantitative use of genetic toxicity data for hazard and risk assessment purposes and has an interest in high content and multiplex in-vitro test systems. He currently has active roles in the HESI-GTTC, IWGT 2022, COM and EEMGS-EXCOM, and carries out teaching, research, and consultancy at Swansea.