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. Susanne Glowienke graduated from the University of Stuttgart-Hohenheim, Germany, in food chemistry/technology. She then undertook research in the area of analytical chemistry and obtained her PhD degree from the faculty of food technology (cereal chemistry) in 1997 at the same university. In 2000, she joined Novartis in Basel, Switzerland, as a postdoc in the area of Q(SAR) for toxicological endpoints. Susanne was working as a lab head for bacterial mutagenesis in genetic toxicology, preclinical safety and is responsible for the QSAR predictions and impurity/excipient assessments at Novartis. 

Currently, Susanne is a director in preclinical safety at Novartis, Basel, Switzerland. She held several positions at Novartis, including positions in genetic toxicology and QSAR modelling. She is currently head of the impurity safety group and as such responsible for contaminant issues including nitrosamines. Susanne is part of and has led a number of industry expert groups within DruSafe IQ (US), European Federation of Pharmaceutical Industries and Associations (EFPIA), the Extractables and Leachables Safety Information Exchange (ELSIE), and several data sharing initiatives.

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.

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to chemistry manufacturing and control (CMC) project manager. During his GSK career, Mike has led the primary development/delivery of 10 products, spanning early through to late phase development. Mike’s current roles are co-chair of the Impurities Oversight Panel, where he is a GSK mutagenic impurity risk assessment subject matter expert and Scientific Director as well as the GSK Drug Substance nitrosamine risk assessment lead for small molecules.  Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium and presents externally on best practice for mutagenic impurity control strategies for pharmaceutical products.

Philippe André is a Belgian pharmacist and GMP auditor. He is the director of Qualandre, an auditing company in Hangzhou, China. He lectured in pharmacology at the University of Tianjin between 2006-11. He has since performed about 400 audits of pharmaceutical manufacturers in China, India, and other countries. 

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.

Dr. Frank Liu has more than 10 years’ experience in chemical risk assessment and safety evaluation, many years of solid research experience, significant publication and paper review experience, and successful NIH grant application record in DNA and telomere damage and repair and general toxicology. After his master’s and PhD education in environmental toxicology and two postdoctoral trainings in pharmaceutical sciences and human toxicology, Frank moved to the product safety assessment area in the personal care and pharmaceutical product industries. One of his major responsibilities while working in the pharmaceutical industry is to perform safety assessment of impurities such as extractables, leachables, intermediates, catalysts, particulate matters, and of genotoxic, elemental and solvent impurities using classic and alternative approaches (e.g., read-across, in silico, QSAR, and TTC). Currently, he leads a team responsible for safety assessment of personal care products.

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.

Manuela Pavan provides toxicology consulting services to the industry for the evaluation of human health endpoints, including the genotoxic and carcinogenic potential assessment of pharmaceutical impurities. Her main interest lies in the use of in silico approaches (read-across, QSAR, alerts, grouping, categories) that the industry uses in compliance with regulations such as ICH M7, REACH, CLP guidelines, biocides, and cosmetics guidelines; she is then committed to combining information and data coming from different sources in an efficient and informed way. Her experience thus includes topics such as weight of evidence, integrated testing strategy, chemical safety assessment. She was working for the former European Chemicals Bureau (ECB) at JRC of the European Commission from 2004 to 2008, where she was actively involved in developing technical guidance documents for REACH.

Nadim Mira graduated in 2013 from the University of Orleans, France, with a master’s degree in biochemistry, molecular biology, and biotechnology. He then joined the department of fundamental microbiology at the University of Lausanne, Switzerland, as a PhD student in an SNF-funded research project. After two years, he decided to pursue a corporate career instead of working in academic research. In 2018, he completed a second master’s degree in sales and marketing in the life science industry at the University of Grenoble Alpes, France, before joining Andrew Alliance as an inside sales representative. In 2019, he moved to a new role in the marketing team, serving as a product marketing analyst responsible for protocol publication and labware integration in the OneLab cloud-based software.

Dr. Marc Audebert is a research director at INRA (France). He studies the relation­ship between the biotransformation of xenobiotics and their genotoxicity. He has developed a novel genotoxic assay based on the quantification of histones H2AX/ H3 phosphorylation, with simultaneous examination of the cytotoxicity and geno­toxicity of xenobiotics on human cells. Using this assay, he successfully evaluated the genotoxic potential of several groups of food contaminants (including pesti­cides, polycyclic aromatic hydrocarbons, heterocyclic aromatic amines, mycotoxins, bisphenol, heavy metals, etc.), including at low concentrations, using single com­pounds as well as mixtures. Marc also investigates the genotoxic mode of action of food contaminants (DNA adducts, aneugens, oxidative stress). He has coordinated or participated to several projects contributing to establishing the scientific basis for predicting and assessing the genotoxic effects of multi-component mixtures.