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.

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.

Dr. Frank Liu has close to 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. Currently, he leads the pharmaceutical risk assessment and safety evaluation team responsible for the patient, environmental and occupational safety at Takeda. One of his major focusses and capabilities is to perform safety assessments 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).

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.

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.

Jon Bardsley has over a decade of experience in small-molecule pharmaceutical DMPK and regulated bioanalytical studies within large Pharmaceutical environments. His passion for the development of robust and accurate analytical methods for high-throughput studies has seen him also gain experience in contract research organizations. Jon sits on the Reid BioAnalytical committee of the Chromatography Society and is a subject matter expert in the bioanalysis community. Following a period as Senior Applications Specialist for Chromatography, Jon now holds the position of Vertical Marketing Specialist for Pharma & BioPharma within Thermo Fisher Scientific, with a view to bringing relevant technologies together to help solve customer challenges.

Nathan Anderson is a Senior Business Development Manager at Waters Corporation, focusing on the pharmaceutical market. Prior to Waters, Nathan consulted on commercialization feasibility and strategy projects, recommended external partnerships, identified strategic capability gaps, and standardized technology assessment processes for various organizations in the biopharmaceutical space. He was also a project manager for a pre-clinical oncology drug development CRO, as well as a research technician at Georgetown University and Johns Hopkins University. Nathan holds an M.B.A from Boston University's Questrom School of Business (Boston, MA) and an M.S. in Biology from American University (Washington, DC). 

Dr. Tino Otte is the Head of Sales and Consulting at Intertek in Switzerland. He joined the company in 2016. Tino is specialized in Extractables & Leachables Studies, Impurity Characterization, and Method Development. Tino has more than 13 years of experience in Analytical Chemistry, Pharmaceuticals, and Polymer Characterization. He holds a degree in Polymer-Chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. Prior to joining Intertek, he worked at different CROs and Laboratory Instrument Manufacturers in Switzerland and Germany.

Technical specialist with substantial experience of the pharma sector. Within the last 5 years, my main emphasis has been on small molecule analysis, specializing in high-performance liquid chromatography (HPLC) and high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS).