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).

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.

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.

Kausik Nanda has more than 23 years of experience in the pharmaceutical industry. In his early career as a medicinal chemist, Kausik worked on discovery programs in the neuroscience, cardiovascular, and infectious disease areas, where his team successfully developed lead identification, lead optimisation, and pre-clinical candidates. In his later career, Kausik’s work focussed on solving a multitude of problems in the development area, arising from chemical interaction in the drug product. Primarily, Kausik’s work focusses on drug degradation, mutagenic impurities, nitrosamine risk assessment and novel formulations inhibiting nitrosamine formation. The range of activities encompasses early development through commercial launch.

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.

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.

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.

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.

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.

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.

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. 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.

Aloka Srinivasan, PhD, the principal and managing partner of RAAHA LLC (www.raahallc.com) has more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the US FDA in the office of generic drugs, Lupin Pharmaceuticals, Lachman Consultants, and Parexel International.

Prior to starting her own consulting, Aloka was the VP and head of regulatory at Lachman, VP of regulatory at Lupin, and principal at Parexel. Aloka spent more than nine years in the FDA’s office of generic drugs as a reviewer and team leader and spearheaded the establishment of a division for review of APIs in Type II DMFs. Aloka was also part of the team that initiated the question-based review (QbR– QOS) for generic drugs in CDER.

Aloka is one of the world-class experts on nitrosamine based on her research background and has been supporting the industry in addressing these carcinogenic impurities in the drugs.

She received her PhD from the University of Missouri, Columbia, under Dr. Richard N. Loeppky of nitrosamine fame. Her thesis was titled, “Putative Intermediates in Activation of Beta Hydroxy Nitrosamines”. Aloka also spent seven years as a scientist at National Cancer Institute, working for Dr. Larry K. Keefer, researching on nitrosamines in potential nitric oxide donor drugs.

Gabriela Silveira has strong academic and professional background in toxicological sciences, holding both master’s and PhD degrees in that same area. Relying on that background, Gabriela pursued a productive career as an independent consultant and as a toxicologist in the pharmaceutical industry in Brazil. Since then, Gabriela has become thoroughly familiar with regulatory guidelines, and to the evaluation of multiple toxicity endpoints in the context of toxicological risk assessments. Gabriela leads the complex nitrosamines data sharing initiative at Lhasa Limited and integrates the Kaptis for carcinogenicity and read-across teams at Lhasa.

Dr. Yuriy Svartsov, originally from Ukraine, holds a PhD in Physical Chemistry from the Institute of Physical Chemistry and Spectroscopy of the Polish Academy of Sciences in Warsaw, Poland. After holding two academic post-doc positions in Germany (at Heinrich-Heine-Universität Düsseldorf) and Austria (at Johannes Kepler Universität Linz), he transitioned to the pharmaceutical industry, focusing on quality control of solid drug forms, and later, sales of products and services for the pharmaceutical sector. In 2023, he joined Intertek as a Global Business Development Manager.