Dr. Matthias Herzler has more than 15 years of practical experience in the risk assessment of pesticides, biocides, and industrial chemicals under EU legislation and is currently working as senior scientist in the Chemicals Safety unit of the Department of Chemical and Product Safety at the Berlin-based German Federal Institute for Risk Assessment (BfR). Beside performing toxicological assessments under REACH and CLP, his scientific interests in the field of regulatory toxicology include – but are not limited to – in silico and other non-animal „new approach methodologies“ (NAM), Integrated Approaches/Defined Approaches to Testing and Assessment (IATA/DA), and uncertainty in risk assessment. Since the beginning of his work at the BfR in 2002, Dr. Herzler has been an active member of diverse EU, OECD, UN, and WHO working groups, inter alia the OECD (Q)SAR Toolbox Management Group, the drafting groups for the WHO/IPCS Guidance on Evaluating and Expressing Uncertainty in Hazard Characterization and the OECD Guidance Document on an IATA for Skin Corrosion/Irritation (both released in 2014), and several ECHA Partner Expert Groups for updating the REACH and CLP guidance. He was one of the EU Member State experts involved in preparing ECHA’s Read Across Assessment Framework (RAAF) and was part of the Scientific Committee which in 2016 helped prepare and oversaw ECHA’s Topical Scientific Workshop – New Approach Methodologies in Regulatory Science. Dr. Herzler studied chemistry at the Technical University Berlin, obtained his PhD in analytical chemistry at the Institute of Forensic Medicine of the Charité/Humboldt University Berlin (on the subject of General Unknown Toxicological Analysis), and holds a post-graduate degree in toxicology from the University of Leipzig. He is a member of the German Society of Toxicology (GT/DGPT).
Andrea Terron, graduate in Veterinary Medicine, Diplôme Universitaire de Pathologie Anatomique, Toxicologique et Experimentelle, Diplomate Royal College of Pathologists, Fellow of the Royal College of Pathologists. Expertise in toxicologic pathology and toxicology, pre-clinical drug development and pesticide risk assessment. Senior Scientific Officer, toxicologist, at EFSA, Pesticides Unit, since 2013. Former professional activities: Director of Pathology at Pharmacia, Director of Toxicology at GSK, Director of Pre-clinical Safety Project at GSK.
Dr. Bodo Haas is Pharmacology and Toxicology Assessor and, since 2010, leader of a research group at the German Federal Institute for Drugs and Medical Devices (BfArM) in Bonn. As Non-clinical Assessor he has vast regulatory experience in toxicological risk assessment of new pharmaceutical entities. His current research focusses on the role of intracellular signaling cascades involved in drug resistance development. He has over 15 years of experience in pharmacological and toxicological research and a track record of peer-reviewed publications, presentations and contributions to textbooks. He also is lecturer at the University of Applied Sciences, Cologne (TH Köln) for pharmacokinetics and pharma management. Dr. Haas was trained as pharmacist at the University of Heidelberg and has a PhD in molecular pharmacology from the University of Munich. Following his doctoral studies, Dr. Haas performed postdoctoral research in molecular pharmacology and toxicology at the University of Bonn. He is a EUROTOX registered toxicologist.
Dr. Derek J Knight, who is British, has worked at the European Chemicals Agency (ECHA) since September 2008. He is a Senior Scientific Officer in the Directorate of Evaluation, focussing on environmental assessment of dossiers. Until March 2017, he was ECHA’s Senior Scientific Advisor. Previously he headed a team of regulatory affairs professionals at a UK contract research organisation for almost 18 years, covering a wide range of regulatory schemes worldwide. He has also registered medicinal products and worked as a Technical Support Chemist. He has a broad understanding of the regulation of chemicals and is especially interested in approaches to hazard and risk assessment using non-standard data. He is also member of the Scientific Advisory Board of EU-ToxRisk. He is a Fellow of the Royal Society of Chemistry and Chartered Chemist, a Chartered Scientist and a Fellow of the Organisation of Professionals in Regulatory Affairs. His doctoral studies at the University of Oxford in the UK were in organosulphur chemistry.
Elke Röhrdanz works as preclinical assessor at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany. Elke Röhrdanz holds a PhD and a State Doctorate in Toxicology. Her current position at the BfArM is head of the unit Genetic and Reproductive Toxicology. She has broad experience in pharmacological and toxicological assessment of drugs (over 17 years). She gives lectures in the field of pharmacology, toxicology and drug safety assessment at different universities. Elke Röhrdanz is a member of the German Society of Toxicology, the Scientific Advisory Committee of the SET foundation (alternatives to animal testing) and is a permanent guest of the Permanent Senate Commission on Food Safety in Germany.
Emiel Rorije has been working as senior Risk Assessor Toxicology for the Dutch National Institute of Public Health and Environment (RIVM) since 2005. He graduated in (theoretical) chemistry (1992) and has been working on (toxicological) QSAR evaluation and development his whole career; in academia (University of Utrecht), government (RIVM), as well as industry (BASF). At BASF, prediction of metabolism and (bio)degradation were his working area, whereas currently he focuses on human toxicological structure-activity models and alternatives for in-vivo animal testing in general. Recent projects involved: development of a priority scoring function for PBT and Long Range Transport potential; retrospective evaluation of the Multi-Generation Reproductive Toxicity Testing Protocol supporting the introduction of the Extended One-Generation Reproductive Toxicity study (EOGRTs); EU FP6 project “OSIRIS” (2008-2011) focusing on Integrated Testing Strategies / Weight of Evidence for Skin Sensitization and Reproductive toxicity; OECD IATAs (Integrated Approach to Testing and Assessment) and Guidance Document for Skin Irritation and Corrosion, the OECD Adverse Outcome Pathway (AOP) document and the OECD IATAs for Skin Sensitization, EU FP8 project “EuroMix” (2015-2019) on the implementation of practical methodologies for the risk assessment of mixture toxicity.
Dr. Janine Ezendam has a MSc in Toxicology and obtained here PhD in immunotoxicology at the Institute for Risk Assessment Sciences of the University of Utrecht, The Netherlands. Since 2004, she is working as an immunotoxicologist at the National Institute for Public Health and the Environment (RIVM) in the Netherlands. She is involved in research and policy advice in the area immunomodulation by chemicals and food in the context of human safety. Recent years she focused mainly on predictive test methods for hazard characterization of skin and respiratory sensitizers, including non-animal testing strategies. She is a member of the Scientific Committee for Consumer Safety (SCCS), where she is involved in the safety assessment of cosmetic ingredients for the European Commission. Due to the ban on animal testing in the EU, the SCCS is closely monitoring the development of non-animal test methods and is evaluating their applicability for the purpose of safety assessment. She is involved in several expert groups of the OECD within their Environment, Health and Safety Programme; including the Expert Group on skin sensitization test methods and the Expert Group on defined approaches for skin sensitisation assessment.
George Kass was trained as a biochemist. He received his PhD in biochemical toxicology from the Karolinska Institute in Stockholm in 1990. After a post-doc at the Swiss Federal Institute of Technology in Zurich, he returned to the Karolinska Institute as Assistant Professor. In 1994, he moved to the University of Surrey in the UK as Lecturer (Associate Professor) in Molecular Toxicology and was subsequently nominated Full Professor of Toxicology. He moved to the European Food Safety Authority (EFSA) in Parma in 2009. George Kass was awarded a DSc from the Karolinska Institute and the University of Turku in Finland and he has held visiting posts with the University of Surrey, Newcastle University, the University of Turku and the University of Rome. He has published over 100 papers and abstracts in the field of Toxicology. A substantial part of his research has focused on the molecular mechanisms of drug toxicity and on liver injury. He has been an invited speaker at many national and international conferences and currently is Associate Editor of the journal Toxicology and Applied Pharmacology and member of the editorial board of Chemico-Biological Interactions.
Dr. Van der Laan was heading the Section Pharmacology and Toxicology Assessment at the National Institute for Public Health and the Environment (RIVM, Bilthoven) from 1990-2007. In this function, he was responsible for the advice on non-clinical safety aspects for the Netherlands ‘College’, the Medicines Evaluation Board (MED). He was from 2002-2010 project leader of the Teratology Information Service at the Institute. He moved in 2012 to the Medicines Evaluation Board located in Utrecht, but his role as Senior Assessor on pharmacology and toxicology has not been changed. On behalf of this Board, he is a member of the Safety Working Party (SWP) of the CHMP, which he has chaired since October 2012. His contributions to the International Conference on Harmonization started in early 1992 when he became a member of the Expert Working Group on Carcinogenicity Testing. He later became EU rapporteur for another topic in the Safety area (i.e. Immunotoxicology). In 2011, he finished as the EU rapporteur on the Addendum for the Preclinical testing of Biotechnology-derived Proteins (ICH S6). In 2012, he again became involved in the Carcinogenicity project. In addition, he is Regulatory Chair in S11, regarding the potential need of safety studies for development of pediatric medicines. In 2011, a HESI project was granted with regard to Adjuvanted vaccines and the association with Autoimmunity, of which Dr. van der Laan was the project leader together with Dr. Sarah Gould. Other grants were received for cooperation with the RIVM on the building of a database on rat and rabbit embryofetal toxicity studies, and with the Wageningen University on rat and mouse carcinogenicity studies in relation to chronic toxicity data and pharmacology. These projects were both successful as reflected by the scientific papers that came out of both.
Joop de Knecht joined the Dutch National Institute of Public Health and the Environment (RIVM) in 1997 where he became an expert in the area of (eco)toxicology and risk assessment, and chemicals legislation. He got involved in the preparation and peer-review of risk assessment reports of various type of chemicals, and in projects dealing with the development of tools for risk assessment. He has been member of expert groups of several international organisations (e.g. European Food Safety Authority and European Medicines Agency). Between 2012 and 2016, he joined the OECD where he was in charge of the OECD Chemicals Hazard Programme and the OECD Project on (Quantitative) Structure Activity Relationships. At present he is senior policy advisor at the Dutch Bureau REACH (part of RIVM) and alternate member of the ECHA Member State Committee, participating in several REACH processes, such as evaluation and authorisation.
Leon van Aerts obtained his Ph.D. in toxicology in 1995 with research on neural tube defects using rat whole embryo culture. He is a EUROTOX registered toxicologist since 1997. In 1999, he joined the Section Pharmacology and Toxicology Assessment at the National Institute for Public Health and the Environment (RIVM). In 2012, this group moved to Utrecht where it is now part of the Department of Pharmacology, Pharmacokinetics and Toxicology at the Medicines Evaluation Board (MEB, Utrecht). In this function as Senior Assessor, he is responsible for the advice on non-clinical safety aspects of human medicines for this board. On behalf of this board, he is a member of the Safety Working Party (SWP) of the CHMP, and former member of the Biosimilar Medicinal Products Working Party. He is a founding member (2010) of the section Pharmaceutical Toxicology of the Dutch Society for Toxicology (chairing the section board from 2014 to 2019). He has also been contributing to the risk assessment of New Psychoactive Substances for over two decades, currently as member of the Dutch Committee for Risk Assessment of New Drugs, and as invited expert in the risk assessment meetings of the Extended Scientific Committee of the European Centre for Drugs and Drug Addiction in Lisbon.
Drs. Lidka Maślankiewicz is a Toxicologist, Risk Assessor of industrial chemicals, and Scientific Researcher working at the Dutch National Institute for Public Health and the Environment (RIVM), the Netherlands. In 1995, she joined the Risk Assessment of New Chemical Substances department and participated in the OECD High Production Volume Chemicals project (SIAM), where she built her experience with QSARs, read-across, and chemical categories. Later she became the OECD HPV Manager. Currently, she is managing the OECD IATA Chemical Categories Case Studies Project (implementation of the classical read-across and new methodologies in hazard assessment). In addition, she is an expert working for the OECD Working Party Hazard Assessment. Since 2008, she has been responsible for a variety of tasks under the EU REACH regulation (substance evaluations, prioritization and screening). She has experience using several in silico (Q)SAR models (DEREK, EpiSuite, Meteor), and has started to gain more experience using AOP and IATA. She is (co)-author on mostly confidential reports on hazard and risk assessment of industrial chemicals. Drs. Maślankiewicz graduated from the Medical Academy in Warszawa, Poland, Pharmacy Department, and completed her Masters of Science in Toxicology and Ecotoxicology.
Dr. Magda Sachana is Policy Analyst within the Health and Safety Division of the OECD’s Environmental Directorate. She manages the development and implementation of policies in the field of chemical safety and contributes to pesticide, test guidelines and hazard assessment programmes. Dr. Sachana has significant experience in developing and assessing adverse outcome pathways (AOPs) from her previous work in the Institute of Health and Consumer Protection, JRC, and from her current employment, as she is in charge of the external reviewing of AOPs that feature in the OECD’s AOP workplan. She also served as a member of the working group for the adoption of an evolved and improved weight of evidence approach for the AOP framework. She has over 10 years of experience in academic research and scientific project management, having served as a Lecturer at the University of Liverpool in the United Kingdom and as an Assistant Professor at the Aristotle University of Thessaloniki in Greece. She has over 20 years of experience in in vitro toxicity research and a track record of peer-reviewed publications, presentations and contributions to textbooks on the subjects of adult and developmental neurotoxicity. She has an interest in the integration of science along multiple lines of evidence (epidemiology, in vivo & in vitro experimental toxicology) and development of Integrated Approaches to Testing and Assessment (IATA). Dr. Sachana is a trained veterinarian with an M.Sc. in Biotechnology from Nottingham Trent University in the United Kingdom and a Ph.D. in toxicology from the Aristotle University of Thessaloniki in Greece.
Dr. Judson is with the EPA National Center for Computational Toxicology where he is developing computer models and databases to help predict toxicological effects of environmental chemicals. As part of the EPA ToxCast team, one current major focus is on the development of models of chemicals interacting with the endocrine system. His team has developed numerous databases and web-based dashboards. He has published in areas including computational biology and chemistry, bioinformatics, genomics, human genetics, toxicology and applied mathematics. Dr. Judson has a BA in Chemistry and Chemical Physics from Rice University and an MA and PhD in Chemistry from Princeton University.
Suzanne Fitzpatrick, PhD, DABT, ERT is the Senior Science Advisor for Toxicology in the US Food and Drug Administration Center for Food Safety and Applied Nutrition. A board-certified toxicologist in the United States and in Europe, Dr. Fitzpatrick is the FDA lead for the federal collaboration among FDA, EPA, NCATS, and NIH, Toxicology Testing in the 21st Century (Tox 21), which looks to develop alternatives to animal testing, as well as chair of the FDA Predictive Toxicology Roadmap Committee. Dr. Fitzpatrick played a pivotal role in helping launch the organs-on-a-chip tool, a revolutionary testing technology being evaluated by FDA. Dr. Fitzpatrick is the FDA lead to the Interagency Coordinating Committee on Alternative Test methods (ICCVAM) and the chair of the ICCVAM Developmental and Reproductive Testing Work Group. She is also an Adjunct Professor at Johns Hopkins University, the FDA representative to the Johns Hopkins Center for Alternatives to Animal Testing Board, and past president of the American College of Toxicology and of the Nation’s Capital Chapter of the Society of Toxicology. Dr. Fitzpatrick received her B.A. from the University of California at San Diego and her Ph.D. from Georgetown University.
Dr. Bernauer is a chemist by education and has a PhD in biochemical toxicology with focus on different aspects of chemical metabolism. She continued research on metabolism at university and later at the German Federal Institute for Risk Assessment (BfR) and its predecessor institute (BgVV). From research she turned into the regulatory area where she gained wide experience in risk assessment of chemicals within different regulatory contexts (e.g. industrial chemicals, cosmetics, workplace safety). She has been involved in the development of conceptual frameworks for risk assessment, in test method developments and projects on human biomonitoring. Apart from being a regulatory toxicologist at BfR’s Chemical Safety unit, Dr. Bernauer is also a member of the European Commission’s Scientific Committee on Consumer Safety (SCCS) where she has been involved in the risk assessment of a broad range of cosmetic ingredients, including nanomaterials. Since 2016, she has been chairing the SCCS working group on nanomaterials in cosmetic products. Due to the complete animal testing ban laid down in the European Cosmetic Regulation, she has become familiar with the challenges associated with chemical testing and assessment based on alternative strategies.
Dr. Tong is the Director of the Division of Bioinformatics and Biostatistics at the FDA’s National Center for Toxicological Research (NCTR/FDA). He has served as a science advisory board member for several large projects involving multiple institutes in Europe and in the USA. He also holds several adjunct positions at universities across the US and China. His division at the FDA develops bioinformatic methodologies and standards to support FDA research and regulation, as well as to advance regulatory science and personalised medicine. The most visible projects from his group are: (1) leading the Microarray Quality Control (MAQC) consortium to develop standard analysis protocols and quality control metrics for emerging technologies to support regulatory science and precision medicine; (2) the development of a liver toxicity knowledge base (LTKB) for drug safety; (3) in silico drug repositioning for the enhanced treatment of rare diseases; and (4) the development of the FDA bioinformatics system, ArrayTrackTM suite, to support FDA review and research on pharmacogenomics. In addition, his group also specialises in molecular modeling and QSARs with a specific interest in estrogen, androgen, and endocrine disruptors. Dr. Tong has published more than 200 papers and book chapters.
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 681002
