Dr. rer. nat. Thomas Steger-Hartmann (VP) is Head of Investigational Toxicology at Bayer, Germany. His department comprises more than sixty scientists and technicians at the two experimental testing sites in Berlin and Wuppertal. Dr. Steger-Hartmann is responsible for both early and mechanistic safety assessment of pharmaceuticals as well as environmental risk assessments. He has more than 20 years of experience in the field of preclinical and eco-toxicological assessment of pharmaceuticals and early drug development, particularly in the field of contrast agents, hormonal compounds and oncology indications. Dr. Steger-Hartmann is member of Bayer's Animal Welfare Committee. Dr. Steger-Hartmann is involved in several international research collaborations in the field of toxicology and environmental safety. He was deputy leader of the European Innovative Medicines Initiative (IMI) project “eTox”, a European public-private partnership for gathering in vivo drug toxicity data for the development of improved in silico prediction tools. He will co-lead the respective follow-up project under IMI2. Dr. Steger-Hartmann is a trained biologist with an M.Sc. degree from the University of Michigan and a PhD from the University of Freiburg i.Br., Germany. He is a Eurotox registered toxicologist.
Dr. Derek J Knight, who is British, has worked at the European Chemicals Agency (ECHA) since September 2008. As the Senior Scientific Advisor, he is responsible for providing the Executive Director and the Director of Regulatory Affairs with expert scientific and technical advice on matters relating to chemical regulation, with the focus on the EU REACH, CLP and Biocides Regulations and the operations of ECHA. 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 an external expert member of the Scientific Expert Panel of the SEURAT-1 research initiative ‘Towards the replacement of in vitro repeated dose systemic toxicity testing’. 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.
Henrik Appelgren is Senior Scientific Officer at the Swedish Chemicals Agency (KemI). Henrik has a PhD in Genetic Toxicology. He has vast regulatory experience (over 13 years) of human health risk assessments (includes hazard assessment as well as risk characterisation) of active ingredients in pesticides (plant protection products and biocides), all toxicological areas included (e.g. acutetox, short-term tox, genotox, cancer, chronic tox, reprotox, developmental tox, etc.) including exposure. Henrik is/has been present and former member of different scientific committees/expert panels for the Swedish Research Council Formas, the Swedish Research Council Vetenskapsrådet, The Fund for Research without Animals and The Scandinavian Society for Cell Toxicology. Henrik is especially interested in modernising methods/strategies for human health risk assessment and is National Coordinator for Sweden within the OECD Test Guideline Programme.
Dr. Van der Laan was, from 1990-2007, heading the Section Pharmacology and Toxicology Assessment at the National Institute for Public Health and the Environment (RIVM, Bilthoven). In this function, he was responsible for the advice on non-clinical safety aspects for the Netherlands ‘College’, the Medicines Evaluation Board. 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, for 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.
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 both Pesticide 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 in 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.
Michael Schwarz is the Director of the Department of Toxicology in the Institute of Pharmacology and Toxicology at the University of Tübingen, Germany. Michael Schwarz has a PhD in Biology and the “Habilitation” in Toxicology (University of Tübingen). He is member of executive board of the Society of Toxicology in the German Society of Experimental and Clinical Pharmacology and Toxicology (DGPT). His special expertise is in molecular toxicology and chemical carcinogenesis. Michael was the coordinator of the Euro FP6 EU-project ReProTect, coordinating the work of 33 partners from large drug and chemical companies, SMEs and academia, and has therefore intense insight into alternative test strategies in the field of reproductive toxicology. He was also a partner in the FP7 EU-projects CancerSys, ChemScreen, COACH (SEURAT-1) and the EU/IMI project MARCAR.
Richard S. Paules, PhD, is the Acting Chief of the Biomolecular Screening Branch (BSB) in the Division of the National Toxicology Program at the National Institute of Environmental Health Sciences, NIH. He also holds adjunct faculty appointments as Professor in the Department of Pathology and Laboratory Medicine and Member in the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill. The BSB develops and carries out programmes in medium and high throughput screening of environmental substances for rapid detection of biological activities of significance to toxicology and administers the NTP programs designed to implement its vision for toxicology in the 21st century. In support of this program, BSB members represent the NTP in the Toxicology in the 21st Century (Tox21) Partnership between members of the NTP, US EPA, US FDA and the National Center for Advancing Translations Science (NCATS) at NIH. The research interests of Dr. Paules include integrating conventional studies of environmental exposures and toxicity with global systems or “omics” approaches, or toxicogenomics. Prior to joining the BSB, Dr. Paules was a Principal Investigator in the Division of Intramural Research, NIEHS, leading a research group investigating DNA damage signaling responses and the role of cell cycle checkpoint proteins, especially the ATM and ATR protein kinases, in normal DNA damage signaling and in cancer. Dr. Paules received his PhD from the Department of Pathology at UNC-CH and then received postdoctoral training with George F. Vande Woude at the National Cancer Institute, NIH, before joining NIEHS in 1990. He has authored approximately 100 peer-reviewed articles in leading biomedical journals, as well as approximately 18 book chapters and invited publications. Since joining the NIEHS, he has been recognised with several awards, including four NIH Merit Awards and an NIH Director’s Award, as well as the Society of Toxicology’s Leading Edge in Basic Science Award at the 2010 SOT Annual Meeting.
Russell Thomas is the director of the National Center for Computational Toxicology at the U.S. Environmental Protection Agency (EPA). The Center is researching new, more efficient, ways to evaluate the safety of chemicals, particularly in assessing chemicals for human health effects. Prior to coming to the U.S. EPA, Dr. Thomas was the director of the Institute for Chemical Safety Sciences at The Hamner Institutes for Health Sciences and worked in the biotech and biopharmaceutical industry. Dr. Thomas’ academic training includes a B.A. in chemistry from Tabor College, an M.S. in radiation ecology and health physics from Colorado State University, and a PhD in toxicology also at Colorado State. Following his doctoral studies, Dr. Thomas performed postdoctoral research in molecular biology and genomics at the McArdle Cancer Research Laboratory at the University of Wisconsin. Dr. Thomas also maintains an adjunct faculty appointment in the Division of Pharmacogenomics and Individualized Therapy at the University of North Carolina at Chapel Hill.
Professor Heinonen is a toxicologist with over 25 years of theoretical education and practical experience in toxicology, especially toxicology related to the pharmaceutical regulatory context. Dr. Heinonen’s practical experience covers acting as a toxicologist and a project manager for large international and national drug development and other research projects. Dr. Heinonen has been responsible for material preparation and participation in pre-submission and scientific advice meetings with NAM, Swedish Medical Agency, EMA and the FDA. In addition to the general toxicity risk assessment, her specific therapeutic expertise covers cardiovascular, CNS, HRT and cancer therapy for small molecules, and anti-infective therapy and probiotic area for biotechnology molecules (proteins). Dr. Heinonen has been responsible for setting up FICAM, the Finnish Center for Alternative methods (10th December 2008), for which she has been acting as its director. FICAM is an expert center at the University of Tampere, School of Medicine that focuses on the development of validated tissue and organ models to supplement and to replace animal experiments, educate scientists and share information. FICAM is the official OECD-GLP grade validation laboratory for EURL ECVAM for in vitro methods. Dr. Heinonen acts as an adjunct professor both in the university of Turku (biochemical toxicology) and Helsinki (biochemistry/toxicology). She is lecturing on toxicology and the information and testing needs set by regulators (pharmaceuticals, biocides, chemicals, cosmetics), on Good Laboratory Practice (GLP) and on how in vitro methods can be used in the regulatory context and biomedical sciences. She is the Finnish PARERE person (Preliminary Assessment of REgulatory RElevance) under Article 47(5) of Directive 2010/63/EU.
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 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.