Speakrs &
Chairpersons

Dr. Robert M. Califf was confirmed earlier this year as the 25th Commissioner of Food and Drugs. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute. He has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine. He is a nationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, and a leader in the growing field of translational research, which is key to ensuring that advances in science translate into medical care.   read more...   read less

Professor Carlos Gonçalo das Neves, a Portuguese and Norwegian citizen, graduated in Veterinary Medicine, from the Technical University of Lisbon in 2004, and obtained his PhD in veterinary science in 2009 from the Norwegian School of Veterinary Sciences. He holds also a Postgraduate Certificate in Public Health from the London School of Hygiene and Tropical Medicine, and a Certificate in Public Policy from the London School of Economics. He is the Chief Scientist of the European Food Safety Authority, having served previously between 2019 and 2022 as the Director of Research and Internationalization of the Norwegian Veterinary Institute (NVI), and between 2014 and 2017 as head of virology and head of food safety and emerging threats at the same institution. He holds a joint position as Full Professor at the Faculty of Medical Sciences at the University of Tromsø. Prof. das Neves has worked in the field of wildlife diseases, and has experience on topics related to ONE HEALTH, emerging threats, wildlife health and food safety and systems. He has a strong background in science to policy translation, advocacy and societal awareness. In 2013 he obtained the diploma of specialist of the European College of Zoological Medicine, and is currently the chair of the Wildlife Population Health Speciality. Between 2014-2018 we served also as an expert in animal welfare and health for the Norwegian Scientific Committee for Food and the Environment. He is a Commissioner of the Lancet ONE HEALTH Commission, and a member of the Global 1 Health Network and of the One Sustainable Health Forum, as well as a lead author on the ongoing IPBES Nexus assessment on the interlinkages among biodiversity, water, food and health. He is a Member of the IUCN Wildlife Health Specialist Group, and has served between 2019 and 2021 as the President of the Wildlife Disease Association. He has also served as Honorary Consul of Portugal in Norway between 2010 and 2017.   read more...   read less

Tucker A. Patterson, Ph.D. is Center Director at the FDA’s National Center for Toxicological Research (NCTR). Dr. Patterson previously served as the Deputy Director for Research in the Office of the Center Director/Office of Research. Prior to this appointment, he served two years as the Associate Director for Science & Policy and over seven years as the Associate Director and Health Science Program Manager in Regulatory Compliance & Risk Management at NCTR. Dr. Patterson received a B.S. in Chemistry from the University of Arkansas at Fayetteville and a Ph.D. in Pharmacology from the University of South Carolina. He completed a two-year postdoctoral fellowship with the Center for the Neurobiology of Aging at the University of Florida and continued his postdoctoral training at NCTR through a postgraduate research appointment with the Oak Ridge Institute for Science and Education and as a staff fellow. Dr. Patterson has been involved in neuroscience and neurotoxicology research for more than thirty years and has authored or co-authored over 100 peer-reviewed scientific articles and book chapters.   read more...   read less

Sonja Beken holds a Master in Biological Sciences and PhD in Pharmaceutical Sciences from the Vrije Universiteit Brussel (VUB), Belgium and a Master in Applied Toxicology from the University of Surrey, UK. Sonja Beken is the Coordinator of the Unit of non-clinical evaluators at the Belgian Federal Agency for Medicines and Health Products (FAMHP). This Unit is responsible for the evaluation of non-clinical data submitted to support all phases of drug development (e.g. marketing authorizations, clinical trials, EU/national scientific advice, etc). Sonja Beken is the Chair of the CVMP/CHMP Joint 3Rs Working Party (3RsWP) and is Member of the Non-Clinical Working Party at the European Medicines Agency (EMA). She was Member of the EMA Safety Working Party (Vice-Chair 2013-2016) and of the CVMP/CHMP Joint 3Rs Working Group (Chair 2011-2016) and ICH Rapporteur for the revision of the S5(R2) Guideline (2014-2016). Over the years, Sonja Beken has contributed to the direct identification of opportunities for regulatory implementation of 3R testing paradigms through her active involvement in large-scale international initiatives (EPAA, CAAT, ILSI HESI, NC3Rs, AIMBE & NIH, etc). Her main areas of expertise relate to regulatory science, non-clinical drug development, (in vitro) toxicology and metabolism as well as alternative models to animal experiments (3Rs).   read more...   read less

Dr Mounir Bouhifd is currently a regulatory officer at the European Chemicals Agency. He is member of the Alternative Methods Team of the computational Assessment unit. Part of his tasks is on the assessment of QSAR predictions. NAMs are another area of his work. Mounir was working on the development and application of Alternative methods and especially their validation, at the European Centre of Validation of Alternative methods (ECVAM). He was also a faculty member at the Johns Hopkins university.

Luigi Calzolai, Ph.D. Project Leader, Joint Research Centre of the European Commission Dr. Calzolai has a MS (University of Florence) and PhD (University of Siena) in chemistry. After a Postgraduate Research at the University of California, Davis, he joined, in 1998, the Swiss Institute of Technology in Zurich, in the laboratory of the then Nobel laureate Kurth Wuthrich, where he determined the three dimensional structure of prion proteins responsible of neurological disorders, such as Mad Cow Disease. In 2007, he moved to the University of Kent (UK) as Senior Lecturer in biochemistry. In 2008, he joined the Joint Research Centre of the European Commission where his research focuses on the development of methods for the characterization of nanomedicines (in particular RNA-based) and biotherapeutics.   read more...   read less

Dr James Chan graduated with a Bachelor of Pharmacy degree and obtained his doctoral degree in Pharmaceutical Science from the National University of Singapore. Subsequently he joined A*STAR in 2018 and established an independent research group in 2020 in both the Singapore Institute of Food and Biotechnology Innovation (SIFBI), and the A*STAR Skin Research Labs (ASRL). He is currently a Junior Principal Investigator with extensive expertise in physiologically-based pharmacokinetic models. In particular, his team develops in vitro and in silico tools to investigate transporter-mediated pharmacokinetics. His current research interests include the modelling of long half-life environmental PFAS contaminants, prediction of the biokinetics for pharmaceutical, nutritional and consumer care compounds, and modelling sensitive populations such as pregnant mothers and maternal-fetal transfer.   read more...   read less

Dr. Djork-Arné Clevert has a background in computer science and received his doctorate on machine learning for computational biology. In 2022 he accepted a global role as VP, Head of Machine Learning Research within Pfizer Research. Prior to that, he was seven years in pharmaceutical research at Bayer and became Director, Head of Machine Learning Research in 2019. He was a senior scientist in the prestigious Hochreiter Lab at the Institute of Bioinformatics at Johannes Kepler University from 2007 to 2015. He has been Co-PI in several large projects with pharma industry, in particular, transcriptome analysis and statistical genetics with Johnson and Johnson and Merck Serono Geneva, respectively. His research has mainly been concerned with microarray data in earlier years. Later he shifted this research focus to the prediction of biological effects of compounds with methods, such as, deep neural networks. A highlight of his Marie Curie fellowship was the introduction of the Exponential Linear Units (ELUs), which has become a de-facto standard in the field of deep learning. Dr. Clevert is the author of over 60 research articles, scientific reviews, and book chapters with more than 10000 citations in total and released the Open Source software packages FARMS, cn.FARMS, RFN and Img2Mol.   read more...   read less

In 2022, Dr. Tammy Collins joined the Burroughs Wellcome Fund (BWF), a nonprofit philanthropic organization whose mission is to improve human health. At BWF, Dr. Collins serves as a Program Officer where she directs the Career Awards at the Scientific Interface (CASI) program and the Innovations in Regulatory Science Awards (IRSA). She serves on the US National Academies of Science, Engineering, and Medicine’s (NASEM) Forum on Drug Discovery, Development, & Translation as well as NASEM’s Forum on Regenerative Medicine. Prior to joining BWF, Dr. Collins served as Training Director at the National Institutes of Health | National Institute of Environmental Health Sciences (NIH | NIEHS) and was Chair-elect of the NIH-wide Training Directors’ Committee. At NIEHS, Dr. Collins made career outcomes of postdoctoral scholars transparent (see Nature Biotechnology publication). Dr. Collins received her bachelor’s in chemistry from Appalachian State University (ASU), and her Ph.D. in biochemistry from Duke University. After a brief postdoc at Duke, she joined NIEHS as a postdoc in 2009 where she developed her passion for helping foster scientific leaders.   read more...   read less

Dr. Cubadda is Senior Scientist and Team Leader at the Italian National Institute of Health with expertise in analytical sciences, exposure assessment and toxicology. He leads a group with a long track record in research on analytical determination and toxicology of nanomaterials as well as risk assessment of nanotechnology applications. Current interest is mainly in the area of NAMs in nanotoxicology, in which he coordinates international projects (NANOCELLUP, NAMS4NANO Lot 3). Expert in food safety risk assessment, in both the chemical and the nutritional domain, he has been member of several working groups of the European Food Safety Authority (EFSA) and is a current member of the Cross cutting Working Group on Nanotechnology. Author of >180 papers in international journals, he acted as chairman of national and international conferences and as lecturer for different Universities.   read more...   read less

Dr Jean Lou Dorne has been working in EFSA as a Senior Scientific Officer in Toxicology since 2006 and is currently working in the preparedness team of the Methodological and Scientific Support Unit. Previously, he spent 9 years at the University of Southampton between a PhD and 5 years of postdoctoral research UK on “human variability in kinetics and metabolism and refinement of uncertainty factors for chemical risk assessment”. His work focuses on NAMs in chemical risk assessment, toxicology, ecotoxicology including development of a)EFSA’s OpenFoodTox database and associated in silico tools, b) TKPlate 1.0 platform, c) harmonised methods for mixture risk assessment for humans, animals and the environment d)Training programmes in chemical risk assessment in the NAM area.   read more...   read less

Clinical physiologist and PhD in biology with 23 years of experience in drug discovery and drug development. Founder of Inoviem Scientific highly focused on personalised medicine using proprietary technologies and Artificial Intelligence platform to help pharma and biotech companies in develop of their compounds from early discovery to patient. Professor in experimental medicine at University hospital KSMA in Bishkek in connection to Germane higher education.

Dr. Hong Fang is a highly accomplished Senior Health Information Scientist at the US FDA, bringing over 20 years of experience in computational science, data science, chemoinformatics, toxicoinformatics, and bioinformatics to her role. At the FDA, Dr. Fang spearheads bioinformatics research and is responsible for the development of tools that support FDA's health informatics initiatives. A comprehensive list of the currently available software tools and informatics systems can be found on NCTR/FDA webpage: https://www.fda.gov/science-research/bioinformatics-tools. One noteworthy tool is FDALabel, which is hosted on the Amazon Cloud. FDALabel is a web-based application that facilitates full-text search of the FDA's drug labeling documents. It experienced a significant user access rate last year, with 100,000 visits recorded. In addition to her research and project management roles, Dr. Fang is a prolific writer. She has authored and co-authored a remarkable 164 manuscripts, accumulating an impressive 15,900 citations. Her Google Scholar H-Index is 59, highlighting the impact and influence of her scholarly contributions   read more...   read less

Dr. Suzanne Fitzpatrick is the Senior Advisor for Toxicology at the US Food and Drug Administration Foods Program. She is a board-certified toxicologist in the US and in Europe. Dr. Fitzpatrick chairs the FDA’s Alternative Methods Work Group that is currently focusing on in vitro Microphysiological Systems. Dr. Fitzpatrick helped develop the FDA DARPA NCATS program on Organs on a Chip and continues to work and give presentations on this evolving area. Dr. Fitzpatrick was the chair of the FDA Predictive Toxicology Roadmap Committee. Dr. Fitzpatrick co-chairs with EFSA the International Working Group on New Approach Methods for Food Safety. She is on the International Regulatory Board for the newly formed EU APSIS (Risk Hunter, Precision Toc, Ontox) Research Collaboration for developing New non- animal methods. She is the FDA representative tp PARC- The European Collaboration for Chemical Risk Assessment. She is on the Board of Directors for the International MPS Society. Dr. Fitzpatrick is the FDA lead for ICCVAM and for Tox 21. She received her BA from the University of California at San Diego and her PhD from Georgetown University.   read more...   read less

Dr. Xingchao Geng is the director of National Center for Safety Evaluation of Drugs (NCSED), National institutes for Food and Drug Control (NIFDC), China. He received the bachelor and master degree from Peking University Health Science Center (Beijing, China) and Ph.D in pharmacology at The Fourth Military Medical University in China. He joined the National Center for Safety Evaluation of Drugs (NCSED), National Institutes for Food and Drug Control (NIFDC) for Toxicological Research to develop toxicological methods for safety evaluation of novel drugs in 2004. Currently, Xingchao Geng is director of NCSED/NIFDC. He is excellent in pharmacology and new compound researching and discovery. He has more than twenty years experience in drugs screening and studying, especially in safety evaluation of drugs and has performed about 200 non-clinical drug safety assessment studies according to GLP regulations including 20 international studies from USA and France. He specializes in the research of new Biomarkers, immunotoxicity and hepatotoxicity research. He has published more than 100 papers and book chapters, and has been invited to present in national and international conferences. AS a visiting scholar, He worked and was trained in Huntingdon life Sciences company in United Kingdom, National Toxicology Research Center (NCTR) of US FDA, the United States Environmental Protection Agency (EPA) and National Institute of Environmental Health Sciences (NIEHS), et al.   read more...   read less

Justin M Gorham is a Group Leader and research chemist in the Nanomaterials Research Group at NIST. Dr. Gorham received his bachelor’s degree in chemistry from Bates College in Lewiston, Maine in 2003 and his PHD in surface chemistry from the Johns Hopkins University in 2008. He was awarded a position as an NRC postdoctoral fellow at the National Institute of Standards and Technology in 2009 to study environmentally induced transformations to the surface chemistry and stability of nanomaterials. He became a research chemist in 2011 and a group leader in 2018. Dr. Gorham currently works on research involving nano-enabled products, microplastic and nanoplastic metrology, standards development (both physical and documentary), and developing/applying surface chemical characterization methodologies especially with respect to the MMSD XPS facilities.   read more...   read less

Dr. Gouin received a PhD specializing in the field of environmental chemistry from Trent University, in Canada, through the Watersheds Ecosystems Graduate Programme in June 2006. Following his graduate studies, Dr. Gouin, has obtained both experimental and modelling experience in assessing diverse chemical exposures. More recently, he was employed for eight years by Unilever, where he was involved in the development and application of tools aimed at both screening and prioritization of chemicals and higher-tier risk assessment methods. He now provides consultancy work on a range of topics, where his current research interests include the development and application of risk assessment methods, such as for microplastic particles, as well as the development and application of models to better assess chemical exposures for both humans and the environment.   read more...   read less

Claudius Griesinger has been working for the European Commission’s Joint Research Centre (JRC) since 2006. He worked on biomedical testing methods, contributing to OECD guidelines and coordinating expert advice and stakeholder dialogue. From 2015 to 2022 he was responsible for the JRC’s contribution to the implementation of the EU’s medical devices/in vitro diagnostics regulations, focusing on signal detection, emerging technologies including artificial intelligence (AI) and setting up expert panels on high-risk devices, now managed by EMA. Since 2022 he is member of the leadership team of the JRC’s project portfolio on “Innovation in Life and Health Sciences”, with his team focusing on AI in healthcare & medicine and innovative cancer treatments. Claudius has a neurosciences degree from the University of Tübingen. His PhD at Max Planck Institute for Developmental Biology was about molecular mechanisms of neural network development in visual cortex. As a postdoc at University College London he worked on ultrafast synaptic transmission. Before joining the EC, Claudius was an assistant professor for physiology at University of Freiburg.   read more...   read less

Andrea Haase studied biochemistry at the University of Tübingen and obtained a PhD from the University of Heidelberg. In addition she finished a postgraduate study in Toxicology at the University of Leipzig and completed her habilitation in pharmacology and toxicology at the Freie Universität Berlin. Since 2008 she is working at the German Federal Institute for Risk Assessment (BfR) in Berlin, where she is the head of the unit “Fibre and Nanoparticle Toxicology” and the deputy department head of the department ""Chemical and Product Safety"". Since 2008 Andrea Haase’s work is focused on nanomaterials. She is involved in addressing the integration of nanomaterials in different regulatory frameworks in the EU but also conducts research in the context of nanosafety. She has published more than 100 scientific publications and is involved in several large national and European projects (e.g. GRACIOUS, NanoInformTIX, HARMLESS, POLYRISK).   read more...   read less

Thomas Hartung, MD PhD, is the Doerenkamp-Zbinden-Chair for Evidence-based Toxicology in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health, Baltimore, with a joint appointment at the Whiting School of Engineering. He also holds a joint appointment for Molecular Microbiology and Immunology at the Bloomberg School. He is adjunct affiliate professor at Georgetown University, Washington D.C.. In addition, he holds a joint appointment as Professor for Pharmacology and Toxicology at University of Konstanz, Germany; he also is Director of Centers for Alternatives to Animal Testing (CAAT, http://caat.jhsph.edu) of both universities. CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (http://www.ebtox.org), the Good Read-Across Practice Collaboration, the Good Cell Culture Practice Collaboration, the Green Toxicology Collaboration and the Industry Refinement Working Group. As PI, he headed the Human Toxome project funded as an NIH Transformative Research Grant. He is Chief Editor of Frontiers in Artificial Intelligence. He is the former Head of the European Commission’s Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy, and has authored more than 600 scientific publications (h-index 100).   read more...   read less

As Director of the Center for Biological Safety Research (CBSR) at the NIHS, Dr. Hirabayashi oversees all testing and research activities related to the comprehensive safety evaluation chemicals, foods, and drugs using biological resources (laboratory animals, cells, etc.). She also chairs the Steering Committee of the Japan Center for Alternative Test Methods and Validation (JaCVAM), a member of the International Cooperation on Alternative Test Methods (ICATM), and is working to implement appropriate animal experiments and promote alternative test methods under international cooperation. In addition, she has served as the Japanese National Coordinator of the OECD Test Guidelines Program for human health from 2020 and as its Vice-Chair from 2021.   read more...   read less

Dr. Masamitsu Homma has been Director of the National Institute of Health Sciences (NIHS) in Japan since April 2023. He received his PhD in molecular genetics from the University of Tokyo. After completing his postdoctoral fellowship at the Harvard School of Public Health, he began his research career at the NIHS in the field of genetic toxicology. He has published over 250 papers on DNA repair, mutagenesis, genotoxicity testing, and QSAR models. Dr. Homma has also held numerous regulatory positions in Japan and international organizations. He has worked for the International Council on Harmonization (ICH) and the Organization for Economic Co-operation and Development (OECD) for nearly 30 years.   read more...   read less

Dr. Kristi Muldoon-Jacobs is the acting director of the Office of Food Additive Safety (OFAS). In her role, she directs the office responsible for overseeing the safety of ingredients in food and substances that come into contact with food through packaging and manufacturing. What drives Dr. Muldoon-Jacobs, a toxicologist and mother, are the safety and nutrition of food. She is equally passionate about the FDA’s mission as she is about informing consumers about food science and safety. She wants to help consumers understand that most chemicals are not harmful. Chemicals are the building blocks for everything in the world. People, animals, and plants are all made up of chemicals. Chemicals are also used in food during food production and in food packaging for useful purposes, such as preserving quality, adding nutritional value, extending shelf life, and protecting food from pathogens that can make people sick. Above all, Dr. Muldoon-Jacobs believes that the FDA’s food safety system is one of the best in the world, and U.S. consumers should have confidence in the food they eat and feed to their families.   read more...   read less

Ákos Jóźwiak is the head of Department of Digital Food Science at the Institute of Food Chain Science, University of Veterinary Medicine Budapest. Before, he worked for the National Food Chain Safety Office (NÉBIH) and its predecessors for 15 years in various positions. He is a member of the European Food Safety Authority (EFSA) Advisory Forum and the EFSA Emerging Risk Exchange Network. He also chairs the EFSA Advisory Group on Data. In his research activities, he focuses on developing and applying new data analytical methods for improving the effectiveness of the controls of the food system. Within this domain, his main research areas are (1) applying computational science methods for identifying emerging food systems risks; (2) food safety risk assessment; (3) applying data science for optimizing food production; (4) determining the economic burden of foodborne diseases and applying health technology assessment methods for food systems decision making.   read more...   read less

I completed my undergraduate degree in pharmaceutical science at Kyushu University, Fukuoka in Japan. Then I studied antibody engineering, protein science, protein structure, and immunology for my doctoral work at The University of Tokyo in Japan. Currently, my research field is molecular characteristics of therapeutic antibodies, such as structure, function, therapeutic potency, and stability.

Dr. Nicole Kleinstreuer is the director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), which is the US federal resource for alternatives to animal testing, and the executive director of the congressionally mandated Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Her work is centered on domestic and international efforts to develop novel testing, modeling, and analysis strategies that provide more rapid, mechanistic, and human-relevant predictions of potential environmental chemical hazards. Dr. Kleinstreuer has adjunct faculty positions in the Yale University School of Public Health and the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. She has published over 130 peer-reviewed publications and won numerous awards, including the 2022 NIH Director’s Award and the 2019 Society of Toxicology Achievement Award.   read more...   read less

Anna Lanzoni is a Senior Scientific Officer, Toxicologist at the European Food Safety Authority (EFSA; Italy). Currently she in involved in the peer review of pesticides at the PREV Unit, while from 2013 to 2021 she was involved in the risk assessment of genetically modified organisms at the GMO Unit. Previously she worked for 20 years as toxicological pathologist in a pharmaceutical company (GSK), involved with preclinical regulatory studies and in interdisciplinary project teams for the development of potential new medicines. Anna is a Veterinary Medicine Doctor and has a PhD in Veterinary Hygiene and Pathology obtained at the University of Milan.   read more...   read less

Dr. Nicolas Löffler-Perez is a Data Scientist at Swissmedic, the Swiss Agency for therapeutic products. After obtaining his Ph.D at The Johns Hopkins University, he moved to Switzerland to work on Clinical Machine Leaning in the University Hospital of Zurich and the University of Zurich where he developed a multimodal model for comprehensive analysis of images and reports in the hospital as well as optimization algorithms among other projects. He currently works with the Swissmedic 4.0 Team as the technical lead in multiple AI-based applications including the search of illegal medicinal substances in e-commerce, medicament recognition from images, and document similarity. His work focuses in innovation and the implementation of new technologies within Swissmedic. These solutions are mostly oriented towards the improvement of processes at Swissmedic making the stakeholder’s engagement essential for the success of these innovative solutions.   read more...   read less

Dr. Annamalai Manickavasagan (Manick) received PhD in Biosystems Engineering from the University of Manitoba, Canada. Currently, he is an Associate Professor at the School of Engineering, University of Guelph, Canada. He has published more than 100 research papers in journals and edited 10 books. Manick’s research is focused on improving the availability of safe and healthy food. He is exploring several techniques in Artificial Intelligence, including: a non-destructive testing system development for biological application, optimizing a bioimaging system, optimizing machine learning, validating imaging protocols, and comparing bioimaging systems with traditional methods for performance and costing.   read more...   read less

Manuela works as a scientific officer at EMA since 2010 with focus on human vaccines particularly in the context of public health emergencies. Her background is in veterinary medicine with a PhD in molecular biology, and 6 years work experience as a virologist in various Universities.

Yusuke Okubo, a Senior Researcher at Japan's National Institute of Health Sciences, specializes in developmental biology and toxicology. Actively promoting the principles of the 3Rs (Replacement, Reduction, and Refinement), he is applying his expertise in developmental biology to the development of a new in vitro developmental toxicity testing method. In addition, he has developed a wearable multimodal vital measurement device for rats. This device is designed to gather more comprehensive data from each individual animal, an effort that aims to contribute to the reduction of the number of animals required in toxicity testing.   read more...   read less

Luis Pinheiro is a Senior Epidemiology Expert at the European Medicines Agency (EMA), in the Data Analytics Workstream of the Data Analytics and Methods Taskforce. He is responsible for designing and running real-world data analytics studies and is tasked with methods development and learning within the team. Luis is also a co-chair of the AI Technical Group at EMA. Before moving to the Data Analytics Workstream, Luis worked eight years in drug safety at EMA. Prior to joining the EMA, he was the Head of the Signal Detection Unit at Infarmed, the Portuguese Regulatory Authority and the Portuguese representative at the Pharmacovigilance Working Party at EMA. Before that, he worked in the Pharmacovigilance Unit of the Faculty of Pharmacy of Lisbon for eight years where he assisted in the teaching of Pharmacoepidemiology and Public health in undergraduate and postgraduate courses. Luis holds a PharmD and a Masters in Epidemiology and post-graduate certifications in Data Science.   read more...   read less

Andrea Valsesia has a PhD in Physics on Nanofabrication of surfaces for biological application. He has experience in the field of nano-micro fabrication, thin films deposition, surface analysis and integration of devices, development of high-tech laboratory equipment, characterization of engineered nanomaterials. His research has been always oriented toward development of methods and experimental tools to support EU regulation in particular in the nanotechnology domain.

Prof. Bob van de Water is professor in Drug Safety Sciences and chair of the division of Drug Discovery and Safety at the Leiden Academic Center for Drug Research. He has longstanding experience in mechanisms of toxicity with a focus on liver and kidney. Functional genomics and transcriptomics approaches are applied to identify novel mechanisms that contribute to AOP development. He is currently the coordinator of the Horizon2020 RISK-HUNT3R project, part of the ASPIS cluster, and participates in the Horizon Europe PARC program.   read more...   read less

Clinical Pharmacologist, Senior Scientific Officer, Scientific Advice Office, European Medicines Agency, Amsterdam

Mathieu Vinken is a full professor affiliated with the Vrije Universiteit Brussel-Belgium. He has a background in pharmaceutical sciences (Pharm.D.), holds a doctoral degree in experimental in vitro toxicology (Ph.D.), is a European registered toxicologist (E.R.T.) and a trained chemical risk assessor. His research focus is situated in the fields of experimental hepatology (connexin and pannexin channels as drug targets and biomarkers for the therapy and diagnosis of liver disease), in vitro toxicology (mechanistic modelling of liver toxicity as the basis for the development of liver-based in vitro systems) and space toxicology (adverse effects of pharmaceutical drugs in astronauts). He is author of more than 200 publications in international peer-reviewed journals (h-index 45) and books. He is editor of 3 books. He is editor-in-chief of Toxicology, associate editor of Archives of Toxicology and European editor of Applied In Vitro Toxicology. He is promoter of 9 completed predoctoral projects and 5 finalized postdoctoral projects as well as of 9 ongoing predoctoral projects and 6 running postdoctoral projects. He is a regularly invited speaker on international conferences in the area of toxicology and hepatology. He is past-president of the European Society of Toxicology In Vitro and current chair of the In Vitro and In Silico Toxicology Speciality Section of EUROTOX. He has received several grants of the excellent science pillar of the European Commission, including from the European Research Council. He received a number of scientific awards, among which the ‘Galenus Award for Pharmacology’. - ORCID ID: orcid.org/0000-0001-5115-8893 - Researcher ID: H-7513-2013 - Website: www.mathieuvinken.com   read more...   read less

Prof. Maurice Whelan is Deputy Director of the Directorate for Health and Food and head of the Systems Toxicology Unit at the European Commission's Joint Research Centre (JRC) based in Ispra, Italy. He also heads the JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM). Maurice is the EU co-chair of the OECD Advisory Group on Emerging Science for Chemicals Assessment (ESCA); a member of the Steering Committee of the European Partnership for Alternative Approaches to Animal Testing (EPAA); and chair of the Regulatory Advisory Board of the European Organ-on-Chip Society (EUROoCS). His publications include over 200 scientific papers and a book on the validation of alternative methods for toxicity testing. He has held a number of external appointments including the 2017-2018 Francqui Chair for alternative methods at the Vrije Universiteit Brussel (VUB, Belgium) and is currently visiting Professor of Bioengineering at the University of Liverpool (UK).   read more...   read less

Dr. Joshua Xu received his Ph.D. degree in electrical engineering from Texas A&M University with research in medical image analysis. Currently he is the Branch Chief for Research-to-Review and Return (R2R) at the Division of Bioinformatics and Biostatistics of FDA's National Center for Toxicological Research (NCTR). He specializes in bioinformatics, text mining, image analysis, artificial intelligence, and informatics system development. He leads the Division’s efforts in developing regulatory informatics applications and systems. Some ongoing projects are Data Analysis and Search Host (DASH), Breakthrough Therapy Designation (BTD), Safety Policy and Research Team (SPRT), Smart Template System (STS) and FDA drug labeling documents (FDALabel) in collaboration with CDER. The R2R program has also developed a prototype for the Automated Laboratory Information System (ALIS), a customizable system that can be tailored to specific needs across all FDA sample testing laboratories; and created the ASSIST4Tobacco, which uses AI/NLP for deeper searching of documents concerning tobacco products.   read more...   read less

Dr. Takashi Yamada is a section chief at Division of Risk Assessment, National Institute of Health Sciences (NIHS). He is mainly engaged in research on the development of toxicity databases and evaluation of in silico approaches for chemical risk assessment including quantitative structure-activity relationships (QSAR) and read-across. He is an expert member of FSCJ and Chemical Management of Control Law. He also works as a member for several programs of in silico approaches for chemical hazard assessment at Organisation for Economic Co-operation and Development (OECD).   read more...   read less

Dr. Daiju Yamazaki is the Section Chief of the Division of Pharmacology at the National Institute of Health Sciences. He had been involved in developing of a proarrhythmic risk assessment using human iPS cardiomyocytes (hiPS-CMs). He had also collaborated with Comprehensive in vitro Proarrhythmia Assay (CiPA). Subsequently, he acquired the method for constructing three-dimensional cardiac tissues, one of the microphysiological systems (MPS) from hiPS-CMs at the University of Washington for the in vitro evaluation of congestive heart failure caused by anticancer drugs. Currently, he is involved in the development and standardization of MPS. In Japan, this year, there has been active discussion on MPS through collaboration between industry, government, and academia, leading to the establishment of the Japan MPS consortium, which aims to standardize MPS evaluation systems originating. Dr. Yamazaki also serves as the secretariat of this consortium.   read more...   read less

Satoshi YASUDA, PhD, is currently Chief at Division of Cell-Based Therapeutic Products, National Institute of Health Sciences (NIHS). He is also a visiting associate professor at Nagoya City University. He received his PhD in Pharmaceutical Sciences from Nagoya City University. In his research career, he worked on biochemistry and cell biology of lipids as a postdoctoral researcher at National Institute of Infectious Diseases and University of Tennessee Health Science Center. After continuing his area of interest as an instructor of Sapporo Medical University School of Medicine, he joined Division of Cellular and Gene Therapy Products at NIHS as Senior Researcher in 2009. Until now, he has been dedicated to development and validation of testing methods evaluating safety and quality of cell-based therapeutic products derived from human pluripotent stem cells, from the perspective of their tumorigenicity and differentiation biases.   read more...   read less

Dr. Yu obtained his PhD in Organic Chemistry & Material Science from Jilin University, China, in 2008, He later joined Harvard University in USA as a Postdoctoral Research Associate (2008-2010). In 2010, he joined the Institute of Bioengineering and nanotechnology (IBN) in Singapore as a Research Scientist & Project Leader (2010-2016) leading a research group to develop new organo/organometallic synergy catalytic systems for Green Synthesis and Biomass Conversion. Dr. Yu is currently the Chemical Specialist Team Lead (2019-present) in Singapore Food Agency (SFA). The applied research strategies include forecasting food safety risks through early detection of food safety concerns and exploration of new technologies to advance in-lab and on-site rapid testing capabilities. His research interests cover 1) Non-targeted Analysis for early food safety alert, 2) Nanomaterial detection, characterization and monitoring in food and food Contact Materials and 3) Micro-/Nanoplastics detection and identification in food and water.   read more...   read less

Mr. ZHAO Junning, MD, Research Fellow, Deputy Commissioner of the National Medical Products Administration of China. Management Committee Chair of the State Key Laboratory of Drug Regulatory Science. Vice Chairman of the 12th Chinese Pharmacopoeia Commission. Specialized fields: Drug Regulatory Science, Pharmacology in Traditional Chinese Medicine, and Translational Medicine.

Dr. Catherine Carrillo completed a Ph.D. in molecular biology at the University of Ottawa in 2000. She began working on food pathogen genomics in 2001, as a visiting fellow at the National Research Council (Canada). From 2006 to 2012, Cathy led the Campylobacter laboratory in Health Canada’s food microbiology group, where she worked on improved methods for detection of campylobacters in foods and on the implementation of a Campylobacter genomics program. She began her current position at the Canadian Food Inspection Agency in January 2013, focusing on the application of whole-genome sequencing (WGS) technologies for the detection, identification and characterization of foodborne bacterial pathogens. In the past few years, Dr. Carrillo's laboratory has sequenced several thousand bacterial genomes, and this work has led to the implementation of methods for real-time WGS of bacterial pathogens isolated in CFIA's food-testing programs. Her current research interests include the development of tools for bacterial phenotype prediction based on WGS data (e.g. serotype, antimicrobial resistance), and the application of novel technologies to improve methods for detection of bacterial pathogens in foods. Dr. Carrillo currently co-leads the Canadian Shared Priorities Genomics Research and Development Initiative project on antimicrobial resistance (GRDI AMR 2).   read more...   read less

Joanne Chan is the Centre Director leading a multi-disciplinary team of regulatory scientists in the National Centre for Food Science in the Singapore Food agency. She leads the team to leverage scientific expertise to shape food safety ecosystem through strategic partnerships with regulators, industries, consumers and the scientific community to enable effective and prompt control of food safety risks. She has over 30 years of experience in food safety testing, laboratory quality management and co-chair the Council Committee for Laboratory under the national accreditation body. She played an instrumental role in driving the formation of the SFA’s laboratory recognition programme with an established network of competent private testing laboratories to support the industries’ food safety needs as well as the regulatory testing programme.   read more...   read less

Guilhem de Seze is Head of the Risk Assessment Production (ASSESS) Department at the European Food Safety Authority (EFSA). Together with external experts from the 10 sectoral scientific panels of EFSA, the staff of the ASSESS department prepare scientific advice for decision makers in the European Union to support the management of risks in the food chain, from farm to fork. Guilhem joined EFSA in 2016 as Head of the Scientific Evaluation of Regulated Products (REPRO) Department. Prior to joining EFSA he had been with the European Chemicals Agency (ECHA) in Helsinki since 2008. His two last positions in ECHA were Head of Unit, first for Substance Identification and Data Sharing, and then for Evaluation. Before this, Guilhem worked in the field of hazardous chemicals management in academia and in the chemical industry for over ten years. He holds a Ph.D. in Chemical Engineering from Louisiana State University, USA, specialising in mechanisms of environmental exposure to pollutants.   read more...   read less

Susanne Bremer-Hoffmann, Dr. rer nat, holds a PhD degree in Biology obtained from the Charite University Hospital Berlin in Germany for her work on the development of immunotherapies against leukemia. After her post-doctoral research at the Federal Institute for Risk Assessment in Germany, Susanne moved to the Joint Research Centre (JRC) of the European Commission and became a team member of the European Centre for the Validation of Alternative Methods (ECVAM) in 1995. She was involved in formal validation studies of toxicological in vitro tests detecting embryotoxicity and endocrine disruption as well as their acceptance as OECD test guideline. Susanne collaborated in several European projects focusing on alternatives to animal experiments, the characterization of nanomedicines and the regulatory science of nanotechnology enabled health products. Recently, she supported the EFSA funded project “Nanocellup” and is currently participating in EFSA’s NAMS4NANO project.   read more...   read less

Sebastian Hoffmann is running the independent consultancy ‘seh consulting + services‘ in Paderborn, Germany, since 2009, specialised in the assessment of new approach methods (NAM) and test strategies, application of evidence-based approaches to toxicology as well as in the regulation of chemicals and cosmetic ingredients. Being statistician by training, Sebastian received a Ph.D. from the University of Konstanz (Germany) for his thesis ‘Evidence-based in vitro toxicology’. He is a key contributor to the development of the evidence-based toxicology (EBT) movement from the beginning and directly supports the EBTC since 2011. Sebastian is a non-voting member of the Board of Trustees of the EBTC and a member of the German Federal Institute for Risk Assessment’s (BfR) Committee for Evidence-Based Methods in Risk Assessment. Since 2017, he is a European Registered Toxicologist.   read more...   read less

Marta holds a BSc in biological sciences, an MSc in genetics and microbial biotechnology and a PhD in food microbiology. In 2020 Marta was appointed to the scientific group preparing for the UN Food Systems Summit held in 2021 co-coordinating Action Track 2: Shifting to sustainable consumption habits. In 2023, she´s been appointed to the Scientific Advisory Committee advising the UN Food Systems Hub to reach the SDG´s. She joined EFSA in 2003 and held several scientific and managerial responsabilities: Head of Biological Hazards Unit, Head of the Biological Hazards and Contaminants Unit, Head of Risk Assessment and Scientific Assistance Department and Chief Scientist (2017-2022). She retired form EFSA in 2022.Prior to joining EFSA, she worked for the Institute for Food and Agricultural Research and Technology (IRTA) in Spain (1983-2002), where she was Head of the Food Microbiology and Biotechnology Unit. From 1992 to 2004 she was an Associate Professor at the University of Barcelona.Her main areas of expertise are on food safety, risk assessment and sustainability as well as the science of providing scientific advice to policy makers. Marta was co-chair of GCRSR (2018- 2022) together with Bill Slikker Jr.   read more...   read less

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 where he became Professor of Toxicology. He moved to the European Food Safety Authority in 2009, where is Lead Expert in toxicology. He is on the UK Register of Toxicologists and is EUROTOX Registered.   read more...   read less

Dr. Li Bo is the director of drug safety of China National Medical Products Administration (NMPA), and concurrently director general of National Institutes for Food and Drug Control (NIFDC). He is also the chairman of Council for Bioassay, China Pharmacopoeia Committee, and chairman of Council for Drug Safety Research and Evaluation, Chinese Pharmaceutical Association, et al. His main research works is on safety evaluation of drugs. He firstly established a safety evaluation system in accordance with the international GLP standards in China, presided over 11 national toxicology projects, developed some new technologies and new methods on immune toxicity, biological distribution, tissue cross reactivity, and new biomarkers. Leading the academic field of the safety evaluation of biotech drugs, he established the academic committee in this field to promote the standardization development of GLP in China. He also developed a series of technical standards for the national standard of bacterial endotoxin, which had independent intellectual property rights in China, and improved the quality control level of products and ensured the drug safety. He is the recipient of several public health awards such as the second prize of China National Science Progress Award and the second prize of the Beijing Science Progress Award. Dr Li published widely in journals and books in the field of drug safety and quality. He is the author of Safety Evaluation of Biotechnology Pharmaceuticals and Methodology of New Drug Research in Toxicology.   read more...   read less

Prof. Dr. Thomas Margoni is Research Professor of Intellectual Property Law at the Faculty of Law and Criminology, KU Leuven, where he is also a member of the Board of Directors of the Centre for IT & IP Law (CiTiP). Thomas' research concentrates on the relationship between law and technology, with a focus on comparative and European copyright law. Currently, he is exploring the transformations occurring in the creation, access, and distribution of information brought by technologies like the Internet, data and AI. Examples of relevant research projects include the Data Spaces Support Centre (https://dssc.eu/) a Digital Europe funded project dedicated to explore current data space initiatives, define common requirements and establish best practices, where Thomas is KUL's PI for the legal contribution; reCreating Europe, the EU H2020 project developing an integrated policy approach to copyright in the EU digital single market, where Thomas leads the task on AI and data ownership; Skills4EOSC the Horizon Europe project aimed to accelerate the upskilling of European researchers and data professionals in the field of Open Science; DAFNE+ the Horizon Europe project dedicated to the use of blockchain technologies to define novel revenue and business models for the cultural and creative industries; ZOOOM the Horizon Europe project focusing on awareness raising in the field of IP generation and management in collaborative innovation ecosystems, among others (for a full list see link below). Other areas of interest where Thomas has developed institutional as well as funded research include the processes of EU copyright and design law harmonisation; Data ownership and AI; Copyright, design rights and additive manufacturing; The digitisation of cultural heritage and the digital public domain; Open access and open science; Online intermediaries, fundamental rights and the platform economy; and the role of property rights in sports.   read more...   read less

TBC

Dr. Anil Patri serves as the Director, Nanocore and Chairs FDA’s Nanotechnology Task Force to conduct and coordinate regulatory science research, provide reviewer training, and standards development. He serves on the Nanoscale Science, Engineering, and Technology Subcommittee (NSET) on behalf of FDA. He chairs the Nanotechnology Working Group of the Global Coalition for Regulatory Science Research (GCRSR) to address emerging challenges, consensus development and capacity building. Prior to joining FDA in 2014, Dr. Patri served as the Deputy Director, Nanotechnology Characterization Laboratory at the Frederick National Laboratories for Cancer Research to oversee the clinical translation of nanomedicines. A synthetic organic chemist by training, his graduate research was on dendritic nanomaterial, followed by exploring their potential for cancer targeting, imaging and drug delivery at the University of Michigan.   read more...   read less

Currently Head of Unit for Communication at the European Food Safety Authority (EFSA), with responsibility for communicating the Authority’s scientific and corporate activities through its website and other channels. Portfolios under my remit include content development and dissemination for risk communications, media relations, social media and analytics, social science, and scientific publishing, among others. Previous role as Head of Unit for External Relations. Prior to EFSA, I worked as a communications consultant in London for public and voluntary sectors clients, including UK government departments and the European Commission, as well as for the financial services industry. Academic background in International Relations (MA) and Hispanic Studies (BA).   read more...   read less

Heather Schaefer is a toxicologist in the Contaminant Assessment Branch of the Center for Food Safety and Applied Nutrition (CFSAN) at the US Food and Drug Administration (FDA). During her tenure at the FDA, Heather has led multiple efforts related to reducing dietary cadmium exposure including a review of cadmium mitigation strategies, a systematic review of adverse health effects associated with oral cadmium exposure, and the development of a cadmium toxicological reference value. Heather also routinely conducts human health assessments to determine if contaminants found in various commodities pose a risk to consumers. Prior to joining the FDA, Heather was a toxicologist at the Texas Commission on Environmental Quality based in Austin, TX. While there, she co-authored authored guidance on conducting systematic reviews for the development of chemical-specific toxicity factors. Heather has a keen interest in evidence -based methods for use in risk assessment and is currently a member of the Evidence Based Toxicology Collaborative where she serves as co-chair of the Interim Science Advisory Council.   read more...   read less

Dr. Supriya Sharma became Health Canada's Chief Medical Advisor in August 2015. In that role she provides medical and scientific advice on cross cutting files, liaises with health professional and patient groups, and acts as spokesperson on high profile files. She added these responsibilities to those in the role of Senior Medical Advisor in the Health Products and Food Branch, a role she has had since March 2013. The Health Products and Food Branch has the responsibility to regulate pharmaceuticals, medical devices, biologics, vaccines,‎ natural health products, veterinary medicines and food. Prior to that, Dr. Sharma has held a number of positions in Health Canada over the past decade in both the pre-market and post-market health product regulatory areas, senior pharmaceutical policy advisory roles as well as a sabbatical returning to academic research in health innovation adoption in the Canadian health system. Trained as a pediatrician in both Canada and Australia, Dr. Sharma was a research fellow in hematology focused on clinical research relating to thalassemia and sickle cell disease and has worked on a number of large multi-center clinical studies, including research in collaboration with Oxford University on a project in Sri Lanka. She then went on to complete a Masters of Public Health at the Harvard School of Public Health with a concentration in International Health and an interest in Health Policy.   read more...   read less

With a PhD in Pharmacology and Toxicology from the University of California at Davis, I have authored or co-authored over 350 publications that have been cited over 18,000 times with topics including developmental neurotoxicology, pharmacokinetics, systems toxicology, emerging technologies and risk assessment. I have had the privilege to mentor a dozen PhD students and over 20 Postdoctoral Fellows, serve as director of the National Center for Toxicological Research/FDA for 16 years (recently retired) and as past president of the Teratology Society, the Academy of Toxicological Sciences and the Society of Toxicology.   read more...   read less

Birgit Sokull-Klüttgen, who has a PhD in Natural Sciences (Biology), is the Deputy Head of the Technologies for Health Unit (F.2) of the European Commission's Joint Research Centre (JRC) in Ispra (Italy). Joining the European Commission in 1995, Birgit worked for many years on the scientific/technical support to the conception, implementation and monitoring of EU legislation on chemicals. Birgit is involved in research and policy support projects on safety assessment of nanomaterials and JRC work on micro(nano)plastics. She is particularly interested in linking science to policy needs in order to provide circumspect opinions for a better regulation to the European Commission and to EU Agencies.   read more...   read less

Dr. Weida Tong is the Chair of Global Coalition of Regulatory Science Research (GCSRS). He is working at FDA's National Center for Toxicological Research (NCTR) as a division director for Bioinformatics and Biostatistics.

Dr. Tsaioun is an experienced executive and entrepreneur with core expertise in pharmaceutical programs de-risking strategies and managing geographically distributed research advocacy teams. Her interests are in driving innovation spanning across academic, industry, regulatory, healthcare and non-profit sectors. She spent two decades in translational drug discovery R&D before taking on the leadership position at Evidence-based Toxicology Collaboration at Johns Hopkins Bloomberg School of Public Health (EBTC), where she is leading international efforts to establish evidence-based methodologies and practices in toxicology by building multi-sector stakeholder alliances. She earned her Ph.D. in Human Nutrition Science from Tufts University Friedman School of Nutrition Science and Policy and completed post-doctoral training in neurochemistry at Harvard Medical School. She has served on the advisory boards of private companies, charities, and on the review committees at the NIH, National Academies of Science, Engineering and Medicine, EFSA.   read more...   read less

Didier is heading the Knowledge Innovation and Partnership management unit in EFSA. Responsibilities include: Defining EFSA’s scientific outlook through foresight and the scanning of scientific, technologica and societal information, including emerging risk identification. Envisioning EFSA's long-term competency needs. Make EFSA join forces by setting up multilevel partnership frameworks, in line with ecosystem thinking. Developing scientific sourcing solutions and promote capacity building.​​​​​​​ Facilitating the management of knowledge and innovation within the EU and globally, including the coordination of cross-cutting scientific knowledge activities. Evolving the risk assessment process by bringing in AI based process automation and engage with society and knowledge communities using crowdsourcing and citizen science.   read more...   read less

Paul Whaley, PhD, is a researcher, consultant, and academic editor, specialising in evidence synthesis methods and open science publishing practices. He has a particular interest in using systematic review and evidence mapping to make sense of research in support of policy goals, and the development and use of data standards for improving the quality of published research and allowing our approaches to storing and analysing scientific evidence to scale with the rate at which it is being produced. Paul is Editor-in-Chief of Evidence-Based Toxicology, a new open science journal for environmental health research. EBT's mission is to support the use of evidence-based methods in toxicology and implement new academic publishing models that lead to a better-functioning research ecosystem.   read more...   read less

Dr Calvin Yeo is a cell biologist and microbiologist by training with 10 over years of experience at the agency. His current research interests focused on the safety of nanomaterials in food, novel foods, and food botanicals. He currently has several research grants as a co-investigator looking at the food safety aspects of cultured meats. He is also particularly interested in the research of New Approach Methodologies (NAMs) for use in Toxicology. At the National Centre for Food Science, Dr Yeo is responsible for leading several food safety toxicological research projects that further the research agenda in NAMs. For instance, he is currently investigating on the toxicity effects on microplastics and nanoplastics (MNPs) using a multi-omics approach.   read more...   read less