Percorrer por autor "Zare Jeddi, Maryam"
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- A human biomonitoring (HBM) Global Registry Framework: further advancement of HBM research following the FAIR principlesPublication . Zare Jeddi, Maryam; Virgolino, Ana; Fantke, Peter; Hopf, Nancy B.; Galea, Karen S.; Remy, Sylvie; Viegas, Susana; Mustieles, Vicente; Fernandez, Mariana F.; von Goetz, Natalie; Vicente, Joana Lobo; Slobodnik, Jaroslav; Rambaud, Loïc; Denys, Sébastien; St-Amand, Annie; Nakayama, Shoji F.; Santonen, Tiina; Barouki, Robert; Pasanen-Kase, Robert; Mol, Hans G.J.; Vermeire, Theo; Jones, Kate; Silva, Maria João; Louro, Henriqueta; van der Voet, Hilko; Duca, Radu-Corneliu; Verhagen, Hans; Canova, Cristina; van Klaveren, Jacob; Kolossa-Gehring, Marike; Bessems, JosData generated by the rapidly evolving human biomonitoring (HBM) programs are providing invaluable opportunities to support and advance regulatory risk assessment and management of chemicals in occupational and environmental health domains. However, heterogeneity across studies, in terms of design, terminology, biomarker nomenclature, and data formats, limits our capacity to compare and integrate data sets retrospectively (reuse). Registration of HBM studies is common for clinical trials; however, the study designs and resulting data collections cannot be traced easily. We argue that an HBM Global Registry Framework (HBM GRF) could be the solution to several challenges hampering the (re)use of HBM (meta)data. The aim is to develop a global, host-independent HBM registry framework based on the use of harmonized open-access protocol templates from designing, undertaking an HBM study to the use and possible reuse of the resulting HBM (meta)data. This framework should apply FAIR (Findable, Accessible, Interoperable, and Reusable) principles as a core data management strategy to enable the (re)use of HBM (meta)data to its full potential through the data value chain. Moreover, we believe that the implementation of FAIR principles is a fundamental enabler for digital transformation within environmental health. The HBM GRF would encompass internationally harmonized and agreed open access templates for HBM study protocols, structured web-based functionalities to deposit, find, and access harmonized protocols of HBM studies. Registration of HBM studies using the HBM GRF is anticipated to increase the FAIRness of the resulting (meta)data. It is also considered that the harmonization of existing data sets could be performed retrospectively. As a consequence, data wrangling activities to make data ready for analysis will be minimized. In addition, this framework would enable the HBM (inter)national community to trace new HBM studies already in the planning phase and their results once finalized. The HBM GRF could also serve as a platform enhancing communication between scientists, risk assessors, and risk managers/policymakers. The planned European Partnership for the Assessment of Risk from Chemicals (PARC) works along these lines, based on the experience obtained in previous joint European initiatives. Therefore, PARC could very well bring the first demonstration of the first essential functionalities within the development of the HBM GRF.
- Towards a systematic use of effect biomarkers in population and occupational biomonitoringPublication . Zare Jeddi, Maryam; Hopf, Nancy B.; Viegas, Susana; Price, Anna Bal; Paini, Alicia; van Thriel, Christoph; Benfenati, Emilio; Ndaw, Sophie; Bessems, Jos; Behnisch, Peter A.; Leng, Gabriele; Duca, Radu-Corneliu; Verhagen, Hans; Cubadda, Francesco; Brennan, Lorraine; Ali, Imran; David, Arthur; Mustieles, Vicente; Fernandez, Mariana F.; Louro, Henriqueta; Pasanen-Kase, RobertEffect biomarkers can be used to elucidate relationships between exposure to environmental chemicals and their mixtures with associated health outcomes, but they are often underused, as underlying biological mechanisms are not understood. We aim to provide an overview of available effect biomarkers for monitoring chemical exposures in the general and occupational populations and highlight their potential in monitoring humans exposed to chemical mixtures. We also discuss the role of the adverse outcome pathway (AOP) framework and physiologically based kinetic and dynamic (PBK/D) modelling to strengthen the understanding of the biological mechanism of effect biomarkers, and in particular for use in regulatory risk assessments. An interdisciplinary network of experts from the European chapter of the International Society for Exposure Science (ISES Europe) and the Organization for Economic Co-operation and Development (OECD) Occupational Biomonitoring activity of Working Parties of Hazard and Exposure Assessment group worked together to map the conventional framework of biomarkers and provided recommendations for their systematic use. We summarized the key aspects of this work here and discussed these in three parts. Part I, we inventory available effect biomarkers and promising new biomarkers for the general population based on the H2020 Human Biomonitoring for Europe (HBM4EU) initiative. Part II, we provide an overview of AOP and PBK/D modelling use that improved the selection and interpretation of effect biomarkers. Part III, we describe the collected expertise from the OECD Occupational Biomonitoring subtask effect biomarkers in prioritizing relevant mode of actions (MoAs) and suitable effect biomarkers. Furthermore, we propose a tiered risk assessment approach for occupational biomonitoring. Several effect biomarkers, especially for use in occupational settings, are validated. They offer a direct assessment of the overall health risks associated with exposure to chemicals, chemical mixtures and their transformation products. Promising novel effect biomarkers are emerging for biomonitoring of the general population. Efforts are being dedicated to prioritizing molecular and biochemical effect biomarkers that can provide a causal link in exposure-health outcome associations. This mechanistic approach has great potential in improving human health risk assessment. New techniques such as in silico methods (e.g. QSAR, PBK/D modelling) as well as ‘omics data will aid this process. Our multidisciplinary review represents a starting point for enhancing the identification of effect biomarkers and their mechanistic pathways following the AOP framework. This may help in prioritizing the effect biomarker implementation as well as defining threshold limits for chemical mixtures in a more structured way. Several ex vivo biomarkers have been proposed to evaluate combined effects including genotoxicity and xeno-estrogenicity. There is a regulatory need to derive effect-based trigger values using the increasing mechanistic knowledge coming from the AOP framework to address adverse health effects due to exposure to chemical mixtures. Such a mechanistic strategy would reduce the fragmentation observed in different regulations. It could also stimulate a harmonized use of effect biomarkers in a more comparable way, in particular for risk assessments to chemical mixtures.