Weiterentwicklung der TKPlate-Plattform der EFSA fuer toxikokinetische und toxikodynamische Modellierung

TK Plate is EFSA’s open-access web application implemented in R and ran in MCSim to allow fast and reliable high-throughput simulations toxicokinetic and toxicodynamic modelling of chemicals (https://r4eu.efsa.europa.eu/app/tktd). TKplate has been built within a workflow which includes a series of modules: input, forward dosimetry, reverse dosimetry, toxicodynamic, dynamic energy budget, mixtox and automated report (Bossier et al., 2023a, Dorne et al., 2023). Over the last few years, EFSA has invested in further developing TKPlate to update the platform and include new models developed under EFSA such as the ADME4NGRA and EU projects (i.e. PARC, ASPIS) and identified as priority by EFSA and the European Chemical Agency. In addition, the recently published EC road map for the pashing out of animal studies has also prioritised a number of in silico models including QSARs, physiologically-based kinetic (PBK), Toxicokinetic-Toxicodynamic (TK-TD) and bioaccumulation models to support its implementation for next generation chemical risk assessment across regulatory silos. This negotiated procedure aims to structure and test the codes of new models for their integration within TKPlate including QSARs, PBK, advanced bioaccumulation models and TKTD models. Objectives This negotiated procedure has 3 objectives: Objective 1: Objective 1: Further develop TKPlate modules through integration of physiological data for humans, animal species, available model codes in R and MCSim and modular design Objective 2: Further develop PBK, QIVIVE, advanced bioaccumulation models and TK TD models through re-engineering available priority models identified by EFSA Objective 3: Testing updated TKPlate modules and models using case studies of relevance to chemical risk assessment Selection criteria - technical and professional capacity Requirement 1: The tenderer overall must have extensive and demonstrable experience in the area of toxicokinetic and/or physiologically-based kinetic and /or bioaccumulation modelling Evidence requested: A list of three (3) major projects or publications related to the above mentioned areas of research carried out over the course of the past 5 years. Requirement 2: The tenderer must be able to provide a team of four (4) experts compliant with the following minimum expertise requirements: • One (1) senior team leader with: o A PhD in biomedical sciences or toxicology or toxicokinetics or biostatistics and At least 7 years of professional experience in applying toxicokinetic, physiologically-based kinetic and biologically-based modelling to chemical risk assessment using R and MCSim. • Three (3) senior experts with: o A PhD in biomedical sciences or toxicology or toxicokinetics or biostatistics and o At least 5 years of professional experience in the area of toxicokinetics, physiologically-based kinetic modelling, toxicokinetic-toxicodynamic modelling, biologically-based modelling and/or bioaccumulation modelling using languages of relevance including R and MCSim. Requested evidence: • Detailed CVs (max. 3 pages) of the 4 project team members proposed for the assignment. • One-page summary with the project team members, the covered profiles and indication of how the requirements are met. Requirement 3: Professional Capacity (English language capacity) All team members must have an excellent level of spoken and written English. For non-native speakers, this should be demonstrated by an official certificate of English proving a B2 level or at least 3 years of work or study in an English-speaking environment or by proof of (co)authorship of 7 scientific publications and/or reports in English language. Requested evidence: • Detailed CVs (max. 3 pages) of the project team members proposed for the assignment. • One-page summary with the project team members and indication of how the English requirement is met.