Descrizione del progetto
Migliorare la previsione di eventuali gravi effetti avversi all’inizio della pipeline di sviluppo dei farmaci
Circa 9 farmaci candidati su 10 non ottengono l’approvazione. Spesso i farmaci possono progredire in sperimentazioni cliniche di fase III, le sperimentazioni con i pazienti, prima che possano manifestarsi alcuni effetti collaterali rari ma potenzialmente letali. Una scoperta del genere in fase avanzata ha conseguenze significative per i tempi e i costi di sviluppo di farmaci. La farmacologia di sicurezza è una disciplina in rapido sviluppo che cerca di prevedere quanto sia probabile che un farmaco risulti non sicuro una volta somministrato agli esseri umani. Il progetto INSPIRE prevede di avanzare nel campo della farmacologia di sicurezza con particolare attenzione agli eventi cardiovascolari. Riunendo competenze correlate comprendenti studiosi, aziende farmaceutiche, ospedali e legislatori, il team sta promuovendo l’innovazione tra i ricercatori all’inizio della carriera per rilevare e ridurre al minimo gli eventuali eventi avversi cardiovascolari all’inizio della pipeline.
Obiettivo
New drug candidates often have off-target effects resulting in adverse events, thus representing a major limitation for drug R&D. Safety Pharmacology (SP) aims to detect, understand and reduce undesirable pharmacodynamic effects early-on. Especially, cardiovascular (CV) toxicity is problematic, as it is the most prevalent reason for failure during preclinical development. Moreover, CV toxicity remains a key reason for drug attrition during clinical development and beyond. This indicates current SP screens fail to detect a number of (late-onset) functional or structural CV toxicities. Additionally, SP uses a significant number of laboratory animals, thereby creating opportunities for a better implementation of the 3Rs. The vision of INSPIRE is to advance and “inspire” SP by exploring new technological capabilities (WP1), addressing emerging CV concerns (WP2) and delivering new validated solutions for CV safety screening (WP3). To this end, INSPIRE unites expertise from academic teams, technology-providers, pharmaceutical companies, regulators and hospitals to create a European training platform for 15 Early Stage Researchers (ESRs). Key innovative aspects of INSPIRE include: i) in vitro humanized cardiomyocytes assays, ii) unparalleled in vivo hardware/software solutions, iii) in silico predictions of haemodynamics, iv) mass spectroscopy imaging of drug exposure, v) exploration of mechanisms of late-onset CV toxicity, as observed in cardio-oncology, and vi) early integration of feedback from industry and regulators. Overall, INSPIRE constitutes a multidisciplinary and intersectoral training programme (WP4) with a balanced combination of hands-on research training, intersectoral secondments, local courses and network-wide events on scientific and transferable skills, enabling future R&I collaborations. Hence, INSPIRE will equip the future generation of SP scientists with a wide range of scientific knowledge and the ability to adapt to a dynamic ever-changing industry.
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MSCA-ITN - Marie Skłodowska-Curie Innovative Training Networks (ITN)Coordinatore
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