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INnovation in Safety Pharmacology for Integrated cardiovascular safety assessment to REduce adverse events and late stage drug attrition.

Project description

Enhancing prediction of severe adverse effects early in the drug development pipeline

Around 9 of every 10 drug candidates fail to win approval. Drugs can often progress into phase III clinical trials - trials with patients - before some rare but potentially lethal side effects become apparent. This late-stage discovery has significant consequences for the time and cost of drug development. Safety pharmacology is a rapidly developing discipline that seeks to predict whether a drug is likely to be found unsafe if administered to human beings. INSPIRE plans to advance the field of safety pharmacology with a focus on cardiovascular events. Bringing together interrelated expertise including academics, pharmaceutical companies, hospitals, and regulators, the team is fostering innovation among early stage researchers to detect and minimise cardiovascular adverse events early in the pipeline.

Objective

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.

Coordinator

UNIVERSITEIT ANTWERPEN
Net EU contribution
€ 768 960,00
Address
Prinsstraat 13
2000 Antwerpen
Belgium

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Region
Vlaams Gewest Prov. Antwerpen Arr. Antwerpen
Activity type
Higher or Secondary Education Establishments
Links
Other funding
€ 0,00

Participants (10)