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DeCISIoN

Drug CandIdates ScreenINg

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

DeCISIoN project word cloud

Explore the words cloud of the DeCISIoN project. It provides you a very rough idea of what is the project "DeCISIoN" about.

trl9 62 lack human cardiovascular amongst predictive differentiate regulatory efficacy closures strategy examples risk scaled specialised astrazeneca discovery cells market belgian dutch provides trl6 preclinical company customers throughput screening pluriomics accelerate muscle failures death toxicity pluripotent cell validated decision 82 innovations pharmacology tackle commercialisation 17 hypertension models 24 emphasised protocol rates hipscs decline biotech function abovementioned compliant hypertrophy drugs reg clinical safety arrhythmias overcome pluricyte manufacturing possibly ventricular heart assay proprietary additional cardiac cardiomyocytes assays stem drug marketing international

Project "DeCISIoN" data sheet

The following table provides information about the project.

Coordinator	NCARDIA BV Organization address address: GALLILEIWEG 8 city: LEIDEN postcode: 2333 BD website: www.pluriomics.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Netherlands [NL]
Project website	http://www.ncardia.com
Total cost	3˙228˙570 €
EC max contribution	3˙228˙570 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SMEINST-2-2016-2017
Funding Scheme	SME-2
Starting year	2016
Duration (year-month-day)	from 2016-07-01 to 2018-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	NCARDIA BV NCARDIA BV Organization address address: GALLILEIWEG 8 city: LEIDEN postcode: 2333 BD website: www.pluriomics.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (LEIDEN)	coordinator	3˙228˙570.00

Map

Project objective

Pluriomics is an international Dutch/Belgian biotech company specialised in developing stem cell-based assays for cardiac safety pharmacology and drug discovery and development. Pluriomics developed a unique proprietary protocol to differentiate heart muscle cells derived from human induced pluripotent stem cells (hiPSCs). The company provides its customers with reliable cell technology systems to test potential drugs in the preclinical phase with high predictive value. Safety issues remains a key problem in drug development. This is amongst others emphasised by the case of AstraZeneca where 82% of pre-clinical and 62% of phase I project closures where related to safety issues. Out of the safety related failures the cardiovascular system is involved in 17% of the preclinical failures and 24% of the clinical failures. Examples of cardiovascular effects, include arrhythmias, hypertrophy, hypertension and reduced ventricular function, which may lead to increased cardiac risk and possibly death. Additional reasons for the decline in success rates are related to the lack of predictive models for early drug efficacy screening. Pluriomics has developed Pluricyte® Cardiomyocytes and integrated proprietary assay systems to overcome the abovementioned challenges. Enabling market uptake and distribution of cell technology based innovations can be challenging, with large scale production and development of regulatory compliant predictive models as main challenges. DeCISIoN will tackle these challenges and thus accelerate market uptake of their cardiac safety assays. DeCISIoN will take the next steps and deliver 1) an up-scaled and more cost-effective manufacturing process; 2) novel, validated, predictive high-throughput cardiac assays for further improved cardiac toxicity and drug efficacy testing and 3) a fully developed marketing and commercialisation strategy for the cardiac assays. As such, DeCISIoN will take Pluriomics' cardiac assays from TRL6 to TRL9.

Publications

List of publications.
year	authors and title	journal	last update
2018	Petra Mulder, Tessa de Korte, Elena Dragicevic, Udo Kraushaar, Richard Printemps, Maria L.H. Vlaming, Stefan R. Braam, Jean-Pierre Valentin Predicting cardiac safety using human induced pluripotent stem cell-derived cardiomyocytes combined with multi-electrode array (MEA) technology: A conference report published pages: 36-42, ISSN: 1056-8719, DOI: 10.1016/j.vascn.2018.01.003	Journal of Pharmacological and Toxicological Methods 91	2019-07-19

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