About: Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk

Facets (new session)
Description
Metadata
Settings
- owl:sameAs
- Inference Rule:

About: Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk Goto Sponge NotDistinct Permalink

An Entity of Type : http://linked.opendata.cz/ontology/domain/vavai/Projekt, within Data Space : linked.opendata.cz associated with source document(s)

Attributes	Values
rdf:type	http://linked.opendata.cz/ontology/domain/vavai/Projekt
rdfs:seeAlso	http://www.isvav.cz/projectDetail.do?rowId=7H12016
Description	Clinical development of new biopharmaceutical products (BPs) offers the opportunity to biologically treat entirely new classes of diseases than ever before. As advances in the design and development of these complex biologic entities evolve, the ability to assess, or even predict, the immunogenicity potential of each new product must be considered. Through this ABIRISK Consortium we are bringing together in a very significant way, a world class group of clinicians with experience administering BPs, access to clinical samples from large cohorts of treated patients, leading EFPIA companies with extensive experience in development of medicines and the regulatory aspects of drug registration, renowned academic scientists, immunologists, database experts, and statisticians. Collectively, this group will critically evaluate the immunogenicity of existing BPs for Hemophilia A, Multiple Sclerosis, and Inflammatory Diseases, and develop standardized Anti-Drug-Antibody assays, including Neutralizing Antibody Assays, for each BP. Novel integrated approaches to characterize anti-drug lymphocyte responses will be used to provide insight into the basic mechanisms by which BPs drive immune cell activation. The predictive value of existing as well as new tools used for prediction of protein drug immunogenicity will be explored and evaluated, including T cell assays, in silico prediction, in vitro generated BP-derived agretopes generated by processing in human dendritic cells, measurement of peptide affinity for HLA class II molecules, modulation of dendritic cell function and activation by BPs, human in vitro PBMC assays, use of artificial lymph nodes, animal models, and generation of post-translational modifications and aggregates and characterizing them in various models. (en) Clinical development of new biopharmaceutical products (BPs) offers the opportunity to biologically treat entirely new classes of diseases than ever before. As advances in the design and development of these complex biologic entities evolve, the ability to assess, or even predict, the immunogenicity potential of each new product must be considered. Through this ABIRISK Consortium we are bringing together in a very significant way, a world class group of clinicians with experience administering BPs, access to clinical samples from large cohorts of treated patients, leading EFPIA companies with extensive experience in development of medicines and the regulatory aspects of drug registration, renowned academic scientists, immunologists, database experts, and statisticians. Collectively, this group will critically evaluate the immunogenicity of existing BPs for Hemophilia A, Multiple Sclerosis, and Inflammatory Diseases, and develop standardized Anti-Drug-Antibody assays, including Neutralizing Antibody Assays, for each BP. Novel integrated approaches to characterize anti-drug lymphocyte responses will be used to provide insight into the basic mechanisms by which BPs drive immune cell activation. The predictive value of existing as well as new tools used for prediction of protein drug immunogenicity will be explored and evaluated, including T cell assays, in silico prediction, in vitro generated BP-derived agretopes generated by processing in human dendritic cells, measurement of peptide affinity for HLA class II molecules, modulation of dendritic cell function and activation by BPs, human in vitro PBMC assays, use of artificial lymph nodes, animal models, and generation of post-translational modifications and aggregates and characterizing them in various models.
Title	Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk (en) Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk
skos:notation	7H12016
http://linked.open...avai/cep/aktivita	Joint Technology Initiatives
http://linked.open...kovaStatniPodpora	http://linked.opendata.cz/resource/domain/vavai/projekt/7H12016/celkovaStatniPodpora
http://linked.open...ep/celkoveNaklady	http://linked.opendata.cz/resource/domain/vavai/projekt/7H12016/celkoveNaklady
http://linked.open...datumDodatniDoRIV	2015-03-20 (xsd:date)
http://linked.open...i/cep/druhSouteze	RP - Spolufinancování programu ES
http://linked.open...ep/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open.../cep/fazeProjektu	101112294
http://linked.open...ai/cep/hlavniObor	FH - Neurologie, neurochirurgie, neurovědy
http://linked.open...vai/cep/kategorie	AP - Aplikovaný výzkum
http://linked.open.../cep/klicovaSlova	Biopharmaceutical; Immunogenicity of Biologics; anti-drug antibody; neutralizing antibody; predictive immunogenicity; immunotoxicology (en)
http://linked.open...ep/partnetrHlavni	1. lékařská fakulta
http://linked.open...inujicichPrijemcu	0 (xsd:int)
http://linked.open...cep/pocetPrijemcu	1 (xsd:int)
http://linked.open...ocetSpoluPrijemcu	0 (xsd:int)
http://linked.open.../pocetVysledkuRIV	0 (xsd:int)
http://linked.open...enychVysledkuVRIV	0 (xsd:int)
http://linked.open...lneniVMinulemRoce	2014-04-04 (xsd:date)
http://linked.open.../prideleniPodpory	http://linked.opendata.cz/resource/domain/vavai/cep/prideleniPodpory/MSMT-35199%2F2012-32
http://linked.open...iciPoslednihoRoku	2015
http://linked.open...atUdajeProjZameru	2015
http://linked.open...usZobrazovaneFaze	DRRVB
http://linked.open...ai/cep/typPojektu	P - Projekt výzkumu a vývoje financovaný ze státního rozpočtu
http://linked.open...ep/ukonceniReseni	2017-02-27 (xsd:date)
http://linked.open.../cep/vedlejsiObor	FH - Neurologie, neurochirurgie, neurovědy
http://linked.open...ep/zahajeniReseni	2012-10-01 (xsd:date)
http://linked.open...tniCyklusProjektu	ZBBB
http://linked.open.../cep/klicoveSlovo	Immunogenicity of Biologics anti-drug antibody neutralizing antibody predictive immunogenicity Biopharmaceutical
is http://linked.open...vavai/cep/projekt of	http://linked.opendata.cz/resource/domain/vavai/cep/ucast/7H12016/2012/orjk%3A11110 http://linked.opendata.cz/resource/domain/vavai/cep/ucast/7H12016/2013/orjk%3A11110 http://linked.opendata.cz/resource/domain/vavai/cep/ucast/7H12016/2014/orjk%3A11110 http://linked.opendata.cz/resource/domain/vavai/cep/ucast/7H12016/2015/orjk%3A11110 http://linked.opendata.cz/resource/domain/vavai/cep/ucast/7H12016/2016/orjk%3A11110 http://linked.opendata.cz/resource/domain/vavai/cep/ucast/7H12016/2017/orjk%3A11110

Faceted Search & Find service v1.16.118 as of Jun 21 2024

Alternative Linked Data Documents: ODE Content Formats:

RDF

ODATA

Microdata

About

OpenLink Virtuoso version 07.20.3240 as of Jun 21 2024, on Linux (x86_64-pc-linux-gnu), Single-Server Edition (126 GB total memory, 58 GB memory in use)
Data on this page belongs to its respective rights holders.
Virtuoso Faceted Browser Copyright © 2009-2024 OpenLink Software