Enhancing Hungarian participation in ECRIN’s international independent drug research network (Q3923183): Difference between revisions
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The HECRIN Consortium, approved by the Ministry and countersigned by the Health Scientific Council, has as its task the organisation of clinical investigation centres and the management of domestic clinical trials, the preparation of an international protocol, the implementation of administrative tasks related to the submission, the tasks related to the use of test materials (medicines, devices), data processing, the selection of the study site, the recruitment of patients, the monitoring of the study and the collection of adverse reactions. It is of particular importance that domestic universities are able to participate in international cooperation with their own project proposals. Through the purchase of equipment, Hungary will be able to participate in independent research on medicinal products that have been initialised at international level and to launch such research in a much larger scale. The participation of Western European countries in international independent drug research is multiple times the Hungarian participation, which is the disadvantage we wish to work through the implementation of this project. In the project, 7 parts belong to the PTE, 1 to the SZTE, which can be broken down into 3 main areas: I. Pharmaceutical developments underpinning the development of a clinical research infrastructure 1. GLP certified laboratory development: The purpose of the development of the GLP-certified testing laboratory is to allow the analysis of samples resulting from the development of medicinal products to be carried out in a laboratory environment that meets the requirements of the development of medicinal products. The acquisition and operation of a HPLC-MS system is essential for the professional and economically efficient operation of the laboratory. 2. Pharmaceutical technology: The next step of the project will be to create the conditions for carrying out pharmaceutical technology activities. A pharmaceutical technology experimental lab would be developed, based essentially on formulation. In our rooms we plan the production of liquid, semi-solid and solid pharmaceutical forms and their proper packaging. After proper official registration of the batches between lab and artisanal size produced, they can be sold as a dietary supplement in the human pharmaceutical supply. II. Drug Impact Assessments underpinning the development of clinical research infrastructure 1. An in vivo effect study The research team at the Institute of Pharmacology and Pharmacotherapy of PTE investigates the role of capsaicin-sensitive nerve endings, the receptors and neuropeptides released from them in inflammatory and pain processes. The Task Force’s new research area is the development of drugs that affect neurodegenerative and neuroinflammative diseases of the central nervous system (e.g. multiple sclerosis). Integrative examination of pathophysiological mechanisms is carried out on cells, tissue cultures, isolated organs, and animal disease models, which also have important aspects of drug development. Our aim is to explore the role of sentient nerve endings, neuropeptides and neuro-immune interactions in pathologies and to identify potential new drug targets. 2. Patient group stratification and development of focused oncotherapy therapy The aim of the sub-development is to provide the opportunity to carry out studies in the field of molecular oncology and gerontology as a Hungarian and European centre (cellular and circulating biomarker patterns for pathological tumour diseases and physiological mosaic senescence). Cell biomarkers: The regionally unique digital PCR workstation of the PTE Department of Pharmaceutical Biotechnology is suitable for the task, allowing it to function as a center. Circulating biomarkers: the Department’s regionally unique digital PCR workstation is suitable for measuring individual miRNA levels with high precision, but due to the lack of a high-permeability flexible qPCR platform, it cannot currently serve regional ECRIN needs identifying full miRNA patterns. After the acquisition of the instrument park, we will be able to stratify cancer patient material, which allows clinicians to undergo focused oncotherapy treatment and contributes significantly to basic molecular oncology and gerontology academic research. III. Research carried out through the development of clinical research infrastructure 1. Establishment of an accredited clinical laboratory centre to serve clinical trials: The aim of the sub-development is to build a laboratory diagnostic background that helps achieve the main goal of the tender, i.e. international and more effective drug monitoring. Testing and handling of biological samples (e.g. blood, urine) required in a significant number of clinical trials, carried out in certified laboratories. The current standard MSZ EN ISO 15189:2013 is mandatory for international comparability and quality in clinical laboratories participating in multicentri (English) | |||||||||||||||
| Property / summary: The HECRIN Consortium, approved by the Ministry and countersigned by the Health Scientific Council, has as its task the organisation of clinical investigation centres and the management of domestic clinical trials, the preparation of an international protocol, the implementation of administrative tasks related to the submission, the tasks related to the use of test materials (medicines, devices), data processing, the selection of the study site, the recruitment of patients, the monitoring of the study and the collection of adverse reactions. It is of particular importance that domestic universities are able to participate in international cooperation with their own project proposals. Through the purchase of equipment, Hungary will be able to participate in independent research on medicinal products that have been initialised at international level and to launch such research in a much larger scale. The participation of Western European countries in international independent drug research is multiple times the Hungarian participation, which is the disadvantage we wish to work through the implementation of this project. In the project, 7 parts belong to the PTE, 1 to the SZTE, which can be broken down into 3 main areas: I. Pharmaceutical developments underpinning the development of a clinical research infrastructure 1. GLP certified laboratory development: The purpose of the development of the GLP-certified testing laboratory is to allow the analysis of samples resulting from the development of medicinal products to be carried out in a laboratory environment that meets the requirements of the development of medicinal products. The acquisition and operation of a HPLC-MS system is essential for the professional and economically efficient operation of the laboratory. 2. Pharmaceutical technology: The next step of the project will be to create the conditions for carrying out pharmaceutical technology activities. A pharmaceutical technology experimental lab would be developed, based essentially on formulation. In our rooms we plan the production of liquid, semi-solid and solid pharmaceutical forms and their proper packaging. After proper official registration of the batches between lab and artisanal size produced, they can be sold as a dietary supplement in the human pharmaceutical supply. II. Drug Impact Assessments underpinning the development of clinical research infrastructure 1. An in vivo effect study The research team at the Institute of Pharmacology and Pharmacotherapy of PTE investigates the role of capsaicin-sensitive nerve endings, the receptors and neuropeptides released from them in inflammatory and pain processes. The Task Force’s new research area is the development of drugs that affect neurodegenerative and neuroinflammative diseases of the central nervous system (e.g. multiple sclerosis). Integrative examination of pathophysiological mechanisms is carried out on cells, tissue cultures, isolated organs, and animal disease models, which also have important aspects of drug development. Our aim is to explore the role of sentient nerve endings, neuropeptides and neuro-immune interactions in pathologies and to identify potential new drug targets. 2. Patient group stratification and development of focused oncotherapy therapy The aim of the sub-development is to provide the opportunity to carry out studies in the field of molecular oncology and gerontology as a Hungarian and European centre (cellular and circulating biomarker patterns for pathological tumour diseases and physiological mosaic senescence). Cell biomarkers: The regionally unique digital PCR workstation of the PTE Department of Pharmaceutical Biotechnology is suitable for the task, allowing it to function as a center. Circulating biomarkers: the Department’s regionally unique digital PCR workstation is suitable for measuring individual miRNA levels with high precision, but due to the lack of a high-permeability flexible qPCR platform, it cannot currently serve regional ECRIN needs identifying full miRNA patterns. After the acquisition of the instrument park, we will be able to stratify cancer patient material, which allows clinicians to undergo focused oncotherapy treatment and contributes significantly to basic molecular oncology and gerontology academic research. III. Research carried out through the development of clinical research infrastructure 1. Establishment of an accredited clinical laboratory centre to serve clinical trials: The aim of the sub-development is to build a laboratory diagnostic background that helps achieve the main goal of the tender, i.e. international and more effective drug monitoring. Testing and handling of biological samples (e.g. blood, urine) required in a significant number of clinical trials, carried out in certified laboratories. The current standard MSZ EN ISO 15189:2013 is mandatory for international comparability and quality in clinical laboratories participating in multicentri (English) / rank | |||||||||||||||
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| Property / summary: The HECRIN Consortium, approved by the Ministry and countersigned by the Health Scientific Council, has as its task the organisation of clinical investigation centres and the management of domestic clinical trials, the preparation of an international protocol, the implementation of administrative tasks related to the submission, the tasks related to the use of test materials (medicines, devices), data processing, the selection of the study site, the recruitment of patients, the monitoring of the study and the collection of adverse reactions. It is of particular importance that domestic universities are able to participate in international cooperation with their own project proposals. Through the purchase of equipment, Hungary will be able to participate in independent research on medicinal products that have been initialised at international level and to launch such research in a much larger scale. The participation of Western European countries in international independent drug research is multiple times the Hungarian participation, which is the disadvantage we wish to work through the implementation of this project. In the project, 7 parts belong to the PTE, 1 to the SZTE, which can be broken down into 3 main areas: I. Pharmaceutical developments underpinning the development of a clinical research infrastructure 1. GLP certified laboratory development: The purpose of the development of the GLP-certified testing laboratory is to allow the analysis of samples resulting from the development of medicinal products to be carried out in a laboratory environment that meets the requirements of the development of medicinal products. The acquisition and operation of a HPLC-MS system is essential for the professional and economically efficient operation of the laboratory. 2. Pharmaceutical technology: The next step of the project will be to create the conditions for carrying out pharmaceutical technology activities. A pharmaceutical technology experimental lab would be developed, based essentially on formulation. In our rooms we plan the production of liquid, semi-solid and solid pharmaceutical forms and their proper packaging. After proper official registration of the batches between lab and artisanal size produced, they can be sold as a dietary supplement in the human pharmaceutical supply. II. Drug Impact Assessments underpinning the development of clinical research infrastructure 1. An in vivo effect study The research team at the Institute of Pharmacology and Pharmacotherapy of PTE investigates the role of capsaicin-sensitive nerve endings, the receptors and neuropeptides released from them in inflammatory and pain processes. The Task Force’s new research area is the development of drugs that affect neurodegenerative and neuroinflammative diseases of the central nervous system (e.g. multiple sclerosis). Integrative examination of pathophysiological mechanisms is carried out on cells, tissue cultures, isolated organs, and animal disease models, which also have important aspects of drug development. Our aim is to explore the role of sentient nerve endings, neuropeptides and neuro-immune interactions in pathologies and to identify potential new drug targets. 2. Patient group stratification and development of focused oncotherapy therapy The aim of the sub-development is to provide the opportunity to carry out studies in the field of molecular oncology and gerontology as a Hungarian and European centre (cellular and circulating biomarker patterns for pathological tumour diseases and physiological mosaic senescence). Cell biomarkers: The regionally unique digital PCR workstation of the PTE Department of Pharmaceutical Biotechnology is suitable for the task, allowing it to function as a center. Circulating biomarkers: the Department’s regionally unique digital PCR workstation is suitable for measuring individual miRNA levels with high precision, but due to the lack of a high-permeability flexible qPCR platform, it cannot currently serve regional ECRIN needs identifying full miRNA patterns. After the acquisition of the instrument park, we will be able to stratify cancer patient material, which allows clinicians to undergo focused oncotherapy treatment and contributes significantly to basic molecular oncology and gerontology academic research. III. Research carried out through the development of clinical research infrastructure 1. Establishment of an accredited clinical laboratory centre to serve clinical trials: The aim of the sub-development is to build a laboratory diagnostic background that helps achieve the main goal of the tender, i.e. international and more effective drug monitoring. Testing and handling of biological samples (e.g. blood, urine) required in a significant number of clinical trials, carried out in certified laboratories. The current standard MSZ EN ISO 15189:2013 is mandatory for international comparability and quality in clinical laboratories participating in multicentri (English) / qualifier | |||||||||||||||
point in time: 8 February 2022
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Revision as of 17:46, 8 February 2022
Project Q3923183 in Hungary
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Enhancing Hungarian participation in ECRIN’s international independent drug research network |
Project Q3923183 in Hungary |
Statements
959,311,032 forint
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2,622,397.195 Euro
0.0027336256 Euro
15 December 2021
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959,311,032.0 forint
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100.0 percent
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1 July 2016
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31 October 2020
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PÉCSI TUDOMÁNYEGYETEM
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46°4'35.72"N, 18°13'40.94"E
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A HECRIN Konzorcium – minisztérium által is elfogadott és az Egészségügyi Tudományos Tanács által ellenjegyzett - alapító okiratában feladatául szerepel a klinikai vizsgáló központok szervezése, és a hazai klinikai vizsgálatok menedzselése, nemzetközi protokoll elkészítése, a benyújtással kapcsolatos adminisztratív feladatok végrehajtása, a vizsgálati anyagok (gyógyszerek, eszközök) felhasználásával kapcsolatos tennivalók, az adatfeldolgozás, a vizsgálati helyszín kiválasztása, a betegtoborzás, a vizsgálat monitorozása és a mellékhatások összegyűjtése. Különösen fontos, hogy a hazai egyetemek saját projekt javaslatokkal tudjanak megjelenni a nemzetközi együttműködésekben. Az eszközbeszerzések révén Magyarország sokkal nagyobb volumenben lesz képes nemzetközi szinten inicializált független gyógyszerkutatásokban részt venni, ill. saját jogon indítani ilyen kutatásokat. A nyugat európai országok részvétele a nemzetközi független gyógyszerkutatásokban többszöröse a magyar részvételnek, ezt a hátrányt kívánjuk ledolgozni jelen projekt megvalósításával. A projektben 7 rész tartozik a PTE-hez, 1 az SZTE-hez, melyeket 3 főbb területre lehet bontani: I. Klinikai kutatási infrastruktúra fejlesztését megalapozó gyógyszerfejlesztések 1. GLP minősítésű laboratórium fejlesztése: A kialakítandó GLP minősítésű vizsgáló laboratórium fejlesztésének célja, hogy a gyógyszerfejlesztés során keletkező minták elemzése a gyógyszerfejlesztés során előírt követelményeknek megfelelő minősítéssel rendelkező laboratóriumi környezetben legyenek elvégezhetők. A laboratórium szakmailag és gazdaságilag is eredményes működéséhez elengedhetetlen egy HPLC-MS rendszer beszerzése és működtetése. 2. Gyógyszertechnológia: A projekt következő lépését a gyógyszertechnológiai tevékenységek elvégzéséhez szükséges feltételek megteremtése jelenti. Kialakításra kerülne egy gyógyszertechnológiai kísérleti labor, amely alapvetően a formulálásra épül. Helyiségeinkben folyékony, félszilárd és szilárd gyógyszerformák előállítását, azok megfelelő csomagolását tervezzük. Az előállított labor- és kisüzemi méret közötti sarzsok megfelelő hatósági regisztrálását követően a humán gyógyszerellátásban étrend kiegészítőként értékesíthetők lesznek. II. Klinikai kutatási infrastruktúra fejlesztését megalapozó gyógyszer hatásvizsgálatok 1. In vivo hatástan vizsgálat A PTE ÁOK Farmakológiai és Farmakoterápiai Intézetében működő kutatócsoport a kapszaicin-érzékeny érzőideg-végződések, az ezeken lokalizálódó receptorok és a belőlük felszabaduló neuropeptidek gyulladásos és fájdalom-folyamatokban betöltött szerepét vizsgálja. A munkacsoport újabb kutatási területe a központi idegrendszer neurodegeneratív és neuroinflammációs betegségeiben (Pl. Szklerózis multiplex) ható gyógyszerek kifejlesztése. Sejteken, szövet-tenyészeteken, izolált szerveken, és állatkísérletes betegségmodellekben a kórélettani mechanizmusok integratív vizsgálatát végezzük, amelynek fontos gyógyszerfejlesztési aspektusai is vannak. Célunk az érzőideg-végződések, a neuropeptidek és a neuro-immun interakciók kórfolyamatokban betöltött szerepének feltérképezése és potenciális új gyógyszercélpontok azonosítása. 2. Betegcsoport stratifikálás és fókuszált onkoterápiás kezelés fejlesztése A részfejlesztés célja, hogy hazai és európai centrumként lehetőségünk nyíljon vizsgálatokat végezni a molekuláris onkológia és gerontológia területén (sejtes és keringő biomarker mintázatok patológiás daganatos betegségek és fiziológiás mozaikos szeneszcencia esetében). Sejtes biomarkerek: A PTE Gyógyszerészi Biotechnológia Tanszék regionálisan egyedülálló digitális PCR munkaállomása alkalmas a feladatra, lehetővé téve centrumként történő működését. Keringő biomarkerek: a Tanszék regionálisan egyedülálló digitális PCR munkaállomása alkalmas egyedi miRNS szintek nagy precizitású mérésére, azonban nagy áteresztőképességű flexibilis qPCR platform hiánya miatt jelenleg nem szolgálhat ki teljes miRNS mintázatokat azonosító regionális ECRIN igényeket. A műszerpark beszerzéseit követően alkalmasak leszünk daganatos beteganyag sztratifikálására, mely lehetővé teszi klinikusok számára a fókuszált onkoterápiás kezelést, ill. jelentősen hozzájárul a molekuláris onkológiai és gerontológiai akadémiai alapkutatásához. III. Klinikai kutatási infrastruktúra fejlesztésével megvalósuló kutatások 1. Akkreditált klinikai laboratóriumi centrum kialakítása a klinikai vizsgálatok kiszolgálására: A részfejlesztés célja olyan laboratóriumi diagnosztikai háttér kiépítése, ami elősegíti a pályázat fő céljának az elérését, azaz a nemzetközi szintű és hatékonyabb gyógyszer monitorozást. A klinikai vizsgálatok jelentős részében szükséges biológiai minták vizsgálata, kezelése (pl. vér, vizelet), melyeket minősített laboratóriumokban végeznek. A jelenleg hatályos MSZ EN ISO 15189:2013 szabvány a nemzetközi összehasonlíthatóságot és a minőséget szolgálva kötelezően alkalmazandó azokban a klinikai laboratóriumokban, amelyek részt vesznek a multicentri (Hungarian)
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The HECRIN Consortium, approved by the Ministry and countersigned by the Health Scientific Council, has as its task the organisation of clinical investigation centres and the management of domestic clinical trials, the preparation of an international protocol, the implementation of administrative tasks related to the submission, the tasks related to the use of test materials (medicines, devices), data processing, the selection of the study site, the recruitment of patients, the monitoring of the study and the collection of adverse reactions. It is of particular importance that domestic universities are able to participate in international cooperation with their own project proposals. Through the purchase of equipment, Hungary will be able to participate in independent research on medicinal products that have been initialised at international level and to launch such research in a much larger scale. The participation of Western European countries in international independent drug research is multiple times the Hungarian participation, which is the disadvantage we wish to work through the implementation of this project. In the project, 7 parts belong to the PTE, 1 to the SZTE, which can be broken down into 3 main areas: I. Pharmaceutical developments underpinning the development of a clinical research infrastructure 1. GLP certified laboratory development: The purpose of the development of the GLP-certified testing laboratory is to allow the analysis of samples resulting from the development of medicinal products to be carried out in a laboratory environment that meets the requirements of the development of medicinal products. The acquisition and operation of a HPLC-MS system is essential for the professional and economically efficient operation of the laboratory. 2. Pharmaceutical technology: The next step of the project will be to create the conditions for carrying out pharmaceutical technology activities. A pharmaceutical technology experimental lab would be developed, based essentially on formulation. In our rooms we plan the production of liquid, semi-solid and solid pharmaceutical forms and their proper packaging. After proper official registration of the batches between lab and artisanal size produced, they can be sold as a dietary supplement in the human pharmaceutical supply. II. Drug Impact Assessments underpinning the development of clinical research infrastructure 1. An in vivo effect study The research team at the Institute of Pharmacology and Pharmacotherapy of PTE investigates the role of capsaicin-sensitive nerve endings, the receptors and neuropeptides released from them in inflammatory and pain processes. The Task Force’s new research area is the development of drugs that affect neurodegenerative and neuroinflammative diseases of the central nervous system (e.g. multiple sclerosis). Integrative examination of pathophysiological mechanisms is carried out on cells, tissue cultures, isolated organs, and animal disease models, which also have important aspects of drug development. Our aim is to explore the role of sentient nerve endings, neuropeptides and neuro-immune interactions in pathologies and to identify potential new drug targets. 2. Patient group stratification and development of focused oncotherapy therapy The aim of the sub-development is to provide the opportunity to carry out studies in the field of molecular oncology and gerontology as a Hungarian and European centre (cellular and circulating biomarker patterns for pathological tumour diseases and physiological mosaic senescence). Cell biomarkers: The regionally unique digital PCR workstation of the PTE Department of Pharmaceutical Biotechnology is suitable for the task, allowing it to function as a center. Circulating biomarkers: the Department’s regionally unique digital PCR workstation is suitable for measuring individual miRNA levels with high precision, but due to the lack of a high-permeability flexible qPCR platform, it cannot currently serve regional ECRIN needs identifying full miRNA patterns. After the acquisition of the instrument park, we will be able to stratify cancer patient material, which allows clinicians to undergo focused oncotherapy treatment and contributes significantly to basic molecular oncology and gerontology academic research. III. Research carried out through the development of clinical research infrastructure 1. Establishment of an accredited clinical laboratory centre to serve clinical trials: The aim of the sub-development is to build a laboratory diagnostic background that helps achieve the main goal of the tender, i.e. international and more effective drug monitoring. Testing and handling of biological samples (e.g. blood, urine) required in a significant number of clinical trials, carried out in certified laboratories. The current standard MSZ EN ISO 15189:2013 is mandatory for international comparability and quality in clinical laboratories participating in multicentri (English)
8 February 2022
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Pécs, Baranya
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Identifiers
GINOP-2.3.3-15-2016-00012
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