PIAC_13

A sportolók felkészítésénél jelentkező stressz hatás mélyrehatóbb vizsgálatához egy metodika és mérőrendszer kidolgozása a gasztrointesztinális motilitás (EGIG) és kardiális változások alapján

Brief description of the project

Az Experimetria Kft. vezetésével létrejövő Pharmagora Klaszter konzorciuma (Szegedi Tudományegyetem, Adexgo Kft, AdWare Research Kft.) támogatást nyert a Nemzeti Fejlesztési Minisztérium által meghirdetett „Piacorientált kutatás-fejlesztési tevékenység támogatása, PIAC_13” című pályázati kategóriában A közös, konzorciumi fejlesztés célja egy olyan módszer és eszköz kidolgozása, amely objektívan és gyorsan tudja elemezni a külső stressz hatásokra adott belső válaszokat és ezek hatását a fizikai és szellemi teljesítményre. A megvalósítók célja, hogy a fejlesztés során létrejövő módszer-, és eszközrendszert valamint a kutatás során létrejövő mérési eredményeket hatékonyan be tudják építeni a „Sport-egészségügy” területén foglalkozó kutatók és szakemberek munkájába, illetve, hogy a vizsgálat eredményei olyan kiegészítő információt adjanak a megfelelő táplálkozáshoz és annak hasznosulásához, amelyek a további jelen fejlesztésre épülő kutatásokba is hatékonyan beépíthetők.

Pályázati azonosító: PIAC_13-1-2013-0201

Adware Research Kft részére megítélt támogatás: 57.379.065 Ft.

A közös fejlesztés várhatóan befejeződik: 2016. 06. 30.

EU_KP_12

Develop data management system for functional food development, performing data management tasks and biostatistical evaluation of results.

Brief description of the project

PATHWAY-27 explores selected bioactive compounds as ingredients of foods that, within the common diet, could significantly benefit human health and wellbeing. Three model compounds (docosahexaenoic acid – DHA, beta-glucan – BG, and anthocyanins – AC) and three model food matrices (bakery, dairy and egg products) are being studied to derive widely applicable conclusions. AdWrare Research Ltd. is actively involved in 4 of 8 work packages and it has small tasks in another 2 work packages. Also, we are managing partner in 1 task. AdWare ensures biostatistics and data management services to support the development of functional foods under the project. Data management activities are supported by its own software called Mythos.

AdWare Research Ltd. were founded for tender writing and preparing the contracts of FP7 project.

The amount of the grant awarded: 2.489.700 Ft

Name of beneficiary: AdWare Research Ltd.

The project is funded by the Research and Technology Innovation Fund.

The project was closed successfully on 11.30.2012.

FP7 – PATHWAY-27

Pivotal assessment of the effects of bioactives on health and wellbeing. From human genoma to food industry.

Brief description of the project

PATHWAY-27, a pan-European interdisciplinary team of life/social scientists and high tech/ food processing SMEs, uniquely addresses the role and mechanisms of action of 3 bioactives, namely docosahexaenoic acid (DHA), β-glucan (BG),and anthocyanins (AC), fortifying 3 different widely-consumed food matrices (dairy-, bakery-, egg products).
Critical evaluation of bioactive-food matrix interactions and determining the extent of synergies between the 3 bioactives are key elements of PATHWAY-27. The project will also consider the technological modifications occurring during food processing and production, as well as the frequency of consumption and the consumers’ acceptance of the BEF.


Countries participating in the tender:

  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • Sweden
  • Turkey
  • United Kingdom

NKFP -1A/0027/2002

Developing DNS chips for renal failure

The development of prognostic and diagnostic DNA chips to improve the quality of life and to promote cost effective management of patients with renal failure.

Brief description of the project

According to the data in Hungary there are more than 38 000 patients with chronic renal diseases and this number is raising by 10% yearly. Dialysis treatment and substitution of erythropoetin and calcitriol substantially increases the cost of the patients’ treatment. During long lasting dialysis therapy a number of complications develop seriously influencing the quality of life the patients. The patient’s condition is seriously damaged by bone-, cardiovascular-, gastroenterologic-, endocrine diseases and the disturbance of lipid metabolism, raising the risk of incurable complications both alone and in combination.

The basic goal of the project is to provide data enabling the prevention of those complications. We would also like to optimalize the applied treatment protocols according to the patient’s individual risk factors, thus increasing the efficiency of the therapy while reducing total costs. Based on the results of genetical informations collected, the development of a prognostical DNS chip is planned, to identify those risk factors to focus on during the long-lasting treatment of uremia.

A consortium based on the cooperation of the Semmelweis University’s Clinics was founded to realize the project. The work is coordinated by the Ist Department of Pediatrics. The IInd Department of Internal Medicine and the IIIrd Department of Internal Medicine join the University Side of the consortium. The Hoffman La-Roche, the AdWere Ltd. and the Izinta Ltd. companies represent the industry in the cooperation. The activity of the consortium is fully supported by the Hungarian Society of Nephrology providing the coordination of the examinations of the large number of patients. The active support of the Dialysis companies is also assured.

The research work is based on a sequence of molecular genetic examinations [for the details of genepolimorfic studies see below]. Further, detailed clinical check-up [see below] of bone metabolism, cardiovascular diseases, lipid metabolism, endocrin status and gastroenterological complications is planned to compare the clinical and genetic data of the patient groups studied.

The databases compiled will be examined by logistic regression-analysis and loglinear analysis searching those associated genetic divergences, able to forecast the clinical and laboratory divergences with high probability. Based on data provided by the project and previous studies the development of diagnostic DNS chips capable to provide accurate evaluation of the risk factors of a given renal disease is planned.

AdWare Research contributed to the success of the project with its high-quality data-management, biostatistics and ISO 9001 quality assurance services.


Consortium members:

  • Semmelweis Egyetem
  • Izinta Ltd.
  • Roche Ltd.
  • AdWare Research Ltd.

NKFP – 1A/003/04 (2004)

Preventing Diabetes II and multi-metabolic syndrome

Pharma-innovative Consortium for Developing Modified Products for preventing and treating diabetes II and multi-metabolic syndrome.

Brief description of the project

The project aim was to create a consortium of scientists and experts in experimental and clinical medicine for drug development research. The consortium established a pre-clinical & clinical research unit according to ICH (International Conference of Harmonisation) guidelines of the good laboratory practice (GLP) and good clinical practice (GCP). In the frame of the project the important baseline mechanisms of insulin sensitization are studied, with special regards to endogenous insulin sensitizing processes linked to the original observation by the applicant concerning the effector function of sensory nerves supplying the liver. Among these mechanisms, special attention is paid to those, which confer endogenous protection on the development of cardiac arrhythmias. The project involves the development of low dose captopril, the prototype of angiotensin convertase enzyme inhibitors for insulin sensitizing purposes, as an example of modifying product innovation for the treatment of diseases characterized by insulin resistance (type II diabetes & polycystic ovary sy.)

AdWare Research contributed to the success of the project with its high-quality data-management, biostatistics and GLP compliant quality assurance services.


Consortium members:

GAK DEKARDIO, OMFB-01009/2005

Cardiovascular prevention with innovative functional foods

Cardiovascular prevention with innovative functional foods

Brief description of the project

The aim of the project was to develop a functional food product-family of red meat products rich in omega-3-6 polyunsaturated fatty acids (PUFAs). The program was realised by a consortium of small and medium sized enterprises supported by a university. Dietary manipulations were planned to achieve a significant rise in omega-3-6 PUFA content of the beef in which the ratio of these fatty acids is 1:1, known to elicit beneficial effects in the treatment and prevention of cardiovascular and immunological diseases. Succeeding prospective placebo controlled double blind clinical studies were planned to characterize health protection afforded by the omega 3-6 PUFA-rich beef. The 24-month project was to be closed by the introduction of some of these products to the market.

AdWare Research contributed to the project with its high-quality data-management, biostatistics and quality assurance services.


Consortium members:

NKFP_07_A2/DIAVITA7

Vition, as a supportive anti-diabetic

Vition, as a supportive anti-diabetic: modified product innovative program

Brief description of the project

The aim of the project was to develop a new antidiabetic drug being used for supplementary therapy of both type I (T1DM) and type II diabetes (T2DM), starting from VITION, a drug formulation originally registered as a food supplement (principle aim). However, VITION capsule was found suitable for registration as a drug to support mainstay treatment of congestive heart failure. Further aims of the project were to make VITION appropriate for treatment and prevention of insulin resistance syndrome, a state preceding the onset of type II diabetes, and late complications of diabetic complications of either type such as nephropathy, neuropathy, angiopathy and cardiomyopathy (secondary aim). Of course, current composition of VITION should be modified to meet these expectations and this secondary aim is also involved in the current proposal. The degree of drug development research directed towards these latter indications is to reach the clinical phase.

In case of the principle aim, the study is to reach the early clinical phase II degree i.e. to get a reliable proof for the ability of VITION to support treatment of type II diabetes and the insulin resistance syndrome. Final report on these „proof of concept” type clinical studies at CGP (good clinical practice) standards are the major deliverables of the work.

As far as the secondary aim of the project is concerned, completions of the preclinical studies serve as the major end-point. Predictive safety, efficacy and toxicology studies are carried out with the follow-up product (the VITION-based prototype of modified composition).

AdWare Research contributed to the project with its high-quality pre-clinical, clinical data-management, biostatistics and quality assurance services.


Consortium members:

NKFP_07_A1/CARPA777

Prevention of anaphylactic reactions

New Diagnostic and Therapeutic Methods to Prevent Anaphylactic Reactions to Intravenous Drugs and Contrast Media

Brief description of the project

The goal of the project is the prediction and prevention of anaphylactic shock and other (pseudo)allergic immune reactions caused by intravenous drugs, focusing on the pathogenic role of complement activation. We propose a multi-angle approach from molecular studies to the development of a laboratory test, a bedside prognostic instrument and therapeutic procedures and drugs. The latter work involves a broad spectrum of preclinical drug development, from molecular synthesis to large animal experiments. The concrete endpoints will include a new laboratory test or kit, a bedside diagnostic instrument, a desensitizing procedure and results of preclinical studies with a few drug candidate molecules that allows the selection of complement inhibitory drug candidate molecules for further clinical development.

AdWare Research contributed to the success of the project with its high-quality pre-clinical and clinical data-management, biostatistics and quality assurance services.


Consortium members:

  • SeroScience Ltd.
  • DIATRON MI Ltd.
  • Bay Zoltán Alkalmazott Kutatási Közalapítvány
  • Semmelweis University
  • Szegedi Tudomány University
  • AdWare Research Ltd.

TECH_08_A1_CARDIO08

Developing komplex, heart electrophysiological and genetic clinical filter systems

Developing komplex, heart electrophysiological and genetic clinical filter systems for identifying and preventing sudden cardiac death

Brief description of the project

The main objective of the project is to develop a complex, hearth electrophysiological and genetic clinical filter system for people endangered by sudden cardiac death and also for those healthy people who are living stressful life and are sportsmen. We aim to develop genetic filter methods, mobile equipments employing special and new algorhythms. The basic researches – functioning as the background of the whole project – may result in a more detailed description of the mechanism of sudden cardiac death caused by heart rhythm disorders. Data gained from these researches are to use during the project.

Within the framework of the project, we aim to develop a new measuring system, a new diagnostic KIT and a new service / a diagnostic method for the above discussed disorder.

AdWare Research contributed to the success of the project with its high-quality pre-clinical and clinical data-management, biostatistics and quality assurance services.


Consortium members:

  • Experimetria Ltd.
  • Semmelweis University
  • Szegedi Tudomány University
  • Semmelweis University
  • Diagnosticum Zrt.
  • AdWare Research Ltd.

GVOP-3.3.3-05/2-2006-01-0101/3.0

Development of a validated information and data-handling technology

Development of validated information and data-handling technologies for functional foods containing drug and bioactive materials and creating service for this specific area.

Brief description of the project

The aim of the project was to develop a validated information and data-handling technology for functional foods containing drug and bioactive materials and creating service for this specific area. The product (service) is appropriate for pharmacodynamics comparison of data – considering the pharmacodynamics areas – for the statistical data processing and for the archiving according to the international standards. The specific data handling includes the automatic traceability of data either in case of paper based CRF or eCRF. Applying “audit trail” function was an important aspect. The name of the new product is MYTHOS 1.0

GOP-1.3.1-07/1-2008-0011

Development of an on-line trial-planning and automatic statistical evaluator system that confirms the efficacy and safety of pre-clinical studies

Development of an on-line trial-planning and automatic statistical evaluator system that confirms the efficacy and safety of pre-clinical studies. The system is developed for analysing drugs, functional food and diagnosticums medicine.

Brief description of the project

The aims of the project were to develop an on-line trial-planning and automatic statistical evaluator system that confirms the efficacy and safety of pre-clinical studies and with this to realise a file transfer to make the trial evaluation more effective and safer. The specific planning gives a guideline to the safe and validated data handling. The name of the new product: MYTHOS PDMS 1.0, MYTHOS CDMS 1.5

GOP-1.3.1-08/B-2009-0004

On-site data-management development of toxicology studies

Improvement of pre-clinical experiment planning and automatic statistical evaluation system in toxicology, and REACH trials complying with CDISC SEND standards.

Brief description of the project

The aim of the project was to develop an on-line validated trial designer and automatic statistical evaluation system that is in compliance with „CDISC (Clinical Data Interchange Standards Consortium) SEND (Standard for Exchange of Nonclinical Data)” standards. This project is a special further development of the system that was developed in our GVOP-2005-3.3.3. grant. The new data structure resulted from our development make the authority submission process easier and faster. As a result of this project a new product was born that makes the pre-clinical works safer and more effective on the one hand, on the other using which AdWare Research could provide a new toxicological data capturing service.


Partners:

  • Toxicoop Ltd.
  • Measuring and Software Ltd.

GOP-1.3.1-11/B-2012-0007

Development of adaptive-designed clinical trial management

Funkcionális élelmiszer vagy gyógyszer hatásosságát és/vagy biztonságosságát igazoló adaptív tervezésű klinikai vizsgálatok, GCP követelményeknek is megfelelő validált adat és vizsgálat menedzsment háttér megvalósítása.

Brief description of the project

A projekt célja olyan validált adat és vizsgálat menedzsment rendszer kifejlesztése, elsősorban a funkcionális élelmiszer és gyógyszerfejlesztés klinikai vizsgálataihoz, amely alkalmas az adaptív tervezésű klinikai és egyéb kutatás során a vizsgálatok elektronikus adatbevitelére úgy, hogy az adatbázis struktúra, az adatbeviteli felület és a vizsgálat menedzsment képes legyen a változások gyors követésére. Célunk továbbá, naprakész validált adatokat szolgáltatni a statisztikus, a projekt, klinikai vezető vagy a kutató részére, hogy gyors döntéseket tudjanak hozni a vizsgálat menetének megváltoztatásával kapcsolatban.

A projekt során kifejlesztett termék vizsgálattervező és adattároló moduljának rugalmasan változtatható adatstruktúrájú, nyitott rendszerré történő továbbfejlesztését szeretnénk megvalósítani, úgy hogy a jól működő funkciók (Audit trail, Query kezelés stb.) megmaradjanak. A rendszer tovább bővül egy közvetlenül a vizsgálati személyek által kitöltött elektronikus napló modullal is. Ez lehetőséget biztosít a modern számítástechnikai eszközök (okostelefon, táblaszámítógép, …) alkalmazására a valós idejű adatrögzítésben. A projekt során kifejlesztésre kerül a vizsgálat menedzsment modul, amely naprakész valós idejű információt biztosít a felhasználók számára, előkészítve és megalapozva a gyors és helyes döntéshozatalt és az időben történő beavatkozást. A projekt során tervezzük továbbá azt az import export modul kifejlesztését, amely alkalmas az on-line egészségügyi mérési adatokat a klinikai vizsgálat központi adatbázisába importálni, majd a vizsgálat struktúrájának megfelelően export adatbázist biztosítani a további statisztikai kiértékeléshez.

A projekt során tervbe vettük a meglévő irodaház bővítését, egy bemutató fejlesztő központ létrehozásával.