AGORA
ATMP GMP Open Access Research Alliance - AGORA
| Coordinatore | UNIVERSITY COLLEGE LONDON
Organization address
address: GOWER STREET contact info |
| Nazionalità Coordinatore | United Kingdom [UK] |
| Totale costo | 554˙970 € |
| EC contributo | 497˙432 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2013-INNOVATION-1 |
| Funding Scheme | CSA-SA |
| Anno di inizio | 2013 |
| Periodo (anno-mese-giorno) | 2013-09-01 - 2015-10-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
UNIVERSITY COLLEGE LONDON
Organization address
address: GOWER STREET contact info |
UK (LONDON) | coordinator | 180˙823.00 |
| 2 |
KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN
Organization address
address: ISMANINGER STRASSE 22 contact info |
DE (MUENCHEN) | participant | 74˙040.00 |
| 3 |
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Organization address
address: HEIDELBERGLAAN 100 contact info |
NL (UTRECHT) | participant | 63˙130.00 |
| 4 |
MEDIZINISCHE HOCHSCHULE HANNOVER
Organization address
address: Carl-Neuberg-Strasse 1 contact info |
DE (HANNOVER) | participant | 45˙368.00 |
| 5 |
PHARMACELL BV
Organization address
address: OXFORDLAAN 70 contact info |
NL (MAASTRICHT) | participant | 42˙800.00 |
| 6 |
UNIVERSITY OF NEWCASTLE UPON TYNE
Organization address
address: Kensington Terrace 6 contact info |
UK (NEWCASTLE UPON TYNE) | participant | 41˙088.00 |
| 7 |
ACADEMISCH ZIEKENHUIS LEIDEN
Organization address
address: Albinusdreef 2 contact info |
NL (LEIDEN) | participant | 29˙853.00 |
| 8 |
KLINIKUM DER UNIVERSITAET REGENSBURG
Organization address
address: FRANZ JOSEF STRAUSS ALLEE 11 contact info |
DE (REGENSBURG) | participant | 20˙330.00 |
Mappa
Word cloud
Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.
Obiettivo del progetto (Objective)
'We propose an academic & industrial partnership to facilitate safe and effective delivery of new advanced therapy medicines within the framework of the relevant EU regulations which our previous FP7 funded project have identified as creating unanticipated barriers to development of this field. Over 80% of advanced therapy medicines (ATMPs) trials in the EU are academic investigator led and sponsored. Many ATMPs are not making it to first-in-man trials due to the difficulties of academic manufacture to GMP compliance and the variation of application of the Directives between EU MS. We will deliver a supporting programme of resources to academic trialists to streamline their development programmes, enhance compliance with GMP requirements, develop industrial partnerships for improved manufacture and scale-up and establish the first university certified training programmes in cell/tissue engineering to address the critical shortage in scientific/technical/regulatory staff in this newly expanding field across the EU. The future supply of successful ATMPs to EU citizens will require partnerships between academic GMP facilities, contract ATMP manufacturers (CMOs) and the biopharma industry and this project will deliver the necessary support and training structure to create this partnership. The need for this project has been identified from the impact assessment part of our current FP7 project, “Academic GMP” and the culmination of the project will be a scientific analysis of the effect of the programme on the impact of the legislation relevant to ATMP development and provision across the EU.'