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ATMP GMP Open Access Research Alliance - AGORA

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.

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CSA-SA - Support actions

Coordinator

University College London
Address
Gower Street
WC1E 6BT London
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 180 823
Administrative Contact
Mark Lowdell (Dr.)

Participants (7)

KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN
Germany
EU contribution
€ 74 040
Address
Ismaninger Strasse 22
81675 Muenchen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Renate Rädlein (Ms.)
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 63 130
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Susan Zwaagstra (Ms.)
MEDIZINISCHE HOCHSCHULE HANNOVER
Germany
EU contribution
€ 45 368
Address
Carl-neuberg-strasse 1
30625 Hannover
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ulrike Koehl (Prof.)
UNIVERSITY OF NEWCASTLE UPON TYNE
United Kingdom
EU contribution
€ 41 088
Address
Kings Gate
NE1 7RU Newcastle Upon Tyne
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Fiona Airey (Mrs.)
KLINIKUM DER UNIVERSITAET REGENSBURG
Germany
EU contribution
€ 20 330
Address
Frans Josef Strauss Allee 11
93053 Regensburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Andrea Hauser (Dr.)
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 29 853
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sonja Croes-De Bruin (Dr.)
LONZA NETHERLANDS BV
Netherlands
EU contribution
€ 42 800
Address
Oxfordlaan 70
6229 EV Maastricht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cedric Volanti (Dr.)