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Oral biopharmaceutics tools

Objective

The OrBiTo project will deliver novel methods and a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. This will be achieved through novel propsective studies to define new methodlogies which will be validated using historical datasets from EFPIA partners. A combination of high quality in vitro or in silico characterizations of API and formulations will be integrated into physiologically based in silico models capturing the full complexity of oral drug absorption. This approach will drive model based pharmaceutical product development in accordance with visions of Quality by Design. Benefits include an accelerated formulation development process, particularly for challenging projects e.g. for low solubility molecules or modified-release formulations as well as allowing optimization of clinical product performance for patient benefit. In addition, it will significantly reduce the need for future animal experiments in this area and reduce the need for human bioequivalence studies for bridging between formulations within clinical programmes. The consortium is composed of world-leading scientists in a unique multidisciplinary collaboration where competences from nine academic partners, one regulatory agency, one non-profit research organisation and three SMEs are brought together with the twelve EFPIA partners giving an unparalleled opportunity to deliver transformational change in European industrial product development.

Call for proposal

IMI-JU-04-2011
See other projects for this call

Coordinator

ASTRAZENECA AB
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Sweden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Bertil Abrahamsson (Senior Principle Scientist)
Administrative Contact
Eva Lindgren (Senior Director)

Participants (26)

UPPSALA UNIVERSITET
Sweden
EU contribution
€ 2 470 300
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Krister Halldin (PhD)
THE UNIVERSITY OF MANCHESTER
United Kingdom
EU contribution
€ 528 000
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Liz Fay (Ms)
UNIVERSITAET GREIFSWALD
Germany
EU contribution
€ 606 225
Address
Domstrasse 11
17489 Greifswald
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Diana Lode (Mrs.)
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
EU contribution
€ 488 400
Address
6 Christou Lada Str
10561 Athina
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Efstathia Kafentzi (Secretary of the Research Committee)
NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO
Netherlands
EU contribution
€ 438 000
Address
Anna Van Buerenplein 1
2595 DA Den Haag
Activity type
Research Organisations
Administrative Contact
C.J.O.M. (Kees) Strien, van (Controller)
CERTARA UK LIMITED
United Kingdom
EU contribution
€ 438 000
Address
One London Wall 6Th Floor
EC2Y 5EB London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Susan Lundie (Miss)
LAKEMEDELSVERKET
Sweden
Address
Dag Hammarskjolds Vag 42
75103 Uppsala
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Joakim Brandberg (Head of Legal Affairs)
PION INC.(UK) LTD
United Kingdom
EU contribution
€ 402 000
Address
Riverside Forest Row Business Park
RH18 5DW Forest Row
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Brett Paul Hughes (Mr)
JOHANNES GUTENBERG-UNIVERSITAT MAINZ
Germany
EU contribution
€ 784 800
Address
Saarstrasse 21
55122 Mainz
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Julia Dore (Dr.)
JOHANN WOLFGANG GOETHE-UNIVERSITAET FRANKFURT AM MAIN
Germany
EU contribution
€ 468 600
Address
Theodor W Adorno Platz 1
60323 Frankfurt Am Main
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Edmund Kostewicz (Dr.)
UNIVERSITY OF STRATHCLYDE
United Kingdom
EU contribution
€ 546 292
Address
Richmond Street 16
G1 1XQ Glasgow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Martin Gregory (Mr)
KOBENHAVNS UNIVERSITET
Denmark
EU contribution
€ 785 400
Address
Norregade 10
1165 Kobenhavn
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Arly Christophersen (Economic consultant)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 1 019 375
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Elke Lammertyn (Dr.)
ABBVIE DEUTSCHLAND GMBH & CO KG
Germany
Address
Mainzer Str. 81
65205 Wiesbaden
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Frank-Christophe Lintz (Dr.)
BAYER AKTIENGESELLSCHAFT
Germany
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Petra Freitag (Finance Administrator)
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
Address
Binger Strasse
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Rolf Göggel (Dr.)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sally Miles (-)
JANSSEN PHARMACEUTICA NV
Belgium
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Anneleen Stincke (Dr.)
H. LUNDBECK AS
Denmark
Address
Ottiliavej 7-9
2500 Valby
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ejner Moltzen (Dr.)
MERCK SHARP & DOHME CORP
United States
Address
One Merck Drive
08889 Whitehouse Station Nj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Karen McGurk (Dr)
NOVARTIS PHARMA AG
Switzerland
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Barbara Stolz (Dr.)
ORION OYJ
Finland
Address
Orionintie 1
02200 Espoo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ville Hassinen (N/A)
PFIZER LIMITED
United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olga Krylova (Dr)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Patricia Zane (Dr.)
Simulations Plus, Inc.
United States
Address
10Th Street West
93534 Lancaster
Administrative Contact
John DiBella (Mr.)
BRISTOL-MYERS SQUIBB COMPANY CORP
United States
Address
Park Avenue 345
10154 New York
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jonathan Brown (xx)