Oral biophamaceutics tools (ORBITO)

At a Glance
  • Status: Active Consortium
  • Year Launched: 2012
  • Initiating Organization: Innovative Medicines Initiative
  • Initiator Type: Government
  • No disease focus
  • Location: Europe

Abstract

Most drugs are taken orally, for example as tablets or capsules. However, designing these pharmaceutical products in such a way that the active ingredient is absorbed at an appropriate rate and extent by the gut is far from easy. The ORBITO project aims to enhance understanding of how orally administered drugs are taken up from the gastrointestinal tract into the body and to apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients. The project duration is 60 months.

Mission

Through partnership, collaboration, and data sharing, ORBITO will develop fundamental knowledge of the gastrointestinal environment to deliver innovative biopharmaceutics tools, which will accurately predict product performance over a range of clinically relevant conditions. The integration of in vitro and in silico approaches will provide a biopharmaceutics toolkit, validated using clinical data, to accelerate drug development.

Consortium History

January 2012: Project started

Structure & Governance

Project Coordinator
Bertil Abrahamsson
AstraZeneca AB

Deputy Coordinator
Mark McAllister
Pfizer
 
Managing Entity
Hans Lennernäs
Uppsala Universitet

Consortium Manager
Christer Karlsson
AstraZeneca AB

Financing

This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), resources of which are composed of financial contribution from the EU Seventh Framework Programme and EFPIA companies’ in kind contribution. Large pharmaceutical companies participating in IMI projects do not receive IMI funding. IMI contributed €9.0 million, EFPIA contributed €11.5 million in kind, and other sources contributed €4.0 million, for a total cost of €24.5 million.

Intellectual Property

The IMI intellectual property (IP) policy governs the IP regime of all projects funded by the IMI Joint Undertaking. To assist with specific IP queries, IMI has set up a dedicated IP Helpdesk, which can be contacted by emailing IMI-IP-Helpdesk@imi.europa.eu. The IMI IP policy can be accessed at http://www.imi.europa.eu/sites/default/files/uploads/documents/imi-ipr-policy01august2007_en.pdf

Data Sharing

According to IMI’s IP policy, the participants undertake to disseminate the data as soon as reasonably practicable but not later than one year after the termination or expiry of the project. The project agreement shall include a description of the material, which must be disseminated in accordance with the IP policy and referenced in the grant agreement. If the participants do not disseminate within such time periods without good reason, then the Executive Office has the right to disseminate such results in a manner consistent with the grant agreement.

Impact/Accomplishment

Ultimately, the project will help to facilitate and speed up the formulation development process and to significantly reduce the need for animal experiments in this area as well as human clinical studies in the future.

For patients, the main benefit will be high-quality medicines that have a well-calculated required dose and that are released in a way that consistently provides an optimal clinical effect.

Points of Contact

Bertil Abrahamsson
AstraZeneca AB
Tel: +46 31 7761262
E-mail: bertil.abrahamsson@astrazeneca.com
 
Mark McAllister
Pfizer
E-mail: Mark.McAllister@pfizer.com
 
Hans Lennernäs
Uppsala Universitet
Tel: +46 18 471 4317
E-mail: hans.lennernas@farmaci.uu.se
 
Christer Karlsson
AstraZeneca AB
E-mail: Christer.ha.Karlsson@astrazeneca.com
 
Krister Halldin
Uppsala Universitet
E-mail: Krister.Halldin@uadm.uu.se

Sponsors & Partners

AbbVie Deutshland GmbH & Co. KG

AstraZeneca AB

Bayer Pharma AG

Boehringer Ingelheim International GmbH

Copenhagen University

Ernst Moritz Arndt University Greifswald

GlaxoSmithKline Research and Development Ltd.

H. Lundbeck A/S

Janssen Pharmaceutica NV

Johann Wolfgang Goethe-Universität Frankfurt am Main

Johannes Gutenberg Universität Mainz

Katholieke Universiteit Leuven

Medical Products Agency

Merck Sharp & Dohme Corp

National and Kapodistrian University of Athens

Netherlands Organization for Applied Scientific Research TNO

Novartis Pharma AG

Orion Corporation

Pfizer Ltd.

Sanofi-Aventis Research and Development

Simcyp Limited

Simulations Plus, Inc.

Sirius Analytical Ltd.

University of Manchester

University of Strathclyde

Uppsala Universitet


Last Updated: 04/08/2016

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