ORBITO

Oral biopharmaceutics tools
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FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 4
Grant agreement number
115369

Contributions
IMI Funding
8 975 392
EFPIA in kind
12 360 856
Other
3 403 189
Total Cost24 739 437

Summary

Most drugs are taken orally, as tablets or capsules for example. 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 our understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients.

Predicting performance

The majority of drug products are administered orally, yet designing oral formulations and determining dosages involves a lot of trial and error. Current laboratory tests do not mimic accurately the highly variable and dynamic environment of the human gut, and so their ability to predict the performance of an orally-administered drug in the human body is limited. As a result, researchers rely heavily on tests in animals and clinical studies in humans to verify drug performance, rendering the entire process rather lengthy and expensive. 

The issue is likely to become even more pressing in the future as new drug discovery technologies are increasingly delivering active drugs that are very hard to put into simple oral formulations, for example because they are hydrophobic, have low aqueous solubility, and/or variable uptake in large intestine.

There is therefore an urgent need for improved tools to predict the performance of orally-administered drugs.

From trial and error to rational models

The ORBITO project aims to tackle this problem at all levels, beginning with improving our fundamental understanding of the gastro-intestinal absorption process. This information will be integrated into the development of new (or refinement of existing) laboratory tests and computer-based methods that will deliver more accurate predictions of drug product behaviour in real life. The new methods will be validated with the use of industrial data and material. Crucially, the project will set up a framework to guide the use of these new tools in drug development.

What sets ORBITO apart from other projects is the way it will integrate data from many existing studies while also initiating new studies that will generate better data. By combining existing data with new data, and by bringing together so many different partners, it has a good chance of achieving its goals.

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

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

Achievements & News

Drug delivery project ORBITO wins prizes at major conference
Scientists from IMI project OrBiTo hit the prize jackpot at the annual meeting of the American Association of Pharmaceutical Scientists (AAPS) in Florida recently. ### The AAPS meeting is the world’s largest pharmaceutics conference. ORBITO’s prize winners were:
- Andrés Olivares-Morales of the University of Manchester, UK scooped an AAPS Graduate Student Research Achievement Award in Pharmacokinetics, Pharmacodynamics and Drug Metabolism and Clinical Pharmacology and Translational Research.
- Philip Jonas Sassene of the University of Copenhagen won an AAPS Lipid-Based Drug Delivery Graduate Student Award.
- Bart Hens of the University of Leuven won second prize in the AAPS Oral Absorption Focus Group Graduate Student Poster Award.
OrBiTo was highly visible at the conference; the project had a total of seven posters on display, and a symposium featuring speakers from the project was live-streamed via the internet. The goal of OrBiTo is to enhance our understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients.

OrBiTo Open Science Day 1st July – ‘Beyond the BCS based biowaivers’

The OrBiTo project plans an Open Science Day with a regulatory focus entitled ‘Beyond the BCS based biowaivers’. The event takes place Wednesday 1st July, 09.00-18.30 in Chilly Mazarin, France, during the three day 2015 OrBiTo annual meeting. ###Participants will come from EFPIA partners, universities and SMEs as well as scientists from outside of OrBiTo and regulatory agencies. The ORBITO project aims to enhance our understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients. More information about the Open Science Day is available through the following sources: 
- Event flyer and speakers list
- Programme 
- Registration 
(May 2015) 

Participants Show participants on map

EFPIA companies
  • AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany
  • AstraZeneca AB, Södertälje, Sweden
  • Bayer AG, Berlin, Germany
  • Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • Bristol-Myers Squibb Company , Princeton, NJ, United States
  • Glaxosmithkline Research And Development LTD, Brentford, Middlesex, United Kingdom
  • H. Lundbeck A/S, Valby, Denmark
  • Janssen Pharmaceutica NV, Beerse, Belgium
  • Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States
  • Novartis Pharma AG, Basel, Switzerland
  • Orion Corporation, Espoo, Finland
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Research and Development, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
  • Ernst Moritz Arndt University Greifswald, Greifswald, Germany
  • Johann Wolfgang Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany
  • Johannes Gutenberg Universitaet Mainz, Mainz, Germany
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • Københavns Universitet (University of Copenhagen), Copenhagen, Denmark
  • Medical Products Agency, Uppsala, Sweden
  • National & Kapodistrian University of Athens, Athens, Greece
  • Netherlands Organization for Applied scientific Research TNO, Den Haag, Netherlands
  • Simcyp Limited, London, United Kingdom
  • The University of Manchester, Manchester, United Kingdom
  • University of Strathclyde, Glasgow, United Kingdom
  • Uppsala universitet, Uppsala, Sweden
Small and medium-sized enterprises (SMEs)
  • Simulations Plus, Inc., Lancaster, United States
  • Sirius Analytical Ltd, Forest Row, United Kingdom
Third parties
  • TNO Triskelion, Zeist, Netherlands
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz, Germany

CONTACT

Project coordinator
Bertil Abrahamsson
AstraZeneca AB
Bertil.Abrahamsson[at]astrazeneca.com
Managing entity
Hans Lennernäs
Uppsala Universitet
hans.lennernas[at]farmaci.uu.se