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.