Orbito Progress update June 2016

Below is a brief summary of Orbito achivements July 2015 to June 2016.

  • OrBiTo has had its most productive year so far by means of submission of about 40 manuscripts to international high impact pharmaceutical journals with contribution from all work packages (accepted papers listed on www.orbitoprojects.eu).
  • There has also been extensive dissemination through presentations by invited and short presentations at international scientific meetings with a dedicated OrBiTo session at the major pharmaceutics conference last year, American Association of Pharmaceutical Sciences (AAPS) annual meeting, a meeting that gathered several thousands of participants.
  • There has been focused interactions with European and US regulatory bodies regarding possible future use of predictive tools and approaches developed within OrBiTo for example to reduce number of clinical bioequivalence studies. A paper has been submitted on this topic with contribution both by OrBiTo scientists and leading scientists at regulatory bodies. A series of webinar has also been started where OrBiTo results are presented for scientists at European and US regulatory authorities which has generated very positive feed-back from regulators.
  • “Young OrBiTo”, consisting of PhD students and post-docs in the project, has successfully been organising webinar sharing “hot off the press” new science within OrBiTo as well as a poster session at the annual OrBiTo face to face meeting. Finally, three research awards were granted to “Young OrBiTo scientist” at the AAPS annual meeting!
  • A brief survey among EFPIA partners has revealed a significant number of examples of early implementation of OrBiTo deliverables in the industrial process. For example, the standardised experimental protocols developed in WP1 and 2 have been implemented in several companies.  Enhanced physiological understanding generated in WP3 has been used for refinement of internal in vitro test and in silico modelling approaches.  The database generated in WP4 has been used for internal validations and as a source to enhance the learnings from experience. Finally, the output from OrBiTo has also been used to increase knowledge internally and build confidence with stakeholder regarding replacing in vivo studies with in vitro/in silico based predictive tools.