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Programme

The Innovative Medicines Initiative (IMI) ORBITO project is a pre-competitive collaboration between pharma, academia and specialist technology companies which aims to enhance our understanding of how orally-administered drugs are absorbed from the gastrointestinal tract and apply this knowledge to develop new in vitro tests and in silico models that will better predict the performance of oral formulations in patients.

The OrBiTo project started in October 2012 and following a twelve-month non-cost extension phase will finish in October 2018. This open meeting will highlight key advances made by the consortium team across the four technical work packages, progress with industrial implementation of tools and the regulatory opportunities for improved guidance on the use of in vitro and in silico approaches for oral biopharmaceutics. The Biopharmaceutics collaborative ecosystem has significantly changed during the period of the OrBiTo programme and we will include updates from groups such as the Pharma IQ working group on dissolution, PEARRL, UNGAP and the FDA US oral biopharmaceutics research programme led by Professor Gordon Amidon.

This meeting is aimed at industrial and academic scientists working in the areas of biopharmaceutics, formulation design, regulatory CMC and analytical development. Scientists who are new to the area will also find the meeting useful for gaining a broad understanding of the key scientific and technical issues relevant to oral biopharmaceutics. Poster presentations are welcomed from all attendees.

Day One – Monday 17th September

11.30 – 13.00 Registration and lunch

13.00 – 13.15 Welcome and Introduction

Session 1 – IMI OrBiTO Scientific progress

13:15 – 14:00 Small-scale in vitro tools to profile biopharmaceutics properties of an API
René Holm, Anette Müllertz
14:00 – 14:45 Dissolution for oral drug products
James Butler, Patrick Augustijns

14:45 – 15:15 Coffee break

15:15 – 16:00 Developing our understanding of GI Physiology
Peter Langguth, Pat Zane
16:00 – 16:45 Physiologically-based Pharmacokinetic modelling
Xavier Pepin, Amin Rostami
16:45 – 17:30 Combined dissolution and permeation
Kerstin Frank, Joachim Brouwers

17:45 – Evening poster session and drinks reception

Day Two – Tuesday 18th September

08:00 – 09:00 OrBiTo Consortium Stakeholder Meeting (restricted attendance)
• OrBiTo operations and office support post Oct-2018

Session 1 (continued) – IMI OrBiTO – Scientific progress

09:15 – 10:00 Supersaturation and precipitation
Sara Carlert, Edmund Kostiewicz
10:00 – 10:45 Integration of dissolution with in silico modelling
Filippos Kesioglou, Masoud Jamei

10:45 – 11:15 Coffee break and poster session

Session 2 – IMI OrBiTO – Regulatory Biopharmaceutics

11:15 – 11:45 Sandra Suarez (FDA)
11:45 – 12:15 Evangelos Kotzagiorgis (EMA)
12:15 – 12:30 Roundtable Q&A

Lunch and poster session

Session 3 – The evolving biopharmaceutics ecosystem

13:30 – 14:15 FDA Oral Biopharmaceutics Research programme (Gordon Amidon)
14:15 – 14:45 Pharma IQ dissolution WG & Food interaction (Filippos Kesisoglou)
14:45 – 15:15 UNGAP (Patrick Augustijns)

15:15 – 15:45 Coffee break

15:45 – 16:15 PEARRL (Jenny Dressman)
16:15 – 17:00 IMI OrBiTo Summary (Hans Lennernäs, Bertil Abrahamsson, Mark McAllister)– impact on biopharmaceutics science, industrial Implementation examples, strengthening the EU biopharm community, developing the skill base, database and future opportunities for collaborative biopharmaceutics research

Posters can be viewed during the meeting with sessions

Day 1

17:45 – Evening poster session and drinks reception

Day 2

10.45-11:15 Coffee break and poster session

12.30-Lunch and poster session

Day 1- for all delegates – 17:45 – Evening poster session and drinks reception

Day 2- for OrBiTo Consortium Members…………..

Final OrBiTo Dinner @ Trinity College, Cambridge.

Event information

Academic

APS Member £175 (ex VAT)

Non-member £225 (ex VAT)

Student

APS Members £60 (ex VAT)

Non-member £75 (ex VAT)

Industry

APS Member £250 (ex VAT)

APS Non-member £300 (ex VAT)

OrBiTo consortium member £ 50 (ex VAT) with Dinner £100 (ex VAT)

Please note that attendance at this event as a non-member includes membership of APS until renewal on 1 April 2019 at no additional cost.

Exhibitors – £500 (Ex VAT) includes free delegate place.

AstraZeneca, Cambridge, UK