What We Do
Find out what has happened and the plans for the Focus Group.
We’ve run many successful symposia over the years but one of our meetings (November 2017) on the challenges with developing clinically relevant specifications for oral drug products stands out for me. This meeting brought together the many strands of the biopharmaceutics discipline and provided a forum to discuss how our science could be implemented in a regulatory context. The involvement of FG steering committee members in the early planning phase of the OrBiTo programme also enabled this collaborative project to get off the ground quickly. OrBiTo is at the top of my list as an example of how we’ve worked together to advance our understanding of the gastrointestinal tract and develop the next generation of predictive tools for oral absorption.
Details of our most recent meeting:
17th-18th September-Innovative Medicines Initiative (IMI) ORBITO project -AstraZeneca, Cambridge, UK
“5 Years of progress in Oral Biopharmaceutics– IMI OrBiTo project and global biopharmaceutics research”
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.
To build links with special interest groups in kindred organisations and contribute to the development of the global biopharmaceutics community.
Identified by each Focus Group to make a significant contribution to pharmaceutical science in developing medicines
We compiled our list of hot topics back in 2016 but they remain current today:
1. Developing an understanding of the critical biopharmaceutics attributes of molecules with beyond ‘rule of 5’ physicochemical properties.
2. Understanding the factors determining oral absorption and their impact on overall clinical variability – defining opportunities for pre-competitive collaboration post-IMI OrBiTo.
3. Integrating in vitro and in silico tools to improve the prediction of oral formulation performance.
In 2019 we are planning to run two events,
Develop your knowledge on core theoretical principles and the application of biopharmaceutics to aid progression of oral drug development projects. A unique opportunity of a one-day workshop focused on oral biopharmaceutics and the science of oral absorption delivered by a mix of industrial and academic experts with many years of experience.
Developing Clinically Relevant Dissolution Specifications for Oral Drug Products – Industrial and Regulatory Perspectives
This meeting aims to contribute to the longer-term goal of establishing a regulatory framework to guide the development of Clinically Relevant Dissolution Specifications for Oral Drug Products.