Industry is always looking for ways to increase the accuracy and efficiency of the research and development process. Physiologically-based pharmacokinetic (PBPK) modelling and simulation is a tool that can help to improve this process. We explored its applications at the ABPI-MHRA MISG New Technologies Forum on PBPK held on 30 June.
One way that industry is innovating to improve research and development (R&D) is in modelling and simulation, which plays an important part in the drug development process. Although the concept has been around for some time, PBPK is an emerging technique that is rapidly gaining traction within the pharmaceutical industry. Its many diverse applications enable it to be used throughout the R&D process, from informing study design and first-in-man dose selection to modelling trial results in paediatric studies. However, this area currently lacks the regulatory guidance required to support and develop its use.
The MISG New Technologies Forum on PBPK offered an exciting and unique opportunity to bring together global regulators (MHRA/EMA, FDA, PMDA), industry, PBPK experts and software companies to strengthen and develop dialogue between user, developer and regulator. Both EU-wide and global perspectives based on science and real experience were presented from industry and regulators to explore current and future use of this tool and to inform best practice and development of future guidance. A meeting report will soon be available on the ABPI and MHRA websites.
The timely nature of this meeting is reflected in the publication of the EMA concept paper on PBPK, now open for consultation. The MISG Forum provided a very constructive platform to initiate discussions in this area and I look forward to continuing these discussions in collaboration with the MHRA.
Dr Louise Leong
Director of R&D Policy