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PBPK Modeling White Paper Working Group (Author & Review Teams)

Formed in response to exchange with FDA.  The goal is to present industry best practices for PBPK modeling to serve as a reference for future PBPK modeling regulatory guidance.
General Opportunities for Successful & Impactful Application in Drug Development

• Increase in knowledge of the system (e.g. enzymes and transporters)

• Increased collaboration to advance capabilities (e.g. Orbito consortium on absorption)

• Rapidly improving software tools requires increasing level of expertise among preclinical, clinical & modeling & simulation

scientists

• PBPK modeling facilitates collaborative working within companies to deliver impactful decisions & optimize drug development

• PBPK modeling supports effective regulatory interactions

Milestones (information current as of April 2015)

• March 10, 2014 - FDA Public Workshop : “Application of Physiologically-Based Pharmacokinetic Modeling To Support Dose Selection”
– https://federalregister.gov/a/2014-02883

• June 30, 2014 - ABPI and MHRA : “MISG New Technologies Forum on physiologically based pharmacokinetic (PBPK) modelling and simulation”
– http://www.abpi.org.uk/our-work/library/medical-disease/Pages/190914.aspx
– http://www.abpi.org.uk/our-work/library/medical-disease/Documents/pbpkmodelling.pdf

• November 14, 2014 - IQ White paper accepted for publication.  Published as:
Jones, H. M. et al. (2015). "Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective." Clinical pharmacology & Therapeutics 97(3): 247-262.