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Unlocking Discovery and Enabling Clinical Evaluation: Predicting Human Pharmacokinetics and Dose

This webinar will cover strategy and methodology for predicting human PK evolving from a discovery to a First in Human setting.

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Agenda: 

1. Intro to human extrapolation. Why? When? The Value.
   • Different approaches to predictions, including PBPK's role in discovery and in FiH predictions
   • Model evolution: Discovery to clinic to filing
   • Regulatory guidance awareness
2. Core data requirements for an extrapolation
   • Physchem, ADME (Volume), and tissue composition
   • Clearance
   • Absorption (modelling)
   • Fa, Fg, Fh
   • Transporters
3. Case study
   • Simple extrapolations
   • PBPK model development and assumptions
   • Utility of model (DDI predictions, concs drive PKPD model, and dose predictions)

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Moderated by: Chris Bode, Ph.D. - VP Scientific and Corporate Communications at Absorption Systems, a Pharmaron company

Speakers:

Hannah Jones - Vice President, Head of PBPK Consulting Services at Certara UK Limited, Simcyp Division

Hannah Jones is the Vice President of PBPK Consulting within the Simcyp Division of Certara.  In this role, Hannah leads a team of approximately 30 PBPK consultants who support discovery and development programs using the Simcyp Simulator.  In particular, Hannah and her team use the Simcyp Simulator for human PK prediction, DDI prediction, special population prediction and biopharmaceutics modelling. 

Hannah previously worked at Pfizer Inc, Cambridge, MA, US, Pfizer Ltd, Sandwich, UK and at F. Hoffmann La Roche, Basel, Switzerland. Her roles at Pfizer and Roche focused on modelling and simulation of human pharmacokinetics and pharmacodynamics for discovery and early development small and large molecule compounds.  Hannah received a BSc (Hons) in Pharmacology and a PhD in Drug Metabolism from the School of Biological Sciences and the School of Pharmacy at the University of Manchester, UK, respectively. Hannah is particularly interested in the mechanistic modelling of pharmacokinetics and pharmacodynamics and has many research publications in this area.

Simon Taylor - Vice President, DMPK at Pharmaron 

Simon Taylor is Vice President of DMPK and is based in Hoddesdon, UK.  He is responsible for DMPK/ADME and PKPD strategy for Pharmaron’s integrated drug discovery projects from early discovery through to IND submission. Prior to Pharmaron, Simon worked at GSK for 20 years leading DMPK and Quantitative Pharmacology teams and projects from the Hit Identification stage through to Phase 2.  He has worked across respiratory, inflammation, oncology and cardiovascular therapy areas with drugs of varying routes of administration.  Simon is a committee member of the DMDG and has tutored on the DMDG ‘PK in discovery’ course since 2010.

Simon has a BSc in Pharmacology from the University of Leeds and an MSc in Model Based Drug Development from the University of Manchester.  He has co-authored over 30 scientific publications in the literature.