
Specialist expertise in in vitro ADME, IVIVE, clearance mechanisms, and DDI assessment to support early de-risking and decision-making in drug discovery.
I am an experienced senior preclinical DMPK and DDI (Drug-Drug Interactions) scientist, manager and consultant working in Drug Development for over 30 years in LifeSciences with both Contract Research and Pharma companies. I am based in Northamptonshire in the UK.
In addition to ADME one of my focused areas in particular, is in the application of modern in vitro techniques to support crucial aspects of modern DMPK requirements including early de-risking and IVIVE, determination of clearance mechanisms and DDI assessment.
I have been fortunate to have developed, managed and led numerous R&D DMPK groups and have extensive experience of scientific and regulatory consultancy, development of strategic marketing, revenue building (inbound and outbound), business development and client management (Europe/International Overseas - USA/Japan)for all aspects of DMPK, DDI and ADMET.
I have worked on numerous successful NDAs and regularly give webinars and presentations at Scientific meetings and to clients F2F on the critical aspects of Regulatory DMPK: ADME, DDI, MIST (Metabolites In Safety Testing) and DILI(Drug Induced Liver Injury).
I author the appropriate sections for BBs, CTAs, IND (2.6.4/5) and IBs.
My previous positions, all within DMPK, have included:
In these roles I have worked with many different companies on a wide variety of molecules (small, large, hybrid eg. ADC) and have been part of various IND and NDA teams.
In particular, I am expert in Cannabinoid(s) DMPK and their DDI assessment(s).