DMPK Consulting Services

Professional Consulting for Drug Metabolism and Pharmacokinetics

Guy Webber,BSC, MSc (Dist):

Senior Director for DMPK and DDI assessment with 30+ years experience in drug development with both Pharma/Biotech and CROs. Based in Northamptonshire, UK
‍
Senior roles at:

ICON Plc, Evotec, Covance (now Fortrea), GlaxoSmithKline (GSK), Quotient Bioresearch (now Pharmaron), GW Pharmaceuticals (now Jazz Pharma) providing integral support and guidance to multiple successful NDAs

Contact me

Providing either dedicated embedded project support or consultancy and advice by the hour.

Experienced and focussed DMPK support from drug discovery, early de-risking and lead optimisation through to IND and Phase 1.

Lead Optimisation

Early Studies to assess:
  • De-risking away from known development red flags (DDI risks, MIST alerts and DILI potential)
  • Metabolic clearance (CLint) and metabolic pathways
  • Plasma/blood protein binding (Fu)
  • Early dose2man (IVIVE/C) estimation
  • CYP/other DME/Transporter interactions

IND Pathway

Regulatory Support Studies to assess:
  • Pharmacokinetics and toxicokinetics
  • Comprehensive in vitro DDI assessment in compliance with ICH M12 guidance(s)
  • Biotransformation and metabolite identification and pathways
  • GLP Bioanalytical method development (required for TK)
  • Radiolabelled ADME studies

Regulatory support:

  • Authoring of nonclinical regulatory documents including BB, IND (sec 2.6.4/5), CTA and IB
  • CRO selection and study management
  • Data/gap fill review(s) and interpretation

Custom Radiosynthesis:

  • Advise on specialist custom radiosynthesis providers
  • Advice on most appropriate position for radiolabelling with most appropriate isotope (14C/3H)
  • Design strategic studies to maximise the application of this valuable material
Contact me

About Me

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 Life Sciences with both Contract Research and Pharma companies. I am based in Northamptonshire in the UK.

I’m happy to work as an embedded external team member taking project ownership or by ad- hoc consultancy on an hourly basis as and when needed.

One of my focused areas in particular, is in the application of modern in vitro techniques to support crucial aspects of modern DMPK requirements, particularly early de-risking and optimisation through to Regulatory DDI assessment and other IND-enabling studies.

I have developed, managed and led numerous R&D departments 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 supported numerous successful NDAs and regularly give webinars and presentations at Scientific meetings and to clients F2F on the critical aspects of Regulatory DMPK: ADME, Biotransformation, 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.

In particular, I am expert in Cannabinoid(s) DMPK and their DDI assessment(s).

‍