Independent DMPK consultant: expert support from discovery to Phase I
Independent drug metabolism, pharmacokinetics and drug–drug interaction consultancy from Guy Webber, BSc (Hons), MSc. 30+ years across pharma, biotech and CROs.
Value adding decisions that move your asset forward
I help biotech and pharma teams make strategic, asset-progressing and value-adding decisions using crucial DMPK information. This includes early de-risking analysis, identifying metabolic and DDI liabilities early to aid lead optimisation and candidate selection. Once the lead is selected, I can efficiently design the appropriate study package to progress through IND and CTA for entry into Phase I.
I can work either as an embedded member of your project team, or as an external remote adviser by the hour.
My experience
- 30+ years in DMPK and ADME
- Contributed DMPK/DDI support to 4 successful NDAs, including Epidiolex (NDA team member)
- Senior roles at Quotient Bioresearch (Chief Scientist), ICON PLC (Senior Director), Evotec (Group Leader, Early DMPK), Covance (Scientific Manager), Envigo (Scientific Manager for Metabolism and DDI) and GW Pharmaceuticals (ADME Leader)
- Specialist in cannabinoid DMPK and regulatory DDI
What I do
01
Lead optimisation and early de-risking
Early analysis to assess potential development red flags, highlighting potential DDI, MIST and human idiosyncratic DILI (hiDILI) liabilities.
02
IND/CTA-enabling studies
Regulatory in vitro DDI to ICH M12, metabolite ID, radiolabelled ADME and PK/TK.
03
Regulatory writing and CRO management
IND Modules 2.6.4/2.6.5, IBs, CTAs, briefing books, and CRO selection and management.
