TAKING TIME AND COST OUT OF CLINICAL DRUG DEVELOPMENT

Garner Consulting provides specialist consultancy services in pharmacology and toxicology to small and large pharma and biotech companies as well as academia.

Specialist services include the following;

• Review and interpretation of genetox studies and recommendation of programmes to meet international regulatory requirements
• How to address issues of drug DNA and protein binding in preclinical and clinical studies
• Study designs for human ADME / PK studies to address regulatory guidances or guidelines such as a) the US FDAs ‘Safety Testing of Drug Metabolites, 2008’ b) the US FDAs draft guidance on ‘Drug Interaction Studies — Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations, 2012’ 3) the EMA’s ‘Guideline on the Investigation of Drug Interactions, 2012 4) ICHM3 R2 ‘Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, 2009
• Programme management for the conduct and sourcing of suppliers for;
  • Human Phase 0 microdose studies to include radiochemistry, preclinical toxicology, clinical and bioanalysis using AMS, LC/MS or other appropriate analytical method
  • Preclinical and clinical mass balance / metabolite profiling studies
  • Intravenous pharmacokinetics including determination of Absolute Bioavailability, renal and faecal excretion and identifying the role of the liver and gut in overall PK
• Human ADME / PK study reviews in particular to address regulatory questions or to provide answers to problems arising from such studies
• Putting drug development research programmes together between academic institutes and SMEs and seeking funding