Bioanalysis in Small Molecule Drug Development
> Designing bioanalytical strategies from early development up to submission for marketing authorisation (e.g. FDA, EMA)
> Selection of CROs with appropriate capabilities and capacity to meet timelines
> Supervision and monitoring of method development, optimisation, and validation
> Trouble-shooting and data interpretation
> Review of method validation reports
> Review of draft study protocols/plans
> Monitoring of sample analysis
> Interpretation of study data
> Review of draft study reports
> Support with regard to specimen/sample retention and disposal from non-clinical GLP and clinical studies
CRO Monitoring for Small Molecule Bioanalysis
> Transfer of existing bioanalytical methods to bioanalytical CRO
> Monitoring of assay performance at bioanalytical CRO
> Act as liaison between pre-clinical/clinical team and bioanalytical CRO
> Monitor data delivery to meet project timelines, perform trouble-shooting, and check data quality
> Review of draft method validation and study reports
> Organisation of audits at CROs (testing facilities/test sites) and act as co-auditor
In vitro ADME Planning
> Planning and interpretation of in vitro metabolism studies (metabolic stability, profiling, and identification)
> Planning and interpretation of in vitro drug transporter studies
> Planning and interpretation of plasma protein binding studies (e.g. equilibrium dialysis with the RED device)
Planning of Drug-Drug Interaction Studies
> Planning and interpretation of in vitro and in vivo drug-drug interaction (DDI) studies
> Which comedications have to be considered in a certain indication?
> Which potential DDIs (metabolism, transporters) have to be considered?
Scientific Writing
> Support in writing submission documents, e.g. non-clinical study protocols (e.g. PK, TK), Investigator’s Brochures, clinical study protocols, lab manuals for the sampling of various matrices, INDs
> Co-authoring of NDA and MAA: eCTD chapters like 2.6.1, 2.6.4, 2.6.5, 2.7.1, 2.7.2
> Review of and support for SOPs and other procedures
Due Diligence Support
> Independent expert review of bioanalytical assay reports, study data reports, data interpretation and conclusions, or relevant submissions documentation
> Assess scientific integrity of data and alignment with Health Authority/Regulatory Agency expectations
> Advise due diligence teams on reliability and significance of data, analysis of gaps, risks, and recommended next steps
Management Consulting
> Support in research facility and laboratory planning and organization
> Risk assessment and support of research institutions in the organization of laboratories, their occupational safety and the legally required periodic inspections
> General corporate resilience optimization (with regard to e.g. epidemics and pandemics, blackouts, and general Black Swan events)
> (Interim) CEO (for Austria also Managing Director in terms of Trade Law for Chemical Laboratories, Gewerberechtlicher Geschäftsführer für Chemische Laboratorien)