- Device strategy for biomarkers and precision medicine (PM)/companion diagnostic (CDx)
- Guide decision making to pursue universal IVD manufacturer or lab-developed-test as CDx provider
- Qualify, negotiate, and manage third party laboratory and IVD partners
- Audit third party labs and IVD providers
- Assess strengths, weaknesses, opportunities, and threats (SWOT) for CDx and advise on product target profile
- Plan and manage CDx bridging studies
- Advise on clinical trial design from translational medicine aspects for POC, POM, efficacy, and safety assessment
- Plan, manage, and interpret results from studies for therapeutic target and biomarker discovery
- Ensure assay/technology validity for its purpose
- Enable mitigation of biological, pre-analytical, analytical, and post-analytical variables; establish lab manual for sample acquisition, processing, storage, and handling
- Adjudicate, analyze, and present clinical biomarker data for exploratory purposes or go/no-go decisions
- Review and advise on preclinical data robustness and its commutability to clinic
- Conduct due diligence and product assessment for in-licensing and M&A
- Advise on organizational structure of biomarker, translational medicine, and precision medicine functions, as well as build/ buy/ally growth strategies
- Guide startups from plan to operation, including obtaining required certifications and accreditation
- Direct CLIA labs with different specialties nationwide
- Enable established organizations to introduce new lines of service (e.g. bioanalysis, pharmacogenomics and other molecular diagnostics, abuse-deterrent-formulation testing)
- Support assay development and validation, and implementation of efficient QC/QA tools including proficiency testing
- Lead lab compliance, resolve emerging QC/QA or regulatory issues, and implement corrective action-preventive action (CAPA) plans
- Enable labs to meet pharma/biotech expectations in biomarker/bioanalytical services and CDx development
- Guide lab engagement with pharma/biotech and CRO for clinical trial sample testing and CDx development
- Improve lab efficiency and profitability by maximizing utilization of resources and implementing Lean Six Sigma