Consulting Services

Pharma and Biotech

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

Evaluate Diagnostics and Drug candidates for investment, asset prioritization, and mergers & acquisitions.
Evaluate tech’s unmet need, landscape and market opportunities
Guide establishing competitive product target profiles and pricing