BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
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Pharma and Biotech


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  • 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

Clinical Labs


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  • 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​

Investors and Tech Appraisals 


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  • 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
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All Rights Reserved.
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us