BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us

150+ successful consultations and 35+ full-scale projects

We are exceptionally experienced in whole genome/exome NGS with bioinformatics, target genotyping, IHC, ISH, gene expression, liquid biopsy, CTC, flow cytometry, proteomics, and LC-MS

Our Track Record

  • 25+ years of experience in drug and diagnostic industries
  • 2 FDA-approved drugs
  • 5 FDA approvals of high complexity IVD devices
  • 120+ PI-PIV clinical trials
  • 35+ drug discovery programs in immuno/oncology, cardiovascular, immunology, diabetes, and atherosclerosis
  • 7 oncology CDx programs for registration; from strategy to PMA (4 with major IVD providers and 3 as LDT)
  • 10+ due diligence initiatives for M&A, investment and licensing opportunities of drug candidates or diagnostics​
  • Enabled precision medicine initiatives for patient selection in 3 early-phase programs
  • Assay development and validation for 1000+ biomarkers; diagnostic, prognostic, predictive, target engagement, PD, efficacy, and safety
  • Evaluated 100+ CRO and ARO laboratories in the US and worldwide, established relationships and managed 25+ CLIA/CAP labs in different specialties
  • Built and led 2 biomarker and precision medicine functions at a global pharma and a biotech, and assembled and led several cross-functional, multinational and multi-organizational teams
  • Improved quality and result harmonization in 15+ CRO laboratories including within the world’s largest organizations (e.g., Quintiles, Covance, LabCorp, Medpace)
  • 20+ years of experience in GCP, GCLP, FDA and EMEA regulations and guidelines
  • Enabled 6 biotech and clinical & toxicology laboratory startups; from design to operation including obtaining CLIA/CAP (or COLA) licenses and serving as part-time lab director/consultant of the labs
  • 20+ governmental and public expert panels & advisory boards in the US, Canada and EU
  • 30+ master service agreement (MSA) and master collaboration agreements (MCA), which led to successful collaborations between pharma, CRO labs and diagnostic providers
  • 25+ committees to create guidelines promoting quality and enhancing clinical and laboratory practices worldwide
  • 10 ex-vivo experimental medicine studies which expedited clinical development in oncology, cardiovascular, and sepsis; from planning to execution and interpretation
  • 15+ investigator-initiated research (IIR)/collaborative trials with NCI, CITN and 10+ top academic institutions
  • Licensed in NY, NJ, FL and TN as clinical lab director in clinical chemistry, molecular pathology, toxicology, oncology markers, immunology, endocrinology, hematology, bioanalysis, others
  • Rescued 2 mega PIII trials by resolving multiple critical technical and regulatory issues
  • 1 of 4 triple-board certified clinical lab professionals in the US (Molecular Diagnostics, Clinical Chemistry, Toxicology)​
  • First to uncover acclaimed cytokines multiplex device as a hoax (as confirmed by the FDA 5 years later); qualified an alternative for a sepsis trial
  • Reduced enrollment failure in 4 oncology pivotal trials by ~50% and achieved prospective genotyping in 98% of samples
  • Qualified point-of-care systems for 2 PI and 2 double-blind mega global trials for patient selection and monitoring​
Copyright ©2018 BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
All Rights Reserved.
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us