Empowering Your Vision

Consulting Solutions for On-demand Biomarker Expertise

About Us
IO Biomarker Solutions is a San Francisco Bay Area–based consulting firm specializing in interim and fractional biomarker leadership for biotechnology and pharmaceutical companies developing immuno-oncology (IO) and targeted cancer therapies.

Our mission is to empower clinical development teams with flexible, on-demand biomarker expertise that translates complex data into actionable insights—driving smarter, faster, and more successful oncology trials.
Unlock Your Potential
To bridge scientific innovation and clinical execution by delivering agile biomarker strategies that guide drug development decisions and improve patient outcomes.

Services

Strategic Leadership

- Interim or fractional biomarker lead for preclinical through Phase 3 oncology programs - Development of biomarker strategies grounded in mechanism of action (MOA), mechanism of resistance (MOR) and clinical hypotheses - Authoring biomarker sections for protocols, INDs, and study reports

Operational Excellence

- Assay and CRO/vendor oversight, including validation, QC, and milestone tracking - Translational interpretation of biomarker data to support dose selection and patient stratification - Cross-functional representation on study teams, advisory boards, and regulatory discussions

Regulatory & Communication Support

- IND and BLA biomarker submission packages - Data visualization and interpretation for internal reviews and investor communications - Expert insights on biomarker risk mitigation and regulatory compliance

Why Choose Us

Over a decade of experience in translational oncology

Deep scientific and clinical knowledge

Flexible, fractional biomarker leadership

Vendor-agnostic assay guidance

Clear, actionable strategies to enable smarter clinical decisions

Contact

  • San Francisco, CA, United States