MNM Bioscience (2020-2022)
Streamlining the Development of High-Quality, High-Value Precision Medicine Testing
Boudicca Dx. streamlines the development of innovative precision medicine testing through strategic technical and regulatory fit-for-purpose consulting services. Over 20 years of assay development experience including AI-informed predictive & prognostic algorithms, circulating tumor cells, digital pathology, genomics, transcriptomics, proteomics, & phospho-proteomics. Assays include Adeno-associated virus (AAV) antibody assays for AAV-based gene therapies, heme & solid tumor profiling tests, gene expression (RNAseq, RT-PCR) for tumor-specific antigens, immunohistochemistry (singleplex & multiplex), multiplex immunofluorescence, in situ hybridization, early cancer detection assays, MRD assays (solid tumor MRD, tumor-naive, & tumor-informed), & infectious disease detection (multiplex respiratory viral panels, including COVID-19).
Kelly Gordon, Ph.D., MB(ASCP)CM Founder
Dr. Gordon is the founder of Boudicca Dx, LLC, a global virtual consulting firm supporting pharmaceutical companies, diagnostic test developers & clinical laboratories with their precision medicine testing strategies. Boudicca Dx. supports all technical & regulatory aspects of test development to significantly reduce costs and timelines to get precision medicines to patients faster.
Dr. Gordon has over 20 years of hands-on experience analytically and clinically validating diagnostic tests, establishing and managing biobanks to support test development, and leading clinical biomarker development programs. Dr. Gordon has an expansive network and can guide CRO, laboratory and diagnostic partnership decisions based on project-specific, fit-for purpose technical and regulatory needs.
Dr. Gordon knows the regulatory pathways for investigational clinical trial assays and marketed in vitro diagnostics and has direct experience developing tests in accordance with CAP, CLIA, NYS-DOH, EU (IVDR), UK, and US-FDA regulations. Dr. Gordon will create the optimal regulatory strategy for your product and is highly skilled in generating high quality, technically strong regulatory submissions to discuss assay development topics with regulators to streamline clinical development. Dr. Gordon is a Subject Matter Expert in analytical & clinical validation & offers technical and regulatory fit-for-purpose training workshops to prepare developers for their regulatory submissions.
Scientific Advisory Board Memberships
Education & Professional Certifications
Postdoctoral Fellowships
Certifications
Boudicca, the Celtic Warrior
A fierce and determined leader who was able to inspire & motivate the Celtic tribes to come together to take bold & decisive action even in the face of adversity to help them work as a team to navigate a Roman rebellion and emerge stronger on the other side.
