MNM Bioscience (2020-2022), Out-licensed technology to IVD developer.
Kelly Gordon, PhD, MB(ASCP)CM, RAC-Devices Founder & CEO
Dr. Gordon founded the precision medicine consulting firm in 2015 with the goal to streamline precision medicine product development to get products to patients faster. Dr. Gordon leads both the United States (Boudicca DX™, LLC) & European Union (Boudicca DX™ Limited) consulting operations as a dual citizen.
Dr. Gordon is an ASCP-certified molecular technologist, PhD-trained translational scientist, & RAPS-certified device regulatory affairs expert with hands-on clinical laboratory, diagnostics & pharma industry experience, previously working at HTG Molecular, Kura Oncology, Loxo Oncology, Provista Diagnostics, Roche Tissue Diagnostics (Ventana Medical Systems) & Southern Arizona Veterans Affairs Molecular Dx CLIA/CAP Laboratory. As a consultant to 100+ clients with multiple projects/client for 10+ years, she has supported clients taking novel precision medicine products to global regulatory authorities, including clinical diagnostics, companion & complementary diagnostics, drug development tools, digital health tools (CDSTs & SaMDs), digital imaging software, digital pathology products & novel medical devices.
Dr. Gordon serves on multiple Scientific Advisory Boards for emerging diagnostic companies applying novel AI/ML approaches & is an appointed Scientific and Regulatory Advisor for multiple Small Business Innovation Research (SBIR) and European Innovation Council (EIC) grants currently funding client projects. Dr. Gordon is also a NIH SBIR/STTR application reviewer, participating on review panels for small business applications.
Dr. Gordon is also a fractional regulatory executive for an emerging digital health technology company supporting their clinical and regulatory roadmap for a software capturing real-time patient-reported outcome (PRO) symptom data.
Dr. Gordon has several peer-reviewed precision medicine publications:
- Integration of Serum Protein Biomarker and Tumor Associated Autoantibody Expression Data Increases the Ability of a Blood-Based Proteomic Assay to Identify Breast Cancer
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Role of transforming growth factor-beta superfamily signaling pathways in human disease
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The type III TGF-beta receptor suppresses breast cancer progression
- Loss of type III transforming growth factor beta receptor expression increases motility and invasiveness associated with epithelial to mesenchymal transition during pancreatic cancer progression
Scientific Advisory Boards
Education
- PhD in Pharmacology & Graduate Certificate in Cell and Molecular Biology
- BS magna cum laude, Molecular and Cellular Biology
Postdoctoral Fellowships
- Translational Oncology
- Cancer Biology
Certifications
- RAC-Devices, Regulatory Affairs Professionals Society (RAPS)
- Technologist in Molecular Biology, American Society of Clinical Pathology
Boudicca, the Celtic Heroine
Pronounced “boo·di·kuh”
She who Brings “Victory”
Boudicca was a fierce, determined & strong Celtic leader who was able to inspire & motivate the Celtic tribes to all 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 with a victory.
Precision medicine product development requires a strategic, passionate & decisive heroine like Boudicca DX to quickly navigate & help clients pivot in an ever-changing (global regulations), challenging (budget-restricted, never enough time & resources), and competitive (emerging competing technologies) landscape.
Kelly (from the Gaelic word for “warrior”) was born in Belfast, Northern Ireland during The Troubles & enjoyed visiting Celtic ruins on school trips, learning about warriors & their extraordinary bravery. Kelly immigrated to America when she was 15 years old, two years before the Good Friday/Belfast Agreement was signed & ended The Troubles.
Carlos Murrieta, CFO & COO
Mr. Murrieta oversees day-to-day administrative & operational functions, financials & employee 401(k), cash balance & profit sharing plans.
He has over 10 years of medical device instrumentation development experience with previous roles at Roche Tissue Diagnostics, Bio-Rad, & 10X Genomics. He is an expert in medical device instrument engineering, instrument regulatory documentation & audits, including Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ) documentation procedures, calibration, preventative maintenance & reliability testing. He has over 20 years of manufacturing operations experience managing small & large teams in highly regulated industries (automotive, battery development & medical devices).
Mr. Murrieta has an Associates of Applied Sciences degree in Electronics Engineering Technology from ITT Technical Institute (Tucson, AZ) & is bilingual in Spanish.
Ellie Murrieta, Assistant to CEO
Ms. Murrieta is responsible for all clerical duties (part-time) in the US office.
