MNM Bioscience (2020-2022), Out-licensed technology to IVD developer.
Kelly Gordon, PhD, MB(ASCP)CM, RAC-Devices Founder & CEO
Dr. Gordon founded Boudicca DX™ & oversees US (Boudicca DX, LLC) & EU (Boudicca DX Limited) consulting operations as a dual citizen.
Dr. Gordon is a ASCP-certified molecular technologist, PhD-trained translational scientist, & RAPS-certified device global regulatory affairs expert with hands-on clinical laboratory, diagnostics & biopharma industry experience 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 130+ clients with multiple projects/client for 10+ years, she has taken 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 software & medical devices.
Dr. Gordon is appointed to emerging diagnostic company Scientific Advisory Boards applying AI/ML approaches & is an Advisor for multiple Small Business Innovation Research (SBIR) and European Innovation Council (EIC) grant recipients. Dr. Gordon is an invited panel reviewer for:
- National Institute On Aging Special Emphasis Panel SBIR/STTR Phase I and II applications
- Small Business SBIR/STTR Commercialization Readiness Pilot (CRP) Program applications
Dr. Gordon has published several peer-reviewed precision medicine manuscripts:
- 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 & emerge stronger on the other side with a victory.
Precision medicine product development & commercialization 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), & 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 operational functions, financials, human resources & 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 (Ventana Medical Systems), Bio-Rad, & 10X Genomics working on 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, Personal Assistant to COO
Ms. Murrieta is responsible for all clerical duties (part-time) in the US office.
EU Office Manager & Executive Assistant to CEO
Manages Limerick, Ireland Office & Supports CEO
