MNM Bioscience (2020-2022), Out-licensed technology.
Kelly Gordon, PhD, MB(ASCP)CM, RAC-Devices Founder & CEO
Dr. Gordon founded Boudicca DX™ & is responsible for the overall management and strategic direction of the US (Boudicca DX, LLC) & EU (Boudicca DX Limited) consulting offices as a dual citizen of Ireland and the US.
Dr. Gordon is an ASCP-certified molecular technologist, PhD-trained translational scientist & RAPS-certified device regulatory affairs expert (EU, US, and ROW) 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) & the Southern Arizona Veterans Affairs Molecular Dx CLIA/CAP Laboratory. Dr. Gordon meets the qualifications required to be an EU IVDR and MDR Person Responsible for Regulatory Compliance (PRRC) under Article 15(6).
As a consultant to 140+ 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 several diagnostic company Scientific Advisory Boards (SABs) applying AI/ML approaches & is an Advisor supporting multiple Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR) and European Innovation Council (EIC) grants. Dr. Gordon was an invited NIH Committee Member and Reviewer for the National Institute on Aging Special Emphasis Panel SBIR and STTR Applications. Dr. Gordon is also recognized as a CLSI member.
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, limited time & personnel resources), & competitive (emerging competing technologies & companies with bigger budgets) 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, COO
Mr. Murrieta oversees daily operational functions, information technology, human resources & employee 401(k), pension plans, cash balance & profit sharing plans.
Mr. Murrieta 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 English & Spanish. Mr. Murrieta grew up in Nogales, Mexico and moved to the US to attend college.
Ellie Murrieta, Personal Assistant to COO
Ms. Murrieta is a second year high school student responsible for all clerical duties in the US office and supports the COO.
Courtney Hyland, Executive Assistant to the CEO
Ms. Hyland is responsible for Operations in the Limerick, Ireland Office and supports the CEO. Ms. Highland is a dynamic and results-driven sales and marketing leader with over 15 years of experience cultivating, managing, and expanding long-term corporate relationships in the hospitality and health services sectors. Ms. Hyland has extensive experience identifying growth opportunities, negotiating contracts & fostering enduring business partnerships with key stakeholders.
Ms. Hyland holds a Diploma in Public Relations (UCC Irish Academy of Public Relations) and a Diploma in Digital Marketing (Irish Times Training). Ms. Hyland was born in the US and moved to Ireland when she was 3 years old and lives in beautiful County Tipperary.
