Kelly Gordon, PhD, MB(ASCP)cm, RAC-Devices, Founder & CEO
Dr. Gordon leads the Boudicca Dx consulting team. She has biopharma, clinical laboratory & diagnostics industry work experience built on top of technical acumen acquired from developing molecular and cellular-based assays to explore the phenomenon of cancer cell epithelial to mesenchymal transition (EMT) during her PhD training (Pharmacology) at Duke University. This is when Dr. Gordon first became captivated by testing biological specimens to understand the underlying biology of disease. She had the opportunity to follow a pancreatic cancer tissue specimen from the operating room (distal pancreatectomy) to the pathology laboratory for testing to ensure the surgical margins were clean.
She believes that every precious specimen that leaves a patient’s body should be maximally used to understand the biology of their disease in order to effectively manage and treat their individual disease.
After two years of postdoctoral training in translational oncology, she built a biobank for Veterans Affairs (VA) clinical research & developed molecular diagnostic LDTs hands-on as a ASCP-certified molecular technologist in a CLIA-certified, CAP-accredited VA laboratory. She published on the development of an early breast cancer detection LDT (Provista Diagnostics CLIA, CAP laboratory) & developed global companion diagnostic (CDx) IVDs working at Roche Tissue Diagnostics (Ventana Medical Systems) so she is familiar with both LDT & IVD requirements & regulations. As an independent consultant, she has taken multiple CLIA LDTs through the single-site IVD FDA process.
She has held several executive roles at precision medicine companies (HTG Molecular, Loxo Oncology, & Kura Oncology) managing clinical biomarker testing & CDx programs.
She was a Scientific Advisory Board (SAB) Member for two AI/ML biomarker discovery platforms (one was acquired & one out-licensed its predictive biomarker signature) and is currently a SAB member for two companies (Cellens and Proteotype Diagnostics) developing tests incorporating novel clinical biomarkers for cancer detection.
She holds a RAPS RAC-Devices certification, demonstrating deep knowledge of global regulatory requirements for medical devices and IVDs.
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
-
Role of transforming growth factor-beta superfamily signaling pathways in human disease
-
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
Postdoctoral Fellowships
Certifications
Boudicca, the Celtic Heroine
Boudicca was a fierce & determined Celtic 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.
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 & no time), competitive (emerging technologies) landscape.
Kelly (from the Gaelic word for “warrior”) was born in Belfast, Northern Ireland during The Troubles & always enjoyed visiting Celtic ruins on school trips. Kelly immigrated to America when she was 15 years old.
Carlos Murrieta, COO & CFO
Mr. Murrieta oversees day-to-day administrative & operational functions, manages all financials & employee 401(k), cash balance & profit sharing plans. He has 10+ years of IVD instrumentation development experience (Roche Tissue Diagnostics, Bio-Rad, & 10X Genomics) and supports clients with instrument engineering, instrument regulatory documentation & audits, including Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ) procedures, calibration, preventative maintenance & reliability testing. He has 20+ years of manufacturing operations experience managing small to large teams in highly regulated industries (automotive, battery development & IVDs).
Associates of Applied Sciences, Electronics Engineering Technology, ITT Technical Institute
For all inquiries, reach out to: carlos@boudiccadx.com, Hablo español
Ellie Murrieta, Office Support Assistant
Ms. Murrieta is responsible for all office clerical duties (part-time) and is a high school freshman.