• Boudicca Dx

    Best-In-Class Precision Medicine Product Development Accelerator

Precision Medicine Product Development

Immediate & actionable guidance on developing & validating precision medicine testing products & innovative medical devices spanning diverse applications with over a decade of experience developing testing for clinical biomarkers, clinical laboratories (LDTs), IVD manufacturers (kits & single-site IVDs), & innovative medical devices (digital health, digital pathology & medical imaging).

Clinical Biomarker & Companion Diagnostic Development

Pragmatic clinical biomarker & CDx co-development guidance based on extensive Biopharma CDx experiences, direct IVD industry CDx know-how, deep assay development technical acumen & contemporary CDx regulatory insights across diverse biomarkers, specimen types, technologies & indications.

Global Precision Medicine Regulatory Strategy

Deep regulatory insights & intelligence from global Rx & Dx product development experiences, regulatory submissions for global clinical trials, IVDs & medical device regulatory marketing submissions.

Best-In-Class Consulting Team

Global precision medicine product development accelerator with a best-in-class united team of affiliate consultants & strategic alliance partners that is immediately deployed to help clients deliver first-in-class precision therapies & high-value, high-quality, regulatory compliant precision medicine testing & medical devices to patients faster.  Clients include biopharma, biotech, clinical laboratories, consulting firms, digital health developers, digital pathology developers, investment firms, IVD developers, professional medical associations & life science research companies.

Founding of Boudicca Dx

Kelly Gordon, PhD, MB(ASCP)cm, RAC-Devices founded the consulting firm in 2015 with the mission to help clients streamline their precision medicine product development to get life-changing products to the market faster. Science is the foundation of precision medicine and coupling it with efficient quality and regulatory approaches with a focused clinical & commercial strategy enables high-quality, high-value, life-changing precision medicines, testing & medical devices to get to patients faster.

This is the framework for Boudicca Dx: a united team of affiliate consultants & strategic alliance partners, who are qualified & trained subject matter experts that provide immediate actionable expert guidance to seamlessly guide clients on their precision medicine product development.

What others say about us…

​Dr. Kelly Gordon and I have worked together on several diagnostic development projects over the past 5 years, and her scientific, regulatory and strategic experience provided the guidance necessary for the success of the biostatistical support that I provided. She is smart, forward-thinking and understands the landscape. Her ability to communicate with her clients and her team members is outstanding. She is dedicated, attentive to details and is vested in the work she undertakes. I look forward to many future collaborations with Kelly.

I have known Dr. Gordon for about 5 years. We worked together at Ventana where it became clear that Dr. Gordon’s knowledge and expertise in assay development were very strong. Dr. Gordon not only has a strong regulatory and scientific background, but she has the ability to develop assays for a variety of purposes including regulatory approval, CE marking, pharmacodynamics/target engagement, etc. As a consultant, Dr. Gordon is instrumental in helping us with assay development and regulatory strategy for our current program in development. On a personal level, Dr. Gordon is straight-forward and easy to work with – I highly recommend her!

Dr. Gordon and I collaborated together on an IVD development project. Her knowledge of the product development process is strong and multilayered. Dr. Gordon had the exceptional ability to take complicated processes and information and translate it to basic laymen’s terms for my staff to understand. The accuracy and clarity of her analytical and clinical validation reports were thorough and impressive, not to mention on time and underbudget. She is accessible, responsive and very efficient. Furthermore, Dr. Gordon has a robust understanding and comprehension of the LDTs in the clinical laboratory. Dr. Gordon has the unique ability to function in both a research/development and clinical laboratory space. I hope to work with her again soon.

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