Discovery to Diagnostic Consulting
Innovative Precision Medicine Strategies
About D2Dx
Discovery to Diagnostic “D2Dx” Consulting provides an extensive network of independent consultants who bring first-hand experience and subject matter expertise for precision medicine. Working together, we can provide the optimal support for the ever-changing precision medicine development continuum of biomarker discovery to commercialized precision diagnostics and therapeutics. We not only provide strategic and tactical support but also offer true implementation with both project-based teams and opportunities for fractional or interim executives to support your growing organization.
DISCOVERY & PLANNING
- Technology Evaluation
- RWD/RWE projects
- POC study support
- Biomarker and Competitive Landscape Analysis
CLINICAL DEVELOPMENT
- CLIA Clinical Trial Assay Development and Validation
- Dx Partners Selection
- CTA/CDx Workplan Development and Contract Negotiation
- Patient Identification and site selection strategy
- Regulatory filing strategy
COMMERCIALIZATION
- Commercialization Plan development
- Reimbursement and Payer strategy
- Clinical Utility and Evidence Generation
- Salesforce enablement and RWD/RWE programs
Brian Kelly
Founder and Principal, Discovery to Diagnostic “D2Dx” Consulting
Brian Kelly brings over two decades of experience as a scientific business leader specializing in the application of advanced technologies to Life Science and Clinical Diagnostic markets. His experience includes leading and developing teams for strategic business partnerships, global sales and market development, and biomarker strategy consulting for diagnostic and biopharma.
Brian provides technical subject matter experience in next generation sequencing, microarrays, and real-time PCR technologies for research, clinical trials and commercial diagnostic markets. He provides extensive experience in the diagnostic development and co-development partnerships for companion diagnostics with over 20 formal CDx co-development programs.
Brian has helped lead the technological revolution enabling precision medicine with many well-known organizations such as ThermoFisher Scientific, Life Technologies, Pacific Biosciences, Affymetrix, Bio-Rad Laboratories, and most recently Caris Life Sciences. His scientific background includes research positions at Johns Hopkins University focused on discovery of genetic markers of prostate cancer and molecular mechanisms of angiogenesis in cancer and cardiovascular disease. Brian holds a master’s degree from Johns Hopkins University and a bachelor’s degree from Towson University. His personal ethos is to advance the adoption of precision medicine to support better healthcare solutions for the benefit of all patients.
