Cascadia Drug Development Group
Seasoned consulting firm passionate about immunology and therapeutic development that have partnered with Boudicca Dx. on several CDx projects.
Boudicca Dx has strategic alliances to be a precision medicine testing accelerator.
Seasoned consulting firm passionate about immunology and therapeutic development that have partnered with Boudicca Dx. on several CDx projects.
Pathology consulting firm with extensive early-stage clinical biomarker development and late-stage CDx development experience. GoTo when additional pathology advisement is needed.
Participates in all ad hoc client mock regulatory advisory boards with 30+ years of co-development regulatory experience and many regulatory interactions on both the Rx and Dx side.
Bioinformatics consulting firm that have partnered with Boudicca Dx on biomarker discovery projects, indication prioritization, and clinical biomarker development & validation. GoTo for Bioinformatics.
GoTo for IVD Biostatistics Consulting. Has supported LDT and IVD validation studies for 14 years & extensive experience aligning studies with regulators.
Translational Science Consulting supporting all pre-clinical, exploratory, and early-stage translational science projects at Boudicca Dx.
Boutique Cell and Gene Therapy Testing Accelerator. Gene and Cell Therapy development needs more attention given the diverse therapies, biomarker needs & expansive indications. Boudicca Dx and SisuCentric partner on clinical trial testing projects and CDx needs for these complex co-development programs.
Regulatory Lead for all Boudicca Dx. submissions; manages, submits & leads all Boudicca Dx. regulatory submissions with over 30 years of experience submitting 510(k)s, De Novos, PMAs, EUAs, IDEs, & SRDs for IVDs and traditional medical devices.