Consulting Team
Boston | San Diego | San Francisco
Consultants
Subject Matter Experts | Consulting Agreements (under NDA), CVs & Certifications On File for Audits | Interface Directly with Clients
Ryan Ice, PhD
Translational Science, Preclinical to Phase 2
PhD, Cancer Cell Biology
School of Medicine, West Virginia University, West Virginia
BS, Biological Sciences
Vanderbilt University, Tennessee
ryan.i@boudiccadx.com
Based in San Francisco
- 13+ years translational science experience from pre-clinical stage to Phase 2 clinical trials designing & implementing biomarker strategies, translational data generation, preclinical and clinical assay troubleshooting, pharmacokinetic & pharmacodynamic analysis, and in vitro and in vivo models for drug discovery
- Supports preclinical research, early-stage translational research
- Supports exploratory research laboratories testing human clinical trial specimens with GCLP compliance. Success story: helped Biopharma bring ADA screening in-house in under 30 days!
- Executes Research Use Only (RUO) promotional labeling reviews to mitigate FDA warning letters. Success story: identified clinical claims on RUO product websites & provided recommendations for removal/rewording
- Develops patient selection/eligibility assays. Success story: supported 4 immunohistochemistry assays & executed cut-off analysis to determine the best cut-off to use for the clinical trial
- Participates in audits; reviews all technical documentation (validation data), and inspects molecular laboratories to ensure compliance with best practices for molecular testing. Success story: identified a specificity issue that could have resulted in false positives being enrolled into a clinical trial
- Deployed to global laboratories to set up new biomarker testing
- Animal-based techniques (long term voting member of Institutional Animal Care & Use Committee (IACUC) committee member)
- Supports IRB submissions for clinical research & biobanking.
Mariano Severgnini, PhD
Clinical Biomarkers & Companion Diagnostics
PhD, Health Sciences
Universidad Católica de Córdoba, School of Medicine, Argentina
BS, Biology
Universidad Nacional de Córdoba, Argentina
mariano.s@boudiccadx.com
Based in Boston
- 20+ years working in clinical oncology, biomarker discovery, translational strategy, clinical trial and correlative studies in heme and solid tumors, chronic and acute pulmonary inflammation
- Managed 80+ clinical trials at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute at Harvard Medical School (Dr. Hodi laboratory)
- Supports clients with clinical biomarker development for both non-oncology and oncology
- Reviews all client clinical biomarker documentation
- Supports identification of prognostic and predictive biomarkers to support therapeutic clinical development & works closely with strategic alliance bioinformatics partners
- Prepares clinical biomarker regulatory submissions
- Supports acquisition of CLIA LDT & EU in-house testing information for regulatory submissions. Success story: generated information gathering workflows and documentation templates for Biopharma
- Supports LDT & IVD regulatory submissions & evaluates analytical & clinical data. Success story: identified a key performance issue for a heme MRD assay
- Works with US CLIA & EU clinical laboratories to set up clinical trial testing
- Reviews EU IVDR performance evaluation applications
- Supports CDx co-development; develops CDx strategy & identifies CDx partners
- Travels to global laboratories to set up clinical biomarker testing
David Liu, PhD
Quality & Regulatory Compliance
PhD, Chemistry
University of Florida
BS, Chemistry
University of North Carolina
ISO 13485:2016 Lead Auditor (TPECS)
david@boudiccadx.com
Based in San Diego
- 12+ years of leadership experience in quality assurance, quality management system, & regulatory affairs
- Supports IVD premarketing submissions (breakthrough device designations (BDDs), pre-submissions & IDEs). Success Story: spearheaded & successfully granted FDA BDD for a liquid biopsy assay designed to detect cancer at an early stage.
- Establishes & implements quality systems, policies, and procedures to comply with FDA, ISO, and other applicable regulatory & quality requirements. Success Story: implemented a quality system from scratch & successfully obtained ISO 13485 certification for an emerging IVD start-up.
- Supports clients with quality and regulatory compliance, including gap analysis and establishment of compliance with 21 CFR Part 820, ISO13485, ISO9001, & ISO15189, & ISO 14971 (Risk Management)
- Supports technical file review and compilation, including EU Technical File, FDA Design Dossier, DHF, DMR, DHR. Success Story: Managed technical files for multiple product types, including CLIA LDTs, RUOs, and CE-IVD.
- Travels to clients for gap analysis & audits
Dario Cabrera, MBA
Commercial Insights & Business Development
MBA
Carnegie Mellon University
MA, Biochemistry
Harvard University
BS, Biochemistry
Arizona State University
dario@boudiccadx.com
Based in Boston
- 12+ years in Biopharma & Biotech focused on competitive intelligence & opportunity assessment
- Led market research and competitive intelligence efforts at Curis, Inc., guiding strategic decisions for oncology drug development & identifying new market opportunities
- Managed global forecasting & conducted in-depth scenario analyses for ADC assets at Daiichi Sankyo, informing commercial strategies & global brand positioning
- Provided strategic insights for hematology-oncology brands at Bristol Myers Squibb through actionable, data-driven product sales forecasts as well as comprehensive market analysis & competitive landscape assessments.
- Developed & launched innovative products in synthetic biology at GenScript, using market research and competitive analysis to drive product strategy
- Negotiated technology transfer agreements at MIT, facilitating successful collaborations with researchers & industry partners
- Conducted early-stage market research at Selecta Biosciences, identifying potential licensing & partnership opportunities in nanoparticle-based therapies
- Supports clients with commercial strategies & analytics, business development, competitive intelligence, & market research
- Supports clients with indication prioritization based on market needs, global market mapping, & biopharma lead generation to support the pursuit of biopharma partnerships
