Consulting Team
Boston | Mobile | San Diego | San Francisco
Affiliate Consultants
Subject Matter Experts | All Affiliates are 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.
Emily Powers MLS(ASCP)CM
Revenue Cycle Management Specialist
BS, Clinical Laboratory Science
University of South Alabama
BA, Religious Studies
Loyola University
Based in Mobile
- 15+ years of clinical laboratory experience (Revenue Cycle Management, Quality Assurance, & Clinical Analyst) including positions at Velsera (one of the largest -omics analytics providers), Synergy Laboratories, & University of South Alabama Medical Center.
- Support clients navigating the challenging reimbursement landscape of NGS-based clinical diagnostics.
- Support clients formulating a reimbursement strategy based on region and assay.
- Support clients applying for Z-Codes, preparing MolDX dossiers & technical assessments. Success Story: Assisted clients in achieving successful Technical Assessments and premium pricing for multiple Comprehensive Genomic Profiling and Inherited Cancer assays.
- Support clients preparing for Technical Assessment resubmission when necessary.
- Molecular Laboratory experience includes automated nucleic acid extraction, RT-PCR, Saliva Direct, Roche Cobas 6800 assays, NGS assays performed on Illumina NextSeq 550Dx platform.
- Histology Laboratory experience including FFPE block preparation, microtomy, H&E staining, special stains and immunohistochemical staining.
- Clinical Laboratory experience including automated liquid handlers, LC-MS/MS (toxicology), routine chemistry, hematology, coagulation, immunohematology, and microbiology.
Advyzom, LLC (Acquired by Danforth Advisors, LLC)
Leading boutique consulting company specializing in highly strategic regulatory and development advice and services for the biotechnology, pharmaceutical and healthcare industry. Experienced leaders in regulatory affairs and drug development and provide US and Global Regulatory strategy for development programs. Support Fast Track Designation, Breakthrough Therapy Designation, Orphan Designation, Rare Pediatric Disease Designation, and Qualified Infectious Disease Product Designations and lead all aspects of IND, BLA, and NDA filings and review.
CE plus – a division of regenold GmbH
Preferred Partner for EU IVDR regulatory strategy & execution (EU authorized representative). Experience with both clinical trial testing regulations & commercial phase (CE marking) & have established relationships with Notified Bodies & Competent Authorities.
Stat4ward, LLC
Partner for biostatistical consulting services; extensive experience with CDx, novel IVDs, CLIA LDTs, & regulatory submissions.
Cascadia Drug Development Group
Preferred Partner for immunology and therapeutic drug development; have partnered on multiple CDx projects.
Commercialization Partners for Go-to-market Strategies
Partnerships with marketing consultants/firms with specific domain expertise.
CDx Pathology, PLLC.
Preferred Partner for pathology consulting.
Molecular Diagnostics Consulting, Inc.
Preferred Partner for regulatory advisory boards; 30+ years of Rx & Dx co-development regulatory experience.
NxGen BioStats, LLC
Preferred Partner for biostatistics support.
SisuCentric, LLC
Boutique Cell and Gene Therapy Testing Accelerator.
