Consulting Team
Boston | Mobile | San Diego | San Francisco
Affiliate Consultants
Subject Matter Experts | All Affiliates under NDA | CVs & Certifications On File | Interface Directly with Clients
Ryan Ice, PhD
Translational Science
PhD, Cancer Cell Biology
School of Medicine, West Virginia University
BS, Biological Sciences
Vanderbilt University
ryan.i@boudiccadx.com
Based in San Francisco
Dr. Ice has 13+ years of preclinical & translational science experience designing & implementing biomarker strategies, translational biomarker data generation, preclinical and clinical assay troubleshooting, pharmacokinetic & pharmacodynamic analysis, and in vitro and in vivo models for drug discovery. Supports clients with preclinical research, early-stage translational research & exploratory biomarker research. Supports clients with grant-writing- successfully supported a SBIR grant for a nanoparticle delivery of RNA/DNA/and silencing nucleotides to treat cancer and other diseases.
Mariano Severgnini, PhD
Clinical Biomarkers & CDx
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
Dr. Severgnini has 20+ years of experience working in clinical oncology, biomarker discovery, translational strategy, clinical trial and correlative studies in heme and solid tumors, chronic and acute pulmonary inflammation, managing 80+ clinical trials at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute at Harvard Medical School. Supports clients with clinical biomarker development.
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
Dr. Liu has 12+ years of leadership experience in quality assurance, quality management system oversight, & regulatory affairs. Supports clients with IVD regulatory submissions & establishing & implementing quality systems, policies, and procedures to comply with FDA, ISO, and other applicable regulatory & quality requirements, including gap analysis & establishment of compliance with 21 CFR Part 820, ISO 13485, ISO 9001, & ISO 15189, & ISO 14971 (Risk Management). Supports clients with technical file review and compilation (EU Technical Files, FDA Documentation, DHF, DMR, & DHR).
Dario Cabrera, MBA
Commercial Insights
MBA
Carnegie Mellon University
MA, Biochemistry
Harvard University
BS, Biochemistry
Arizona State University
dario@boudiccadx.com
Based in Boston
Mr. Cabrera has 12+ years working in Biopharma & Biotech focused on competitive intelligence & opportunity assessment. Supports clients with commercial strategies & analytics, business development, competitive intelligence, & market research, including indication prioritization based on market needs, global market mapping, & biopharma lead generation.
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
Mrs. Powers has 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. Supports clients navigating the challenging reimbursement landscape & formulating a reimbursement strategy based on region and NGS-based assay. SupportS clients applying for Z-Codes, preparing MolDX dossiers & technical assessments, including resubmission when necessary.
Alyssa Masciarelli
Clinical Biomarker & CDx Operations
BA, Biology
Assumption College
Based in Boston
Ms. Masciarelli has 5+ years working in clinical biospecimen management in biopharma and large academic research centers. Supports clients with collecting biomarker testing data (e.g., US LDTs & EU in-house testing, & ROW clinical testing), monitoring biomarker testing labs, clinical sample management (biobanking to support clinical bridging if required), clinical sample reconciliation & tracking (clinical sites, clinical laboratories, CROs, & biomarker central testing labs), & clinical study documentation (ICFs, IRBs, ECs, protocols, lab manuals, etc.).
Aviso Group
International Human Resources Consultancy Services
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.
