Strategic Alliance Partnerships

Affiliate Consultants

Based in Boston, San Diego, and San Francisco

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, Nashville, Tennessee

ryan.i@boudiccadx.com

Based in San Francisco

Over 13 years of on-hands experience in oncology translational science 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 Boudicca Dx. clients with preclinical research, early-stage translational research and early clinical biomarker development; review plans, reports, and manages project deliverables
Supports Boudicca Dx. clients with set-up of exploratory research (RUO) laboratories testing human clinical trial specimens that comply with relevant GLP & GCP regulations (Biopharma internal laboratories, IVD developers, & clinical laboratories); provide all compliance documentation & guidance. Success story: set-up all required compliance infrastructure for Biopharma to bring ADA screening in-house in 30 days!
Supports Boudicca Dx. Research Use Only (RUO) promotional labeling reviews to ensure regulatory compliance & mitigate receiving FDA warning letters. Success story: identified clinical claims on RUO product websites & provided immediate recommendations to client.
Supports Boudicca Dx. clients with developing early stage patient selection/eligibility assays. Success story: supported 4 immunohistochemistry (IHC)-based clinical trial assays & associated analysis for clinical trial cut-off decision
Supports Boudicca Dx. CLIA laboratory clients with Final FDA LDT rule compliance; evaluates CLIA analytical validation reports, identifies gaps & provides recommendations for alternative FDA-authorized reagents & instruments if available to eliminate need for a marketing submission and supplemental validation if no FDA options available
Supports Boudicca Dx. audits of clinical laboratories & IVD companies; reviews all assay technical documentation, including validation data, and performs molecular laboratory inspections to ensure compliance with best practices for molecular testing. Success story: identified a non-specificity IHC assay issue that could have resulted in false positives being enrolled in a clinical study; communicated risk to client.
Deployed to Boudicca Dx. client’s global laboratories to set up new biomarker testing; technical expertise includes: animal-based techniques (long term voting member of Institutional Animal Care & Use Committee (IACUC) committee member), PD & PK assays, molecular biology & cell-based techniques, purified protein-based techniques, and immunohistochemistry, as well as other histology assays.

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

Over 20 years of experience in clinical oncology, biomarker discovery, translational strategy, clinical trial and correlative studies in heme malignancies and solid tumors, as well as chronic and acute pulmonary inflammation & managed more than 80 clinical trials at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute at Harvard Medical School (Dr. F.S. Hodi laboratory)
Reviews Boudicca Dx. client biomarker content in clinical trial documents (Investigator’s Brochure, Informed Consent Form, Clinical Protocol, Laboratory Manual, Nonclinical Study Reports, etc.) to ensure biomarker testing is clearly described to avoid regulatory and ethics submission stalls
Supports Boudicca Dx. clients on identification of prognostic and predictive biomarkers to support therapeutic clinical development & works closely with strategic alliance partner bioinformaticians
Supports Boudicca Dx. clients with Study Risk Determinations (SRDs) based on review of the clinical protocols & evaluation of primary, secondary & exploratory endpoints to determine the investigational requirements for laboratory partners & support implementation of these requirements
Supports Biopharma with acquisition of CLIA LDT & EU in-house testing information for regulatory submissions (e.g., methodology details, assay qualification process, etc.). Success story: generated information gathering workflows and documentation templates for Biopharma to streamline the collection of CLIA LDT information.
Supports Boudicca Dx. clients with Breakthrough Device Designation IVD submissions & evaluates the strength of feasibility data. Success story: provided detailed technical feedback on a heme monitoring assay as a Biopharma end user
Supports Boudicca Dx. with writing technical content of pre-marketing and marketing IVD submissions
Supports Boudicca Dx. clients with clinical biomarker development for both non-oncology and oncology therapies
Support Boudicca Dx. clients with using CLIA LDTs and EU in-house testing if appropriate based on the specific biomarkers; work with EU clinical laboratories to set up in-house testing for clinical trials
Support Boudicca Dx. clients with EU IVDR performance evaluation application and notification documentation
Supports Boudicca Dx. clients with companion diagnostic (CDx) development; develop CDx strategy and identify CDx development partners if needed for novel predictive biomarkers
Supports Boudicca Dx. CLIA LDT clients with Final FDA LDT rule compliance; provide guidance on investigational requirements for LDTs & marketing submission requirements based on intended use
Deployed to Boudicca Dx. client’s global laboratories to set up clinical biomarker testing; technical expertise includes CyTOF, flow cytometry, luminex, next generation sequencing, high-throughput screening of oligonucleotides, biodistribution, efficacy, and toxicological studies

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

Over 12 years of experience in quality assurance, quality management system, and regulatory affairs.
Supports Boudicca Dx clients with premarketing submissions, including breakthrough device designation, pre-submissions, and IDEs. Success Story: spearheaded and successfully granted FDA Breakthrough Device Designation for a liquid biopsy assay designed to detect cancer at early stages.
Supports Boudicca Dx clients to establish and to implement quality systems, policies, and procedures to comply with FDA, ISO, and other applicable regulatory requirements. Success Story: implemented quality system from scratch and successfully obtained ISO 13485 certification for an emerging IVD start-up.
Supports Boudicca Dx clients to ensure quality and regulatory compliance with biopharma-sponsored clinical trials, clinical laboratories, and IVD developers with ISO 13485, ISO 14971, Final FDA LDT rule, GCP and GLP.
Supports Boudicca Dx clients with 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 Marking.
Supports Boudicca Dx clients with compliance gap assessments and IVD audits.

CE plus – a division of regenold GmbH
Preferred Partner for EU IVDR regulatory strategy & execution (EU authorized representative); experience in both EU clinical trial assay/investigational phase & commercial phase (CE marking) & have established relationships with Notified Bodies and Competent Authorities.

https://www.regenold.com/
Stat4ward, LLC
Preferred Partner for statistical consulting services; extensive experience with Companion Diagnostics, novel IVD development, CLIA LDTs, & regulatory submissions experience.

https://stat4ward.com/
Monoceros Biosystems, LLC
Preferred Partner for Bioinformatics; biomarker discovery, clinical trial indication prioritization, and clinical biomarker development & validation.

https://monocerosbio.com/
Cascadia Drug Development Group
Preferred Partner for immunology and therapeutic drug development; have partnered on multiple CDx projects.

https://www.thecddg.com/
CDX PATHOLOGY, PLLC.
Preferred Partner for pathology consulting; extensive early-stage clinical biomarker development & late-stage CDx development experience.
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 for early-stage CLIA LDTs and IVDs.
SisuCentric, LLC
Boutique Cell and Gene Therapy Testing Accelerator; partner for cell and gene therapy clinical trials

Strategic Alliance Partnerships

Affiliate Consultants

Ryan Ice, PhD

Mariano Severgnini, PhD

David Liu, PhD

CE plus – a division of regenold GmbH

Stat4ward, LLC

Monoceros Biosystems, LLC

Cascadia Drug Development Group

CDX PATHOLOGY, PLLC.

Molecular Diagnostics Consulting, Inc.

NxGen BioStats, LLC

SisuCentric, LLC

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