Consultants & Partners
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Affiliate Consultants
Subject Matter Experts | Under NDA | CVs & Certifications On File | Interface Directly with Clients | Immediately Deployable
Ryan Ice, PhD
Preclinical & Translational Science
PhD, Cancer Cell Biology
School of Medicine, West Virginia University
BS, Biological Sciences
Vanderbilt University
Dr. Ice has over 13 years of preclinical & translational science experience designing & implementing biomarker strategies, translational biomarker data generation & analysis, preclinical and clinical assay troubleshooting, pharmacokinetic & pharmacodynamic analysis, & development of in vitro and in vivo models for drug discovery. Supports clients with preclinical research, translational research, & grant-writing (successfully supported obtaining a SBIR grant for a nanoparticle delivery of silencing nucleotides to treat cancer and other diseases).
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
Dr. Severgnini has over 20 years of experience working in clinical biomarker development, biomarker discovery, translational strategy, managing clinical trial and correlative studies in heme and solid tumors, chronic and acute pulmonary inflammation. Managed over 80 clinical trials at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute at Harvard Medical School. Supports clients with clinical biomarker & companion diagnostic development.
David Liu, PhD
Quality Compliance
PhD, Chemistry
University of Florida
BS, Chemistry
University of North Carolina
ISO 13485:2016 Lead Auditor (TPECS)
Dr. Liu has over 12 years of leadership experience in quality assurance & quality management system oversight. Supports clients with establishing & implementing quality systems, policies, and procedures to comply with FDA, ISO, and other applicable 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 quality compliance.
Dario Cabrera, MBA
Biopharma Commercial Insights
MBA
Carnegie Mellon University
MA, Biochemistry
Harvard University
BS, Biochemistry
Arizona State University
Mr. Cabrera has over 12 years of experience working in biopharma 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 & Reimbursement Specialist
BS, Clinical Laboratory Science
University of South Alabama
BA, Religious Studies
Loyola University
Mrs. Powers has over 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
Biomarker Operations
BA, Biology
Assumption College
Ms. Masciarelli has over 5 years of experience working in clinical biospecimen management in biopharma and large academic research centers. Supports clients with collecting local laboratory biomarker testing data, monitoring biomarker testing data, clinical sample management (biobanking to support CDx bridging & follow-on test development), clinical sample reconciliation & tracking at clinical sites, clinical laboratories, CROs, & biomarker central testing labs, & manages clinical study documentation (ICFs, IRBs, ECs, protocols, lab manuals, etc.).
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. 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.
