Consultants
CVs & Certifications On File | Immediately Deployable | Interface Directly with Clients | Under NDA
Ryan Ice, PhD
Preclinical & Translational Science Consultant
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. Dr. Ice supports clients with preclinical research, translational research, scientific writing & grant-writing (e.g., SBIRs).
Mariano Severgnini, PhD
Clinical Biomarkers & Companion Diagnostics Consultant
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 over 80 clinical trials and correlative studies in oncology (heme & solid tumor) and chronic and acute pulmonary inflammation at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute at Harvard Medical School. Dr. Severgnini supports clients with clinical biomarker & companion diagnostic (CDx) development.
David Liu, PhD
Quality Compliance Consultant
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. Dr. Liu 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.
Dario Cabrera, MBA
Commercial Insights Consultant
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. Mr. Cabrera 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 Consultant
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. Mrs. Powers supports clients navigating the challenging reimbursement landscape & formulating a reimbursement strategy based on region and NGS-based assay, including applying for Z-Codes, preparing MolDX dossiers & technical assessments.
Alyssa Masciarelli
Biomarker Operations Consultant
BA, Biology
Assumption College
Ms. Masciarelli has over 5 years of experience working in clinical biospecimen management in biopharma and large academic research centers. Ms. Masciarelli supports clients with collecting local laboratory biomarker testing data, monitoring biomarker testing data, clinical sample management (biobanking to support CDx bridging & follow-on tests), 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.).
MCDXI Medical Diagnostics Inc.
Provides fractional CLIA/CAP/NYS-CLEP Laboratory Directors and Chief Medical Officers with deep clinical diagnostics expertise and an entrepreneurial mindset to support emerging diagnostic companies and laboratories.
Advyzom, LLC (Acquired by Danforth Advisors, LLC)
Boutique consulting company specializing in highly strategic regulatory and development advice and services for the biotechnology, pharmaceutical and healthcare industry (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).
Stat4ward, LLC
Biostatistical consulting services; extensive experience with CDx, novel IVDs, CLIA LDTs, & regulatory submissions.
Molecular Diagnostics Consulting, Inc.
Participates on medical device regulatory advisory boards.
NxGen BioStats, LLC
Biostatistics support.
