Molecular Genetic Pathology Fellowship,
University of Pittsburgh Medical Center
Anatomic Pathology/Clinical Pathology Residency
University of New Mexico
Research Fellow, Molecular Pathology
Temple University
Senior Resident, General Surgery
Praja Vydyasala, Kurnool, India
Master of Surgery, General Surgery
PGIMER, Chandigarh, India
Bachelor of Medicine and Bachelor of Surgery
Kurnool Medical College, Kurnool, India
Dr. Vennapusa is trained and board-certified in Anatomic and Clinical Pathology and Molecular Genetics. Dr. Vennapusa is an expert in diagnostic product development; she has served as a CAP/CLIA Laboratory Director and as a Principal Investigator overseeing many diagnostic clinical trials. She has deep biomarker discovery and early translational biomarker assay development expertise across many modalities, including IHC, mRNA ISH, multiplex, and molecular assays. Dr. Vennapusa has extensive experience developing companion diagnostic (CDx) assays under design control and is routinely a Pathology Subject Matter Expert for Pharma and Diagnostics EU and FDA regulatory submissions. Her Digital Pathology experience includes algorithm development for machine and deep learning algorithms. Dr. Vennapusa supports Boudicca DX clients with their Anatomic Pathology, Clinical Pathology and Molecular Genetics product development.
PhD, Statistics
Virginia Tech
MS, Statistics
Virginia Tech
BS, Mathematics
Elizabethtown College
Dr. Gillis has over 30 years of experience in analytical consulting including the planning and execution of statistical methodology and supervision of analytical staff. She has expertise in Clinical Trial Design and Analysis, Clinical and Analytical Assay Validation, Medical Counter Measures, Predictive Modeling, Diagnostic Development and Validation, Medical Device, Data Editing and Pharmaceutical Marketing. She has the ability to apply statistics to a variety of areas; to choose the right statistical approach to address the key question/problem; and to assess talent and teach/train others. Skilled in developing innovative solutions to answer the big picture questions. Extensive programming experience in SAS, R, SPSS, LatentGold and VBA/Excel. Dr. Gillis is the CEO & Founder of NxGen BioStats, LLC and has worked with Boudicca DX since its inception.
Leslie Dow, PhD
Ph.D. Chemistry, University of Oklahoma
B.S. Microbiology, University of Oklahoma
ISO 19011:2018 Lead Auditor (TPECS)
ISO/IEC 27001:2022 Information Security Management Systems
ISO/IEC 42001:2023 AI Management Systems
ISO 14971:2019 Risk Management
IEC 62304:2006 Medical device software — Software life cycle processes
BSI Process Improvement Auditor
ISO 13485: 2016 (BSI)
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 through managing over 80 clinical trials and correlative studies in oncology (heme & solid tumor) & chronic and acute pulmonary inflammation at the Center for Immuno-Oncology at the Dana-Farber Cancer Institute at Harvard Medical School. Dr. Severgnini supports Boudicca DX clients with clinical biomarker development and clinical trial assay set-up at Contract Research Organizations (CROs).
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 Boudicca DX clients with establishing & implementing quality systems, policies, & 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.
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. Mrs. Powers supports Boudicca DX clients with reimbursement strategies.
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 Boudicca DX clients with commercial strategies & analytics, business development, competitive intelligence, & market research, including indication prioritization based on market needs, global market mapping, & biopharma lead generation.
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 Boudicca DX 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.).
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, generating & analyzing translational biomarker data, troubleshooting preclinical and clinical assays, & developing pharmacokinetic & pharmacodynamic in vitro and in vivo models for drug discovery. Dr. Ice supports Boudicca DX clients with preclinical research, translational research, scientific writing (nonclinical study reports for INDs), & grant writing (e.g., SBIRs).
PhD, Molecular, Cell, and Developmental Biology University of California, Los Angeles
MS, Plant Physiology, Biochemistry & Molecular Biology
University of Kentucky, Lexington
BS, Biology
Peking University, Beijing, China
Dr. Xie has over 20 years of experience developing FDA-regulated molecular IVDs & led the development of commercialized IVD products working as a development scientist at Biocept, Pfizer, Gen-Probe, Illumina, Invivoscribe, Genova, and Curative. Dr. Xie’s most recent role was at FDA Center for Devices and Radiological Health (CDRH) as a Senior Science Advisor where she reviewed 30+ PMAs, IDEs, and Q-submissions for IVD & companion diagnostics (CDx) devices and provided 15+ written CDx consultations in oncology to the Center for Drug Evaluation and Research at FDA. Dr. Xie supports Boudicca DX clients with IVD analytical validation studies, EU IVDR technical dossiers preparation & review, regulatory submissions review and support (BDDs, pre-submissions, IDEs, 510(k)s, De Novos, & PMAs), and IVD Study Risk Determinations for INTERACT, pIND, and IND filings.
PhD, Immunology
University of California Davis
MS, Biochemistry
California State University
BS, Cell & Molecular Biology
California State University
Dr. Benoun is a seasoned biomarker scientist and translational medicine expert with over eight years of experience in the biotech and pharmaceutical industries. With training in immunology and a strong background in cell and molecular biology, biochemistry, and clinical trial biomarkers, Joe has led biomarker strategies for both hematologic and solid tumor clinical trials. He specializes in multiomic data analysis, including flow cytometry, RNA sequencing, TCR sequencing, IHC/mIF, and proteomics, helping bridge scientific discovery with clinical application. Passionate about improving translational research efficiency, Dr. Benoun also brings expertise in project management, bio-sample operations, and supporting companies in optimizing biomarker-driven strategies for drug development.
PhD University of Manitoba
BSc University of Manitoba
Dr. deVos brings over 25 years of expertise in molecular diagnostic product development and commercialization, focusing on oncology and infectious diseases for US and European companies. His experience encompasses biomarker discovery, preclinical and clinical validation, regulatory approvals, and product launches.
Dr. deVos supports Boudicca DX clients through every stage of product development. His support includes preclinical and clinical study design under design control, technical writing, coordination of scientific and clinical advisory boards, regulatory submissions (pre-submissions, BDDs, IDEs, 510(k)s, and PMAs), as well as navigating coding (AMA CPT), pricing (CLFS), and coverage (LCDs and NCDs) processes.
Graduate Student, Vanderbilt University
BS, Biochemistry and Molecular Biology
Centre College
Ms. Garcia Lopez is a fifth year PhD graduate student studying at Vanderbilt and interning at Boudicca DX, LLC to learn about Regulatory Science. Her thesis work at Vanderbilt focuses on determining which molecular and cell signaling pathways are involved in the dysregulation of thyroid hormones and she collaborates with multiple Vanderbilt labs to deliver datasets that answer scientific questions ranging from genetic diseases to perturbations of small molecules in cells.
Graduate Student, Vanderbilt University
BA in Biology and Spanish, St. Olaf College
Ms. Bindeman is a sixth year PhD candidate at Vanderbilt University and interning at Boudicca DX, LLC to learn about Regulatory Science and Medical Writing, with a focus on EU markets. Her thesis work at Vanderbilt focuses on triple-negative breast cancer brain metastasis.
https://globalbioclinical.com/
Comprehensive, cost-effective CRO solution, offering full-service support for clinical study documentation, data management, and IRB and Ethics Committee submissions, as well as clinical site management services including qualification, initiation, training, monitoring and close-out.
