Boudicca DX™ Consultants & Interns

Reach out to info@boudiccadx.com to work with our experts | All NDAs, CVs & certifications on file to support vendor qualification for purchasing control compliance

Bharathi Vennapusa, MD

Translational & Companion Diagnostics Pathologist

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 & commercial launch.

Mark Roberts, PhD

Companion Diagnostic Development & Commercialization

Therapy & Companion Diagnostic (CDx) Co-development
CDx Commercialization

PhD Pharmaceutical Sciences (Mucosal Vaccines)
University of Nottingham, UK
BSc. (Hons) Biological Sciences
Wolverhampton Polytechnic UK

Dr Roberts has over 30 years of experience in the IVD, clinical laboratory and CRO industries. Following 10 years at ThermoFisher leading their Seradyn IVD development and manufacturing division he joined Labcorp (formerly Covance) in 2012 to establish and lead their therapy and companion diagnostic (CDx) co-development strategy that supported the clinical trials for over two-thirds of the FDA-approved CDx assays. He brings proven expertise in CDx assay development, three-way partnering between IVD developers, drug developers and central laboratories as well as commercialization of both FDA-cleared / approved assays and Laboratory Developed Tests (LDTs). Dr. Roberts also has experience with CDx development and commercialization under EU IVDR. Dr. Roberts is supporting Boudicca DX™ clients with global CDx co-development from feasibility through commercialization.

Laura Gillis, PhD

Biostatistics

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 supporting the robust design of analytical validity, clinical validity, & clinical utility studies to support regulatory submissions and reimbursement dossiers.

Leslie Dow, PhD

IVD & Medical Device Software

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)

Dr. Dow is a Software Quality Assurance and Compliance expert with 15+ years of specialized experience in medical device software validation strategies and regulatory compliance. She has a proven track record developing and implementing FDA-compliant software development lifecycles and quality management systems for innovative diagnostic platforms, including NGS and IVD technologies. She has extensive experience leading ISO 27001 certifications, clinical trial software validation, and cloud service compliance initiatives and audits. She is known for successfully bridging technical complexity with regulatory requirements while maintaining operational efficiency. Dr. Dow supports Boudicca DX™ clients with quality & regulatory software compliance both as an implementor & auditor.

Mariano Severgnini, PhD

Clinical Biomarkers

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™ pharma clients with clinical biomarker development and clinical trial assay set-up at Contract Research Organizations (CROs).

Michael Wienholt

Quality Affairs and Regulatory Affairs

Bachelor of Science
North Carolina State University, Raleigh, NC

Mr. Wienholt brings over 30 years of experience working in medical devices and diagnostics, focused on global regulatory affairs and quality management systems. Mr. Wienholt supports Boudicca DX™ clients with regulatory strategies & submissions support, and the phased implementation of quality management systems to comply with ISO 13485 and the QMSR.

Emily Powers, MLS(ASCP)CM

Revenue Cycle Management & Reimbursement

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.

Dario Cabrera, MBA

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. 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.

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. 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.).

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, 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).

Zhiyi (Jean) Xie, PhD

In Vitro Diagnostics and Companion Diagnostics

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 US FDA CDx regulatory strategy & submissions.

Joseph (Joe) Benoun, PhD

Clinical Biomarkers & Translational Science

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. Dr. Benoun supports Boudicca DX™ translational science projects.

Theo deVos, PhD

Molecular Diagnostics

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.

Valeria Garcia Lopez

Regulatory Science Intern

Graduate Student, Vanderbilt University
BS, Biochemistry and Molecular Biology
Centre College

Ms. Garcia Lopez is a fifth year PhD graduate student studying at Vanderbilt School of Medicine and interning at Boudicca DX™ through the ASPIRE program 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.

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. Dr. Liu supports Boudicca DX™ IVD & medical device 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.

Clinical Operations Consultants
https://globalbioclinical.com/

Clinical trials in 30 countries | 50+ medical devices and IVDs | 39 precision medicine clients| 56 clinical studies supported | 1100+ Clinical Collaborators in US | International Collaborators in 65 Cities across 30 countries
- Clinical Trial Manager & Clinical Research Associate Consultants under NDA & immediately available to Boudicca DX™ clients to provide seamless support
- Clinical Protocol Development (clinical validity & clinical utility studies)
- ICF Development
- Clinical Site & Investigator Selection
- Study Management & Execution
- Data Management
- Independent Study Monitoring
- Clinical Trial Logistics Management
- US FDA BIMO Support
- Import & Export Support
- IRB & EC submissions
- Patient Information Materials
- Oncology, Infectious Disease, & Other Therapeutic Areas