Elizabeth Neyens, DVM, DABT, ERT

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Double board-certified toxicologist and veterinary pathologist with 20+ years of expertise in preclinical research, regulatory toxicology, and digital pathology innovation. Founder of ElizabethToxPath Consulting Inc. and core team member of NexusBio Partners, supporting global pharmaceutical and biotech companies in accelerating drug development timelines while maintaining rigorous GLP compliance.

Transform Your Preclinical Program with Expert Pathology Leadership

In today's rapidly evolving pharmaceutical landscape, toxicology and pathology has evolved far beyond traditional diagnostic endpoints. At NexusBio Partners, we understand that successful drug development requires strategic pathology input from day one—not just at the end of your studies.

The pharmaceutical industry faces unprecedented challenges: accelerated timelines, complex biologics, stringent regulatory requirements, and the need for global collaboration. Traditional pathology approaches are no longer sufficient for today's demanding development environment.

Modern toxicologic pathology must be:

• Strategic - Guiding study design and risk mitigation from the earliest stages
• Digital - Leveraging AI-driven workflows for enhanced accuracy and global collaboration
• Specialized - Providing organ-specific expertise for complex therapeutic areas
• Regulatory-focused - Ensuring compliance across FDA, EMA, and international guidelines

Early Program Risk Assessment

• Proactive identification of target organ liabilities
• Strategic guidance on study design and dose selection
• Background finding interpretation and regulatory context
• Therapeutic index optimization for IND submissions

IND & First-in-Human Support

• Clear safety narrative development
• Regulatory strategy alignment
• Risk mitigation planning
• Cross-functional team integration

COVID-19 Proven Workflows During the pandemic, we pioneered digital pathology solutions that maintained GLP compliance while enabling seamless remote evaluations across continents. These innovations now provide permanent advantages:

• Global Collaboration - Real-time pathology review across time zones
• Enhanced Reproducibility - AI-driven consistency in lesion detection
• Transparent Peer Review - Digital annotation and collaborative evaluation
• Accelerated Timelines - Immediate access to pathology data worldwide

AI Integration & Implementation

• Digital workflow validation for GLP studies
• AI-driven image analysis for enhanced precision
• Quality assurance system optimization
• Technology transfer and training

Ocular Toxicology Deep understanding of ocular anatomy, dosing strategies, and lesion characterization crucial for:

• Ophthalmic drug development
• Targeted ocular delivery systems
• Preclinical-to-clinical translation
• Regulatory acceptance strategies

Medical Device Safety

• ISO 10993 compliance and risk analysis
• Chronic implantation study design
• Extractable/leachable assessments
• Biocompatibility evaluation strategies

Biologics & Advanced Therapeutics

• Complex molecule safety assessment
• Immunotoxicity evaluation
• Novel delivery system evaluation
• Mechanism-based pathology endpoints

Multi-Jurisdictional Expertise Bridge European and North American regulatory expectations through dual board certification (DABT, ERT):

• FDA submission strategies
• EMA regulatory alignment
• Health Canada requirements
• ICH guideline compliance

GLP Audit & Quality Assurance

• Study monitoring and compliance verification
• Regulatory inspection preparation
• Quality system optimization
• 21 CFR Part 11 compliance

20+ Years of Excellence

• Led pathology departments at major CROs and pharmaceutical companies
• Guided multiple programs from discovery to IND approval
• Managed cross-functional teams up to 15 scientists
• Published thought leader in digital pathology innovation

Truly International Perspective

• Locations: Vancouver, Canada & Brussels, Belgium
• Languages: Dutch, French, English, German, Hebrew
• Citizenship: EU & Canadian dual citizenship
• Experience: Europe, North America, Israel, Asia-Pacific

Double Board Certification

• DVM - University of Utrecht
• DABT - American Board of Toxicology
• ERT - European Registered Toxicologist
• Digital Pathology Certified - DPA, NSH
• GLP Auditor - Society of Quality Assurance

Challenge: Global pharmaceutical company needed to maintain GLP-compliant pathology evaluations during pandemic lockdowns while supporting aggressive submission timelines.

Solution: Implemented comprehensive digital pathology workflow enabling remote evaluation across three continents.

Result: Zero delays in regulatory submissions, enhanced global collaboration, 40% reduction in study turnaround times.

Challenge: Biotech company developing novel ocular therapeutic faced regulatory concerns about specialized toxicology endpoints.

Solution: Provided expert ocular toxicology consultation, study design optimization, and regulatory strategy development.

Result: Successful IND submission with FDA agreement on pathology endpoints, accelerated clinical timeline.

Challenge: Medical device manufacturer required comprehensive extractable/leachable assessment for novel implantable device.

Solution: Conducted thorough toxicologic risk assessment aligned with ISO 10993 standards and regulatory expectations.

Result: Streamlined regulatory pathway, avoided unnecessary repeat studies, reduced development costs by 30%.

Perfect for specific challenges:

• Study design optimization
• Pathology peer reviews
• Regulatory submission support
• Digital pathology implementation

Ideal for ongoing programs:

• Virtual pathology department services
• Strategic advisory board participation
• Cross-functional team integration
• Long-term regulatory strategy

Build internal capabilities:

• Digital pathology training programs
• Regulatory compliance workshops
• Team mentoring and development
• Knowledge transfer sessions

• Scientific Organizer - British Digital Pathology Congress (2022)
• Distinguished Speaker - Society of Quality Assurance
• Best Junior Academic Lecturer - University of Utrecht
• Double Research Award Winner - University of Utrecht

• Society of Toxicologic Pathologists (STP)
• European Society of Toxicologic Pathologists (ESTP)
• American Society of Toxicologists (ACT)
• Roundtable of Toxicologic Consultants (RTC)
• Society of Quality Assurance Professionals (SQA)

• Published Author Toxicologic pathology and digital innovation
• Conference Speaker International pathology and regulatory meetings
• Industry Expert Quoted in pharmaceutical trade publications
• Educational Content Blog posts and educational materials

• Accelerated Timelines Strategic pathology input from day one prevents costly late-stage surprises and accelerates your path to clinic.
• Regulatory Confidence Dual board certification and global experience ensure your studies meet FDA, EMA, and international standards.
• Cost Optimization Expert study design and dose selection minimize unnecessary studies while maximizing regulatory acceptance.
• Digital Innovation Cutting-edge digital pathology workflows improve efficiency, reproducibility, and global collaboration.
• Risk Mitigation Proactive identification of pathology red flags de-risks your development program and protects your investment.
• Global Perspective Unique ability to bridge European and North American regulatory frameworks for seamless international development.

In an era where biologics and complex molecules dominate development pipelines, the role of the toxicologic pathologist as both evaluator and strategic consultant has never been more critical. The combination of strategic pathology input, GLP-compliant digital workflows, and deep understanding of both traditional and advanced therapeutic platforms is essential for translational science success.

Don't let pathology be an afterthought in your development program.

We offer complimentary 30-minute strategy sessions to discuss your specific challenges and explore how strategic toxicologic pathology consulting can advance your development goals.

Schedule your consultation today and discover how NexusBio Partners can de-risk your pipeline, accelerate your timelines, and ensure regulatory success across global markets.

"The future of drug development belongs to those who integrate strategic pathology thinking from the very beginning. Let us help you build that advantage."

                                                            - Dr. Elizabeth Neyens, DVM, DABT, ERT

Leading a specialized consultancy that has revolutionized how companies approach toxicologic pathology challenges:

• Strategic Consulting: Guided multiple preclinical development programs toward IND and first-in-human studies, proactively identifying pathology and      toxicology red flags to de-risk regulatory pathways
• Digital Pathology Implementation: Pioneered AI-driven digital pathology      workflows during COVID-19, enabling seamless remote histopathology review      and setting new industry standards
• Regulatory Excellence: Provided expert toxicology consulting for medical device safety, including extractable/leachable assessments, chronic implantation studies, and ISO 10993 risk analysis
• Global Impact: Served clients across Europe, North America, Israel, and Asia,      bridging regulatory expectations between FDA and EMA frameworks

Academic Leadership: Assistant Professor of Pathology (2023-2024)

Einstein Medical College, New York, USA

Advanced the next generation of pathologists while conducting cutting-edge research:

• Curriculum Development: Updated pathology curricula to reflect current      advancements in digital pathology and AI integration
• Research Leadership: Conducted independent and collaborative research in      neuropathology and biomarker development
• Clinical Excellence: Provided diagnostic pathology services and collaborated      with clinical teams to support patient care
• Grant Acquisition: Applied for research grants and published findings in      peer-reviewed journals
• Mentorship: Supervised graduate students and postdoctoral fellows in advanced research      projects

Industry Leadership: Head of Pathology Department (2011-2013)

Baxter Biosciences, Vienna, Austria

Managed the preclinical pathology department with full P&L responsibility:

• Team Leadership: Led cross-functional teams of up to 15 scientists      (academics/technicians) with 5 direct reports
• Strategic Planning: Served as preclinical project manager for biologics      targeting autoimmune diseases and oncology therapeutics
• Regulatory Compliance: Ensured all preclinical studies met GLP, FDA, and EMA requirements
• Risk Management: Developed and implemented comprehensive risk management plans for drug candidates
• Business Development: Collaborated with pharmacology, chemistry, and clinical development teams in matrix environment

Technical Expertise: Staff Pathologist Roles (2005-2018)

Major CROs: Charles River, CitoxLab, ITR, Envigo

Built comprehensive expertise across all aspects of toxicologic pathology:

• Study Leadership: Designed and oversaw toxicology studies evaluating adverse      effects of novel drug candidates
• Specialized Expertise: Developed particular expertise in ocular pathology,      carcinogenicity studies, inhalation toxicology, and radiation toxicity      studies
• Peer Review Excellence: Conducted retrospective and contemporaneous peer      reviews, ensuring highest quality standards
• Animal Models: Worked with all types of laboratory animals (small and large      species) across diverse therapeutic areas

Educational Foundation & Certifications

Advanced Degrees & Board Certifications

• Doctor of Veterinary Medicine (DVM) | University of Utrecht (1997-2004)
• American Board-Certified Toxicologist (DABT) | 2015

At NexusBio Partners, we specialize in providing expert consulting services for drug development in the biotechnology sector. Our team of experienced professionals offers insights that can help streamline your research processes and enhance your product development timelines. We are committed to guiding you through the complexities of biotech with tailored strategies.