Dr. Yulia Kaluzhny, MS, Ph.D, ERT, UKRT
Founder and Director, InVitroTox Solutions Consulting LLC
Dr. Kaluzhny is a board-certified European Registered Toxicologist (ERT) who provides expert guidance on non-animal testing strategies, regulatory compliance, and innovative in vitro toxicology solutions. With deep expertise in bioengineering and in vitro toxicology, she specializes in dermal, respiratory, and ocular exposure assessments, helping businesses develop alternative approaches to meet regulatory requirements and enhance product safety.
As a leading expert in in vitro toxicology, Dr. Kaluzhny has led groundbreaking projects in validating 3D tissue models for toxicity testing, including key assays such as the Eye Irritation Test (OECD TG 492) and 3D skin genotoxicity and phototoxicity testing (OECD TG 498). Her work has advanced human-relevant models, bridged rodent and human studies in respiratory toxicity, and supported the adoption of NAMs (New Approach Methodologies) in regulatory frameworks.
About me
I’m passionate about replacing outdated testing methods with better, human-relevant alternatives.
With years of experience in in vitro toxicology, bioengineering, and regulatory strategy, I help clients find practical, science-driven solutions.
I enjoy working with teams to develop new approaches, solve complex problems, and bring innovative technologies into real-world applications.
My goal is to support stakeholders in making smarter, more ethical choices in toxicology and product development.
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Some of my hobbies: outdoors, skiing, traveling the world, audiobooks, flameworking, making unique jewelry, and learning web design.
Professional Experience
2025 - Present
Round Table of Toxicology Consultants (https://www.toxconsultants.com/)
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2024
Toxic Substances Control Act (TSCA) Consultant, Science Advisory Committee on Chemicals (SACC), U.S. EPA, Washington DC
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• risk assessment advisory
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2023 – Present
Founder and Director, InVitroTox Solutions Consulting LLC
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• strategic advisory for life sciences companies
• market positioning for in vitro testing solutions
• customized toxicology solutions for industry needs
• technical consulting for innovative toxicology tools
• advisory on toxicology policy and regulations
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2019 – 2023
MatTek Life Sciences / a BICO company (Ashland, MA)
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• strategic toxicology consulting
• biotechnology market insights
• regulatory compliance expertise
• in vitro respiratory toxicology
• in vitro safety pharmacology
• scientific training and mentorship
• cross-functional team leadership
• pharmaceutical product development support
• translation of scientific innovation into business strategy
• advanced applications of in vitro models in disease modeling and drug discovery
• contributed to ADME and pharmacokinetics research through in vitro methods
• provided technical guidance on integrating in vitro models into compliance workflows
• facilitated knowledge exchange between academia, industry, and regulators
• helped shape regulatory policy for integrating NAMs into global safety assessments
• established the first human reconstructed proximal tubular epithelium model for ADME and kidney injury research
• drove the adoption of innovative toxicology solutions to reduce reliance on animal testing
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2010 – 2019
MatTek Life Sciences (Ashland, MA)
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• developed best practices for GLP-compliant in vitro toxicology studies
• advancing regulatory acceptance of NAMs
• toxicology risk communication and strategy
• NAMs development and implementation
• in vitro skin/eye absorption
• genetic toxicology expertise
• in vitro metabolism research
• product safety assessment
• innovation in human-relevant models
• grant funding and budget oversight
• project management and commercialization
• contract research organization engagement
• scientific training and mentorship
• regulatory engagement with OECD, EPA, FDA
• development of new safety assessment strategies
• integration of in vitro and in silico approaches
• scientific writing and regulatory documentation
• data interpretation for risk assessment
• compliance with GLP and GMP standards in research and testing
• played a key role in OECD guideline adoption for genotoxicity and phototoxicity
• developed frameworks for regulatory acceptance of innovative toxicology tools
• led the creation of an organotypic mucosal corneal tissue model for ophthalmic drug development and dry eye disease
• focused on kidney injury, cancer biology, oxidative stress, inflammation, and fibrosis
• secured NIH/SBIR Phase I and II funding for R&D initiatives leading to successful product commercialization
• developed EpiOcular™-Eye Irritation Test, leading to OECD guideline 492 for replacing the in vivo Draize test
• contributed to OECD guideline development for dermal genotoxicity using RSMN and comet assays
• advanced systemic and topical phototoxicity testing with 3D in vitro models like EpiDerm
• collaborated with regulatory agencies and industry stakeholders to integrate in vitro testing into global safety guidelines
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2003 - 2010
MatTek Corporation (Ashland, MA)
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• led initiatives to implement OECD guidelines for toxicity testing
• developed standardized protocols for eye and skin irritation assessments
• worked with OECD, REACH, and ECVAM to validate non-animal testing methods
• collaborated with industry leaders to align testing technologies with regulations
• designed, optimized, and validated assays for ocular, dermal, and inhalation toxicity testing
• advancing regulatory acceptance of NAMs
• product safety assessment
• innovation in human-relevant models
• assay development and validation
• technology evaluation and adoption
• grant funding and budget oversight
• project management and commercialization
• scientific training and mentorship
• development of new safety assessment strategies
• toxicology education and public outreach
• proposal development for research funding
• secured and managed NIH/SBIR research grants
• expanded the applicability domain of OECD TG 431 for skin corrosion subcategorization
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