

​Dr. Yulia Kaluzhny, MS, Ph.D, ERT, UKRT
Founder and DirectorInVitroTox Solutions Consulting LLC
Expert: In Vitro Toxicology Consultant
​​Expertise in ocular/dermal / inhalation toxicology, drug absorption, genotoxicity, 3D tissue models, and microphysiological systems.
Tackling complex challenges with advanced approaches.
Achievements
• Led the development and validation of OECD-approved in vitro assays, including the Eye Irritation Test (OECD TG 492), Reconstructed Skin Micronucleus and Comet Assays, and Reconstructed Skin Phototoxicity Testing (OECD TG 498)
• Secured and managed NIH/SBIR Phase I and II research grants, leading to the successful commercialization of multiple in vitro models
• Expanded the applicability domain of OECD TG 431, enabling more precise skin corrosion subcategorization
• Developed and optimized first-in-class 3D tissue models for kidney, ocular, mucosal, melanoma, and airway research
• Established a human reconstructed proximal tubular epithelium model, advancing ADME and kidney injury research
• Pioneered a non-animal inhalation toxicity testing method, using human respiratory EpiAirway 3D models
• Played a key role in integrating NAMs and in vitro models into OECD, REACH, and ECVAM regulatory frameworks
• Secured multimillion-dollar funding for R&D initiatives, collaborating with global stakeholders and industry leaders
• Provided strategic consulting on toxicology, regulatory compliance, and biotechnology trends for investors and corporate clients
• Managed GLP and GMP-compliant studies, ensuring regulatory adherence and high-quality toxicology data
• Developed novel preclinical in vitro assays for drug discovery, safety assessment, and disease modeling
• Advised on market positioning and regulatory adoption of alternative toxicology methods for biotechnology and pharmaceutical industries
• Represented companies at scientific committees, international conferences, and business meetings, shaping industry standards
• Led multidisciplinary teams, mentoring scientists and fostering cross-functional collaborations to advance in vitro technologies
• Evaluated and validated new testing technologies, driving regulatory acceptance and adoption across industries
Education
Post-Doctoral Training
2001 - 2002
Boston University School of Medicine, Boston, MA
Hematology and Oncology
Inducible gene expression system and immune response
Doctor of Philosophy
1996 -2001
Boston University School of Medicine, Boston, MA
​Department of Biochemistry
​Dual Program in Biochemistry & Cell and Molecular Biology
Lineage determination of megakaryocytes.
Transgenic mouse model.
Master of Science
(Equivalent to
a combined BS/MS)
1981 - 1986
Moscow State Pedagogical University, Moscow, Russia
Department of Biochemistry
Transformation of murine fibroblasts in culture. Genetic aberrations.
Certifications
2024
ERT, European Registered Toxicologist, EUROTOX
2024
UKRT, United Kingdon Registered Toxicologist, Royal Society of Biology
Certificate in Animal-Free Safety Assessment for Cosmetics, AFSA Collaboration
2024
Honors and Awards
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Best Paper in Risk Assessment, Toxicological Sciences, 2022
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Best Poster Award, Asian Congress for Alternatives to Animal Experiments, 2022
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Best Abstract/Poster Award, US SOT, Toxicological Sciences, 2017
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Four Paws Poster Award, EUSAAT Congress, 2012
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NIH Training Grant Recipient: Pre-doctoral Training in Aging Research
Invites Speaker / Round Table Discussion
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U.S. EPA Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC), Consultant and Ad Hoc Reviewer, 2024
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Trans-Agency Scientific Meetings (NIH/NIEHS/NIAID/EPA/DOD), 2020
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NIH/NIEHS Small Business Scientific Review Committees, 2013 – 2020
Professional Networks
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Round Table of Toxicology Consultants (RTC) (www.toxconsultants.com)
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​Society of Toxicology (SOT)
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Ocular Toxicology Specialty Section (OTSS)
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Regulatory & Safety Evaluation Specialty Section (RSES)
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New England Society of Toxicology (NESOT)
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In Vitro and Alternative Methods Specialty Section (IVAM SS)
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Inhalation and Respiratory Specialty Section (IRSS)
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Dermal Toxicology Specialty Section (DTSS)
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Women in Toxicology (WIT)
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Association for Research in Vision and Ophthalmology (ARVO)
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Genetic Toxicology Association (GTA)
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PanAmerican Society for Pigment Cell Research (PASPCR)
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The American Society of Hematology (ASH)
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Women in the Enterprise of Science and Technology (WEST)
Scientific Expert and Referee
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Toxicology In Vitro
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Toxicology and Applied Pharmacology
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Mutation Research
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Toxicology Letters
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Experimental Eye Research
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Alternatives to Laboratory Animals
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Alternatives to Animal Experimentation
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Journal of Visualized Experiments
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Blood
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MethodsX
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Clinical Ophthalmology
