Protecting patients and workers
I establish health-based exposure limits and risk management strategies in support of more than 220 development and commercial programs across product quality, manufacturing, and occupational health.
Hello,I’m Tyler Nicholas.
Product Stewardship Toxicologist
San Francisco, California
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About
I’m a board-certified toxicologist advancing the safe development, manufacture, and use of medicines.
Product stewardship is the throughline of my work. I translate toxicological evidence into clear decisions that protect patients and workers across the medicine lifecycle—from nonclinical development through manufacturing and commercialization.
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Experience
My work brings together product stewardship toxicology, nonclinical toxicology, and scientific leadership across the medicine lifecycle.
Characterizing risk across drug development
My experience spans mechanistic and predictive research, nonclinical study strategy, and project toxicology across development portfolios.
Guiding science-based decisions
I lead cross-functional scientific decisions across CMC, EHS, Quality, and Regulatory Affairs and develop guidance and processes that scale across organizations.
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Publications
A selection of research strengthening the scientific foundations of product stewardship, from nonclinical toxicology to health-based exposure limit setting.
Nicholas T, Morinello E, Moudgal C, Beaulieu A, Graham J. Considerations for Establishing Occupational Exposure Limits for Small Molecule Kinase Inhibitors in Drug Development. Frontiers in Toxicology – Occupational Toxicology. 2026. PMID: 41960283.
Graham J, Anand S, Bercu J, Besenhofer L, de Zafra C, Feng Y, Glowienke S, Hillegass J, Hutchinson R, Jolly R, Masuda-Herrera M, Nicholas T, Olszova D, Schmitz M, Semmelmann F, Tien E. Assessment and Control of Host Cell Proteins in Biologics: Survey of Industry Practices and a Vision for Harmonization. Biotechnology and Bioengineering. 2025. PMID: 41517894.
Abdelhamed S, Zhang X, Zeng W, Grogan B, Schilperoort L, James R, Burley K, Sarrett S, Bou L, Raha P, Olson D, Sigurjonsson H, Dominguez M, Nicholas T, Fishburn J, Lim A, Diolaiti D, Gupta P, Abrahams C, Carosino C, Heiser R, Gardai S, Levengood M. Preclinical Development of PF-08046032: A Novel, Investigational CD25-Directed Antibody-Drug Conjugate Optimized for Selective Depletion of Regulatory T Cells in Advanced Malignant Tumors. Molecular Cancer Therapeutics. 2025. PMID: 40293942.
Graham J, Anand S, Bercu J, Besenhofer L, de Zafra C, Feng Y, Fisher C, Hillegass J, Hutchinson R, Jolly R, Moudgal C, Nicholas T, Olszova D, Schmitz M, Semmelmann F. Safety Assessment of Protein A and Derivation of a Parenteral Health-Based Exposure Limit. Regulatory Toxicology and Pharmacology. 2024. PMID: 39243930.
Nicholas T, Boyes W, Scoville D, Workman T, Kavanagh T, Altemeier W, Faustman E. The Effects of Gene × Environment Interactions on Silver Nanoparticle Toxicity in the Respiratory System: An Adverse Outcome Pathway. WIREs Nanomedicine and Nanobiotechnology. 2021. PMID: 33768701.
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