Publication Topic

Mease K. High safety bar, low safety margin case studies. Presented at 29th Annual Charles River Biotech Symposium, Carlsbad, CA, September 8-10, 2025.

Nordyke RJ, Patterson JA, Motyka J, March B, Kirson NY, Long G. 2025. The impact of the Inflation Reduction Act’s drug price negotiation program on incentives for clinical development of new drugs. Value Health; doi: 10.1016/j.jval.2025.08.011. Online ahead of print Sept. 1, 2025. PMID: 40902797.

Monticello TM, MacLachlan TK, Funk KA, Rock BM, Bussiere JL, Grieves JL, Schuh JCL, Henry S. 2025. Nonclinical safety assessment: An overview of drug and medical device development. Chapter 1 in: Bouchard PR, Sahota PS, Wallace S, Wojcinski ZW, Schumacher VL (eds), Toxicologic Pathology: Nonclinical Safety Assessment, 3^rd edition. Boca Raton: CRC Press-Taylor and Francis Group, pp. 3-51.

Patterson JA, Motyka J, Salih R, Nordyke RJ, O’Brien JM, Campbell JD. 2025. Subsequent indications in oncology drugs: Pathways, timelines, and the Inflation Reduction Act. Ther Innov Regul Sci 59(1):102-111; doi: 10.1007/s43441-024-00706-6. PMID: 39369117.

Jackson JW, Frederick C Streich Jr, Pal A, Coricor G, Boston C, …, Wood M, et al. 2024. An antibody that inhibits TGF-β1 release from latent extracellular matrix complexes attenuates the progression of renal fibrosis. Sci Signal 17(844):eadn6052; doi: 10.1126/scisignal.adn6052. PMID: 38980922.

Bak A, Burlage R, Greene N, Nambiar P, Lu X, Templeton A. 2024. Accelerating drug product development and approval: Early development and evaluation. Pharm Res 41(1):1-6; doi: 10.1007/s11095-023-03566-1.

Wagner TD, Westrich KD, Nordyke RJ, Campbell JD. 2024. Inflation-adjusted analysis of ICER’s Unsupported Price Increase reports: Contextualizing drug spending changes. J Med Econ 27(1):1537-1541; doi: 10.1080/13696998.2024.2428109. PMID: 39626873.

Wright PSR, Briggs KA, Thomas R, Smith GF, Maglennon G, Mikulskis P, Chapman M, Greene N, et al. 2023. Statistical analysis of preclinical interspecies concordance of histopathological findings in the eTOX database. Regul Toxicol Pharmacol 138(Feb):105308; doi: 10.1016/j.yrtph.2022.105308. PMID: 36481279.

Wright PSR, Smith GF, Briggs KA, Thomas R, Maglennon G, Mikulskis P, Chapman M, Greene N, et al. 2023. Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database. Regul Toxicol Pharmacol 138(Feb):105309; doi: 10.1016/j.yrtph.2022.105309. PMID: 36481280.

Knotts T, Mease K, Sangameswaran L, Felx M, Kramer S, Donovan J. 2022. Pharmacokinetics and local tissue response to local instillation of vocacapsaicin, a novel capsaicin prodrug, in rat and rabbit osteotomy models. J Orthop Res 40(10):2281-2293; doi: 10.1002/jor.25271. PMID: 35128722.

Coppi A, Davies R, Wegesser T, Ishida K, Karmel J, Han J, Aiello F, Xie Y…, Monticello TM, et al. 2022. Characterization of false positive, contaminant- driven mutagenicity in impurities associated with the sotorasib drug substance. Regul Toxicol Pharmacol 131(June):105162; doi: 10.1016/j.yrtph.2022.105162.

Kato Y, Lim A, Sakolish C, Valdiviezo A, Moyer H, Rusyn I. Testing of reproducibility of a high-throughput liver microphysiological system (OrganoPlate 2-lane plate) for studies of pharmacokinetics and toxicological assessment of drugs. Abstract 4639, Society of Toxicology 61st Annual Meeting, San Diego, CA, March 2022.

Bai P, Miljković F, Ge Y, Greene N, John B, Lu H. Hierarchical clustering split for low-bias evaluation of drug-target interaction prediction. IEEE International Conference on Bioinformatics and Biomedicine (BIBM); doi: 10.1109/BIBM52615.2021.966915. Houston, TX, December 2021.

Miljković F, Martinsson A, Obrezanova O, Williamson B, Johnson M, Sykes A, Bender A, Greene N. 2021. Machine learning models for human in vivo pharmacokinetic parameters with in-house validation. Molec Pharm 18(12):4520-4530; doi: 10.1021/acs.molpharmaceut.1c00718. PMID: 34758626.

Giblin KA, Basili D, Afzal AM, Rosenbrier-Ribeiro L, Greene N, Barrett I, Hughes SJ, Bender A. 2021. New associations between drug-induced adverse events in animal models and humans reveal novel candidate safety targets. Chem Res Toxicol 34(2):438-451; doi: 10.1021/acs.chemrestox.0c00311. PMID: 33338378.

Mease K. Managing immunogenicity in the absence of an ADA assay is no monkey business (case study). Presentation at 25^th annual Charles River Biotech Symposium, Carlsbad, CA, September 2019.

Prior H, Monticello T, Boulifard V, Brennan FR, Kimber I. 2019. Integration of consortia recommendations for justification of animal use within current and future drug development paradigms. Int J Toxicol 38(4):319-325; doi: 10.1177/1091581819852922.

Kimzey AL, Piche M-S, Wood M, Weir AB, Lansita J. 2018. 11.19 – Immunophenotyping in drug development. In: Comprehensive Toxicology, 3^rd Ed. Vol 11:399–427.

Svensson F, Zoufir A, Mahmoud S, Afzal AM, Snit S, Giblin KA, Clements PJ,…, Greene N, et al. 2018. Information-derived mechanistic hypotheses for structural cardiotoxicity. Chem Res Toxicol 31(11):1119-1127; doi: 10.1021/acs.chemrestox.8b00159. PMID: 30350600.

Monticello TM, Bussiere JL. 2018. Nonclinical safety evaluation of drugs. Chapter 2 in: Sahota PS, Popp JA, Hardisty JF, Gopinath C. (eds), Toxicologic Pathology: Nonclinical Safety Assessment, 2^nd edition. Boca Raton: CRC Press-Taylor and Francis Group, pp. 27-64.