Publication Topic

Nordyke RJ, Jensen I, Hooda N, Miller B. Rising levels of innovation in expedited designations among FDA-approved drugs: 2012-2024. Poster Session 2/No. HPR63, ISPOR 2026, Philadelphia, PA, May 18, 2026.

Greene N. The role of AI in advancing drug discovery. Abstract 1055, Society of Toxicology 65^th Annual Meeting, San Diego, CA, March 2026.

Petibone DM, Shemansky JM, Robison TW, Atrakchi AH, Heflich RH. 2026. Assessing carcinogenic outcomes following short-term exposure to potentially DNA-reactive drugs: Are available data sufficient to inform risk assessment? Regul Toxicol Pharmacol 165(Feb):105993; doi: 10.1016/j.yrtph.2025.105993. PMID: 41274540.

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

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.

Xia L, Yan J, Chen Y, Robison TW, Chen T. 2025. Germline mutagenicity of molnupiravir and its active form, β-d-N4-hydroxycytidine, in Caenorhabditis elegans evaluated using whole-genome sequencing. Toxicol Lett 409(Jun):138-144; doi: 10.1016/j.toxlet.2025.05.007. PMID: 40409569.

Lagiakos HR, Zou Y, Igawa H, Therrien E, Lawrenz M, Kato M, Svensson M,…, Dingley K, et al. 2025. In silico enabled discovery of KAI-11101, a preclinical DLK inhibitor for the treatment of neurodegenerative disease and neuronal injury. J Med Chem 68(3):2720-2741; doi: 10.1021/acs.jmedchem.4c02074. PMID: 39670820.

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.

Bienvenu JG, Chouinard L, Felix M, Boyce, RW, Monticello TM. 2024. Inhibition of both sclerostin and DKK1 results in novel skull findings in the rat and non-human primate that is not observed with inhibition of sclerostin alone. Bone 179(Feb):116985; doi: 10.1016/j.bone.2023.116985. PMID: 38052372.

Dobrovolsky VN, Atiq OT, Heflich RH, Maisha M, McKinzie PB, Pearce MG, Robison TW. 2024. Erythrocyte PIG-A mutant frequencies in cancer patients receiving cisplatin. Cancer Med 13(3):e6895; doi: 10.1002/cam4.6895. PMID: 38214136.

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. PMID: 37552384.

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. PMID: 35331777.

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.