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.

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.

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.

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.

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.

Monticello TM. 2015. Drug development and nonclinical to clinical translational databases: Past and current efforts. Toxicol Pathol 43(1):57-61; doi: 10.1177/0192623314557189.

Monticello TM, Bussiere JL. 2012. Nonclinical safety evaluation of drugs. Chapter 2 in: Sahota PS, Popp JA, Hardisty JF, Gopinath C. (eds), Toxicologic Pathology: Nonclinical Safety Assessment. Boca Raton: CRC Press-Taylor and Francis Group, pp. 25-54.

Wang A, Halbert RJ, Baerwaldt T, Nordyke RJ. 2012. U.S. payer perspectives on evidence for formulary decision-making. J Oncol Pract 8(3 Suppl):22s-27s; doi: 10.1200/JOP.2011.000526. PMID: 22942820.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, October 2011.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2009.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2008.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2007.

Robison TW. Toxicology in the nonclinical development of drugs and biologics. Pharmaceutical Education and Research Institute, Genetic Toxicology, Arlington, VA, September 2006.

Rose WC, Marathe PH, Jang G, Monticello TM, Balasubramanian BN, Long B, Fairchild C, Wall ME, Wani MC. 2006. Novel fluoro-substituted campthothecins: In vivo antitumor activity, reduced gastrointestinal toxicity and pharmacokinetic characterization. Cancer Chemother Pharmacol 58(1):73-85; doi: 10.1007/s00280-005-0128-y.

Tao L, Wadsworth S, Mercer J, Mueller C, Lynn K, Siekierka J, August A. 2002. Opposing roles of serine/threonine kinases MEKK1 and LOK in regulating the CD28 responsive element in T- cells. Biochem J 363(Pt 1):175–182; doi: 10.1042/0264-6021:3630175. PMID: 11903060.