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.

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.

Wood M, Mease K, Lueth J. Study monitoring: Expert approaches for a successful nonclinical program. Exhibitor-Hosted Session, Society of Toxicology 64^th Annual Meeting, Orlando, FL, March 2025.

Monticello TM, Potter DM, Huang Q, Hart TK, Shuey D, Troth S, Vergis JM, Tassew N, et al. 2024. Do longer duration nonclinical toxicology studies provide predictive clinical safety value? The IQ Consortium longer duration nonclinical to clinical translational database. Toxicol Appl Pharmacol 492(Sept 5):117087; doi: 10.1016/j.taap.2024.117087.

Petrick J, Mihalchik A, Tiwary A, Kreidl L, Swartz C, Bhattarai N. Nonclinical safety evaluation of 1-monoacetin and 2-monoacetin as potential impurities in pharmaceutical excipients. Abstract 3107, Society of Toxicology 63rd Annual Meeting, Salt Lake City, UT, March 2024.

Fryzek J, Bylsma L, Mease K, Movva N, Welsh BT, Wood M. 2020. Critical insights into nonclinical toxicology and real-world evidence essential for a successful rare disease product launch. EpidStrategies, Inc. White Paper.

Bussiere JL, Davies R, Dean C, Xu C, Kim KH, Vargas HM, Chellman GJ, Balasubramanian G, Monticello TM. 2019. Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol 106(Aug):224-238; doi: 10.1016/j.yrtph.2019.05.013.

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.

Butler L, Guzzie-Peck P, Hartke J, Bogdanffy M, Will Y, Diaz D, Mortimer-Cassen E,.., Greene N, et al. Revised draft EMA guidance on early clinical trials: Potential impacts and industry response. Abstract P204, American College of Toxicology 2017 Annual Meeting, Palm Springs, CA, 2017. Int J Toxicol 37(1):75-76; doi: 10.1177/10915818177494, 2018.

Lansita J,  Mease KM, Qiu H, Yednock T, Sankaranarayanan S, Kramer S. 2017. Nonclinical development of ANX005: A humanized anti-Clq antibody for treatment of autoimmune and neurodegenerative diseases. Int J Toxicol 36(6)449-462; doi: 10.1177/1091581817740873. PMID: 29202623.

Monticello TM, Jones TW, Dambach DM, Potter DM, Bolt MW, Liu M, Keller DA, Hart TK, et al. 2017. Current nonclinical testing paradigm enables safe entry to First-in-Human clinical trials: The IQ consortium nonclinical translational database. Toxicol Appl Pharmacol 334(Nov 1):100-109; doi: 10.1016/j.taap.2017.09.006.

Butler LD, Guzzie-Peck P, Hartke J, Bogdanffy MS, Will Y, Diaz D, Mortimer-Cassen E,…, Greene N, et al. 2017. Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective. Regul Toxicol Pharmacol 87(Sup 3):S1-S15; doi: 10.1016/j.yrtph.2017.05.009. PMID: 28483710.

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.