Publications

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

Grover A, Sankaranarayanan S, Mathur V, Suri P, Qiu H, Andrews-Zwilling Y, Mease K, Taylor LK, Cahir-McFarland E, Keswani S, Yednock T. 2023. Pharmacokinetic and target engagement measures of ANX007, an anti-C1q antibody fragment, following intravitreal administration in nonhuman primates. Invest Opthalmol Visual Sci 64(2)3; 10.1167/iovs.64.2.3. PMID: 36729444.

Knotts T, Diokno R, Husfeld C, Weinberger D, Mease K, Wollowitz S, Kramer S, Donovan J. Vocacapsaicin (formerly CA-008): A water-soluble prodrug for rapid release of capsaicin for the treatment of postsurgical pain. Presentation to American Association of Pharmaceutical Scientists, AAPS PHARMSCI 360, Boston, MA, October 2022.

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.

Kimzey A, Mease K, Mounho-Zamora B, Wood M. 2021. 13. Biosimilar products—A review of past and current regulatory approval standards for preclinical safety studies. In: Translational Medicine: Optimising Preclinical Safety Evaluation of Biopharmaceuticals. CRC Press: Boca Raton, FL.

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.

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.

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.

Mease K, Kimzey A, Lansita J. 2017. Biomarkers for nonclinical infusion reactions in marketed biotherapeutics and considerations for study design. Curr Opin Toxicol 4(June):1–15; doi: 10.1016/j.cotox.2017.03.005.

Mease K, Kimzey A, Lansita J. Failed dose formulation analysis during a GLP study — Now what? Poster presented at Society of Toxicology 56th Annual Meeting, Baltimore, MD, March 2017.

Sane RS, Steinmann GG, Huang Q, Li Y, Podila L, Mease K, Olson S, Taub ME, et al. 2014. Mechanisms underlying benign and reversible unconjugated hyperbilirubinemia observed with faldaprevir administration in HCV patients. J Pharmacol Exp Ther 351(2):403–412; doi: 10.1124/jpet.114.218081. PMID: 25204339.

Mease K, Sane RS, Podila L, Taub ME. 2012. Differential selectivity of efflux transporter inhibitors in Caco-2 and MDCK-MDR1 monolayers: A strategy to assess the interaction of a new chemical entity with P-gp, BCRP and MRP2. J Pharm Sci 101(5):1888–1897; doi: 10.1002/jps.23069. PMID: 22359351.

Taub ME, Mease K, Sane RS, Watson CA, Chen L, Ellens H, Hirakawa B, Reyner EL, et al. 2011. Digoxin is not a substrate for organic anion transporting polypeptide transporters OATP1A2, OATP1B1, OATP1B3, and OATP2B1 but is a substrate for a sodium dependent transporter expressed in HEK293 cells. Drug Metab Disp 39(11):2093–2102; doi: 10.1124/dmd.111.040816. PMID: 21849517.

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.