Publications

Baudy AR, Otieno MA, Hewitt P, Gan J, Roth A, Keller D, Sura R, Van Vleet TR, Proctor WR. 2020. Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry. Lab Chip 20(2):215–225, doi: 10.1039/c9lc00768g.

Roth SE, Avigan MI, Bourdet D, Brott D, Church R, Dash A, Keller D, Sherratt P, Watkins PB, Westcott-Baker L, Lentini S, Merz M, Ramaiah L, Ramaiah SK, Stanley AM, Marcinak J. 2020. Next-generation DILI biomarkers: Prioritization of biomarkers for qualification and best practices for biospecimen collection in drug development. Clin Pharmacol Ther 107(2):333–346, doi: 10.1002/cpt.1571.

Phillips JA, Grandhi TSP, Davis M, Gautier, J-C, Hariparsad N, Keller D, Sura R, Van Vleet TR. 2020. A pharmaceutical industry perspective on microphysiological kidney systems for evaluation of safety for new therapies. Lab Chip 20(3):468–476, doi: 10.1039/c9lc00925f.

Peters MF, Choy AL, Pin C, Leishman DJ, Moisan A, Ewart L, Guzzie-Peck PJ, Sura R, Keller DA, Scott CW, Kolaja KL. 2020. Developing in vitro assays to transform gastrointestinal safety assessment: Potential for microphysiological systems. Lab Chip 20(7):1177–1190, doi: 10.1039/c9lc01107b.

Corliss BA, Delalio LJ, Stevenson Keller TC 4th, Keller AS, Keller DA, Corliss BH, Beers JM, Peirce SM, Isakson BE. 2019. Vascular expression of hemoglobin alpha in Antarctic icefish supports iron limitation as novel evolutionary driver. Front Physiol 10:1389, doi: 10.3389/fphys.2019.01389.

Morgan SJ, Couch J, Guzzie-Peck P, Keller DA, Kemper R, Otieno MA, Schulingkamp RJ, Jones TW. 2017. Regulatory forum opinion piece: Use and utility of animal models of disease for nonclinical safety assessment: A pharmaceutical industry survey. Toxicol Pathol 45(3):372–380, doi: 10.1177/0192623317701004.

Prescott JS, Andrews PA, Baker RW, Bogdanffy MS, Fields FO, Keller DA, Lapadula DM, Mahoney NM, Paul DE, Platz SJ, Reese DM, Stoch SA, DeGeorge JJ. 2017. Evaluation of therapeutics for advanced-stage heart failure and other severely-debilitating or life-threatening diseases. Clin Pharmacol Ther 102(2):219–227, doi: 10.1002/cpt.730.

Ewart L, Fabre K, Chakilam A, Dragan Y, Duignan DB, Eswaraka J, Gan J, Guzzie-Peck P, Otieno M, Jeong CG, Keller DA, de Morais SM, Phillips JA, Proctor W, Sura R, Van Vleet T, Watson D, Will Y, Tagle D, Berridge B. 2017. Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective. Exp Biol Med (Maywood) 242(16):1579–1585, doi: 10.1177/1535370217715441.

Monticello TM, Jones TW, Dambach DM, Potter DM, Bolt MW, Liu M, Keller DA, Hart TK, Kadambi VJ. 2017. Current nonclinical testing paradigm enables safe entry to first-in-human clinical trials: The IQ consortium nonclinical to clinical translational database. Toxicol Appl Pharmacol 334:100–109, doi: 10.1016/j.taap.2017.09.006.

Andrews PA, Keller DA. 2016. On the use of juvenile animal studies to support oncology medicine development in children. Reprod Toxicol 66:128–130, doi: 10.1016/j.reprotox.2016.05.012.

Juberg DR, Knudsen TB, Sander M, Beck NB, Faustman EM, Mendrick DL, Fowle JR 3rd, Hartung T, Tice RR, Lemazurier E, Becker RA, Fitzpatrick SC, Daston GP, Harrill A, Hines RN, Keller DA, Lipscomb JC, Watson D, Bahadori T, Crofton KM. 2017. FutureTox III: Bridges for translation. Toxicol Sci 155(1):22–31, doi: 10.1093/toxsci/kfw194.

Keller DA, Brennan RJ, Leach KL. 2015. Clinical and nonclinical adverse effects of kinase inhibitors. In: Urban L, Patel V, Vaz RJ (eds), Antitargets and Drug Safety, pp. 365–400. Wiley, doi: 10.1002/9783527673643.ch16.

Knudsen TB, Keller DA, Sander M, Carney EW, Doerrer NG, Eaton DL, Fitzpatrick SC, Hastings KL, Mendrick DL, Tice RR, Watkins PB, Whelan M. 2015. FutureTox II: In vitro data and in silico models for predictive toxicology. Toxicol Sci 143(2):256–267; doi: 10.1093/toxsci/kfu234.

Keller DA, Juberg DR, Catlin N, Farland WH, Hess FG, Wolf DC, Doerrer NG. 2012. Identification and characterization of adverse effects in 21st century toxicology. Toxicol Sci 126(2):291–297, doi: 10.1093/toxsci/kfr350.

Sistare FD, Morton D, Alden C, Christensen J, Keller D, Jonghe SD, et al. 2011. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: Support for a proposal to modify current regulatory guidelines. Toxicol Pathol 39(4):716–744; doi: 10.1177/0192623311406935.

Xue C-B, Chen L, Cao G, … Keller D, et al. 2010. Discovery of INCB9471, a potent, selective, and orally bioavailable CCR5 antagonist with potent anti-HIV-1 activity. ACS Med Chem Lett 1(9):483–487, doi: 10.1021/ml1001536.

Bogdanffy MS, Keller DA. 1999. Metabolism of xenobiotics by the respiratory tract. In: Gardener, DE (ed), Toxicology of the Lung, 3^rd ed., pp. 85–124. Taylor and Francis, Philadelphia, PA.