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James M. Gallo

  • PROFESSOR Pharmacology and Systems Therapeutics
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  • B.S., Massachusetts College of Pharmacy

  • Pharm.D., University of Florida

  • Ph.D., University of Arizona


    I'm a pharmacokineticist focused on the experimental therapeutics of anticancer drugs. In particular we are interested in using pharmacokinetic [PK] and pharmacodynamic [PD] approaches to advance drug development and improve drug therapy. Currently, these efforts are directed towards experimental models of brain tumors. We hope to identify new chemotherapeutic strategies that are derived from tumor-directed PK/PD investigations and enhance the translational foundation of preclinical to clinical research.
    At Mount Sinai, I plan to continue my work on the experimental therapeutics of brain tumors, and hope to establish new collaborations in anticancer drug therapeutics and PKs and PDs.

    Gallo Laboratory website 


Drug Disposition and Dynamics in Tumors

My lab is focused on the experimental therapeutics of brain tumors that is cast into a foundation of pharmacokinetic [PK], and pharmacodynamic [PD] methods and strategies. We use in silico, in vitro and in vivo investigations to characterize the PK and PD properties of anticancer drugs. These studies have a common goal of understanding the variables that influence drug disposition and dynamics in the tumor, the target site. Through the use of detailed measurements of drug concentrations in tissues and the associated PD endpoints we build physiologically-based PK/PD models that not only provide mechanistic information, but further allow for model predictions to be made in patients where tumor data is sparse. The progression of preclinical studies may lead to new drug treatment strategies and means to optimize drug treatment regimens in patients.

For more information, please visit the Gallo laboratory website.


Wang S, Zhou Q, Gallo JM. Demonstration of the equivalent pharmacokinetic/pharmacodynamic dosing strategy in a multiple-dose study of gefitinib.. Mol Cancer Ther 2009 Jun; 8(6): 1438-1447.

Russo L, Brock CS, Gallo JM, Saleem A, Price PM, Turkheimer FE, Aboagye EO. A new model for prediction of drug distribution in tumor and normal tissues: pharmacokinetics of temozolomide in glioma patients.. Cancer Res 2009 Jan; 69(1): 120-127.

Zhou Q, Gallo JM. Differential effect of sunitinib on the distribution of temozolomide in an orthotopic glioma model.. Neuro Oncol 2009 Jun; 11(3): 301-310.

Zhou Q, Guo P, Gallo JM. Impact of angiogenesis inhibition by sunitinib on tumor distribution of temozolomide.. Clin Cancer Res 2008 Mar; 14(5): 1540-1549.

Wang S, Guo P, Wang X, Zhou Q, Gallo JM. Preclinical pharmacokinetic/pharmacodynamic models of gefitinib and the design of equivalent dosing regimens in EGFR wild-type and mutant tumor models.. Mol Cancer Ther 2008 Feb; 7(2): 407-417.

Zhou Q, Guo P, Kruh GD, Vicini P, Wang X, Gallo JM. Predicting human tumor drug concentrations from a preclinical pharmacokinetic model of temozolomide brain disposition.. Clin Cancer Res 2007 Jul; 13(14): 4271-4279.

Zhou Q, Guo P, Wang X, Nuthalapati S, Gallo JM. Preclinical pharmacokinetic and pharmacodynamic evaluation of metronomic and conventional temozolomide dosing regimens.. J Pharmacol 2007 Apr; 321(1): 265-275.

Gallo JM, Vicini P, Orlansky A, Li S, Zhou F, Ma J, Pulfer S, Bookman MA, Guo P. Pharmacokinetic model-predicted anticancer drug concentrations in human tumors.. Clin Cancer Res 2004 Dec; 10(23): 8048-8058.

Gallo JM, Li S, Guo P, Reed K, Ma J. The effect of P-glycoprotein on paclitaxel brain and brain tumor distribution in mice.. Cancer Res 2003 Aug; 63(16): 5114-5117.

Ma J, Li S, Reed K, Guo P, Gallo JM. Pharmacodynamic-mediated effects of the angiogenesis inhibitor SU5416 on the tumor disposition of temozolomide in subcutaneous and intracerebral glioma xenograft models.. J Pharmacol Exp Ther 2003 Jun; 305(3): 833-839.

Industry Relationships

Physicians and scientists on the faculty of the Icahn School of Medicine at Mount Sinai often interact with pharmaceutical, device and biotechnology companies to improve patient care, develop new therapies and achieve scientific breakthroughs. In order to promote an ethical and transparent environment for conducting research, providing clinical care and teaching, Mount Sinai requires that salaried faculty inform the School of their relationships with such companies.

Dr. Gallo did not report having any of the following types of financial relationships with industry during 2012 and/or 2013: consulting, scientific advisory board, industry-sponsored lectures, service on Board of Directors, participation on industry-sponsored committees, equity ownership valued at greater than 5% of a publicly traded company or any value in a privately held company. Please note that this information may differ from information posted on corporate sites due to timing or classification differences.

Mount Sinai's faculty policies relating to faculty collaboration with industry are posted on our website at Patients may wish to ask their physician about the activities they perform for companies.

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Annenberg Building Floor 19 Room 40A (Office)
1468 Madison Avenue
New York, NY 10029

Tel: 212-241-7770
Fax: 212-996-7214


Annenberg Building Floor 19 Room 19-03 (Lab)
1468 Madison Avenue
New York, NY 10029


Annenberg Building Floor 19 Room 19-40 (Lab)
1468 Madison Avenue
New York, NY 10029