James M. Gallo PharmD, PhD

James Gallo

James M. Gallo
PharmD, PhD

Empire Innovation Professor

Department of Pharmaceutical Sciences

School of Pharmacy

Specialty/Research Focus

Brain Tumor

Contact Information
472 Pharmacy Building
Buffalo, NY 142114214-
Phone: (716) 645-3606
Fax: (716)829-6569

Professional Summary:

Research: Quantitative Systems Pharmacology (QSP) of Brain Tumor Drug Therapy
Our lab is focused on the experimental therapeutics of anticancer drugs used in brain tumors. We incorporate experimental and computational approaches to advance drug development and address unique biological and pharmacological challenges of brain tumor drug therapy. The net result of these efforts will hopefully improve drug therapy and lead to new chemotherapeutic strategies that enhance the translational foundation and integration of preclinical and clinical research.

Our computational paradigm relies on pharmacokinetic [PK], pharmacodynamic [PD] and quantitative systems pharmacology (QSP) approaches that provide a mechanistic underpinning of drug action. We are interested to depict cell-type specific phenomenon and a platform to scale-up QSP models to patients. We believe the latter process can achieve precision medicine.

Project Areas
We have a number of ongoing projects, briefly described below.
Project 1: Drug Development of Anticancer Drugs for Brain Tumor Chemotherapy
We have implemented a systems-based PK/PD-driven drug development strategy to identify the most active drug in brain tumor models. This approach utilizes in vitro assays such as metabolic stability, blood-brain barrier [BBB] permeability and cytotoxicity to screen compounds that may be further characterized for their mechanism of action in preclinical brain tumor models. QSP models developed for the leading candidate drugs may be scaled to yield virtual patient simulations that can predict responders and non-responders and corresponding classification signatures. The individually tailored models provide a true precision medicine tool and pharmacologically-based means to design early clinical trials.

Project 2: Epigenetic Modulation of Drug Therapy
The epigenetic landscape of brain tumors is a dynamic process that can be affected by a number of variables, and may likely have an important role in drug therapy. Post-translational modifications (PTM) of histones is intimately involved in epigenetic modulation and offers drug targets that can determine gene transcription and cell states. In addition, low-grade brain tumors often possess the mutant IDH1 enzyme that yields an oncometabolite (D2HG) that produces a methylator phenotype. Therefore, through modulation of enzyme targets related to PTM we propose drug therapy may be improved.

Project 3: Drug Therapy and Intratumoral Heterogeneity (ITH)
There is an increasing appreciation that brain tumors are highly heterogeneous, due to different cell types and physiological characteristics, which likely impact drug efficacy. Not only are there regional variations in brain tumor blood flow, oxygenation and blood-brain barrier permeability, but different cell types, for example, glioma stem cells and glioma cells may respond differently to drugs due to differences in protein networks. We are interested to develop cell-type specific QSP models to account for ITH, and provide new drug targets and strategies to improve drug therapy.

Education and Training:

  • PhD, University of Arizona (1985)
  • PharmD, University of Florida (1979)
  • Letters & Science, University of Wisconsin - Madison


  • Professor, Pharmaceutical Sciences, Albany College of Pharmacy and Health Sciences (2016–2018)
  • Professor, Pharmacology and Systems Therapeutics, Mount Sinai School of Medicine, Mount Sinai School of Medicine (2009–2016)
  • Professor, Fox Chase Cancer Center (2003–2004)
  • Associate Professor, Fox Chase Cancer Center (1996–2003)
  • Visiting Professor, University of Washington, School of Engineering - Biomedical Engineering (2001)
  • Assistant Professor, Fox Chase Cancer Center (1993–1996)
  • Visiting Associate Professor, Northwestern University, School of Medicine - Neuro-Oncology (1991)

Awards and Honors:

  • Pharmacometrics and Systems Pharmacology Award (2015)

Grants and Sponsored Research:

  • October 2015–September 2017
    Therapeutic applications of mechanism-based PK/PD models of epigenetic modifiers (10/15-9/17)
    Roche - Postdoctoral Fellowship Program
    Role: Co-Principal Investigator
  • February 2012–December 2016
    Targeting Mitotic Kinases Inhibitors for Cancer Therapy
    Role: Co-Investigator
  • December 2010–November 2016
    Interactions Between Cytotoxic and Antiangiogenic Drugs(CA72937)
    Role: Principal Investigator
  • September 2014–June 2016
    Drug Combination Signatures for Prediction and Mitigation of Toxicity(HG008098)
    Role: Co-Investigator
  • September 2011–June 2015
    Function of the MRP Family
    Role: Co-Principal Investigator
  • July 2008–April 2014
    Development of Targeted Anticancer Drugs
    Role: Principal Investigator

Journal Articles:

See all (86 more)


Evaluative Studies and Case Reports:

Professional Memberships:

  • American Society of Clinical Pharmacology and Therapeutics (2012–present)
  • Society of Neuro-Oncology (2007–present)
  • American Association for Cancer Research (1993–present)


  • "Reprogramming QSP with Epigenetic & Cell State Concepts" 2nd Quantitative Systems Pharmacology Symposium, University at Buffalo, QSP (2018)
  • "Translational microdialysis to assess drug and biomarker tumor disposition" Annual Meeting, AAPS (2017)
  • "Systems-based PK/PD Modeling of Anticancer Drugs" American Conference of Pharmacometrics 6, ISoP (2015)
  • "Bridging Preclinical and Clinical PK/PD of Anticancer Drugs with Systems Pharmacology" Biomedical Engineering Series, JohnsvHopkins University, Biomedical Engineering (2015)
  • "Bridging Preclinical and Clinical PK/PD with Systems Pharmacology" , ACS, North Jersey ACS Drug Metabolism Discussion Group (2015)
  • "Integrating Systems Pharmacology and PBPK Models: Application to Oncology" Annual Meeting, ASCPT, Quantitative Systems Pharmacology: Multiscale Model-Based Drug Development Through Integrating Systems Biology and Pharmacometrics (2015)
  • "A Systems Pharmacological Approach to Drug Disposition Using Physiologically-Based Pharmacokinetic Models" Quantitative Systems Pharmacology Symposium, AAPS, Leveraging High-Dimensional Data In Systems Pharmacology Modeling of Drug Disposition and Diseases (2014)
  • "Next Generation Pharmacodynamic Models" , University of Florida, Center for Pharmacometrics and Systems Pharmacology (2013)
  • "Pharmacokinetic/Pharmacodynamic-Driven Drug Therapy for Brain Tumors" Biochemistry Series, Rutgers University, Biochemistry (2013)
  • "Preclinical Approaches to Rethink Brain Tumor Chemotherapy" BMS Distinguished Lectureship, University at Buffalo, Pharmaceutical Sciences (2013)
  • "Integrating Drug Discovery and Experimental Chemotherapy Using Tumor-based Pharmacokinetic/Pharmacodynamic Investigations" Bridging Bench and Bedside with Quantitative Model-Based Translational Pharmacology, The New York Academy of Sciences, Experimental Therapeutics (2012)
  • "Target Tissue Pharmacokinetic/Pharmacodynamic Models of Anticancer Drugs: A Missing Link in Translational Medicine" Deborah M. Richman Memorial Lectureship, MD Anderson Cancer Center, Neuro-oncology (2009)
See all (2 more)

Service Activities:

  • 3rd Quantitative Systems Pharmacology Symposium; Co-Chair (2018–2019)
  • Scientific and Organizing Committee; CNS Anticancer Drug Discovery/Development Conference (1st, 2nd and 3rd). Meeting held as a pre-conference in conjunction with the Society of Neuro-Oncology annual meeting.; Member (2014–2018)

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Contact Information

472 Pharmacy Building
Buffalo, NY 142114214-
Phone: (716) 645-3606
Fax: (716)829-6569