Gallo, a professor in the Department of Pharmaceutical Sciences at the School of Pharmacy, received a $1.56 million grant in July from the National Institutes of Health to develop a new drug development paradigm for targeted anticancer drugs for brain tumors.

“There are many approaches to moving drugs from discovery to clinical use,” said Gallo. “However, none of them has adequately incorporated quantitative pharmacological methodologies.”

Without a more thorough approach, the end result could lead to the selection of a drug for clinical use based on incomplete data and without a foundation to use the drug clinically.


Gallo’s lab will address these limitations using a strategy based on a progression of studies centered on the pharmacokinetic (PK) and pharmacodynamic (PD) properties of drugs at the target site or tumor.

Both PK drug characteristics, which address relationships between dose and concentration versus time, and PD drug characteristics, which address relationships between concentration and effect versus time, will be cast into predictive models. The goal is that to use the models to relate preclinical data to patients, Gallo said.

“Because these models are focused on the PK/PD behavior of drugs in the tumor, they offer the most rational basis to select drugs for development and to design optimal dosing regimens in patients,” Gallo said.


Gallo’s lab will be analyzing new epidermal growth factor receptor (EGFR) inhibitors— a class of anti-cancer drugs that inhibit cell growth—provided by E. Premkumar Reddy, director and professor at the Fels Institute for Cancer Research and Molecular Biology. Gallo’s lab will perform screening and PK/PD studies on the new EGFR inhibitors over the five-year period.


“As with any new research endeavor, there will be unexpected challenges, yet we’re hopeful that our drug development strategy will be accepted on a broader basis in the drug development hierarchy to ensure the most efficacious drugs are use clinically and in an optimal manner,” Gallo said.

—Written by Anna Nguyen