ABOUT

Welcome to CCPF

Preclinical drug development usually takes several years from the identification of a new chemical entity (NCE) to advance to clinical testing. Most of these pharmacokinetics (PK)/pharmacodynamics (PD) and formulation evaluations are required for Investigational New Drug (IND) applications. Two aspects are generally involved for an NCE at this stage: 1) in vitro PK characterizations (physiochemical properties, metabolism, stability, and cellular and gastrointestinal permeability); and 2) in vivo PK and PD evaluations in animal models. In addition, most NCEs are either unstable or unsuitable for conventional routes of drug administration. Thus, developing an optimal dosage formulation is critical for further NCE candidate development.

Gulf Coast Consortia (GCC) Center for Comprehensive PK/PD & Formulation (CCPF), funded by Cancer Prevention & Research Institute of Texas (CPRIT), is a state-of-the-art drug development core facility with experienced faculty from Texas Southern University College of Pharmacy and Health Science (TSU COPHS), University of Houston College of Pharmacy (UHCOP), and the GCC for Quantitative Biomedical Science. Our primary focus is on preclinical drug development to facilitate rapid advancement of novel cancer drug candidates to clinical trials. We are proud to provide critically needed PK/PD and formulation services to streamline drug development of potential anti-cancer drug candidates identified in existing drug discovery cores, individual labs, and small companies throughout Texas.

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CCPF LEADERSHIP

Dong Liang, Ph.D.

Professor and Chair, Department of Pharmaceutical and Environmental Health Sciences, TSU COPHS.

Dr. Liang has industrial and academic expertise in pre-clinical and Phase I PK and drug development studies. He has worked on Phase I PK studies from protocol design (clinical study monitoring; bioanalysis; and statistical PK data interpretation) to FDA submissions for over 35 generic drug product approvals. He is co-inventor of 5 U.S. patents in dosage formulation development. He is the Director of CCPF with responsibility for the overall operations of the program, as well as providing support in PK studies in rats.

Huan Xie, Ph.D.

Professor of Pharmaceutics and Director of NIH-RCMI Pharmacology Core, TSU COPHS.

Dr. Xie has a broad background in nano-formulation and targeted drug delivery, with specific expertise in cancer therapy applications. Dr. Xie has 4 years of industry experience contributing to the development of silica/gold nanoshell cancer therapy, now in several clinical trials. She is an inventor on 3 patents related to novel drug formulation and PK study and has many collaborators across Texas. She has been consistently funded by NIH, and now serves as Co-Director of the CCPF, providing support in traditional and advanced drug formulation and delivery.

Diana S-L. Chow, Ph.D

Professor of Pharmaceutics and Director of the Institute for Drug Education and Research (IDER) at UHCOP, and Fellow of the National Academy of Inventors.

Dr. Chow is an expert in preclinical and clinical PK/PD, particularly in the development, modeling and analysis of novel drug formulations and drug-delivery systems. Her research has resulted in more than 10 U.S. and international patents, including her co-invention of IV Busulfex® (busulfan), an intravenous conditioning agent for leukemia and cancer patients undergoing blood, bone marrow or stem cell transplantation. Dr. Chow provides PK/PD analysis expertise to the CCPF users.

Omonike Olaleye, Ph.D.

Professor of Pharmacology and Leader of Collaboration & Partnership Activity of NIH-RCMI Program at TSU COPHS.

Dr. Olaleye is an expert in drug discovery with the characterization of multiple promising drug leads and novel assay development. She has rich experience in education and training in biomedical research. Dr. Olaleye is responsible for the education and training component of CCPF.

Suzanne Tomlinson, Ph.D.

Director of Research Programs for GCC.

Dr. Tomlinson has experience in 1) developing and licensing novel therapeutics 2) developing educational initiatives and curriculum for drug discovery, development, and commercialization, 3) coordinating large conferences, and 4) managing web-based educational resources and core project application systems. Dr. Tomlinson works with Dr. Olaleye to deploy CCPF educational programs.