8:30     Breakfast and Poster Setup

9:00     Welcome and Introduction to GCC Center for Comprehensive PK/PD and Formulation (CCPF)
Suzanne Tomlinson, Gulf Coast Consortia for Quantitative Biomedical Sciences

Omonike Olaleye, Texas Southern University

Dong Liang,  Texas Southern University College of Pharmacy and Health Sciences

Convener: Diana Chow, University of Houston

9:10     Keynote: You Have an Active Compound; Where Do You Go from Here in Drug Development
Leslie Benet, University of California San Francisco

 9:50     Clinical Drug Development
W. Johnny Lau

10:25   Break

Session 1:  Drug Metabolism and PK/PD and Formulation 101

Convener:  Omonike Olaleye, Texas Southern University

10:45   Preclinical Pharmacokinetic Studies
Dong Liang, Texas Southern University

11:10   Preclinical Pharmacokinetic and Pharmacodynamic (PK/PD) Correlation and Allometric Scaling
Diana Chow, University of Houston

11:35   Preclinical Drug Characterization and Formulation Development

12:00   Lunch and Poster Session

1:00 Poster Session (Poster presenters stand at posters)

Session 2: Progress and Potential: CCPF Users
Convener:  Huan Xie, Texas Southern University

 2:00     Developing a Novel Mucoadhesive Patch for Drug Delivery and Chemoablation of Oral Premalignant Lesions
Robert Tsai, Institute of Biosciences and Technology, Texas A&M Health Science Center

2:10     A Hindsight Reflection on the Clinical Development of Opaxio (paclitaxel poliglumex): Lessons Learned
Chun Li, PhD, MD Anderson Cancer Center

2:20     Discovery and Development of Novel Mechanism-of-Action Oral Drugs to Reverse Obesity-linked Type 2 Diabetes
Stan Watowich, Ridgeline Therapeutics, University of Texas Medical Branch

2:30     Small Molecule Targeting of Androgen Receptor-associated Cochaperones for the Treatment of Prostate Cancer
Marc Cox, UT El Paso

2:40     Break

Session 3: IND-Enabling Studies: Regulatory Considerations, Current State-of-the-Art and New Opportunities

Convener:  Dong Liang, Texas Southern University

3:00     In Vitro Transfer Tests De-Risk Decisions to IND
Fady Ibrahim, Pfizer

3:20     Pre-clinical Pharmacokinetics, Tissue Distribution and Physicochemical Studies of CLBQ14, a Novel Methionine Peptidase Inhibitor for Infectious Diseases
Oscar Ekpenyong, Merck

3:40     Quantitative Pharmacology in Support of Design, Selection, & Development of Biologic Modalities
Mohammad Tabrizifard, Ascendis Pharma

 4:00     Formulation Considerations in Developing Large Molecule Drugs
Cinzia Stella, Genentech

4:20     Early In Vitro and In Vivo Toxicology Studies to Push Your Drug into Development
Jeff Larson, Iterion

4:40     Reception