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