Clinical Development

Allergan-USC Industry Fellowship

This one-year fellowship provides an understanding of the challenges that the modern pharmaceutical industry faces in developing new drug products and explores how clinical pharmacology principles are applied to support the expensive, long, complex but rewarding journey of drug development.

Fellows develop a thorough understanding of therapeutic areas and are able to devise appropriate strategies for each, paying special attention to trial design and interaction with investigators, as well as ethical and legal issues. The ultimate goal of the program is to make the fellow a competent drug developer, a good clinical investigator and a capable overseer of clinical trials with a keen understanding of safety issues.

After a two-month ramping up time, you will be ready to contribute meaningfully—participating with R&D project teams and assisting in the transition of the compound from non-clinical to clinical development by providing scientific and operational expertise. With the rest of the team, you will generate phase, compound and indication-appropriate data to support key decision-making in early development, taking into consideration dose response based on non-clinical/clinical pharmacokinetics, tolerability, biomarkers, safety profiles, pharmacodynamics, pharmacogenomics, the role of demographic factors and other variables affecting drug response and systemic drug exposure.

The Clinical Development Fellowship also offers a second track, focusing on the quantitative aspects of clinical modeling. Fellows in this track pursue computer modeling, simulations and data analysis. Quantitative track candidates should have either a PharmD or PhD to be considered for this fellowship program.

Learning Activities

The clinical pharmacology and quantitative sciences fellowships emphasize:

  • Understanding the road map of new drug discovery and development.
  • Strategic approach to clinical pharmacology, including a fellow-led project focusing on the compound of interest.
  • Processes of conducting clinical pharmacology studies in humans, with a specific application of accepted Good Clinical Practices and their application to the conduct of human studies.
  • In-depth look at pharmacokinetic and pharmacodynamic principles, including analysis of the type of clinical pharmacokinetic, drug metabolism, immunogenicity and pharmacodynamic data that are generated and the impact of these data on decision making.
  • Determining genotype and biomarkers in humans, requiring knowledge of necessary laboratory support and the attendant information provided to clinical pharmacology by the lab (ie, drug concentration measurements, genotype and biomarker determinants in humans).
  • Recognition of the total team approach to the discovery and development of a new drug—including discovery, clinical research, regulatory, clinical pharmacology, pharmaceutical science and drug safety.

Contact Us

For additional information or to apply for the fellowship, please contact:

William C. Gong, PharmD, FASHP, FCSHP
Director, Residency and Fellowship Training
Associate Professor of Clinical Pharmacy
University of Southern California
School of Pharmacy
1985 Zonal Avenue
Los Angeles, California 90089-9121
Telephone: (323) 442-2625
Email: wgong@usc.edu, Res-Fellow@pharmacy.usc.edu