M-14: Biopharmaceutical Innovation: An Evaluation of Clinical Phase and Market Entry Period in Novel Drug Products

Poster Presenter

Ruoying Sheng

Student
University of Southern California
United States

Objectives

Evaluate innovative drug development with the analysis of clinical development time and market entry period information in the notices of patent term extension.

Method

This study was initiated in January 2019 and conducted at USC under the supervision of Dr. Benson Kuo. Determination notices of patent term extension published on Federal Registrar were searched, and a collection of records of 550 drugs approved from 1992 through 2017 were identified and analyzed.

Results

Our preliminary results indicated a significant time increase on clinical study and reduced time on FDA’s market approval phase, suggesting the utilization of FDA’s expedited review programs. We intend to elucidate the underlying mechanism and promoters for these phenomena. Drug information available in other databases and literature, including Drugs@FDA database, Novel Drug Approvals, and New Molecular Entity (NME) Drug and New Biologic Approvals published by FDA was employed to categorize the innovativeness (First-in-Class, New Molecular Entity, among others) In this data set, about 79% are qualified as new molecular entities, 32% are considered to be first in class agents. FDA has granted expedited process during the drug development and review phases, including priority review (35%) followed by orphan drug designation (21%). Further investigations using drug characterization and expedited program information are actively underway.

Conclusion

The well-defined time periods of the testing phase and review phase mandated by the Drug Price Competition and Patent Term Restoration Act provide a unique opportunity for the study of novel drug development. We have demonstrated that there is significant time increase on clinical study and reduction on FDA’s market approval phase in the current set of innovative drugs from 1992-2007. Efforts are undergoing to investigate the promoters and inhibitors for novel drug development.