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Utilizing 505(b)(2) to Accelerate Drug Development Plans

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 3:30PM - 4:30PM (Pacific Standard Time)

Session Number:
293

Room Number:
6D

Level:
Intermediate

Type:
Session

Title:
Utilizing 505(b)(2) to Accelerate Drug Development Plans

Chair(s):
Kenneth Phelps
President and Chief Executive Officer
Camargo Pharmaceutical Services, LLC, United States

Description:
This session will discuss how the application of the 505(b)(2) development strategy has been embraced by a wide range of drug development companies as a means of shortening the development timeline and reducing development costs when compared with development under the traditional 505(b)(1) process. Because 505(b)(2) allows the use of existing literature and data from approved drugs in support of the application, it may mean that some clinical trials can be completely eliminated in some development programs, while others will require only clinical bridging studies to establish a connection to the approved drug. The result can be a streamlined development program that may still provide significant marketing exclusivity for successful products.

Learning Objective(s):
Discuss how 505(b)(2) differs from other regulatory approval pathways; Describe how a detailed development plan utilizing existing literature and data as well as key bridging studies can greatly enhance the success of a pre-IND meeting with the FDA to obtain agreement for streamlined development.

Presentation(s) & Speaker(s):
Utilizing 505(b)(2) in Clinical Bridging Studies
Kenneth Phelps
President and Chief Executive Officer
Camargo Pharmaceutical Services, LLC, United States

Taking Full Advantage of the 505(b)(2) NDA Pathway
Jeff Antos
Vice President
The Weinberg Group Inc., United States