3rd Annual 505(b)(2) Forum to Discuss Product Development and Regulatory Updates

The 505(b)(2) Forum

The 3rd annual 505(b)(2) Forum will be held in conjunction with the Generic Pharmaceutical Association (GPhA) Fall Technical Conference in North Bethesda, Maryland, on Monday, October 24. The 505(b)(2) Forum focuses on drug development via the United States Food and Drug Administration 505(b)(2) regulatory pathway. The agenda includes:

  • Key factors in identifying a viable 505(b)(2) candidate
  • FDA guidelines covering the 505(b)(2) pathway and recent changes
  • Common mistakes associated with 505(b)(2) filings
  • Examples of successful 505(b)(2) applications including fixed dose combinations, improved drug absorption, and altered route of administration
  • Recent FDA regulations and cases

Representatives from Camargo Pharmaceutical Services and Foley & Lardner LLP will present at the invitation-only dinner event.

"The 505(b)(2) pathway offers the potential to create new, differentiated products with tremendous commercial value."

Ken Phelps, President and CEO at Camargo Pharmaceutical Services

“There is increasing interest in pursuing the 505(b)(2) pathway for NDA approvals given the potential to reduce overall development time and costs by eliminating most nonclinical studies and extensive safety and efficacy tests by referencing existing data,” said Ken Phelps, President and CEO of Camargo Pharmaceutical Services. “The 505(b)(2) pathway offers the potential to create new, differentiated products with tremendous commercial value.”

Despite the increasing percentage of new small molecule drugs being approved via the 505(b)(2) process, the complexities of the pathway create challenges for companies historically focused on 505(b)(1) or ANDA 505(j) development. Significant changes in small molecule development and in the generics market present a growing need for strategies in 505(b)(2) development.

Presentations at this year’s 505(b)(2) Forum include:

  • “Leveraging Patent Options and Other Advantages of the 505(b)(2) Pathway”, given by Ken Phelps, President and CEO, Camargo Pharmaceutical Services 
  • “Legal Issues and Strategic Advantages of 505(b)(2)”, given by David Rosen, BS Pharm, JD, Foley & Lardner LLP

Registration is free, but space is limited. Learn more about the event at 505b2forum.com.

About the 505(b)(2) Forum: The 505(b)(2) Forum was organized by product developers and service providers interested in improving best practices across the 505(b)(2) development process. From candidate identification and Chemistry, Manufacturing, and Controls (CMC) to shaping regulatory and commercial strategies, participating companies and attendees will discuss the 505(b)(2) regulatory approval pathway and supportive technologies for successful product development.

Source: 505(b)(2) Forum