Essential Do's and Don'ts for Navigating a Successful 505(b)(2) Drug Application

Instructor: Thomas Reilly
Product ID: 703314
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This FDA New Drug Approval process training will provide attendees with the knowledge and skills needed to develop a successful 505 (b)(2) program.

Why Should You Attend:

Despite its significant advantages, the 505(b)(2) pathway presents unique scientific, regulatory and legal challenges. Accordingly, knowledge of this regulatory pathway is important for all firms with an interest in utilizing the 505(b)(2) pathway as a means of building their drug portfolios, and also to better understand their competitors who are utilizing this pathway.

This webinar will provide an essential review of the key do's and don’ts for a 505(b)(2) application. Specifically the presentation will provide the information for companies to choose appropriate 505(b)(2) candidates, and to successfully advance them through development.

Areas Covered in the Webinar:

  • History of the 505(b)(2) NDA
  • Strategic considerations for 505(b)(2) projects and common mistakes
  • Examples of 505(b)(2) candidate projects
  • Intellectual property issues and non- patent exclusivity
  • Key development steps for 505(b)(2) candidates
  • 505(b)(2) benefits and risks
  • Trends in FDA review of 505(b)(2) applications; key regulatory issues
  • Examples of successes and failures for 505(b)(2) projects

Who Will Benefit:

This webinar will provide valuable information to professionals in:

  • R&D
  • Regulatory Affairs
  • Clinical Research
  • Business Development and Product Portfolio
  • Marketing
  • Project Management
  • Intellectual Property

Instructor Profile:

Thomas Reilly, PhD, MBA, is the Founder and President of BD HORIZONS, INC., LLC, a company that provides a full range of business development services to the pharmaceutical and biotechnology industries. Dr. Reilly has extensive experience in pharmaceutical R&D, global business development, portfolio planning, and regulatory compliance, gained by serving in a number of senior level roles in large and small life sciences companies including: Senior Vice President and Head of Life Sciences at ICAP Patent Brokerage; Vice President and Head of Drug Repositioning at BTG; Senior Director of Business Development and Licensing at Bristol Myers Squibb and DuPont Pharmaceuticals; and Senior Director and Head of Cardiovascular Discovery at DuPont Pharmaceuticals. Dr. Reilly received his PhD in Microbiology from Rutgers University and holds an MBA from the University of Delaware.

Topic Background:

The 505(b)(2) represents a unique regulatory pathway, available only for marketing approval in the U.S. A 505(b)(2) product is an improved or altered version or a new use application for a previously FDA-approved drug. A commercial incentive to develop 505(b)(2) products is the availability of at least three years of marketing exclusivity available for the approved product. A major cost-savings advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, the reference drug. Therefore the 505(b)(2) application can be likened to a hybrid application between the two other established types of new drug applications, requiring more data than an abbreviated NDA (ANDA), but less than a traditional (505(b)(1) NDA.

The 505(b)(2) pathway, which was added to the federal Food, Drug and Cosmetic Act through the Hatch-Waxman Amendment in 1984, can be utilized for a wide range of products, especially for those that represent a small changes from a previously approved drug. In 2013 alone the FDA approved 38 different 505(b)(2) applications. However, there are various development challenges that are unique to 505 (b)(2) applications. Therefore, careful consideration and planning must be used to identify and resolve all issues associated with a potential 505(b)(2) application

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