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

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Mar 27, 2014 10:00 AM
  • End Time:
  • Thursday - Mar 27, 2014 11:00 AM
  • Location:
  • Online
  • 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:
    -Regulatory Affairs
    -Clinical Research
    -Business Development and Product Portfolio
    -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.
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