This presentation will address the general process, submission content, regulatory considerations and challenges associated with drug or biologic development programs utilizing the Platform Technology Designation Program. Following this overview, a mock case study will explore platforms using a chemically defined targeting moiety in conjunction with a well-characterized synthetic siRNA. The focus will be placed on what are the ‘eligibility factors’ and what constitutes ‘preliminary evidence’ that would be considered sufficient to support a designation request. The objective is to facilitate the application of these principles in submissions of platform technology designation request and enable leveraging of existing data through the program if granted.
