FACET BY THE NUMBERS
Total submissions to FDA July – Sept 2023: over 40 (over 3 submissions a week!)
Early-stage development highlights: prepared/submitted 2 INDs for new chemical entities and over 30 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, annual reports, safety reporting/DSURs); prepared and submitted 2 pre-IND meeting requests/background packages and 1 Type C meeting request/background package; prepared and submitted 2 orphan designation requests; prepared and submitted 1 Breakthrough Therapy Designation (BTD) request; prepared several gap analyses and regulatory development plans; ongoing review of public-facing information (e.g., websites, flyers, conference presentations) for investigational products.
Late-stage development highlights: preparation of Phase 2 and 3 clinical regulatory strategies; 1 late-stage gap analysis; received 2 IND safe to proceed determinations; reached agreement with FDA on 1 IPSP; supported 1 organization to secure external funding; supported 1 organization to divest product; reviewed and submitted 1 program fee waiver request; maintained CT.gov postings; and ongoing ad promo strategy and document review.