FACET BY THE NUMBERS

Total ESG submissions to FDA Apr – June 2024:  Over 30!

Early-Stage Development Highlights

6 formal FDA meetings, 1 investigator-initiated IND, over 25 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, information amendments, IND annual reports, orphan designation annual reports, safety reporting/DSURs); prepared several gap analyses and regulatory development plans; ongoing review of public-facing information (e.g., websites, flyers, conference presentations) for investigational products; responded to numerous FDA information requests; supported initial CMC development of complex drug-device combination product; provided regulatory strategy and guidance for FDA meeting planning; provided IND strategy and planning; secured 1 breakthrough designation; secured 1 fast track designation; clinical trial simulations to improve trial design and probability of success.

Late-Stage Development Highlights

Prepared several gap analyses, Phase 2 and 3 clinical regulatory strategies; Phase 3 clinical trial oversight; used statistical modeling and simulations to design Phase 3 clinical trials; supported registration batch manufacturing; human factors study design recommendations; medical device development strategy for over 3 products; active regulatory submission planning for 3 NDAs/BLAs; designed and authored several protocols and clinical study reports; maintained CT.gov postings; actively engaged in investment/funding partnership support; and ongoing pre-approval ad promo strategy and content review.

Post-Approval and Commercial Highlights

Several NDA CMC supplements; labeling PAS; ongoing advertising and promotional review.