Total ESG submissions to FDA Jan – Mar 2024:  over 30!

Early-stage development highlights:  led 2 formal FDA meetings, over 25 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, 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; secured 1 rare pediatric disease designation; secured 1 breakthrough designation; clinical trial simulations to improve trial design and probability of success; third party validation of CRO clinical trial results.

Lage-stage development highlights: prepared Phase 2 and 3 clinical regulatory strategies; used statistical modeling and simulations to design Phase 3 clinical trials for 2 NCEs; active regulatory submission planning for 2 NDAs; designed and authored several protocols and clinical study reports; maintained CT.gov postings; actively engaged in investment/funding partnership support; and ongoing ad promo strategy and document review.