Early-stage development highlights:  3 IND preparation and submissions for NCEs, 3 IND clearances; over 35 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, annual reports, safety reporting/DSURs); prepared and submitted 2 orphan designation requests; prepared and submitted 1 Breakthrough Therapy Designation (BTD) request; prepared and submitted 1 Rare Pediatric Disease Designation 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; used statistical modeling and simulations to design Phase 3 clinical trials for 2 NCEs; designed and authored several protocols and clinical study reports; maintained CT.gov postings; and ongoing ad promo strategy and document review.