Total ESG submissions to FDA July – September 2024: Over 37!
Early-Stage Development Highlights
- Over 5 formal FDA meetings and 2 breakthrough meetings
- Over 28 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
- Provided regulatory strategy and guidance for FDA meeting planning
- Provided IND strategy and planning
- Secured 2 breakthrough designations
- Secured 1 orphan designation
- Secured 1 rare pediatric disease designation
- Performed several clinical trial simulations to improve trial design and probability of success.
Late-Stage Development Highlights
- Late-stage CMC meeting with FDA
- Completed 1 FDA meeting clarification request
- Prepared several gap analyses
- Phase 1, 2, and 3 clinical regulatory strategies
- Phase 3 clinical trial oversight (i.e., independent validation of tables, listings, figures, and SDTM/ADaM data packages)
- Programmatic data verification to enable efficient site monitoring and query generation/resolution
- Clinical trial safety reporting
- 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 nonclinical protocols, clinical protocols, statistical analysis plans, and clinical study reports
- Maintained CT.gov postings
- Actively engaged in investment/funding partnership support
- Expanded access program support and website content
- Ongoing pre-approval ad promo strategy and content review
- Pre-approval commercial landscape assessment and marketing evaluation.
Post-Approval and Commercial Highlights
- Several NDA CMC supplements
- Post-approval labeling supplement
- Post-marketing requirement and commitment resolution
- Ongoing advertising and promotional review
- Commercial landscape assessment and marketing evaluation
Investor Support Pack for Companies Seeking Funding
A common problem for early life sciences organizations is how to attract and secure investment to support product development. Investors know that product development is time-consuming and expensive. They also know that most products fail in development. As such, investors look for sound organizations that are developing products that have a high probability producing a favorable return on their investment. So, how do you demonstrate that your company and product is worthy of investment? At Facet, we help early life sciences organizations prepare an Investor Support Pack that summarizes the available scientific data, provides a high-level regulatory plan, and outlines the commercial market assessment and strong business case for the product. Talk to Facet today about how the Investor Support Pack can help you secure investment!