Setting the Right Strategy
As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Certara’s solution evaluates the 40 different questions that the agency will ask about your clinical pharmacology data package at the time of a New Drug Application (NDA) submission, facilitating the evaluation and addressing any potential gaps before meeting with the regulators at the end of Phase 1, Phase 2 or Pre-NDA. A gap analysis and clinical pharmacology development strategy ensures that all relevant domains are covered, gaps are properly addressed, all elements needed for informative actionable product labeling are clear, and that data is gathered at meaningful times to enhance decision-making during development.
Benefits at Any Stage of Development
For a target product or program, we will:
- Identify potential R&D or regulatory challenges, custom to the molecule, therapeutic area, and competitive landscape
- Ensure integration of pre-clinical findings with planned clinical programs
- Create a clinical pharmacology development program in line with anticipated regulatory filing strategy
- Identify and leverage pharmacometrics and other model-informed drug development technologies that will increase speed and efficiency
- Provide readiness support and help guide interactions with regulatory agencies for research programs and submittals
ROI of Gap Analysis and Strategic Roadmap
Certara will create a roadmap that prioritizes needs, provides strategic direction, identifies gaps, assesses risk/benefits, helps position the sponsor for successful interactions with regulators and other partners, and creates value. The strategic plan will be harmonized with the sponsor’s overall clinical development plan and takes into consideration strategies to support breakthrough therapy applications and accelerated versus regular approval pathways. In all scenarios, the gap analysis and strategic plan identifies and mitigates risks which could become either decision-making hurdles during development or regulatory hurdles at the time of approval. In our experience, the ROI for this analysis is 10-20x, and frequently 50-100x or more, depending on the program. The ROI aligns to reduced study size, expedited timelines, and studies that can be replaced by MIDD.
By investing in a gap analysis that informs strategic roadmap, you will increase your drug program’s likelihood of regulatory and commercial success.