Build a strong foundation for early drug development success
Learn how emerging and mid-sized biopharma companies can de-risk early development and accelerate time to clinic through strategic planning, cross-functional alignment, and smart study design.
Early development is one of the most pivotal stages in drug R&D. Despite ongoing innovation in discovery, many promising programs stumble before reaching the clinic due to high attrition, rising costs, and fragmented decision-making.
In this guide, Certara experts outline the strategic foundations every emerging and mid-sized company needs to navigate early development with confidence and clarity.
What you’ll learn
Discover actionable insights to streamline your early development program and improve the probability of success.
In this guide, you’ll learn how to:
- Start with the end in mind to align science and strategy
- Understand and plan for modality-specific requirements
- Define a regulatory and biomarker strategy early
- Design model-informed First-in-Human (FIH) studies
- Build a robust, scalable CMC and preclinical plan
- Foster early cross-functional collaboration
- Proactively identify and manage development risks
Each element is designed to help you lay the groundwork for a smarter, more integrated development approach, one that sets the stage for future model-informed success.
Turn early-stage uncertainty into a strategic advantage
Strategic clarity and planning at the earliest stages can determine the fate of your entire program. By applying the right frameworks from the start, you’ll:
- Reduce costly delays and rework
- Strengthen your IND submission package
- Improve translational decision-making
Download the guide and learn how to align science, strategy, and execution to accelerate early development success.
