10 Strategic Foundations for Early Drug Development

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.

Download the guide

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.