New approach methodologies (NAMs) and model-informed drug development (MIDD) offer biotech sponsors new opportunities to generate human-relevant evidence, reduce uncertainty, and inform critical development decisions. Realizing their value requires a program-specific, risk-based strategy grounded in the scientific and regulatory questions that matter most.
In this practical playbook, Premier Research outlines:
- A practical five-step framework for evaluating program suitability, defining context of use, and developing a risk-based NAMs and MIDD strategy.
- Key considerations for building a compelling weight-of-evidence package that integrates human-relevant data, modeling, prior knowledge, and appropriate nonclinical evidence.
- Strategies for cross-functional alignment and FDA engagement to support scientifically defensible decisions, effective governance, and informed regulatory discussions.
Download the guide to explore a strategic, evidence-driven approach to integrating NAMs and MIDD into biotech drug development.
Download the Playbook
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