You Should Read This Before your IND

A practical guide to decision-making, interpretation, and regulatory confidence

Most nonclinical programs don’t fail because the science is wrong.
They fail because no one clearly owns how the data is interpreted, sequenced, and translated into a regulatory story.

This book was written to close that gap.

It’s designed for scientists and biotech leaders who are navigating IND-enabling nonclinical development - often without a full internal toxicology team - and need confidence in the decisions being made long before they reach regulators.

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DATA IS NOT STRATEGY

A nonclinical program is not a collection of studies. It is a sequence of decisions, made visible through data.

Who It's For

This book is written for people who are accountable for nonclinical decisions, including:

Founders and executives responsible for IND-critical risk decisions
Scientists deepening their understanding of IND regulations and nonclinical interpretation
Program leaders navigating uncertainty without a full internal toxicology team
Cross-functional teams preparing for regulatory interactions
Consultants supporting IND-bound programs

What It Covers

Across real-world examples and decision frameworks, this book explores:

Why more data can increase uncertainty rather than reduce it
How execution quietly replaces ownership in many programs
Common myths about what regulators actually expect
How interpretation - not volume - shapes regulatory confidence
How decision-led programs reduce rework, delays, and escalation
What changes when nonclinical strategy is truly working

How To Use It

You can read it cover-to-cover, or use it as a reference when:

You are planning IND-enabling studies
You are interpreting complex or borderline findings
You are preparing for regulatory interactions
You want to pressure-test your nonclinical strategy
You are learning the nuances of nonclinical development

Why This Book Exists

After years working in pharmaceutical development and consulting with early-stage biotech teams, one pattern appeared again and again:

Plenty of execution.

Plenty of data.

Very little ownership of interpretation.

When no one clearly owns nonclinical strategy, programs default to consensus, accumulation, and late-stage course correction.

This book captures the frameworks and questions I use to help teams move from activity to confidence.