Contracts in Biotech: A Practical Roadmap from NDA to M&A: A practitioner's guide to navigating the agreements that power biotech innovation (The Biotech Roadmap Series)

Biotech moves fast. Contracts rarely keep up.

From preclinical research through commercialization, agreements are often treated as isolated legal events rather than what they truly are: operational tools that shape timelines, cost, and risk. The result is predictable: delays, misalignment between stakeholders, unnecessary legal spend, and missed opportunities.

Contracts in Biotech reframes contracting as a core business function, not a back-office exercise.

Written for biotech executives, operators, legal professionals, and investors, this book provides a practical, experience-driven guide to structuring, negotiating, and managing agreements across the full lifecycle of a biotech company. It bridges the gap between legal theory and real-world execution, offering insight into how contracts actually function in clinical and operational environments.

Inside, you will learn how to:

Align contracts with development stage and company strategy Reduce dependency on high-cost outside counsel without increasing risk Build scalable templates, playbooks, and clause libraries Navigate common agreement types, from preclinical partnerships to clinical trial and vendor agreements Integrate legal with clinical operations to accelerate timelines Identify where legal risk ends and business risk begins Rather than focusing on abstract legal principles, this book emphasizes execution. It explains how decisions are made, where friction occurs, and how experienced operators avoid costly mistakes.

Whether you are building your first biotech company or scaling an established organization, Contracts in Biotech provides a clear, actionable framework to turn contracting into a competitive advantage.