The First IND CMC Playbook for Emerging Biotech: A Founder's Guide to US FDA-Ready Strategy Small Molecules, Peptides, and Oligonucleotides

The First IND CMC Playbook for Emerging Biotech is a practical guide for founders, CEOs, and biotech leaders who need to move a promising molecule toward an IND without losing time, capital, or momentum. Written for decision-makers who may not be CMC specialists, the book explains the business-critical choices that shape IND readiness, including development timing, CDMO strategy, analytical planning, stability, documentation, and phase-appropriate quality controls.Built around the realities of small molecules, synthetic peptides, and synthetic oligonucleotides, this book translates complex CMC and regulatory issues into clear, actionable guidance. It gives readers enough technical depth to be useful to regulatory and CMC teams, while keeping the focus on the questions that matter most to founders: What must be committed now, what can still evolve, and where is the hidden risk that could delay the next milestone?