Focusing on early-stage development (TRL 1–4), this workshop dives into building a robust proof-of-concept. Presenters will address essential data requirements for demonstrating safety, efficacy, and regulatory readiness, including toxicology, AMES testing, and CMC standards. Additional presentations will cover funding strategies—transitioning from public to private sources—and how to balance publishing with intellectual property protection. Participants will gain clarity on key decisions around proof-of-concept programs and when to engage industry or regulators. An interactive panel will foster dialogue with the audience around these critical pre-commercial stages, helping researchers prepare their innovations for further development.