Redefining Every Stage of Investment (RESI) Seed to Exit

Speaker: Geoff Fatzinger, Vice President, Regulatory Strategy, Certara

Promising science alone does not create an investable biotechnology company. Investors also need to see a credible path from candidate selection to clinical evidence, regulatory acceptance, value creation, and ultimately a successful partnership or exit. In this practical session, Certara expert, Geoff Fatzinger, will examine five common development gaps that weaken investor confidence: an unclear value proposition, insufficient translational evidence, an untested regulatory path, poorly justified dose and endpoint decisions, and financing milestones that are disconnected from the development plan. Using real-world development perspectives, the speakers will show how integrated scientific, regulatory, and model-informed planning can expose these risks earlier and turn a compelling scientific story into an executable, investor-ready program. Attendees will leave with five questions their teams should be able to answer before their next investor or partnering meeting.