Isaac Stoner's company, MindImmune, posits that Alzheimer's is an immune response to amyloid plaques causing neuron damage. Their therapeutic approach targets immune cells outside the brain to treat a CNS disease, a paradigm shift from traditional methods that focus solely on the brain.
Unlike big pharma, capital-constrained biotechs can't afford long, expensive trials. MindImmune’s CEO advocates for designing clever Phase 1b studies that use biomarker endpoints to get an early efficacy signal in months, not years, thereby de-risking the program for investors much faster.
Reflecting on a past failure, Isaac Stoner asserts that the costliest risk in drug development is ambiguity. A poorly designed study yielding a “thumb sideways” is worse than a well-designed one that produces a clear failure, as ambiguity prevents actionable decisions and wastes invaluable time and capital.
A common failure mode is sprinting forward with a molecule after seeing any signal in an animal model. Isaac Stoner advises overinvesting in robust in-vitro assay development first. This ensures a deep understanding of a molecule's functional activity on human biology, preventing costly translational failures later.
Isaac Stoner warns against overloading early clinical trials with numerous exploratory endpoints. This "fishing for signal" adds significant cost and complexity, and crucially, risks generating data that is confusing or even detrimental, rather than providing the necessary clear go/no-go decision.
Isaac Stoner advises future biotech entrepreneurs to treat their career like learning a skilled trade. Instead of immediately starting a company, they should first spend several years working for a “master”—someone proven to be excellent at building biotechs—to learn the craft in a compressed, hands-on environment.
To succeed, biotechs need open, "in the trenches" relationships with their development partners. Isaac Stoner expects his CROs and CDMOs to communicate problems immediately—"we want to know that yesterday"—allowing for real-time, collaborative troubleshooting rather than waiting for issues to escalate.