Humaneva Insights - Episode 1

Meet Humaneva Insights, a new podcast exploring the science, strategy, and operational realities shaping the future of clinical research and drug development.

Through candid conversations with researchers, industry leaders, and innovators, we’ll explore emerging ideas, tackle real-world challenges, and connect scientific progress with the people and practices that bring it to life.

Whether you’re designing studies, developing therapies, or driving change across the industry, join us for fresh perspectives on what comes next—and what it takes to get there.

Listen. Learn. Move research forward.

Episode 1: Summary

In the inaugural episode of Humaneva Insights, host Patrick McManus speaks with Dr. Brandon Fletcher, Head of Medical Affairs and Cell & Gene Therapy at Kapadi, about when a single adequate and well-controlled clinical trial may be sufficient to support an FDA regulatory decision in oncology. 

A one-trial pathway is not a shortcut to a lower evidentiary standard. In immuno-oncology, the study still needs to produce evidence that is interpretable, attributable, internally credible, and clinically meaningful. Patrick and Brandon discuss when an exceptional response signal may speak for itself, why uncertainty around causality and contribution of components can still require randomization, and how early design choices determine whether a promising program reaches the application stage with evidence regulators can confidently assess. 

Featured Expert 

Dr. Brandon Fletcher is Head of Medical Affairs and Cell & Gene Therapy at Kapadi. She brings more than three decades of drug development experience, with a deep focus on immuno-oncology and cell and gene therapies. Her work spans clinical development strategy, protocol design, scientific and medical oversight, investigator engagement, and translating complex biology into executable clinical programs. She was an original collaborator with the NCI’s origination of cancer cell and gene therapeutics and has continued in the field of immuno-oncology and genetically modified cell therapeutics since. She co-founded a global philanthropic organization that supports and trains investigators in underserved countries.