The sponsor-proxy model: Bridging basic science discovery and investigator-initiated clinical trials

Translating academic discoveries into clinical investigation remains a major barrier in translational science, particularly when investigators lack the regulatory infrastructure required to sponsor clinical trials. These challenges are especially pronounced for natural product therapeutics, which often lack commercial sponsorship despite promising preclinical evidence. The Penn State Cancer Institute established an Investigator-Initiated Trial Sponsor Support Unit (SSU) to facilitate investigator-initiated trials and support progression toward National Cancer Institute designation. We describe a translational science case study of a Sponsor-Proxy operational model in which a centralized institutional unit performs sponsor-level regulatory and trial infrastructure functions while investigators retain scientific and clinical leadership. Two National Institutes of Health-funded trials evaluating Angelica gigas Nakai extract (INM176) illustrate this framework. The SSU authored regulatory documentation including Investigator's Brochures, coordinated Investigational New Drug submissions, and supported trial infrastructure while clinical teams maintained participant oversight. Both trials achieved activation timelines of 112 and 105 days, shorter than previously reported activation times and within National Cancer Institute operational benchmarks. Sponsor-level oversight continued throughout trial conduct, including regulatory reporting, safety monitoring, and protocol amendment support. This case study demonstrates how centralized institutional expertise can overcome sponsor-level barriers and enable translation of basic science discoveries into investigator-initiated early-phase clinical trials.