{"entity":{"id":"idea-fund-phase-zero-fund","kind":"idea","name":"A phase 0 fund to test academic compounds in humans with microdoses and imaging","aka":[],"tldr":"Before investing in a full trial, give a few patients a tiny dose of a new compound and use scans and blood tests to see whether it reaches the tumour and hits its target. Fund these small studies as a matter of routine.","summary":"Phase 0 (exploratory IND) studies use microdoses or short courses to measure pharmacokinetics, target engagement (via PET tracers, tumour biopsies or pharmacodynamic markers) and biodistribution before committing to IND-enabling toxicology at full scale. They are cheap, fast and answer the question that kills most academic compounds late: does it get where it needs to go and do what it should in people? A dedicated fund pays for radiolabelling, tracer synthesis, phase 0 unit costs and biopsy-based pharmacodynamics for academic assets, with a rule that assets failing target engagement are dropped and published.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (The valley of death between lab and product): Butler, Translational research: crossing the valley of death (Nature 2008)","url":"https://doi.org/10.1038/453840a"}],"tags":[],"related":["idea-fund-ind-enabling-fund","idea-fund-fast-grants-oncology","idea-fund-academic-radiopharma-pipeline"],"cancers":[],"sections":[],"technologies":["immuno-pet","pet","liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["suv"],"trials":[],"people":[],"bottlenecks":["b-translational-valley","b-preclinical-models"],"keyPapers":["paper-butler-nature"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Routing academic candidates through funded phase 0 studies kills at least 30% before IND-enabling investment and raises the phase 2 success rate of those that proceed compared with the historical academic pipeline, at a cost per candidate under $1 million.","rationale":"Regulatory frameworks for exploratory INDs exist in the US and EU; the NCI ran a phase 0 programme demonstrating feasibility with a PARP inhibitor. Immuno-PET and radiolabelled small molecules now allow direct measurement of tumour delivery for many modalities, including antibodies and ADCs.","test":"Fund phase 0 studies for ten academic assets and compare downstream attrition and cost with a matched historical cohort that went straight to IND-enabling work.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":2},"route":"/ideas/idea-fund-phase-zero-fund/","neighbours":{"idea":[{"id":"idea-fund-ind-enabling-fund","kind":"idea","name":"A fast IND-enabling fund that pays for toxicology and manufacturing in eight weeks","route":"/ideas/idea-fund-ind-enabling-fund/"},{"id":"idea-fund-academic-radiopharma-pipeline","kind":"idea","name":"A university cyclotron network with shared regulatory files for new tracers","route":"/ideas/idea-fund-academic-radiopharma-pipeline/"},{"id":"idea-fund-fast-grants-oncology","kind":"idea","name":"Forty-eight-hour small grants for bold experiments in neglected cancers","route":"/ideas/idea-fund-fast-grants-oncology/"}],"technology":[{"id":"immuno-pet","kind":"technology","name":"Immuno-PET","route":"/technologies/immuno-pet/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"pet","kind":"technology","name":"PET (positron emission tomography)","route":"/technologies/pet/"}],"term":[{"id":"suv","kind":"term","name":"Standardised uptake value (SUV)","route":"/terms/suv/"}],"bottleneck":[{"id":"b-preclinical-models","kind":"bottleneck","name":"Lab models that fail to predict what happens in patients","route":"/bottlenecks/b-preclinical-models/"},{"id":"b-translational-valley","kind":"bottleneck","name":"The valley of death between lab and product","route":"/bottlenecks/b-translational-valley/"}],"paper":[{"id":"paper-butler-nature","kind":"paper","name":"Translational research: crossing the valley of death","route":"/key-papers/paper-butler-nature/"}]}}