Regional translational institutes with academic GMP suites and IND teams
Build a handful of publicly-funded centres where academic discoveries can be manufactured to clinical grade and written up for regulators, so good ideas do not die for lack of a factory and a filing.
A network of five to ten regional institutes, each with GMP manufacturing for biologics, cell and gene therapies and radiopharmaceuticals, GLP toxicology partnerships, regulatory-affairs staff who write INDs and clinical trial applications, and phase 1 unit access. Academic teams apply with a candidate and leave with a first-in-human trial. Precedents include Cancer Research UK's Centre for Drug Development (which has taken dozens of academic agents into the clinic), NCATS' TRND and BrIDGs programmes, the Netherlands Cancer Institute's in-house pharmacy, and Fraunhofer's translational centres. Institutes are funded on throughput (INDs filed, trials started) and asset outcomes, not on publications.
- The valley of death between lab and product · Most academic discoveries die before anyone tests them in people because nobody funds the middle step.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
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not linked directly; found by shared links- IdeaA public indemnity pool so universities can sponsor first-in-human cancer trials
Shares A national non-profit contract research organisation for academic oncology trials, A global first-in-human network for academic cancer trials with single ethics review, Hospital-exemption cell therapies at scale, backed by a shared registry, The valley of death between lab and product.
- IdeaHospital-based CAR-T manufacturing at cost through a public network
Shares Shared modular GMP facilities for academic personalised vaccines and cell products, Hospital-exemption cell therapies at scale, backed by a shared registry, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaHospital-funded protected time for clinician-scientists, repaid by trial revenue
Shares Two-year translational fellowships that pay scientists to develop their own discovery, The valley of death between lab and product.
- IdeaMutual recognition of GMP inspections for cell, gene and radiopharmaceutical plants
Shares Radioligand therapy (beta emitters), Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaMulti-centre randomised animal trials before committing to a human trial
Shares The valley of death between lab and product, Cancer Research UK, National Cancer Institute (NIH).
- IdeaPublic cell-therapy foundries at cancer centres for academics and start-ups
Shares The valley of death between lab and product, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- Key paperMaude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL
Shares Abramson Cancer Center, University of Pennsylvania, The valley of death between lab and product, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.
- IdeaA diversified royalty pool that finances academic phase 1 trials across fifty assets
Shares A fast IND-enabling fund that pays for toxicology and manufacturing in eight weeks, The valley of death between lab and product.