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.
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.
Shares Two-year translational fellowships that pay scientists to develop their own discovery, 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.
Shares Two-year translational fellowships that pay scientists to develop their own discovery, The valley of death between lab and product.
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.
Shares Manufacturing cost and time for living and radioactive medicines, Radioligand therapy (beta emitters), CAR-T cell therapy.
Shares A fast IND-enabling fund that pays for toxicology and manufacturing in eight weeks, The valley of death between lab and product.
Shares A fast IND-enabling fund that pays for toxicology and manufacturing in eight weeks, The valley of death between lab and product.
Shares The valley of death between lab and product, Manufacturing cost and time for living and radioactive medicines, CAR-T cell therapy.