In the first full year of the five-year plan, the achievements seen in 2017 showcased the potential of a united public-private front as swathes of scientists, advocates, charities, and invested parties pooled their resources. One such effort was a collaboration between the National Institutes of Health and 12 leading biopharmaceutical companies, known as the Partnership for Accelerating Cancer Therapies (PACT). The $215 million project focused on efforts to identify, develop, and validate robust biomarkers to advance new therapies and treatments that harness the immune system to attack cancer.
Under the Moonshot, the National Cancer Institute introduced a new drug formulary. A public/private partnership between the NCI, pharma, and biotech companies, the formulary provides NCI-designated cancer centres and their investigators’ rapid access to agents for cancer trial use and pre-clinical research.
Alongside this formulary, 2017 saw the establishment of the FDA Oncology Center of Excellence. Initially authorised by the 21st Century Cures Act of 2016, the centre brought together regulatory scientists and reviewers with expertise in drugs, biologics, devices, and data science to support an integrated approach to evaluating products for the diagnosis and treatment of cancer. At the core of this mission was the aim to achieve patient-centred regulatory decision-making through innovation and collaboration.
Since its inception, the centre has launched several initiatives to champion patient-focused drug development, including Project Optimus, an initiative to reform the dose optimisation and dose selection paradigm in oncology drug development, and Project Confirm, designed to promote the transparency of outcomes related to accelerated approval for oncology indications.
In 2020, investigator groups from the HTAN made significant progress in advancing our understanding of how cancers develop and respond to treatment. One such team developed a profiling ‘toolbox’ for capturing the complex molecular characteristics of fresh and frozen tumour samples.
Elsewhere researchers from the PDX (patient-derived xenografts) Development and Trial Centers Research Network (PDXNet), a coordinated research programme tasked with the large-scale development and pre-clinical testing of targeted therapeutic agents in patient-derived models, demonstrated the reproducibility of PDX drug responses and sequencing results across diverse experimental protocols, which established the potential for multisite pre-clinical studies to translate into clinical trials.
In January, the nation welcomed President Biden as he began his first term at the helm of the US Government. Unfortunately, while he reaffirmed his commitment to eradicating cancer, Biden’s return – five years on from the launch of the Beau-Biden Cancer Moonshot – was not accompanied by news that the programme had achieved its ambitious goal. But, if at first, you don’t succeed…
Eloise McLennan is the editor for pharmaphorum’s Deep Dive magazine. She has been a journalist and editor in the healthcare field for more than five years and has worked at several leading publications in the UK.