FDA reveals plans for single cancer drug regulation centre
The US regulator is to create a single centre for regulating cancer drugs and devices as part of the Federal government’s $1 billion “Cancer Moonshot” to encourage research into the disease.
As the FDA revealed its plans, vice president and Cancer Moonshot leader Joe Biden announced a series of partnerships involving government, industry and academia to support the initiative.
President Barack Obama announced the Cancer Moonshot during his State of the Union address in January, and aims to find vaccine-based immunotherapies against cancer by 2020.
The FDA said Dr Richard Pazdur, director of its cancer and haematology products division, is to lead its Oncology Center of Excellence.
Pazdur will work with directors of other FDA units – the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Device for Radiological Health, to co-ordinate reviews of oncology products across the whole organisation.
Among the initiatives announced by vice president Biden is a partnership between the US National Cancer Institute and at least 20 drug and biotechnology companies to fast-track development of new treatments.
Cancer Research UK is also involved, developing and refining technology that aims to revolutionise how researchers capture and analyse cancer cells in patients’ blood.
A super-sensitive cell-scanning device will allow researchers to analyse blood samples from patients with early-stage lung and bowel cancer to identify those with traces of the disease, and so will be more likely to relapse.
IBM has also donated use of its Watson computers to the US Department of Veterans Affairs to analyse genomes of 10,000 cancer patients.
The aim is to help develop precision treatment options for almost 30 times more patients than could previously be served.
The National of Institutes of Health (NIH) is launching a new partnership bringing together 12 pharma companies, several research foundations, philanthropic organisations and the Foundation for the NIH.
This Partnership for Accelerating Cancer Therapies (PACT) will fund pre-competitive cancer research and share broadly all data generated for further research, to speed up development of new therapies.
Potential focus areas include understanding responses to cancer therapies, clinical trial platforms for combination therapies, predictive modelling approaches, and therapies for rare cancers.
The Department of Energy, the National Cancer Institute, and GlaxoSmithKline are announcing a new public-private partnership designed to harness high-performance computing and diverse biological data to accelerate the drug discovery process and bring new cancer therapies from target to first in human trials in under one year.
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