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FDA To Advise New NIH/Biopharmaceutical Partnership On Immunotherapy

13 Octobre 2017

The current crop of immunotherapies have produced dramatic responses in certain cancer cases, which is why pharmaceutical companies have dedicated substantial investment to identify promising new treatment options for these patients.

"We have seen dramatic responses from immunotherapy, often eradicating cancer completely for some cancer patients", said NIH Director Francis S. Collins, M.D., Ph.D., in a statement. Research will also integrate immune and other related oncology biomarkers into clinical trials by defining a set of standardized biomarkers to be tested across a variety of studies. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and predict their response to treatment, are urgently needed for these therapies to benefit the maximum number of people.

This approach is expected to consistently generate data, uniform and harmonized assays to support data reproducibility, comparability of data across trials, and discovery and validation of new biomarkers for immunotherapy and related combinations. The Partnership For Accelerating Cancer Therapies (PACT) is a five-year partnership "totaling $215 million as part of the Cancer Moonshot,".

Other aspects of PACT include facilitating information sharing between all groups involved with the clinical trial process to better coordinate investigative approaches and limit data duplication.

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In a Thursday press conference announcing the collaboration, Reed Cordish, who heads the Office of American Innovation, an initiative led by President Donald Trump's son-in-law, Jared Kushner, said the program represents the "type of collaboration and partnership between the private sector and government that this administration is trying to foster across many sectors".

Pfizer Inc, Johnson & Johnson, Amgen Inc, Celgene Corp, Gilead Sciences Inc, GlaxoSmithKline Plc, Novartis AG and Boehringer Ingelheim are also part of the effort, NIH said. "A systematic approach like PACT will help us to achieve success faster".

The partnership will be managed by the Foundation for the National Institutes of Health (FNIH). NIH will contribute $160 million over five years, pending availability of funds.

The National Cancer Institute recently awarded cooperative agreements to support four Cancer Immune Monitoring and Analysis Centers and a Cancer Immunologic Data Commons with a total of $53.6 million in funding over five years.

FDA To Advise New NIH/Biopharmaceutical Partnership On Immunotherapy