IBCD: First regulatory science meeting opens new doors for precision medicine

14/09/2016

Last week, discussions at the Innovative Biomarkers for Cancer Drug Development (IBCD) highlighted the need for a structured transition from biomarker science to more practical applications taking into account the interests and needs of all stakeholders.

The meeting, hosted by EORTC in partnership with EMA, AACR and NCI, was the first Regulatory science meeting, with the participation of the US FDA and the Japanese PMDA, addressing current and forthcoming cancer drug and biomarker development challenges. It gathered representatives from patient advocacy groups, industry, regulatory, academic and scientific institutions.

Grounded on solid bioscience presentations, IBCD offered unprecedented opportunities for cross-stakeholder discussions. Attendees and presenters repeatedly highlighted the need for dialogue-based decisions and a structured approach to biomarker development – from pre-analytical issues to routine use of biomarkers. All saluted the readiness of regulators in taking on the challenges of biomarker implementation and moving to multiplex assays.

Participants all agreed that such a meeting was timely, initiating essential discussions around personalised medicine, and facilitating the integration of new multidisciplinary concepts in regulatory science.

The meeting provided solid grounds for the evolution of clinical research towards the development of precision medicine, bringing together all stakeholders’ viewpoints on providing patients with better therapeutic options and access to innovation.

Watch here the IBCD presentation.

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