Innovation and Biomarkers in Cancer Drug Development, IBCD 2015, will shine a spotlight on multi-stakeholder approaches to cancer drug development with new cancer biomarkers in a scientific program which will include input from regulators, industry, academia, patients and payers.
Without a doubt, the combined efforts of the EORTC, an academic research organization, the US National Cancer Institute, a governmental institution, the European Medicines Agency, a regulatory agency, and the American Association for Cancer Research, a professional scientific association, assure that a unique program focusing on multi-stakeholder approaches to cancer drug development will result. They are assembling a rich scientific program for IBCD 2015 that covers topics of interest to all cancer drug development stakeholders.
The opening session will address quality assurance and quality control (QA & QC) from pre analytical steps to clinical utility and focus on quality management along the pathway to health care implementation as well as in the collection and management of biospecimens for clinical trials biobanking. It will also address standardization and comparison of next generation sequencing (NGS) pipelines and also the question of when, with respect to QA & QC, is an assay ready.
This session transitions naturally into subsequent presentations concerning assay development and their integration into drug development with the intention of stimulating the dialog between those conducting clinical trials and those working in the laboratory. A panel discussion will look into the topic of patient access and regulatory challenges for clinical trials in the era of molecularly defined personalized therapies and include short presentations on existing molecular screening platforms and the US and European regulatory bodies. The panel will include key opinion leaders representing regulators, payers, industry, patients, and academia.
Bioinformatic approaches to big data analysis and the clinical decision process will be scrutinized based on concrete examples for treatment decision as well as identification of recurrent patterns in cancer using big data.
A second panel discussion will look into the impact on health care systems, a multi stakeholder societal challenge for research, pharma and patients. This session will have a debate format, a point-counter point style, and arguments will be made concerning value, macro-economic sustainability, regulatory systems, and pricing and reimbursement in the context of implementation of cancer precision medicine.
The closing session will look towards the horizons and will consider topics of biomarker signatures beyond NGS, using the cancer genome atlas or international cancer genome consortium -omics data as a tumor snapshot, judging the merits of following tumors longitudinally in patients, circulating biomarkers (DNA, plasma proteins, exosomes, etc.), and the use of live disease models for -omics and disease monitoring.
IBCD 2015 will be held on 3-4 December 2015 at the Square Brussels Meeting Centre.
Registration opens for IBCD 2015 on 21 May 2015.
Poster abstract submission will be open from 13 April 2015 to 15 June 2015.