Dear Colleagues,

We are honored to be able to invite you to attend IBCD 2016. Innovation and Biomarkers In Cancer Drug Development, a first of a kind joint meeting organized by the European Organisation for Research and Treatment of Cancer (EORTC), an academic research organization, the US National Cancer Institute (NCI), a governmental institution, the European Medicines Agency (EMA), a regulatory agency, and the American Association for Cancer Research (AACR), a professional scientific association.

Never before has cancer drug and biomarker development been so complex and required such a diverse range of expertise, and IBCD 2016 will help forge the collaborations needed for developing improved treatments for patients with cancer. The intention is to shine a spotlight on multi-stakeholder approaches to cancer drug development with new cancer biomarkers in a scientific program which includes input from regulators, industry, academia, patients and payers.

The combined efforts of the EORTC, NCI, EMA, and AACR have resulted in a unique program. 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.

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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.

We would also like to call your attention to event occurring prior to the IBCD meeting at the same location.

Navigating Safely through the Regulatory Triangle: Clinical Trials – In vitro Diagnostics – Data Protection will be held Wednesday, 7 September 2016 and explore the interface between the Clinical Trial Regulation, expected to be applicable in 2016, and the In vitro Diagnostics and Data Protection Regulations now being discussed by the EU Parliament and Council, and how these three regulations will influence cancer research practice.

We look forward to welcoming you in Brussels and promoting the new forms of partnership required to develop tomorrow’s personalized cancer treatments.

Denis Lacombe and John Martens, Co-chairs