Please note, this is the postponed conference that was originally supposed to take place in December 2015
A first of a kind joint meeting organised by the European Organisation for Research and Treatment of Cancer (EORTC), an academic research organisation, 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 2015 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 programme.
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 standardisation 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 personalised 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 scrutinised 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.
