IBCD 2016

Dr Golfinopoulos meets with ecancertv at IBCD 2016 to discuss SPECTA: a screening platform that sought to encourage patients to participate in clinical trials. He describes how regulatory involvement in trial design and drug design could be streamlined, and the issue of reimbursement for personalised therapy.

Dr Malik speaks with ecancertv at IBCD 2016 to discuss the work of the National Cancer Institute in recruiting patients to clinical trials when subtyping limits disease-wide enrollment. She describes how 'exceptional responders' can be referred to the NCI for genotyping, and schemes to match patients who exhibit mutational drivers with clinical trials that may offer the greatest benefit. In considering the conference debate of the regulatory issues surrounding widespread access to personalised therapy, Dr Malik describes her position that greater participation in clinical trials could ideally lead to increased data gathered from patients, though this may not always be the case.

Dr Beer speaks with ecancertv at IBCD 2016 about making use of genomic data in a clinically actionable setting. He opens with comments on the work of Dr Moritz Gerstung and considers the issues of storage, access and regulation in genomic libraries. Dr Beer describes how unregulated access and off-label use of precision medicine is damaging precision medicine in American clinics, compared to hurdles in data access and funding facing European researchers.

Dr Schneider speaks with ecancertv at IBCD 2016 about the regulatory checkpoints to be passed in the development of assays. He highlights the difference in reproducibility and robustness of research and clinical assays, the clinical utility of validated biomarkers, and how beginning assay development with outcomes in mind will prove more worthwhile than trying to fit an assay to patient subgroups post-hoc. Dr Schneider also prompts vigilance in proper storage, shipping, and sample control to ensure accurate results.

Dr Lacombe speaks with ecancertv at IBCD 2016 about the role of the conference in communicating advances in drug development. He describes the presentations given during a session he chaired at the conference, including the research of Dr Shakun Malik and Dr Vassilis Golfinopoulos. Considering uncertainty in risk management from clinical, regulatory and patient perspectives, Dr Lacombe outlines his hopes for greater collaboration and wider availability of personalised medicines.

Prof van Dongen speaks with ecancertv at IBCD 2016 about gaining deeper insight into drug action and suitability with radiolabelling. He describes how the journey of radiolabelled ligands may steer drug development, aiming for biomarkers and accumulating in tumours with localised tissue damage and low toxicity. Prof van Dongen describes himself as a tyrosine kinase inhibitor skeptic, calling for greater clarity in patient subtypes.

Dr Gerstung speaks with ecancertv at IBCD 2016 about genetic analysis of AML patients that has contributed to a predictive model for treatment risk and outcomes. He describes how modelling can be improved with wider data gathering, across populations and tumour types, though this faces the risk of 'clinical anarchy' if data is not recorded and optimised. Dr Gerstung describes international data sharing as a necessary step for personalised therapy.

Dr Lively joins ecancer at IBCD 2016 to discuss presentations from the conference session she chaired. She discusses the work of Dr Simon Dovedi in developing assays for immune therapy, of Dr Robert Kinders in reproducibility and relevance of assays for clinical trials. Dr Lively reflects on the debate session from the conference, in which the economics of personalised therapy were considered by representatives of research, regulation and clinical application.

Dr Vietz speaks with ecancertv at IBCD 2016 about the regulatory requirements and quality controls necessary for genomic profiling. She describes her work in constructing consistent, up to date guidelines for genomic assays, and considers balancing cost of access against comprehensive genetic testing for multiple markers. Reflecting on the conference, Dr Vietz shares insights from many researchers on sharing data with patients.

Dr Hewitt speaks with ecancertv at IBCD 2016 about development of assays for predictive biomarkers as a part of personalised therapy. The use of biomarkers he describes could help with the selection of the most effective treatment for patients, depending on gene expression within tumours, and importantly in determining which treatments could result in the least toxicity or impact on patients quality of life. In consideration of the economics of developing personalised therapies, Dr Hewitt highlights opportunities for investment in early diagnosis and screening that could result in greater savings later in patient treatment.