Imaging biomarker roadmap for cancer studies.

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.Development of this roadmap received support from Cancer Research UK and the Engineering and Physical Sciences Research Council (grant references A/15267, A/16463, A/16464, A/16465, A/16466 and A/18097), the EORTC Cancer Research Fund, and the Innovative Medicines Initiative Joint Undertaking (grant agreement number 115151), resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies' in kind contribution

A comparative study of three-dimensional printing directions: The degradation and toxicological profile of a PLA/PHA blend

The use of biobased plastics is of great importance for many applications. Blending thermoplastic polylactide (PLA) with polyhydroxyalkanoate (PHA) enables the formulation of a more mechanically powerful material and this enables tailored biodegradation properties. In this study we demonstrate the 3D printing of a PLA/PHA blend as a potential candidate for biocompatible material applications. The filament for 3D printing consisted of PHA, which contains predominantly 3-hydroxybutyrate units and a small amount of 3-hydroxyvalerate units, as revealed by multistage mass spectrometry (ESI-MSn). This research found that the properties of 3D printed species before and during abiotic degradation are dependent on printing orientation. Furthermore, the 3D printed specimens exhibited good biocompatibility with HEK293 cells, indicating real promise as biological scaffolds for tissue engineering applications