Innovation and Open Access to Public Sector Information

Most speakers at this summit have been looking at open access from the supply side, presenting the points of view of custodians of government information. What might we lob over the fence to whoever is on the other side? So far we have not paid much attention to this demand side - the potential beneficiaries of changed information policies. So I see it as my task to address what I believe is the core rationale for this policy initiative, which is the promotion of innovation and creativity. My perspective on the topic brings together my deep interest in the whole matter of innovation, and my long involvement with the digital content industries. Why do we need to act on this possible policy initiative? I will try to put the question in the context of some conceptual frameworks and models of innovation, and of business models for information and content production. My premise is that data and information – content – is the currency of creativity and innovation. Information is what energises our national innovation system. Governments produce and hold a wealth of information and data

Optimization of a Quantitative Anti-Drug Antibodies against Infliximab Assay with the Liquid Chromatography-Tandem Mass Spectrometry: A Method Validation Study and Future Perspectives

Monoclonal antibodies (mAbs), such as infliximab, are important treatment options for different diseases. Immunogenicity is a major risk, resulting in anti-drug antibodies (ADAs), being associated with adverse events and loss of response, influencing long-term outcomes. The development of ADAs against infliximab is primarily measured by immunoassays like radioimmunoassay (RIA). Although liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly utilized across different fields, this technique is currently not used for ADAs against infliximab measurements. Therefore, we developed the first LC-MS/MS method. Stable isotopically labeled infliximab antigen-binding fragments (SIL IFX F(ab')2) were used to bind and measure ADAs indirectly. Protein A magnetic beads were used to capture IgG, including ADAs, whereafter SIL IFX F(ab')2 was added for labeling. After washing, internal standard addition, elution, denaturation and digestion samples were measured by LC-MS/MS. Internal validation showed good linearity between 0.1 and 16 mg/L (R2 > 0.998). Sixty samples were used for cross-validation with RIA, and no significant difference between ADA concentrations was found. The methods had high correlation (R = 0.94, p < 0.001) and excellent agreement, intraclass correlation coefficient = 0.912 (95% confidence interval 0.858-0.947, p < 0.001). We present the first ADA against the infliximab LC-MS/MS method. The method is amendable for quantifying other ADAs, making it applicable as a template for future ADA methods

Busulfan target exposure attainment in children undergoing allogeneic hematopoietic cell transplantation: a single day versus a multiday therapeutic drug monitoring regimen

Busulfan exposure has previously been linked to clinical outcomes, hence the need for therapeutic drug monitoring (TDM). Study objective was to evaluate the effect of day 1 TDM-guided dosing (regimen d1) versus days 1 + 2 TDM-guided dosing (regimen d1 + 2) on attaining adequate busulfan exposure. In this observational study, we included all children receiving busulfan-based allogeneic hematopoietic cell transplantation. Primary outcome was the percentage of patients achieving busulfan target attainment in both TDM regimens. Secondary outcomes were the variance in busulfan exposure and day-4 clearance (Clday4) estimates between both TDM regimens and dosing day 1 and 2. In regimen d1, 84.3% (n = 91/108) attained a therapeutic busulfan exposure, while in regimen d1 + 2 a proportion of 90.9% was found (n = 30/33, not-significant). Variance of Clday4 estimate based on busulfan day 2 concentrations was significantly smaller than the variance of Clday4 estimates based on day 1 concentrations (p < 0.001). Therefore, day 1-guided TDM (pharmacometric model-based) of busulfan may be sufficient for attaining optimal target exposure, provided that subsequent TDM is carried out if required. However, performing TDM on subsequent days may be beneficial, as measurements on day 2 seemed to reduce the variance in the estimated clearance as compared to day 1 sampling

Material interaction and art product in art therapy assessment in adult mental health

Item does not contain fulltextBackground: Art materials have a central role in art therapy. The way a client interacts with art materials - material interaction - is an important source of information in art therapy assessment in adult mental health. The aim of this study was to develop the categories of material interaction and examine the relationship between material interaction, the art product and clients' psychological characteristics. Methods: Three sequential focus groups were conducted, in which 47 art therapists participated. Results: A large number of art therapists recognised that observing material interaction enabled them to gain a perspective on client's psychological functioning. Styles of material interaction could be placed on a continuum from "affective" to "rational" and provided valuable information about a client's affective and rational characteristics. Conclusions: Art therapists were able to describe clients' material interaction and psychological characteristics based on the analysis of the formal elements of the clients' art product. The results provided a preliminary theoretical base for art therapy assessment in adult mental health.16 p