Policy Review: Addressing the Complex Challenges of Regulating Biotherapeutics

The advancing industry of biotherapeutics is providing the public with new promising and innovative drugs which may pose risks if their production, distribution, and marketing are not directly governed by legislation. Apart from international agreements, such as the Cartagena Protocol, there are no specific and direct laws or regulations governing manipulated cell-based therapeutics in Canada. The introduction of these laws and regulations in Canada will allow for the safe research and use of biotherapeutics in a proactive manner

Trans-ancestry meta-analyses identify rare and common variants associated with blood pressure and hypertension

High blood pressure is a major risk factor for cardiovascular disease and premature death. However, there is limited knowledge on specific causal genes and pathways. To better understand the genetics of blood pressure, we genotyped 242,296 rare, low-frequency and common genetic variants in up to ~192,000 individuals, and used ~155,063 samples for independent replication. We identified 31 novel blood pressure or hypertension associated genetic regions in the general population, including three rare missense variants in RBM47, COL21A1 and RRAS with larger effects (>1.5mmHg/allele) than common variants. Multiple rare, nonsense and missense variant associations were found in A2ML1 and a low-frequency nonsense variant in ENPEP was identified. Our data extend the spectrum of allelic variation underlying blood pressure traits and hypertension, provide new insights into the pathophysiology of hypertension and indicate new targets for clinical intervention

Mental health in the workplace: Using the ICF to model the prospective associations between symptoms, activities, participation and environmental factors

Purpose. This prospective study used the framework of ICF components to investigate the magnitude and direction of association between body functions (depression/anxiety symptoms), activity (limitations in work activities), participation (sickness absence), and environment (psychosocial aspects) in the workplace setting. Methods. A cohort of employees completed a self-report survey at baseline and 6 months follow-up, with analysis restricted to those with at least one health condition (n = 204). Self-report measures of depression/anxiety symptoms, limitations in work activities, sickness absences, and psychosocial work environment were mapped to the corresponding ICF component. The prospective association between these components was modelled using relative risks (RR) estimated from log-binomial regression. Results. Depression/anxiety symptoms were more likely to be an outcome of other ICF components, rather than a risk factor. Sickness absence, limitations in work activities, and work environment all conferred a greater than two-fold risk of depression/anxiety symptoms 6 months later. Conclusions. The ICF offers a valuable approach to understanding the contextual influences on employee mental health and work disability. Further application of the ICF framework to mental health should improve the environmental components and encourage a wider adoption of the ICF by mental health researchers and practitioners

Willingness to pay for preserving birds.

<p>Peoples' mean willingness to pay (WTP) for preserving birds as a function of predicted European population (large vertical axis), local policy outcome (large horizontal axis) and whether the bird group is native or immigrating (colours). The columns show mean WTP in Euro/household and year. NB: The error bars shown indicate 95 per cent confidence intervals for WTP, and thus if the mean WTP estimates are significantly different.</p

Estimating preferences for distribution changes.

<p>Here we show one example of how the decision situation was presented to respondents as a choice between policies, each respondent answering several such choice sets. The pictograms illustrating bird groups (not living in Denmark or extirpated,scarce or abundant) were explained to respondents before completing the choice tasks.</p

The policy challenge.

<p>The figure illustrates the overall challenge for conservation management, using the example of Denmark: Species currently breeding in an area may emigrate in the future as climate change alters habitats, whereas others may immigrate and settle for the same reason – provided suitable habitat is available.</p