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Transforming Impossible into Possible (TIP): a bottom-up practice in workforce development for low-income jobseekers
Get PDFThis paper discusses an evidence-informed bottom-up transformative social work practice model that holistically encapsulates multi-system levels of practice. Based on 12 years of empirical evidence on psychological self-sufficiency (PSS), the Transforming Impossible into Possible (TIP) program was developed to focuses on the ‘process’ of human agency development that leads to economic self-sufficiency (ESS) ‘outcomes’. It attempts to bring together various modalities of social work practice into a transformational leadership development framework that reflects a bottom-up, participant-centered approach to empowering individuals to impact larger systems. In workforce development practice, it is being regarded that constructs reflected in TIP improve both employment and retention outcomes
Inaugural Editorial
Get PDFThe Satellite Oceanography and Meteorology (SOM) was launched in 2016, in response to the growing use of remotely sensed satellite data in understanding and identifying important processes and phenomena occurring in the atmosphere and ocean. The SOM provides space for oceanographers, meteorologists, hydrologists and climatologists to publish their research papers on theory, science, technology and applications of satellite remote sensing data of the ocean, atmosphere and climate
Strategy to achieve biomarker-driven immunosuppression after solid organ transplantation by an academic-industry partnership within the European BIO-DrIM consortium
Get PDFSolid organ transplantation has emerged as the “gold standard” therapy for end-stage organ failure as it improves both quality of life and survival. Despite the progress in short-term graft survival, that is closely associated with the impressive reduction of acute rejections within the first year, long-term graft and patient survival remain almost un-changed and unsatisfactory. Incomplete control of chronic allograft injury but particularly the adverse effects of long-term immunosuppression, such as graft toxicity, diabetes, cardiovascular events, infections, and tumours continue to challenge the long-term success. In general, immunosuppression is applied as one-size-fits-all strategy. This can result in over- and under-immunosuppression of patients with low and high alloresponsiveness, respectively. Trial- and -error strategies to minimize or even completely wean of immunosuppression have a high failure rate. Consequently, there is an unmet medical need to develop biomarkers allowing objective risk stratification of transplant patients. To achieve this goal, we engaged in an academic-industrial partnership. The central focus of the European-wide BIO-DrIM consortium (BIOmarker-Driven IMmmunosuppression) is the implementation of biomarker-guided strategies for personalizing immunosuppression to improve the long-term outcome and to decrease the adverse effects and costs of chronic immunosuppression in solid organ transplant patients. The concept includes four innovative investigator-driven clinical trials designed by the consortium
A Foreword from the Editor
Get PDFWelcome to the inaugural issue of the Journal of Medicines Development Sciences. This new open access journal will publish articles on the entire process of discovery and development of new medicinal products, with a particular emphasis on translational research. This inaugural issue is devoted to “Open Innovation”, a booming concept that is starting to deeply change the context of medicines development
Post-disaster social reconstruction and social development
Get PDFThe Asia-Pacific region has experienced major disasters, both natural and man-made, in the recent past. Hundreds of families and communities, and several governments, non-government organisations, international organisations and aid agencies have been engaged in relief, rebuilding and rehabilitation activities with varying degrees of effectiveness and success. This article aims to reflect on some of these post-disaster reconstruction experiences; exploring how a social development approach can be employed for the post-disaster social reconstruction; and suggest regional social policies and strategies for multi-stakeholder cooperation to effectively address post-disaster issues at the local level. Although efforts made by several agencies in very challenging contexts are commendable, there are few examples to show the application of the social development approach. By discussing the social development approach, the paper argues that the conscious use of such an approach facilitates a better planning and preparation for anticipated disasters, rehabilitation processes and the comprehensive development of disaster affected areas, including environmental and psycho-social issues. Towards this end, it underscores the role of regional social policies and multi-stake-holder cooperation. The discussion has implications for local and international communities, which are engaged in pre-planning and preparation for disasters and post-disaster reconstruction
Models for accessing biomedical innovation in Asia
Get PDFAsian countries are striving to transition into innovation-driven economies, and healthcare is a key sector on government agendas. Strong funding at academic institutions, high-impact publications, state-of-the-art clinical infra-structures, vast talent pools, increasing start-up activities and strengthening intellectual property regimes, all aligned with coherent government policies, is creating an evolving innovation ecosystem in countries such as China, South Ko-rea, Singapore, Taiwan and India. Such factors have fuelled a desire from global pharmaceutical companies to seek in-novation in Asia. In this article, we review the varied strategies of large multinationals using two key aspects—the capital investments and operational model—to understand such diverse approaches. Based on a qualitative and quantita-tive analysis, we have classified these strategies into four distinct approaches—“Captive”, “Partner”, “Service” and “Open” models—and discussed case studies that fit into each of these clusters. The model may provide global pharma-ceutical companies with a framework to evaluate their respective approaches for sourcing innovation and align them with the operational, financial, business and strategic needs of their organizations in Asia
TransCelerate: a global collaboration across biopharmaceutical R&D to accelerate and simplify new medi-cines development
Get PDFAs the economic pressures increase on healthcare systems around the world due to aging populations, chronic diseases, expanding patient populations in emerging markets and advances in medical technology, it is crucial that we focus on developing and delivering innovative and quality medicines with true medical value to patients around the world in a more collaborative, quality-focused and cost-effective manner.An important component to this mission across the biopharmaceutical industry is identifying and solving common issues that compromise the success of a clinical development program – the shared pathway to safer and more clinically meaningful medicines. However, subject recruitment challenges, data collection and follow-up issues, identification of high-quality trial sites, and lack of successfully achieving study timelines continue to stress clinical trial operations teams across companies. Although there has been progressing across this range of roadblocks by individual companies, the underlying economics continue to threaten the research and development (R&D) business model.Failure to solve these key issues will affect all parties involved in the clinical trial enterprise: patients, clinical inves-tigators, health authorities, academia, tax-payers and the sponsor companies. The question remains whether a deep and broad collaborative effort that stretches across the clinical development arena—one that is charged with a common goal of improving quality, enhancing the investigator and patient experience, reducing costs and sharing data—can be a catalyst for success. With encouraging signs already realised, the operation of TransCelerate BioPharma Inc., a non-profit organisation created to improve the health of people around the world by accelerating and enhancing the R&D of innovative new therapies will test this premise
The Predictive Safety Testing Consortium: safety bio-markers, collaboration, and qualification
Get PDFThe Predictive Safety Testing Consortium (PSTC) is one of nine consortia comprising the Critical Path Institute (C-Path), a non-profit organisation launched in 2005 and dedicated to playing the role of a catalyst in the development of new approaches that advance medical innovation and regulatory science. C-Path achieves this by lead-ing teams that share data, knowledge and expertise resulting in sound, consensus-based science. PSTC is a unique, public-private partnership that brings pharmaceutical companies together to share and validate safety testing methods under the advisement of worldwide regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The eighteen corporate members of PSTC share a common goal: to find improved safety testing methods and approaches utilizing fluid-based safety biomarkers which accurately predict drug-induced tissue injury. Specifically, the primary goal of PSTC is the qualification of novel translational safety biomarkers for use in early clinical trials in order to ena-ble safer investigations and development of new drug candidates. This manuscript describes the critical importance of improved safety biomarkers to the drug development process and the present state of the biomarker qualification process with regulatory agencies. In addition, the work that the PSTC and its collaborative partners have done and con-tinue to do to identify and qualify more selective and specific safety biomarkers is highlighted. Finally, successes in-cluding the recently adopted regulatory Letter of Support and ongoing efforts to better define the regulatory qualifica-tion process and an integrated translational safety strategy are also discussed
Sea level pressure response to the specification of eddy-resolving sea surface temperature in simulations of Australian east coast lows
Get PDFFour east coast lows (ECLs) were simulated with the Weather Research and Forecast model to investigate the influence of the sea surface temperature (SST) distribution on the sea level pressure (SLP). Each ECL was simulated with two different SST datasets: the Bluelink SST field and NCEP skin temperature field. The former resolved eddies in the East Australian Current while the latter did not. The simulated SLP fields in the eddy-resolving SST runs were compared with those in the non-eddy-resolving SST runs. On time-scales of about 48 hours, higher SSTs were asso-ciated with lower SLPs. The spatial scale of the SLP response was similar to that of the ocean eddies, indicative of the rapidity and robustness of the response given the rapidly evolving conditions within the storms. On shorter time-scales, the SLP response to SST change can become substantially larger. The largest reductions in SLP in the eddy-resolving SST runs were associated with regions of deep atmospheric convection that warm the tropospheric column. These areas were shown to be related to the SST distribution with the greatest SLP reductions associated with convection over strong SST gradient regions. The landfall of a damaging convective mesoscale low pressure system on 8 June 2007 was also investigated. It was found that a region of strong SST gradients on the southern flank of a large warm ocean eddy was associated with lower pressures at the time of formation of this meso-low. In addition, the only case that simulated the low pressure at the correct time (albeit at not quite the correct location) was the eddy-resolved SST run. It was hy-pothesized that the development of this meso-low that impacted the coast around Newcastle, was enhanced because of the eddy-scale SST distribution at the time
Precision medicine: do not neglect the hurdles
Get PDFTremendous expectations have been connected with precision medicine in the past years. Be-side the advantages that this type of therapy offers we should be aware of its challenges too. In this issue we will highlight on specific challenges that the pharmacological industry is opposed with when de-veloping new targeted therapies. In addition, we will discuss issues with the reproducibility of published scientific data