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Philanthropies as partners for drug development in public–private partnerships
Get PDFDisease-focused philanthropic organizations play an increasing role in the strategy and conduct of biomedical research, with many focusing on drug development for specific diseases and patient populations. More and more theynot only provide resources and expertise, but also take active part managing the strategy and objectives of targeted research programs, using approaches such as venture philanthropy. Many also lead and participate in public–private partnerships. One example is the partnership between the Polycystic Kidney Disease (PKD) Foundation and the Critical Path Institute (C-Path) which brings together several pharmaceutical companies and academic institutions to developnew broadly-used biomarkers. Another case is the partnership between JDRF (formerly known as the Juvenile Diabetes Research Foundation) and the Innovative Medicines Initiative (IMI), involving financial support of the IMIDIA project (Innovative Medicines Initiative for Diabetes) which is focused on improving beta-cell function and identifying biomarkers for diabetes treatment monitoring. These examples show that in addition to providing financial support and expertise, philanthropic foundations are also in a unique position to coordinate the patient and research communities to enable and accelerate specific medicines development projects
Investigating the health-economic profiles of biomarker-driven immunosuppresion (BIO-DrIM) following solid organ transplantation
Get PDFImmunosuppression (IS) following solid organ transplantation is indicated to avoid rejection but puts a sig-nificant burden on patients and healthcare systems due to life-long medication dependency and associated costs. Or-gan-tolerance with low or no IS medication has been observed, and might be forecasted with the help of appropriate biomarkers. Individualized treatments raise the question whether benefits of individualization outweigh the costs of stratification. This article outlines the importance of early economic evaluation in the context of biomarker-guided IS and discusses challenges that an economic evaluation should address, using the BIO-DrIM project as a reference exam-ple. We report on design aspects and health-economic study integration into several newly designed biomarker trials. In these studies, health-economic endpoints were defined to measure benefits of individualization and to compare them to the costs associated with stratification. Key economic outcomes to be collected are resource consumption and patient quality of life. Test accuracy of the biomarker-stratification is critical for the clinical success and the health-economic viability of an individualized reduced IS regime. However, IS regimes are not well standardized, rendering comparator choice difficult. The multi-national character of the trials adds further complexity that needs to be addressed. Develop-ers of biomarker tests should stress the importance of integrating health-economic evaluations early into prod-uct-development
Success factors in drug discovery and development
Get PDFThe article aimed to give a personal perspective on drug discovery and development. The author has worked both in Big Pharma as a scientist and manager and more recently also in start-up biotech companies. Drug companies have played a major important role in improving population health and will continue to do so. The hurdles and costs for drug development have continuously risen without a parallel enhancement of productivity. There is no single explanation for this and the article outlines success factors and hurdles for effective drug development. Aspects of the external and internal environments that influence Big Pharma productivity is outlined and discussed
The European lead factory—an experiment in collaborative drug discovery
Get PDFThe European Lead Factory (ELF) is a unique collaborative public–private partnership aiming to deliver innovative drug discovery starting points and improving the value generated by ultra-High Throughput Screening (uHTS) approaches. Composed of a unique compound collection derived from private pharmaceutical company collections and complemented with new chemistries from a unique public collection, it offers a unique uHTS platform accessible to both private companies and publicly funded researchers. One of the key challenges in setting up ELF has been to balance access to screening results with protecting the value of compounds in the collection. Through an ‘honest data broker’ data management platform and a royalty reward scheme based on achieved milestones, ELF has been able to overcome these challenges. Set up in 2013, it has already accepted 42 targets for screening, submitted by publicly funded researchers, and generated 12 Qualified Hit Lists. In addition, 55,000 new library compounds have been generated by the public partners and added to the 320,000 compounds made available by the companies. Although it faced many challenges in becoming operational, this unique experiment in collaboration is already generating exciting results that will hopefully, eventually lead to better medicines and tools to advance our biological knowledge, and should act as a template for future approaches in the area
Prioritization of COPD protein biomarkers, based on a systematic study of the literature
Get PDFChronic Obstructive Pulmonary Disease (COPD) is a chronic lung disease mostly due to smoking and until now diagnosed by spirometry (post bronchodilator FEV1/FVC <70%). However, in spite of the usefulness of FEV1 as diagnostic and prognostic tool, it has proven to be a weak indicator of future exacerbations, unable to predict lung function decline within COPD patients, as well as unable to identify the smokers “susceptible” to developing COPD at an early stage. Thus, there is an urgent need for biomarkers that address these questions and support clinical decision making in the diagnosis and treatment of (early) COPD. In this respect, considerable efforts have been devoted to identifying protein biomarkers that enable a better understanding of this complex disease and leading to better diagnostic and prognostic tools. However, in spite of the wide range of candidates that have been suggested as potentially useful COPD biomarkers, most remained at the level of the initial discovery, and only fibrinogen has been approved by the Food and Drug Administration (FDA) as predictor for all-cause mortality and COPD exacerbations. There is thus a need for future investigations of these biomarkers in large-scale and well characterized studies in order to prove their usefulness as surrogate endpoints. Based on this, the aim of the present review is to advance COPD biomarker development by providing a comprehensive overview of protein biomarker candidates which have been evaluated in clinical studies and prioritize them according to their potential of becoming valid, clinically useful COPD biomarkers
A logical response to corporate social responsibility
Get PDFCorporate social responsibility (CSR) is argued to be a flawed concept in the same way as sustainable development in that it seeks to combine two aspects which are incommensurable. Nevertheless CSR contains an expanding space for social and environmental concerns under the guise of stakeholder management which undoubtedly influences the commercial bottom line. It is proposed that the concept of corporate citizenship is separated from what is now termed corporate social responsiveness to encompass truly ethical and normative considerations which in business should be manifested by a wholehearted acceptance of the need for regulation, lobbying for the universality of that regulation and an avoidance of undue influence on government. Proper roles for the three partners in society, namely government, commerce and civil society are explored together with the nature of citizenship
Impact of climate change on the hydrologic cycle and implications for society
Get PDFShould we attribute all natural disasters, such as floods, droughts, extreme rainfall, extreme snowfall, glacial melting, changes in space-time distribution of rainfall, changes in ecosystems, earthquakes, fire hazards, hurricanes, tsunamis, tornadoes, heat waves, extreme cold weather, wind storms and health epidemics, to climate change? This question often comes up when we review the burgeoning literature on climate change and its impacts. Although climate change is still being debated in certain political, social and economic quarters, there is overwhelming and undeniable scientific evidence supporting climate change. Climate change impacts virtually every facet of society — scientific, technological, environmental, ecological, social, cultural, economic, and political. As a result, strategies for mitigating the impacts and adapting to climate change must be broad and integrated. Some of the impacts stem from the chain reactions in the earth system. Therefore, the socio-economic dimension should be an integral part of climate change discussion. Current literature on climate change is less than balanced among domains of scientific and human thought. This would probably change in the future, since the adaptation strategies are becoming an increasing concern in the scientific community. This article examines the impacts caused by climate change on the hydrologic cycle and discusses their repercussions for the society. It also provides suggestions that may be relevant for redefining policies aiming to improve water security at local and global levels
Relationship between extensive and persistent extreme cold events in China and stratospheric circulation anomalies
Get PDFThis study examines the relationship between the extensive and persistent extreme cold events (EPECEs) in China and geopotential height anomalies in the stratosphere using daily mean fields of outgoing long wave radiation (OLR) produced by the NCAR and daily atmospheric circulations produced by the NCEP/NCAR. The OLR composite analysis for the EPECE in China demonstrates that the negative OLR height anomalies (cold air) originated from Siberia influence China progressively from north to south. The largest negative OLR height anomaly (cooling event) occurs in the region to the north of the Nanling Mountains. This suggests that the OLR height anomalies can be used to represent the temporal and spatial characteristics of extreme low temperatures and cold air activities in winter in China. The composite analysis of large-scale atmospheric circulations during the EPECE reveals characteristic evolutions of stratospheric and tropospheric circulations during the extreme cold event. We demonstrate the important role of atmospheric circulation anomalies in the outbreak and dissipation of the EPECE in China. We also demonstrate that significant perturbations in the stratospheric circulation occur more than 10 days prior to the outbreak of the EPECE, with positive height anomalies in the Arctic stratosphere. These positive anomalies propagate downward from the stratosphere and affect the formation and development of the high pressure ridge in the middle troposphere over the Ural Mountains. Significant changes also occur in the atmospheric circulation in the mid-latitude stratosphere. These changes propagate downward from the stratosphere and strengthen the low pressure trough in the troposphere in the region to the east of Lake Balkhash and Lake Baikal. Therefore, the changes in the stratospheric circulation during the EPECE in China occur prior to changes in the tropospheric circulation and are very useful for predicting extreme wintertime cold temperatures in China
Open innovation to bolster research and development for neglected and emerging infectious diseases
Get PDFInfections remain a significant cause of disease, disability, and death in developing countries. Unfortunately, many of these infections, including centuries-old neglected diseases such as malaria and newly emerging and re-emerging diseases such as Ebola virus disease (EVD), have limited products available to prevent, diagnose, and treat them. One barrier that hinders the development of these products is neglected and emerging disease experts’ limited access to the biopharmaceutical industry’s small molecules, technologies, and know-how. Conversely, the biopharmaceutical industry’s lack of attention to and expertise in these diseases impedes the development of much-needed products. Organisations are addressing these challenges by developing platforms through which disease experts can access industry’s knowledge and assets. Strategic partnerships are applying a synergistic approach to leverage respective strengths of academia and industry. The following article describes two open innovation platforms, the Pool for Open Innovation against Neglected Tropical Diseases (POINT) and WIPO Re:Search, and two strategic, cross-sector collaborative efforts to develop therapeutics for EVD
The role of open innovation in biomarker discovery
Get PDFPrecision medicine aims to treat diseases with special consideration for the individual biological variability. Novel biomarkers (BM) are needed to predict therapeutic responses and to allow for the selection of suitable patients for treatment with certain drugs. However, the identification and validation of appropriate BMs is challenging. Close col-laboration between different partners seems to be a key success factor. While the importance of partnerships and larger, well-established consortia in BM discovery such as the pharmaceutical industry and academic institutions is well un-derstood and has been investigated in the past, the use of open-innovation models, also known as ‘crowd sourcing for biomarkers’, is still in its infancy. Crowd sourcing comprises of a —usually via internet— request for problem solution to an open group of users in a kind of an ‘open call’. The community (crowd) is asked to provide solutions. Since the application of the crowd sourcing method offers the possibility to collect as many as possible novel ideas from a broad community with different expertise, this approach is particularly promising for BM development. In this article we de-scribe the first examples of open-innovation models, such as the ‘grants for targets’ (G4T) and biomarkers initiative ‘InnoCentive’ (innovation/incentive) platform. They may be a fruitful basis for collaborative BM development in the future