Identifying and prioritizing industry-level competitiveness factors: evidence from pharmaceutical market.
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ABSTRACT:
SUBMITTER: Shabaninejad H
PROVIDER: S-EPMC4234990 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDrug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination.ObjectiveThis study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe.MethodsThe case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses.ResultsA total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were 'change in administration setting to hospital' (374%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations belonging to Group 3'-that is, change in administration route (117%, p<0.001), and being a repurposed product with the 'same brand name' as the original product (65%, p<0.05).ConclusionWe found that the ability of the repurposed product to address unmet needs, a reformulation where the target product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in the USA, in particular. Although a change of administration from ambulatory to hospital setting seemed to be significantly correlated with a price increase for the target product, only one case was retrieved for this parameter; as such, it was not possible to infer a firm correlation between this parameter and a change in price.
| S-EPMC4865758 | biostudies-literature
Project description:BackgroundEvidence synthesis is key in promoting evidence-based health care, but it is resource-intense. Methods are needed to identify and prioritize evidence synthesis needs within health care systems. We describe a collaboration between an agency charged with facilitating the implementation of evidence-based research and practices across the Military Health System and a research center specializing in evidence synthesis.MethodsScoping searches targeted 15 sources, including the Veterans Affairs/Department of Defense Guidelines and National Defense Authorization Acts. We screened for evidence gaps in psychological health management approaches relevant to the target population. We translated gaps into potential topics for evidence maps and/or systematic reviews. Gaps amenable to evidence synthesis format provided the basis for stakeholder input. Stakeholders rated topics for their potential to inform psychological health care in the military health system. Feasibility scans determined whether topics were ready to be pursued, that is, sufficient literature exists, and duplicative efforts are avoided.ResultsWe identified 58 intervention, 9 diagnostics, 12 outcome, 19 population, and 24 health services evidence synthesis gaps. Areas included: posttraumatic stress disorder (PTSD) (19), suicide prevention (14), depression (9), bipolar disorder (9), substance use (24), traumatic brain injury (20), anxiety (1), and cross-cutting (14) synthesis topics. Stakeholder input helped prioritize 19 potential PTSD topics and 22 other psychological health topics. To date, 46 topics have undergone feasibility scans. We document lessons learned across clinical topics and research methods.ConclusionWe describe a transparent and structured approach to evidence synthesis topic selection for a health care system using scoping searches, translation into evidence synthesis format, stakeholder input, and feasibility scans.
| S-EPMC6750194 | biostudies-literature
Project description:BackgroundMedicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself. As such, we aim to evaluate if the added value of repositioned or reformulated medicinal products can be systematically described, quantified, and predicted. As a first step toward investigating the impact of market access on drug research and development trends for repositioned and reformulated products, it is necessary to have consistency in the designations for the case studies evaluated in this project. In an attempt to achieve that consistency, the current study aims to propose harmonized definitions for the repositioning and reformulation strategies and to propose a taxonomy for the medicinal products derived thereof.MethodsA systematic literature review was conducted to collect information on existing cases of repositioning or reformulation. A search strategy was developed by defining the search objectives, targeted data sources, search keywords, and inclusion/exclusion criteria for the retrieved documents.ResultsA total of 505 publications were retrieved through a search of the main data sources. The screenings and the ad hoc search led to a total of 56 publications to be used for the case study data extraction. In total, 87 repositioning and/or reformulation cases were found described in the literature, 23 of which presented different definitions and/or classifications by different authors.ConclusionGiven the disparity and inconsistency of terminologies and classifications in the literature, a harmonized nomenclature for drug repositioning, reformulation, and combination cases will allow for a robust analysis of the added value and market access conditions attributed for each strategy and case type as assessed by regulators and payors in Europe and the United States. After evaluation of the existing terminologies and given the absence of clear and consistent definitions for drug reformulation and repositioning in the literature, we propose a global terminology and taxonomy in order to cover all of the previously unclear definitions and classifications for repositioned and reformulated products.
| S-EPMC4865745 | biostudies-literature
Project description:Activated sludge from Pharmaceutical industry Metagenome
| PRJNA509309 | ENA
Project description:Activated sludge as Bioresource: screening of secondary metabolite with antimicrobial potential
| PRJNA509315 | ENA
Project description:Most empirical studies examining the export competitiveness of a country in a target market are undertaken by focusing on supply, only analysing the group of competing countries. In addition, if the target market to be analysed is extensive, like the European Union, it is generally analysed as a whole. This study presents an evaluation of the tomato export competitiveness, from a differentiated demand perspective, analysing its main customers markets in the context of European Union. The methodological framework is implemented through Constant Market Share to analyze variations in exports, allowing the portion attributable to competitiveness and segregation into general or specific competitiveness to be quantified. The Constant Market Share was adapted to focus on the differentiated demand so as to observe the influence of the worldwide crisis (2007/08) on the European tomato market. This study allows the analysis of profile changes into the competitor exporting economies. As a contribution to the methodology, this study presents a new graphical way of representing the results of Constant Market Share methodology by means of export competitiveness maps in the European tomato market for the group for each main competitor in each European client market. According to our results, Spain and Belgium are candidate countries to be competitive in the main European markets.
| S-EPMC8092757 | biostudies-literature
Project description:This paper discusses the importance of absorptive capacity in improving a firm's innovation performance. Specifically, we examine firm interaction with the knowledge and capabilities of outside organizations and the effect on the firm's bottom line. We use the impulse-response function of the vector auto-regressive model to gain insight into this relationship by estimating the time required for the effect of each activity level to reach outputs, the spillover effects. We apply this methodology to pharmaceutical firms, which we classify into two sub-groups--large firms and medium and small firms--based on sales. Our results show that the impact of an activity on any other activity is delayed by three years for large firms and by one to two years for small and medium firms.
| S-EPMC4504511 | biostudies-literature
Project description:Although corporate social responsibility (CSR) activities are common in the pharmaceutical industry, there is little empirical evidence on consumer responses to CSR practices. We investigated public awareness, preferences, and expectations regarding social contribution of the pharmaceutical industry's CSR activities, and identified the factors associated with such activities. We conducted an online survey with 1,298 respondents comprising two groups: healthy individuals (546) and patients (752). Most respondents (78%) expressed interest in CSR activities undertaken by pharmaceutical companies. However, they reported a lack of awareness and experience thereof; only 26.9% were aware of and 7.9% had experience with such activities. Among our six CSR activity categories, both survey groups showed the highest preference for the "promoting public health" (healthy group: 6.34/10; patient group: 6.37/10) and "emergency disaster relief support" (6.31 and 6.35) categories. Among sub-categories, activities related to "development of innovative drugs in untreated areas" (6.63 and 6.82) and "support for research on new drug development" (6.59 and 6.84) received the highest scores. The mean expectation score of social contribution of all CSR activities was slightly higher than the mean preference score (6.37 and 6.06, respectively). The patient group exhibited a larger difference between the highest and lowest expectation scores than the healthy group (1.11 and 0.64, respectively). The results of the regression analysis revealed that being a patient, being male, and having positive attitudes toward CSR and its expected effects significantly and positively affected public preferences regarding CSR activities. We can conclude that CSR activities with high public preference might be an effective strategy to improve public awareness of the pharmaceutical industry's CSR activities. Furthermore, the highest preference for CSR activities relates to new drug development, indicating that our society believes the pharmaceutical industry's key CSR activity should be to pursue its intrinsic mission: to fulfill unmet medical needs by developing new drugs.
| S-EPMC6701779 | biostudies-literature
Project description:To investigate whether adverse effects data for the sponsor's product are presented more favourably in pharmaceutical industry-funded studies than in non-industry-funded studies.We conducted a systematic review of methodological evaluations that had assessed the relationship between industry funding and the reported risk of adverse effects. Searches were undertaken in 10 databases and supplemented with other sources of information such as handsearching, citation searching, checking conference proceedings and discussion with experts. Two reviewers independently screened the records and carried out data extraction for potentially relevant papers. We included studies that compared the results and interpretation of the adverse effects data according to funding source (e.g. adverse effects data in pharmaceutical industry research vs. data from nonprofit organizations, or from one manufacturer vs. another). Methodological evaluations were excluded if categories of funding source were not explicitly specified by the researchers, and if we were uncertain that industry-funded studies were present in the evaluation.The search strategy yielded 4,069 hits, of which six methodological evaluations met our inclusion criteria. One survey of 370 trials covering a wide range of topics found that trials with industry sponsors had more complete reporting of adverse effects compared with non-industry-funded trials, whereas another survey of 504 inhaled corticosteroid studies showed no apparent difference after confounding factors were adjusted for. In contrast, we found evidence from post hoc subgroup analyses involving two products where the likelihood of harm was of a lower magnitude in manufacturer-funded studies compared with nonmanufacturer-funded studies. There is also evidence from four methodological evaluations that authors with industry funding were more likely than authors without pharmaceutical funding to interpret and conclude that a drug was safe, even among studies that did find a statistically significant increase in adverse effects for the sponsored product.Our review indicates that industry funding may not be a major threat to bias in the reporting of the raw adverse effects data. However, we are concerned about potential bias in the interpretation and conclusions of industry-funded authors and studies.
| S-EPMC2675760 | biostudies-literature
Project description:This paper provides a description of how market competitiveness evaluations concerning mechanical equipment can be made in the context of multi-criteria decision environments. It is assumed that, when we are evaluating the market competitiveness, there are limited number of candidates with some required qualifications, and the alternatives will be pairwise compared on a ratio scale. The qualifications are depicted as criteria in hierarchical structure. A hierarchical decision model called PCbHDM was used in this study based on an analysis of its desirable traits. Illustration and comparison shows that the PCbHDM provides a convenient and effective tool for evaluating the market competitiveness of mechanical equipment. The researchers and practitioners might use findings of this paper in application of PCbHDM.
| S-EPMC4718694 | biostudies-literature