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https://www.readbyqxmd.com/read/28935190/a-roadmap-for-cost-of-goods-planning-to-guide-economic-production-of-cell-therapy-products
#1
REVIEW
Yonatan Y Lipsitz, William D Milligan, Ian Fitzpatrick, Evelien Stalmeijer, Suzanne S Farid, Kah Yong Tan, David Smith, Robert Perry, Jessica Carmen, Allen Chen, Charles Mooney, John Fink
Cell therapy products are frequently developed and produced without incorporating cost considerations into process development, contributing to prohibitively costly products. Herein we contextualize individual process development decisions within a broad framework for cost-efficient therapeutic manufacturing. This roadmap guides the analysis of cost of goods (COG) arising from tissue procurement, material acquisition, facility operation, production, and storage. We present the specific COG considerations related to each of these elements as identified through a 2013 International Society for Cellular Therapy COG survey, highlighting the differences between autologous and allogeneic products...
September 18, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28923121/-i-think-it-is-right-a-qualitative-exploration-of-the-acceptability-and-desired-future-use-of-oral-swab-and-finger-prick-hiv-self-tests-by-lay-users-in-kwazulu-natal-south-africa
#2
Lucia Knight, Tawanda Makusha, Jeanette Lim, Roger Peck, Miriam Taegtmeyer, Heidi van Rooyen
BACKGROUND: The uptake of HIV testing has increased in sub-Saharan Africa over the past three decades. However, the proportion of people aware of their HIV status remains lower than required to change the pandemic. HIV self-testing (HIVST) may meet this gap. Assessment of readiness for and the acceptability of HIVST by lay users in South Africa is limited. This paper presents results from a formative study designed to assess the perceived usability and acceptability of HIVST among lay users using several self-test prototypes...
September 18, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28923064/investigating-the-importance-of-the-local-food-environment-for-fruit-and-vegetable-intake-in-older-men-and-women-in-20-uk-towns-a-cross-sectional-analysis-of-two-national-cohorts-using-novel-methods
#3
S Hawkesworth, R J Silverwood, B Armstrong, T Pliakas, K Nanchahal, C Sartini, A Amuzu, G Wannamethee, J Atkins, S E Ramsay, J P Casas, R W Morris, P H Whincup, Karen Lock
BACKGROUND: Local neighbourhood environments can influence dietary behavior. There is limited evidence focused on older people who are likely to have greater dependence on local areas and may suffer functional limitations that amplify any neighbourhood impact. METHODS: Using multi-level ordinal regression analysis we investigated the association between multiple dimensions of neighbourhood food environments (captured by fine-detail, foot-based environmental audits and secondary data) and self-reported frequency of fruit and vegetable intake...
September 18, 2017: International Journal of Behavioral Nutrition and Physical Activity
https://www.readbyqxmd.com/read/28922903/banking-on-living-kidney-donors-a-new-way-to-facilitate-donation-without-compromising-on-ethical-values
#4
Dominique E Martin, Gabriel M Danovitch
Public surveys conducted in many countries report widespread willingness of individuals to donate a kidney while alive to a family member or close friend, yet thousands suffer and many die each year while waiting for a kidney transplant. Advocates of financial incentive programs or "regulated markets" in kidneys present the problem of the kidney shortage as one of insufficient public motivation to donate, arguing that incentives will increase the number of donors. Others believe the solutions lie-at least in part-in facilitating so-called "altruistic donation;" harnessing the willingness of relatives and friends to donate by addressing the many barriers which serve as disincentives to living donation...
October 1, 2017: Journal of Medicine and Philosophy
https://www.readbyqxmd.com/read/28921646/how-often-are-drugs-made-available-under-the-food-and-drug-administration-s-expanded-access-process-approved
#5
Amy E McKee, André O Markon, Kirk M Chan-Tack, Peter Lurie
In this review of individual patient expanded-access requests to the Center for Drug Evaluation and Research for the period Fiscal Year 2010 to Fiscal Year 2014, we evaluated the number of applications received and the number allowed to proceed. We also evaluated whether drugs and certain biologics obtained under expanded access went on to be approved by the Food and Drug Administration. Finally, we considered concerns that adverse events occurring during expanded access might place sponsors at risk for legal liability...
October 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28920757/a-decision-theoretical-modeling-for-phase-iii-investments-and-drug-licensing
#6
Frank Miller, Carl-Fredrik Burman
For a new candidate drug to become an approved medicine, several decision points have to be passed. In this article, we focus on two of them: Firstly, based on Phase II data, the commercial sponsor decides to invest (or not) in Phase III. Secondly, based on the outcome of Phase III, the regulator determines whether the drug should be granted market access. Assuming a population of candidate drugs with a distribution of true efficacy, we optimize the two stakeholders' decisions and study the inter-dependence between them...
September 18, 2017: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/28920059/market-impact-of-foot-and-mouth-disease-control-strategies-a-uk-case-study
#7
Siyi Feng, Myles Patton, John Davis
Foot-and-mouth disease (FMD) poses a serious threat to the agricultural sector due to its highly contagious nature. Outbreaks of FMD can lead to substantial disruptions to livestock markets due to loss of production and access to international markets. In a previously FMD-free country, the use of vaccination to augment control of an FMD outbreak is increasingly being recognized as an alternative control strategy to direct slaughtering [stamping-out (SO)]. The choice of control strategy has implications on production, trade, and hence prices of the sector...
2017: Frontiers in Veterinary Science
https://www.readbyqxmd.com/read/28919589/from-woohwang-cheongsimwon-to-ginseng-the-history-of-medicine-use-in-the-joseon-era
#8
Seong-Su Kim
In Korean traditional medicine, though herbal decoction, acupuncture, and moxibustion are all used to treat diseases, restorative medicines are the most widely preferred treatment method. This paper explores the historical background of restorative herbal medicines and ginseng among the Korean public and Korean traditional medicine practice. It also seeks to clarify how social and cultural perspectives on drug use have changed since restorative medicine became mainstream during the Joseon era. Drug use tendencies were affected by the medical system of the Joseon Dynasty, patients' desires for reliable treatment, and perceptions of the human body and the causes of disease...
August 2017: Ŭi Sahak
https://www.readbyqxmd.com/read/28905078/-task-force-for-falsified-medicines
#9
REVIEW
Gabriele Weber
In 2014, a large number of falsified medicines of Italian origin had come to light. Because of the extent of the falsification, the situation that most of these falsified medicines had been traced back to thefts in Italy by criminal networks, and the necessity of actions by national and local authorities, an intensified exchange of information was essential, in addition to a process of coordination. A task force for falsified medicines was established to optimize the flow of information among all parties involved and to coordinate the necessary measures...
September 13, 2017: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
https://www.readbyqxmd.com/read/28904558/herbal-medicines-personal-use-knowledge-attitude-dispensing-practice-and-the-barriers-among-community-pharmacists-in-gondar-northwest-ethiopia
#10
Dessalegn Asmelashe Gelayee, Gashaw Binega Mekonnen, Seyfe Asrade Atnafe, Mequanent Kassa Birarra, Assefa Belay Asrie
BACKGROUND: Herbal medicine use is increasing and the global market is estimated to be US$107 billion by the year 2017. OBJECTIVES: This study aimed at assessing community pharmacists' personal use, knowledge, attitude, dispensing practice, and the barriers regarding herbal medicines. METHODS: Institution based cross-sectional study was conducted among 47 community pharmacists in Gondar, Northwest Ethiopia, using a structured interviewing questionnaire...
2017: Evidence-based Complementary and Alternative Medicine: ECAM
https://www.readbyqxmd.com/read/28903542/reviewing-the-evidence-for-biosimilars-key-insights-lessons-learned-and-future-horizons
#11
Till Uhlig, Guro L Goll
Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28899202/a-serial-mediation-model-of-workplace-social-support-on-work-productivity-the-role-of-self-stigma-and-job-tenure-self-efficacy-in-people-with-severe-mental-disorders
#12
Patrizia Villotti, Marc Corbière, Carolyn S Dewa, Franco Fraccaroli, Hélène Sultan-Taïeb, Sara Zaniboni, Tania Lecomte
PURPOSE: Compared to groups with other disabilities, people with a severe mental illness face the greatest stigma and barriers to employment opportunities. This study contributes to the understanding of the relationship between workplace social support and work productivity in people with severe mental illness working in Social Enterprises by taking into account the mediating role of self-stigma and job tenure self-efficacy. METHOD: A total of 170 individuals with a severe mental disorder employed in a Social Enterprise filled out questionnaires assessing personal and work-related variables at Phase-1 (baseline) and Phase-2 (6-month follow-up)...
September 12, 2017: Disability and Rehabilitation
https://www.readbyqxmd.com/read/28889030/crowdfunding-our-health-economic-risks-and-benefits
#13
Matthew J Renwick, Elias Mossialos
Crowdfunding is an expanding form of alternative financing that is gaining traction in the health sector. This article presents a typology for crowdfunded health projects and a review of the main economic benefits and risks of crowdfunding in the health market. We use evidence from a literature review, complimented by expert interviews, to extend the fundamental principles and established theories of crowdfunding to a health market context. Crowdfunded health projects can be classified into four types according to the venture's purpose and funding method...
August 31, 2017: Social Science & Medicine
https://www.readbyqxmd.com/read/28886892/the-atlantic-divide-in-coronary-heart-disease-epidemiology-and-patient-care-in-the-us-and-portugal
#14
Mariana F Lobo, Vanessa Azzone, Frederic S Resnic, Bruno Melica, Armando Teixeira-Pinto, Luís Filipe Azevedo, Alberto Freitas, Cláudia Nisa, Leonor Bacelar-Nicolau, Francisco Nuno Rocha-Gonçalves, José Pereira-Miguel, Altamiro Costa-Pereira, Sharon-Lise Normand
INTRODUCTION AND OBJECTIVES: We aimed to compare access to new health technologies to treat coronary heart disease (CHD) in the health systems of Portugal and the US, characterizing the needs of the populations and the resources available. METHODS: We reviewed data for 2000 and 2010 on epidemiologic profiles of CHD and on health care available to patients. Thirty health technologies (16 medical devices and 14 drugs) introduced during the period 1980-2015 were identified by interventional cardiologists...
September 5, 2017: Portuguese Journal of Cardiology: An Official Journal of the Portuguese Society of Cardiology
https://www.readbyqxmd.com/read/28885319/getting-the-word-out-new-approaches-for-disseminating-public-health-science
#15
Ross C Brownson, Amy A Eyler, Jenine K Harris, Justin B Moore, Rachel G Tabak
The gap between discovery of public health knowledge and application in practice settings and policy development is due in part to ineffective dissemination. This article describes (1) lessons related to dissemination from related disciplines (eg, communication, agriculture, social marketing, political science), (2) current practices among researchers, (3) key audience characteristics, (4) available tools for dissemination, and (5) measures of impact. Dissemination efforts need to take into account the message, source, audience, and channel...
September 6, 2017: Journal of Public Health Management and Practice: JPHMP
https://www.readbyqxmd.com/read/28880019/market-access-of-spinraza-nusinersen-for-spinal-muscular-atrophy-intellectual-property-rights-pricing-value-and-coverage-considerations
#16
S Simoens, I Huys
No abstract text is available yet for this article.
September 7, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28874490/networks-in-aca-marketplaces-are-narrower-for-mental-health-care-than-for-primary-care
#17
Jane M Zhu, Yuehan Zhang, Daniel Polsky
There is increasing concern about the extent to which narrow-network plans, generally defined as those including fewer than 25 percent of providers in a given health insurance market, affect consumers' choice of and access to specialty providers-particularly in mental health care. Using data for 2016 from 531 unique provider networks in the Affordable Care Act Marketplaces, we evaluated how network size and the percentage of providers who participate in any network differ between mental health care providers and a control group of primary care providers...
September 1, 2017: Health Affairs
https://www.readbyqxmd.com/read/28873211/analysis-of-genetic-variability-of-commercial-melon-cultivars-using-ssr-molecular-markers
#18
N Carvalho, F M Canela, P H S Leite, M A Ferreira, V R Oliveira, M F Santos, N O S Souza, G S C Buso
Taking into account the scenario of melon production (Cucumis melo L.) in Brazil, it is notable the importance of the culture in the fruit market. The preference of the national market is concentrated in the fruits of the yellow type. Therefore, it is possible that the genetic base of the commercial cultivars is relatively narrow due to the loss of important genes in the breeding process, and it is possible to introgress external genes for increasing recombination possibilities that generate sources of resistance to the main diseases and superior genotypes...
August 31, 2017: Genetics and Molecular Research: GMR
https://www.readbyqxmd.com/read/28871421/biosimilar-uptake-by-british-local-formularies-a-cross-sectional-study
#19
Saja Alnahar, Rachel A Elliott, Murray D Smith
Background Biological medicines are starting to lose their patent protection, so similar, inexact copies (biosimilars) are being developed and licensed. The high acquisition costs of biologics for healthcare providers could be reduced by switching to biosimilars, thus alleviating budgetary pressures and increasing patient access. Therefore, the acceptance of biosimilars by prescribers in Great Britain (GB; England, Scotland, Wales) needs to be described and understood. Objective To determine uptake of the first wave of biosimilars (somatropin, epoetin, filgrastim) by local formularies (lists of preferred medicines for prescribing in local healthcare settings)...
September 4, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28870444/pharmacists-satisfaction-with-their-work-analysis-of-an-alumni-survey
#20
Maria Gustafsson, Sofia Mattsson, Andy Wallman, Gisselle Gallego
BACKGROUND: The level of job satisfaction among practicing pharmacists is important because it has been found to affect job performance and employee turnover. The Swedish pharmacy market has undergone major changes in recent years, and little is known about pharmacists' job satisfaction. OBJECTIVES: The objective of this study was to investigate the level of job satisfaction and associated factors among graduates from the web-based pharmacy programs at Umeå University...
September 1, 2017: Research in Social & Administrative Pharmacy: RSAP
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