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Among the challenges of a pandemic is the need to scale up to billions of doses, at a larger scale than typically needed for vaccines, from raw materials all the way through to the materials for the containers for fill/finish. Having adequate raw materials, building and staffing the facilities, and tech transfer are all keys to success. [...]we can plug into existing infrastructure, including services (gas, water, waste, etc.) as well as analytics and quality labs." Emergent BioSolutions says that its flexible CDMO capacity deployment model can respond quickly to demand fluctuations. The company's facilities in France, Switzerland, and the US are working on the project;at CordenPharma Colorado, unique high-pressure chromatography systems usually used for manufacturing peptides have been reallocated for purifying lipids.
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With nearly 4,500 attendees gathered in San Diego CA, the TMS 2023 Annual Meeting & Exhibition (TMS2023) was the fourth best-attended meeting in TMS history, marking a return to business as usual (more or less) after two decidedly unusual years for the Society's biggest event. By comparison, approximately 2,600 individuals came together in person for TMS2022 in Anaheim CA. One year earlier, TMS2021--held as a fully virtual conference--attracted 2,967 attendees from around the world. This year's event, held Mar 19-23 in one of TMS's most popular meeting locations, brought the conference back closer to its pre-COVID participation numbers. The last time TMS met in San Diego was in 2020 (shortly before widespread pandemic shutdowns began) when more than 4,600 individuals came together for the largest meeting in the Society's history.
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PurposeThis study aims to investigate the factors that influence young consumers' purchase intention towards dietary supplements (DS) in Malaysia.Design/methodology/approachThe supplement industry in Malaysia has been growing rapidly recently due to a paradigm shift in healthcare management, from curative to prevention. Thus, it has sparked interest to conduct a study on the factors that influence young consumers' purchase intentions towards DS. With a response rate of 74.5%, a survey questionnaire was used to elicit data from 149 Gen-Y respondents who consume supplements on a regular basis.FindingsThe results revealed that the influencing factors towards purchase decisions among these Gen-Y respondents aged between 17 and 25 are based on product knowledge and product quality. The implications of these findings and directions for future research are outlined at the end of this paper.Originality/valueThis study offers empirical insights from the perspective of an emerging digital economy on the factors that influence young consumers' purchase intentions towards DS in Malaysia.
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The COVID-19 pandemic has become a partisan issue rather than an independent public health issue in the US. This study examined the behavioural consequences of motivated reasoning and framing by investigating the impacts of COVID-19 news exposure and news frames, as apparent through a Latent Dirichlet topic modelling analysis of local news coverage, on state-level preventive behaviours as understood through a nationally representative survey. Findings suggested that the media effects on various preventive behaviours differed. The overall exposure rate to all COVID-19 news articles increased mask-wearing but did not significantly impact other preventive behaviours. Four news frames significantly increased avoiding contact or avoiding public or crowded places. However, news articles discussing anxiety and stay at home order triggered resistance and countereffects and led to risky behaviours. ‘Solid Republican' state residents were less likely to avoid contact, avoid public or crowded places, and wear masks. However, partisan leanings did not interfere with the impact of differing local COVID-19 news frames on reported preventive behaviours. Plus, statements regarding pre-existing trust in Trump did not correlate with reported preventive behaviour. Attention to effect sizes revealed that news exposure and news frames could have a bigger impact on health behaviours than motivated reasoning.
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In the arena of clinical research, gender equity accelerates research excellence: we need multiple perspectives and all the brain power we can muster to maximize research productivity and quality. [...]women physician investigators enhance enrollment of women as participants in clinical trials, which is crucial to our ability to generalize from the data and to maintain the health of women. Women are underrepresented among academic grand rounds speakers,14 speakers at medical conferences15, and award recipients from medical specialty societies.16 Time pressure is especially intense on young women faculty. Besides spending more time on domestic chores, they spend more time at work on teaching, service, and mentoring. Female primary care physicians spend more time with patients.22 Elderly hospitalized patients treated by female internists experience lower mortality and readmission rates.23 Patients undergoing coronary artery bypass grafting had shorter hospital length of stay when treated by an all-female physician team as compared with an all-male team.24 Female patients treated by male physicians following acute myocardial infarction have higher mortality than those treated by female physicians.25 Sex discordance between patient and surgeon is associated with increased likelihood of adverse postoperative outcomes-and that observation that is driven by worse outcomes for female patients treated by male physicians.26 Clinical trials play a fundamental role in bringing new medications and interventions to our patients, yet women have often been excluded from participation. Among 60 randomized controlled trials (RCTs) of lipidlowering therapies reported between 1990 and 2018, there was a modest increase in enrollment of women over time, but women remain underrepresented compared with the relative burden of disease.30 In another study of 317 RCTs of heart failure with reduced ejection fraction published in highimpact journals over the past 20 years, only 25% of participants overall were female, and females were under-enrolled in 72% of these trials.
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With destinations steadily ‘opening back up for business' (while COVID-19 cases are still high in many areas), there is an increasing need to consider residents. Integrating the cognitive appraisal theory and the affect theory of exchange, this work tests a structural model examining the degree to which residents' perceptions of COVID-19 precautionary measures explain emotions directed toward visitors, and ultimately their willingness to engage in shared behaviors with tourists. Data were collected from 530 residents in 25 U.S. counties with the highest percentages of historical COVID-19 cases per population. A total of 10 of the 12 tested hypotheses were significant, contributing to 60% and 85% of the variance explained in contending and accommodating emotions, and 53% and 50% of the variance explained in engaging in less intimate–distal and more intimate–proximal behaviors with tourists. The implications highlight the complementary use of the two frameworks in explaining residents' preference for engagement in less intimate–distal interactions with tourists.
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PurposeThe purpose of this paper was to determine the profile of dairy product consumers in the organic market.Design/methodology/approachThe study was based on a survey questionnaire developed by the author and administered to a total of 1,108 respondents. The statistical analysis (including descriptive statistics, the analysis of the discriminative function and the Chi2 test was performed with the use of Statistica 13.1 PL. The respondents' gender was the factor behind the differences in how they behaved.FindingsThe consumers indicated the channels they rely upon to find information on organic dairy products;in addition to trusting the opinions of their family members and experts, they also use web platforms. Further, they specified their preferred locations for buying favorite products during the pandemic: specialized organic food shops, large distribution chains and online stores.Practical implicationsThese outcomes will help in identifying target consumer segments and information channels for specific information and advertising messages. They also form an important resource for developing some potential strategies which the supply chain stakeholders could implement to promote organic consumption of dairy products.Originality/valueThis study identifies consumers' preferred dairy products;motives for purchasing organic dairy products;barriers that consumers believe exist in the market;sources of knowledge about products purchased by consumers;and consumers' preferred channels for purchasing organic dairy products. To the best of the author's knowledge, this is the first study of dairy product consumers in the organic market in Poland.
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The limited participation of African Americans in clinical trials has been a topic of discussion among medical and scientific researchers for some time. With the testing of coronavirus vaccines, this discussion has continued, particularly given the disproportionate impact of the virus on members of the African American community. With the public health goal of achieving widespread or "herd" immunity, the concept of "vaccine hesitancy" has also been addressed with regard to the population in general, and in relation to the African American community, among others. Vaccine hesitancy has been reported among groups from healthcare workers to rural residents to the poor. As is the case with all segments of society, African Americans are not monolithic. However, there are aspects of the issue of vaccine hesitancy which are unique and specific to the African American community in the U.S. In particular, the nature of the information about the coronavirus itself and about the vaccine, and importantly, the increasing availability of the information about the Tuskegee experiment, Henrietta Lacks, and other cases, along with the prevalence of misinformation and disinformation on aspects of science, such as that involving vaccines, are relevant to understanding the nature of vaccine hesitancy among African Americans.
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The purpose of this study is to examine and analyze the influence of mental workload and person-organization fit on turnover intention, using basic psychological needs frustration (BPNF) as the intervening variable in the hospital in Daerah Istimewa Yogyakarta. The sample of this study is vocational nurse in the hospital in Daerah Istimewa Yogyakarta. The sample is carried out through survey from 153 respondents, which is processed using Structural Equation Modeling (SEM) method. This study finds that mental workload does not have direct influence on turnover intention, but it is mediated (full mediation) by need for competence frustration and need for relatedness frustration. Person-organization fit has a positive influence on need for autonomy frustration. However, person-organization fit does not have an influence on turnover intention, and basic psychological needs does not mediate the relationship of these variables. This study also found that the category of mental workload is quite low, person-organization fit is low, basic psychological needs frustration is quite low, and turnover intention is low. Nurse has the extrinsic motivation of identified regulation, thus hospital leaders should bring their motivation from identified regulation to intrinsic motivation, through internalization by establishing supportive work environment, namely Islamic spiritual workplace (ISW), with basic psychological needs supporting in each of its dimension. This study is expected to be a reference for practitioners in human resource management, especially regarding human resource retention function through the implementation of ISW. ISW contributes to lower mental workload, the increase of person-organization fit, establishment of basic psychological need satisfaction, as well as the decrease of basic psychological needs frustration and turnover intention.
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More recent policies aim to offset years of underenrollment of minority groups by expanding enrollment criteria, including more research sites in minority communities, and engaging investigators with diverse backgrounds. FDA has also sought to promote research diversity through its Drug Trials Snapshots program, established in 2015 to increase the visibility of clinical trial enrollment by age, sex, ethnicity and race. According to a recent report on the program's impact, though, there still may be a ways to go for clinical trials to reflect the diversity of the US population.
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At the agencies' request, the National Academy of Sciences, Engineering and Medicine iNASEMi has formed a blue-ribbon committee of leading bioethicists, economists, geneticists, and public health authorities to quickly develop a framework for priority vaccine access to assist policymakers in the U.S. and other nations achieve equitable distribution of anticipated vaccines (see: https://bit.ly/33jTCds). Individuals at higher risk will include those in higher age groups, with underlying health conditions, engaged in high-risk occupations, affected by racial and ethnic disparities, and in hardhit geographic locations. State and public health officials are wary of federal pandemic planning efforts so fair given the lack of coordination and effectiveness in distributing COVID-19 test kits and personal protective equipment to healthcare providers and facilities.
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Growing public concerns about politics playing a role in vetting potential vaccines and therapies to combat the COVID-19 pandemic has prompted sponsors of leading clinical trials to make public their study protocols and statistical analysis plans. [...]AstraZeneca's timeframe for enrolling and assessing study participants was delayed by the need to address the report of a serious adverse event in its Phase III study. The disclosure of these usually confidential details on research endpoints, assessment timeframes, and study analysis plans aim to promote information sharing among vaccine developers, and also build public confidence.
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[...]CURES' BILL PROMOTES PANDEMIC PREPAREDNESS Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster (see https://bit.ly/2SKfA4S). Cures 2.0 continues and updates some of the main themes of the first Cures Act: support development of treatments for rare diseases, patient-focused drug development, diversity in clinical trials, expanded use of digital health systems, increased health literacy, and utilization of real-world data. A public education campaign, moreover, would aim to counter concerns about the safety of vaccines to promote widespread vaccination. Because these treatments are costly and unprofitable for biopharma companies to test and market, the legislation proposes additional financial support for both pre-market studies and post-market production and subsidized higher reimbursement rates for antibiotics that address critical needs.
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Studies in mild-to-moderate cases as well as severe disease leave us still searching for a magic pill
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Study Design: We conducted a qualitative stakeholder analysis project with suppliers of the MDPP and health care providers. Am J Manag Care. 2023;29(6):In Press _____ Takeaway Points More than 5 years after CMS enacted coverage of the CDC-approved Medicare Diabetes Prevention Program (MDPP) in 2018, little is known about why MDPP uptake is so limited. * Findings of our stakeholder analysis with program suppliers and health care providers reinforced existing evidence on insufficient reimbursement and low awareness of the program. * Newer insights include recommendations about lagged payments, ongoing virtual delivery, and formally diagnosing prediabetes among MDPP participants. * Our findings on barriers and facilitators can inform policy to refine the MDPP and research on the MDPP, particularly within the field of implementation science. _____ Population-level strategies to prevent type 2 diabetes are urgently needed for the more than 24 million older adults with prediabetes in the United States.1 Evidence-based lifestyle interventions can prevent diabetes onset, per evidence from the landmark Diabetes Prevention Program trial.2 Thus, the CDC launched the National Diabetes Prevention Program (NDPP) in 2010.3 Significant reductions in weight and medical spending were observed among Medicare beneficiaries who participated in the NDPP,4 prompting CMS to fully cover the Medicare Diabetes Prevention Program (MDPP) starting in 2018.5 Despite unprecedented Medicare coverage for a disease prevention program, MDPP uptake is limited. Regarding awareness, national guidelines recommend referral to lifestyle intervention for adults aged 40 to 70 years with prediabetes.9 Yet less than 5% of adults eligible for a NDPP reported receiving a referral,10 which may stem from limited awareness among health care providers.11 Thus, we conducted a qualitative stakeholder analysis to learn about regional awareness of, referral to, facilitators of, and barriers to the MDPP. The 8 interviewees included 5 program directors (3 from YMCAs, 1 from a private organization, and 1 from a hospital system) and 3 health care providers (2 family physicians and 1 dietitian).
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PurposeThis study models the effects of the COVID-19 pandemic on the performance of the private health-care sector in the Middle East and North Africa (MENA) countries. This paper aims to address the economic, societal and sustainability of the health-care sector.Design/methodology/approachData were collected from Bloomberg and the sample consists of 534 firm-year observations from 55 firms listed over 2010–2020. The authors apply panel data and control for the country and governance effects.FindingsThe authors found heterogeneous results regarding the three sub-sectors. The pandemic has a negative effect on the accounting and market performances of the "Pharmaceutical companies” and an insignificant impact on "Healthcare Management and Facilities Services.” Moreover, the impact of COVID-19 on health-care firms' performance depends on the country's economic classification and the degree of regulatory and governance frameworks.Research limitations/implicationsFurther studies may consider a larger sample and other regions. It is recommended to address the health-care sector's challenges to invest in new technologies such as "digital twin” and predictive and personalized medicine. It is worth testing model development theory and its effects on speeding up and designing models to ensure the proper functioning and developing mathematics to determine uncertainties in patient data and model predictions.Originality/valueTo the best of the authors' knowledge, this paper is novel as it is unique in modeling the impact of COVID-19 on the health-care public companies in the MENA region. The findings pinpoint firms' and countries' heterogeneous impacts on financial and market performances.
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According to market research, the pharmaceutical packaging sector is expected to grow at a compound annual rate of 7.4% between 2022 and 2031, reaching an estimated USS178.8 billion (€171.8 billion) by the end of the forecast period (1). "Pharmaceutical waste continues to be a huge problem, so to eliminate non-biodegradable and single-use plastics from the supply chain, more research is taking place around bio-based PET [polyethylene terephthalate]. "By designing a product's primary and secondary packaging well from the outset (including investing ample resources into the process), manufacturers can reduce the amount of materials used and wasted, test new eco materials, ensure safety compliance and efficacy, and benefit from cheaper transportation costs," Quelch surmises. [...]pharma companies can benefit from a packaging supplier with a true global footprint," he says.
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Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.