Successful regulatory agency interaction - A nonclinical regulatory strategist's perspective.

Regulatory agency interaction occurs from before a candidate drug enters clinical development and all the way to marketing approval and beyond. This paper presents ways to enable successful interaction by avoiding issues, with an emphasis on nonclinical testing aspects. Strategic thinking as to whether an early regulatory agency meeting should occur is discussed and if yes, how to make it a success by generating relevant questions with proper preparation including a robust Briefing Document. Examples of unfavourable regulatory agency feedback during meetings is given which may have been avoided. Similarly, ways for successful regulatory submission in the form of a Clinical Trials Application (CTA) in Europe or an Investigational New Drug (IND) application in the US are considered with examples of comments that can be received from regulatory agencies. At marketing application stage with submission of a Marketing Authorisation Application (MAA) in Europe and a New Drug Application (NDA) or a Biologic License Application (BLA) in the US, a key document is the Nonclinical Overview and suggested content and potential deficiencies are presented to allow avoidance of adverse regulatory agency responses and time delay. Successful regulatory agency interaction involves robust scientific thinking, proper planning and well-written documentation.

Evaluation Method of Human Resource Management Efficiency of Chain Retail Enterprises Based on Distributed Database.

The calculation of human resource management efficiency evaluation method is large, which affects the technical efficiency and scale efficiency of evaluation results. Based on distributed database, an evaluation method of human resource management efficiency of chain retail enterprises is proposed. Genetic algorithm is applied to the design of distributed database to realize the best data allocation scheme. The distributed database is used to store the human resource information of chain retail enterprises to ensure the data consistency and information availability. Select the input and output elements that can best reflect the human resource management status of chain retail enterprises in the distributed database, design the management efficiency evaluation index system, and construct the DEA evaluation model. After testing, the technical efficiency and scale efficiency of the design method in this paper are higher than the evaluation methods of human resource management efficiency of chain retail enterprises based on principal component analysis and fuzzy comprehensive evaluation, which is conducive to management decision-making.

RD internationalization, domestic technology alliance, and innovation in emerging market.

Although R&D internationalization plays an important role in enterprises' globalization, few studies explore the mechanism of R&D internationalization and emerging market companies' innovation, or the relationship between R&D internationalization, domestic technology alliances and absorptive capacity. How does the R&D internationalization of emerging market enterprises affect the innovation of those enterprises? Under fierce market competition, do absorption capacity and domestic technology alliances have a significant impact on enterprise innovation? From the perspective of the knowledge-based view, this paper studies 185 enterprises undergoing R&D internationalization in China from 2012 to 2017, using high-dimensional Poisson fixed effects model, we use instrumental (HDFE IV) estimation to explain the impact of R&D internationalization on the innovation of the parent company and the mechanism behind it. The study finds that R&D internationalization positively promotes the parent company's innovation, and domestic technology alliances and absorptive capacity play a partial mediator role in R&D internationalization. In the face of fierce market competition, domestic technical alliances play a significant role in promoting enterprise innovation, while absorptive capacity plays a negative role in promoting enterprise innovation with the moderating effect of market competition.

Determinants of content marketing effectiveness: Conceptual framework and empirical findings from a managerial perspective.

Content marketing has gained momentum around the world and is steadily gaining importance in the marketing mix of organizations. Nevertheless, it has received comparatively little attention from the scientific community. In particular, there is very little knowledge about the effectiveness, optimal design and implementation of content marketing. In this study, the authors conceptualize content marketing as a set of activities that are embedded in and contingent on the specific organizational context. Based on this framework, the authors empirically investigate the context features determining content marketing effectiveness from a managerial perspective, using primary data collected from senior marketers in 263 organizations from various sectors and across different size categories, conducting multiple regression analysis. The empirical results indicate that clarity and commitment regarding content marketing strategy and a content production in line with the organization's target groups' content needs as well as normative journalistic quality criteria are context factors associated with higher content marketing effectiveness. The outcomes also reveal that regularly measuring content marketing performance and using the data obtained as guidance for improving content offerings positively influence content marketing effectiveness, as do structural specialization and specialization-enabling processes and systems. The insights provided in this study could offer important theoretical contributions for research on content marketing and its effectiveness and may help practitioners to optimize the design and implementation of content marketing initiatives.

Alcohol and fast food sponsorship in sporting clubs with junior teams participating in the 'Good Sports' program: a cross-sectional study.

OBJECTIVE: To examine: alcohol and fast food sponsorship of junior community sporting clubs; the association between sponsorship and club characteristics; and parent and club representative attitudes toward sponsorship. METHODS: A cross-sectional telephone survey of representatives from junior community football clubs across New South Wales and Victoria, Australia, and parents/carers of junior club members. Participants were from junior teams with Level 3 accreditation in the 'Good Sports' program. RESULTS: A total of 79 club representatives and 297 parents completed the survey. Half of participating clubs (49%) were sponsored by the alcohol industry and one-quarter (27%) were sponsored by the fast food industry. In multivariate analyses, the odds of alcohol sponsorship among rugby league clubs was 7.4 (95%CI: 1.8-31.0, p=<0.006) that of AFL clubs, and clubs located in regional areas were more likely than those in major cities to receive fast food industry sponsorship (OR= 9.1; 95%CI: 1.0-84.0, p=0.05). The majority (78-81%) of club representatives and parents were supportive of restrictions to prohibit certain alcohol sponsorship practices, but a minority (42%) were supportive of restrictions to prohibit certain fast food sponsorship practices. CONCLUSIONS: Large proportions of community sports clubs with junior members are sponsored by the alcohol industry and the fast food industry. There is greater acceptability for prohibiting sponsorship from the alcohol industry than the fast food industry. Implications for public health: Health promotion efforts should focus on reducing alcohol industry and fast food industry sponsorship of junior sports clubs.

How One Library's Health Information Center Expanded Its Marketing Plan.

When Preston Medical Library moved inside the Medical Center in September 2014, the new patient library, called the Health Information Center (HIC), was added. This addition is a patient focused, consumer health library that, among other things, offers health information and books. After the initial marketing plan was implemented, a task force was created to focus specifically on marketing the consumer health library and its resources. This article discusses how the task force revamped the marketing strategy to include outreach into the medical center's waiting rooms and other opportunities for collaboration.

Guidance for the governance of public-private collaborations in vaccine post-marketing settings in Europe.

INTRODUCTION: The 2009 influenza pandemic highlighted challenges for vaccine post-marketing monitoring in Europe, particularly the need to have appropriate infrastructures to strengthen public-private collaborations (PPCs) with suitable processes to improve stakeholder interactions and collection and analysis of safety and effectiveness data. The ADVANCE consortium comprises public and private stakeholders who have worked together to build and test new system components for vaccine post-marketing projects, one component being a governance framework for efficient, transparent and trustworthy PPCs. METHODS: Based on the results of a landscape analysis and screening of formalised existing governance structures, we identified the elements of a governance framework and developed recommendations to support stakeholders willing and able to implement collaborative projects. These proposals and their implementation were discussed by 70 experts during a workshop to gain from their experience. RESULTS: We identified core governance principles and defined five fundamental functions (decision-making, scientific advice, quality control and audit, implementation and management, and financial administration) that can be attributed to individual partner organisations or to a committee with representatives from more than one partner organisation. We propose a generic governance model with options for its adaptation to specific contexts and projects. The advantages and disadvantages of PPCs were also examined. Stakeholders' concerns (e.g. scientific integrity and public trust) were addressed through recommendations about transparent decision-making rules and conflict of interest management. CONCLUSIONS: No one-size-fits-all solution for PPC governance exists but our recommendations could be used to set-up a tailored-made and fully transparent governance structure supporting collaborative projects in the European vaccine post-marketing environment. To allow the rapid establishment of robust projects, the next steps will involve this guidance being used by real-world collaborations to assess what works and what does not work and what added-value can be obtained from these collaborations.

Implementing condom distribution programs in the United States: Qualitative insights from program planners.

With the growing number of sexually transmitted infections (STIs) among young people (15-24) in the US, condom distribution programs (CDP) remain an integral part of prevention strategies. The objective of the study was to gather qualitative insights from CDP planners to inform effective CDP implementation. Ten semi-structured interviews with program planners were conducted via telephone (response rate of 58.8%). Condom distribution channels included site-based distribution (n = 6), web-based distribution (n = 4), and distribution via Uber (n = 1). Site-based distribution programs had distribution networks ranging from 100 to 3500 sites in a given jurisdiction. Planners of site-based CDPs experienced challenges with ensuring quality control at sites and supplying condoms to sites. Web-based CDPs allow individuals to order free condoms online. These CDP planners reported growing demand for this discreet service, particularly among young people. Web-based CDPs leveraged e-mail surveys to collect data on sexual behavior and behavior change, yielding response rates as high as 63%. All CDPs emphasized the importance of supplying a variety of products. Total supplies distributed (male condoms, internal condoms, lubricant sachets) ranged from 16,000 to 45 million per year. Novel channels of distribution should be explored to ensure reach to adolescents and young adults.

Catalyzing marketing innovation and competitive advantage in the healthcare industry: the value of thinking like an outsider.

BACKGROUND: Marketing arguably is the most critical administrative responsibility associated with the pursuit and realization of growth and prosperity, making prowess in the discipline essential for any healthcare institution, especially given the competitive intensity that characterizes the industry. But in order to truly gain an advantage, healthcare establishments must tap into innovative pathways that their competitors have yet to discover. Here, thinking like an outsider can pay tremendous dividends, as health and medical organizations tend to focus inwardly, limiting their exposure to externally-derived innovations and advancements which often can supply differentiation opportunities. DISCUSSION: Some years ago, during a formative period in preparation for expanding its footprint, Willis-Knighton Health System opted to think like an outsider, peering beyond the walls of healthcare institutions in search of tools and techniques that would allow its growth ambitions to be realized. Associated pursuits and subsequent successes created a culture of challenging status quo perspectives, affording innovations and resulting competitive advantages. Marketing advancements, in particular, have been fueled by this outsider mentality, benefiting the institution and its patient populations. This article profiles several of these advancements, discusses the dangers of insular mindsets, and suggests avenues for encouraging broad perspectives. CONCLUSIONS: Due to extreme competitive intensity and ever-increasing patient needs, health and medical establishments must perform at optimal levels, with marketing efforts playing a critical role in the achievement of such. By shedding status quo perspectives and peering beyond the walls of healthcare institutions, health and medical providers have opportunities to discover new and different marketing approaches for potential use in their own organizations, affording mutual benefits, including all-important competitive advantages.

Using Marketing Science to Understand Contraceptive Demand in High-Fertility Niger.

Global initiatives aim to add 120 million new family planning (FP) users by 2020; however supply-side interventions may be reaching the limits of their effectiveness in some settings. Our case study in Niger used demand analysis techniques from marketing science. We performed a representative survey (N = 2,004) on women's FP knowledge, attitudes, needs, and behaviors, then used latent class analysis to produce a segmentation of women based on their responses. We found that Nigerien women's demand for modern FP methods was low, with majorities aware of modern methods but much smaller proportions considering use, trying modern methods, or using one consistently. We identified five subgroups of women with distinct, internally coherent profiles regarding FP needs, attitudes, and usage patterns, who faced different barriers to adopting or using modern FP. Serving subgroups of women based on needs, values, and underlying beliefs may help more effectively drive a shift in FP behavior.

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.

There is a widely held expectation of clinical advance with the development of gene and cell-based therapies (GCTs). Yet, establishing benefits and risks is highly uncertain. We examine differences in decision-making for GCT approval between jurisdictions by comparing regulatory assessment procedures in the United States (US), European Union (EU) and Japan. A cohort of 18 assessment procedures was analyzed by comparing product characteristics, evidentiary and non-evidentiary factors considered for approval and post-marketing risk management. Product characteristics are very heterogeneous and only three products are marketed in multiple jurisdictions. Almost half of all approved GCTs received an orphan designation. Overall, confirmatory evidence or indications of clinical benefit were evident in US and EU applications, whereas in Japan approval was solely granted based on non-confirmatory evidence. Due to scientific uncertainties and safety risks, substantial post-marketing risk management activities were requested in the EU and Japan. EU and Japanese authorities often took unmet medical needs into consideration in decision-making for approval. These observations underline the effects of implemented legislation in these two jurisdictions that facilitate an adaptive approach to licensing. In the US, the recent assessments of two chimeric antigen receptor-T cell (CAR-T) products are suggestive of a trend toward a more permissive approach for GCT approval under recent reforms, in contrast to a more binary decision-making approach for previous approvals. It indicates that all three regulatory agencies are currently willing to take risks by approving GCTs with scientific uncertainties and safety risks, urging them to pay accurate attention to post-marketing risk management.

How to achieve empirical outcomes in the ED.

Using transformational leadership and innovative marketing strategies.

Tobacco Industry Research on Nicotine Replacement Therapy: "If Anyone Is Going to Take Away Our Business It Should Be Us".

Nicotine replacement therapy (NRT) is recommended for tobacco cessation on the basis of pharmaceutical industry research showing its effectiveness when combined with counseling. The tobacco industry opposed NRT when it first appeared in the 1980s but by 2016 was marketing its own NRT products. We used internal tobacco industry documents dated 1960 through 2010 to identify the industry's perceptions of NRT. As early as the 1950s, tobacco companies developed nonsmoked nicotine replacements for cigarettes, but they stopped out of concern that marketing such products would trigger Food and Drug Administration regulation of cigarettes. In the 1990s, after pharmaceutical companies began selling prescription NRT, tobacco companies found that many smokers used NRT to supplement smoking rather than to quit. In 2009, once the Food and Drug Administration began regulating tobacco, tobacco companies restarted their plans to capture the nicotine market. Although the tobacco industry initially viewed NRT as a threat, it found that smokers often combined NRT with smoking rather than using it as a replacement and began marketing their own NRT products.

An antibiotic's journey from marketing authorization to use, Norway.

Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial infection, there is little need for newer, more expensive antibiotics whose therapeutic superiority to existing compounds has not been demonstrated. Since resistance begins to emerge as soon as an antibiotic is used, Norway's practice of leaving newer antibiotics on the shelf is consistent with the goal of prolonging the effectiveness of newer antibiotics. An unintended consequence is that the country has signalled to the private sector that there is little commercial value in novel antibiotics, which may nevertheless still be needed to treat rare or emerging infections. Every country aims to improve infection control and to promote responsible antibiotic use. However, as progress is made, antibiotic-resistant bacteria should become less common and, consequently, the need for, and the commercial value of, novel antibiotics will probably be reduced. Nevertheless, antibiotic innovation continues to be essential. This dilemma will have to be resolved through the introduction of alternative reward systems for antibiotic innovation. The DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) research consortium in Europe has been tasked with identifying ways of meeting this challenge.

Nous décrivons ici en détail les procédures d'autorisation de mise sur le marché et de remboursement des médicaments en Norvège, en particulier de neuf nouveaux antibiotiques qui ont reçu une autorisation de mise sur le marché entre 2005 et 2015. Cette description montre que, dans les pays comme la Norvège qui ont adopté des politiques d'utilisation raisonnée des antibiotiques et qui affichent ainsi une faible prévalence d'infections bactériennes résistantes aux antibiotiques, il n'est guère besoin de nouveaux antibiotiques plus coûteux dont la supériorité thérapeutique par rapport aux composés existants n'a pas été démontrée. Étant donné que la résistance apparaît dès que l'on commence à utiliser un nouvel antibiotique, la désaffection de la Norvège pour les nouveaux antibiotiques concorde avec l'objectif d'en prolonger l'efficacité. Conséquence inattendue, le pays a signalé au secteur privé que ces nouveaux antibiotiques ne présentaient qu'un faible intérêt commercial mais qu'ils pourraient cependant être nécessaires pour traiter des maladies infectieuses rares ou nouvelles. Tous les pays souhaitent faire avancer la lutte contre les infections et promouvoir l'utilisation responsable des antibiotiques. Cependant, à mesure qu'ils progresseront, les bactéries résistantes aux antibiotiques devraient devenir moins fréquentes et la nécessité ainsi que l'intérêt commercial de nouveaux antibiotiques devraient par conséquent s'en trouver réduits. L'innovation en matière d'antibiotiques reste toutefois essentielle. Ce dilemme devra être résolu avec l'introduction de systèmes de récompenses alternatifs pour l'innovation dans le domaine des antibiotiques. Le consortium de recherche européen DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) a été chargé de trouver des solutions pour relever ce défi.

En este documento se detallan los procedimientos de autorización de comercialización y compensación para productos medicinales en Noruega, con especial referencia a nueve antibióticos nuevos que recibieron la autorización de comercialización entre 2005 y 2015. La descripción ilustra que, en lugares como Noruega, que cuentan con políticas eficaces de administración de antibióticos y una prevalencia baja relacionada de infecciones bacterianas resistentes a los antibióticos, hay poca necesidad de antibióticos nuevos más caros cuya superioridad terapéutica respecto a los componentes existentes no ha sido demostrada. Dado que la resistencia comienza a surgir tan pronto como se utiliza un antibiótico, la práctica de Noruega de dejar nuevos antibióticos de lado es coherente con el objetivo de prolongar la eficacia de los nuevos antibióticos. Una consecuencia inesperada es que el país ha explicado al sector privado que los antibióticos nuevos apenas tienen valor comercial, los cuales, sin embargo, pueden ser necesarios para tratar infecciones raras o nuevas. Todos los países tratan de mejorar su control de infecciones y fomentar un uso responsable de los antibióticos. No obstante, conforme se va progresando, las bacterias resistentes a los antibióticos deberían ser cada vez menos comunes y, por tanto, es probable que la necesidad y el valor comercial de los antibióticos nuevos se vean reducidos. Sin embargo, la innovación en el campo de los antibióticos sigue siendo fundamental. Este dilema deberá resolverse mediante la introducción de sistemas de recompensa alternativos por innovar con antibióticos. El consorcio de investigación europeo DRIVE-AB, que fomenta la reinversión en investigación y desarrollo y en el uso responsable de los antibióticos, deberá identificar formas de lograr este objetivo.