Market Launch Research Articles

Are Manufacturing Patents to Blame for Biosimilar Market Launch Delays?

ObjectivesBiosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics’ large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. MethodsWe reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases. ResultsWe find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays. ConclusionsOur results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility.

Evidence-based medicine: new in the search for evidence

The review is focused on discussing new trends in DM, rethinking the evidence base medicine with an emphasis on demonstrating the efficacy and safety of new therapeutic agents and medical technologies, from gene editing to AI algorithms. At the same time, clinical trials of drugs are also not standing still, there is active development, new approaches, methods and designs are being developed. The process of drug development, registration and market launch of any drug takes a significant period of time, requires high financial costs and human resources. The gold standard of evidence-based medicine was initially considered to be RCTs, but at the same time, they have objective disadvantages: limited sample, inability to control all factors; insufficient follow-up time,negative impact on participants, inability to determine cause-and-effect relationships; limited measurement methods, limited budget and others. This review discusses the trends in the methodology of clinical research. The active implementation of new designs such as Adaptive Clinical Trials, "Master" protocols including Umbrella Study, Basket Study, Platform Studies, Master Observational Trials and the increased use of Single Patient Trials (N-of-1 trials) are allowing studies to become more efficient, relevant and applicable to real-life health care practice settings and patient-centered. In the review, we also look at both the pros and cons of the expanded use of biomarkers and Digital Endpoints in clinical trials and virtual clinical trials, which use mathematical models to study patient heterogeneity and its impact on various therapeutic questions. The process of expertise and regulatory approval continues to slow down the entry of drugs into the pharmaceutical market. The review considers changes in the approaches of regulators (FDA, EMEA and Russian Ministry of Health) to the drug registration procedure. The COVID-19 pandemic and sanctions have led to the need to expand the list of drugs with authorized accelerated registration. However, accelerated registration raises many questions regarding the sufficiency of the level of evidence and safety. As we can see a deep synthesis and integration of all available data is needed to achieve the next generation of evidence-based medicine. The major challenge in the next two decades will be to exploit the potential of multidimensional evidence generation by extracting, collating and generating large data sets of natural course of disease, genomics and all other omics analyses, all published clinical trials, RWD to provide next generation evidence.

Comparison of reminder-preference test to difference and preference tests: An affective approach yielding d-prime results for sensory difference and preference

Preserving the sensory characteristics of reformulated products is crucial for a successful market launch. This underscores the need for precise measurement of consumer perceptions regarding sensory differences and preferences. One approach to assess these aspects is through the utilization of the reminder-preference test, an affective difference-preference test employing the A-Not A with the reminder (A-Not AR) test design. This test measures sensory differences and preferences by employing a consolidated d′ index rooted in signal detection theory and Thurstonian modeling. The aim of this study was to assess the efficacy of the reminder-preference test in measuring the degree of sensory differences and interpreting their relevance concerning consumer preference. To achieve this, the test was compared with both the A-Not AR difference test and the 2-alternative choice (2-AC) preference test. A lemon-lime-flavored carbonated drink and two types of reformulated samples were tested. Young female adult subjects were randomly divided into three groups. Each took one of the following three tests: the reminder-preference test, the reminder test of A-Not AR, or the 2-AC preference test. The reference framing in the reminder-preference and reminder tests was preceded by subjects watching the product’s advertisement to assist them in framing evaluative criteria. This would also facilitate memorizing the perception of the reference product. Test sensitivity in reminder-preference matched reminder and 2-AC tests for sensory differences and preferences. Affective framing enhanced sensitivity to sensory differences resulting in a higher d′ value of the sensory difference than the preference. From the results, it was possible to interpret that the measured sensory differences did not affect consumer preference. The test also illuminated brand marketing effects on preferences through branded reference comparison. Thus, the reminder-preference test shows potential as an efficient sensory method to measure sensory differences and the preference of consumers, while concurrently measuring the effects of marketing on the consumers. Therefore, it can assist in making efficient business decisions regarding product reformulations.

Can synergies in agriculture through an integration of solar energy reduce the cost of agrivoltaics? An economic analysis in apple farming

Agrivoltaics is a relatively new concept of agriculture and photovoltaic power generation on the same area. While an increased land use efficiency and potential synergies between agriculture and power generation speak in favor of agrivoltaics, higher investment cost compared to ground-mounted photovoltaics represents a challenge for a broader market launch in most countries.This work analyses the economic performance of agrivoltaics in apple farming focusing on potential synergies and adverse effects regarding investment requirements and operational cost of the farming system. The analysis is based on literature, expert interviews, and data of three pilot projects in Germany. The results show that average investment cost from the farming system could be reduced by 26% mainly due to partially replacing the hail protection structure. Annual operating costs of the farming system reduce by up to 9% through lower cost for land and maintenance works. However, annual revenues also decrease by about 9% due to an expected reduction in high quality apple yield. Overall, the cost of apple production decreases by about 5%. Regarding the total cost of agrivoltaics, though, the potential contribution from cost savings in the farming sector to reduce the cost of electricity only amounts to <1%. The expected Land Equivalent Ratio of the analyzed agrivoltaic system amounts to 1.54.The results indicate that agrivoltaics in orcharding is only economically feasible if the regulatory framework provides sufficiently high feed-in tariffs or comparable support payments. The work also shows that the theoretical potential of agrivoltaics in apple farming in Germany amounts to 23.8 GWp which could contribute to 13% of the PV development required to meet Germany's climate goals by 2030 [1].

Dynamic Spillovers between Carbon Price and Power Sector Returns in China: A Network-Based Analysis before and after Launching National Carbon Emissions Trading Market

The launch of the national carbon emissions trading (CET) market has resulted in a closer relationship between China’s CET market and its electricity market, making it easy for risks to transfer between markets. This paper utilizes data from China’s CET market and electric power companies between 2017 and 2023 to construct the spillover index model of Diebold and Yilmaz, the frequency-domain spillover approach developed by Barun’ik and Křehl’ik, and a minimum spanning tree model. The comparison is made before and after the launch of the national CET market. Subsequently, this paper examines the market spillover effects, as well as the static and dynamic properties of network structures, considering both the time domain and frequency-domain perspectives. The research findings suggest the following: (1) There is a strong risk spillover effect between China’s CET market and the stock prices of electric power companies; (2) There is asymmetry in the paired spillover effects between carbon trading pilot markets and the national CET market, and differences exist in the impact of risk spillovers from power companies between the two; (3) The results of the MST model indicate that the risk contagion efficiency is higher in the regional CET pilot stage compared to the national CET market launch stage, with significant changes occurring in key nodes before and after the launch of the national CET market; (4) Both the dynamic spillover index and the standardized tree length results demonstrate that crisis events can worsen the risk contagion between markets. Besides offering a theoretical foundation and empirical evidence for the development of China’s CET and electricity markets, the findings of this paper can provide recommendations for financial market participants as well.

Feasible options for point-to-point passenger transport with rocket propelled reusable launch vehicles

For the first time in spaceflight history the flight of a fully reusable launch system with rocket propulsion appears possible within the next couple of years. Apart from the implications for the orbital launch market, a fully reusable system could also enable an entirely new class of commercial point-to-point transport on Earth. Rocket propelled point-to-point systems promise the ability to transport passengers or cargo to any suitable landing site on Earth with extremely short travel times (typically less than 90 min). In this study the primary focus is on DLR-SART's SpaceLiner 7 vehicle concept with an initial comparison to Starship, currently being developed by SpaceX.The trajectories are identified using multi-objective optimization with evolutionary algorithms. These allow the identification of a solution space with regard to multiple objectives, in this case minimal overflight of populated areas and minimal peak heat flux, while still respecting other constraints (e.g. structural loads). The population disturbance is computed by using a global population density database and integrating the number of people along the flight track. Ideally, the solution space consists of a pareto-front which correlates to the most optimal solutions possible for all objectives.The mission analysis identifies various feasible trajectories around the world. Primarily, these routes are going along less populated areas such as the oceans and the polar regions. Especially the latter enable large longitudinal changes during the flight and consequently connecting distant places on Earth. The critical routes are large longitudinal crossings around the equator where land masses must be overflown. These shall be reconsidered and/or improved in the future.Comparing SpaceLiner to Starship, it is found that the mission profiles vary significantly. While SpaceLiner uses its high lift-to-drag ratio in the higher atmosphere to manoeuvre around large land masses, Starship can only follow the direct route. In contrast, Starship flies higher into space and thereby might avoid having large population disturbances on ground. Only the re-entry and landing are critical as it does not have significant cross range capability. As a design option for the next iteration of the SpaceLiner development, SpaceLiner 8, it is planned to assess the possibility of using a smaller wing to follow a similar coast through space like Starship and have a steep re-entry at the end of the flight instead of a prolonged glide.

Vegetables with Enhanced Iron Bioavailability-German Consumers' Perceptions of a New Approach to Improve Dietary Iron Supply.

Iron deficiency is still widespread as a major health problem even in countries with adequate food supply. It mainly affects women but also vegans, vegetarians, and athletes and can lead to various clinical pictures. Biofortification of vitamin C-rich vegetables with iron may be one new approach to face this nutritional challenge. However, so far, little is known about the consumer acceptance of iron-biofortified vegetables, particularly in developed countries. To address this issue, a quantitative survey of 1000 consumers in Germany was conducted. The results showed that depending on the type of vegetable, between 54% and 79% of the respondents were interested in iron-biofortified vegetables. Regression analysis showed a relationship between product acceptance, gender, and area of residence. In addition, relationships were found between consumer preferences for enjoyment, sustainability, and naturalness. Compared to functional food and dietary supplements, 77% of respondents would prefer fresh iron-rich vegetables to improve their iron intake. For a market launch, those iron-rich vegetables appear especially promising, which can additionally be advertised with claims for being rich in vitamin C and cultivated in an environmentally friendly way. Consumers were willing to pay EUR 0.10 to EUR 0.20 more for the iron-biofortified vegetables.

Study on the initial carbon quota allocation and spatial balance compensation strategy at the provincial level in China

With the official national unified carbon market launch on July 16, 2021, the allocation and trading of initial carbon quotas between regions will become the focus of research in the future. Based on a reasonable regional initial carbon quota allocation, introducing the concept of carbon ecological compensation and formulating differentiated emission reduction strategies according to the characteristics of different provinces can better guarantee the realization of China's carbon emission reduction goals. Based on this, this paper first analyzes the distribution effects under different distribution principles from the perspective of fairness and efficiency. Secondly, the Pareto optimal multi-objective particle swarm optimization (Pareto-MOPSO) algorithm is used to build the initial carbon quota allocation optimization configuration model to optimize the allocation results. The optimal initial carbon quota allocation scheme is determined through the comparative analysis of the allocation results. Finally, we explore the combination of carbon quota allocation and the concept of carbon ecological compensation and formulate the corresponding carbon compensation scheme. This study not only reduces the relative sense of exploitation of carbon quota allocation in different provinces but also contributes to the realization of a carbon peak in 2030 and carbon neutrality in 2060 (the "30.60" double carbon target).

How product complexity affects consumer adoption of new products: The role of feature heterogeneity and interrelatedness

Recent technological advancements allow companies to incorporate increasingly heterogeneous and interrelated features into their products, which heightens the products’ complexity. In four experimental studies conducted with two product categories, this article reveals similarities and differences in terms of how the heterogeneity and interrelatedness of product features influence consumer attitudes (i.e., expected product usability and capability) and, in turn, purchase intentions. Moreover, it shows that both neglected dimensions of product complexity affect the corresponding influence of the number of product features but do so in considerably different ways. The findings suggest that companies can foster consumer adoption by deemphasizing a product’s feature heterogeneity, thereby avoiding low expected product usability, and by emphasizing its feature interrelatedness, thereby promoting high expected product capability. This article provides insights into how companies can manage the complexity of products during both product design (i.e., before market launch) and product advertising and selling (i.e., after market launch).

PREREQUISITES FOR CREATING ULTRA-LIGHT LAUNCH VEHICLES WITH POLYMER BODIES

The relevance of the problem of creating new light and ultra-light launch vehicles from the point of view of the development of the modern space industry is shown. First of all, this problem is related to the expansion of the market and the scope of use of small satellites, most of which are now launched into orbit as passing load by medium and heavy launch vehicles, which is not at all prompt and too expensive. The estimated forecast of the small satellite launch market, which is presented herein, indicates a growing demand for their launch services. A low-cost launch vehicle for the launch of small satellites would greatly expand their use, development, and production. This indicates the need for creation of special-purpose cheap transport vehicles for the operative decision of tasks of launching such satellites into orbit. It is shown that the main directions for increasing the efficiency and reducing the cost of launches are reducing the cost of making a transport space system, increasing of mass the payload, increasing the multiplicity of reusable uses, and reducing one-time costs per start. World trends in solving this problem are connected with the solution problem of creating ultra-light launch vehicles. The historical review of studies on prototype rockets that use the principle of reducing the mass of a launch vehicle during flight by burning spent structural elements indicates the possibility of creating launch vehicles on this principle by using complex hydrocarbon polymers as structural materials. It is shown that polymer materials, in particular polyethylene, can become the main material for the manufacture of fuel tanks for solid rockets, which use the new principle of burning the design during flight. The use of fuel tanks as fuel will give a possibility to reduce the cost of the propulsion system, which is one of the most expensive parts of the launch vehicle. The development of such launch vehicles and the commercialization of scientific research will allow domestic aerospace companies to occupy a niche in the market of small satellite launches.

A Quasi-Dimensional Burn Rate Model for Pre-Chamber-Initiated Jet Ignition Combustion

&lt;div class="section abstract"&gt;&lt;div class="htmlview paragraph"&gt;Prospective combustion engine applications require the highest possible energy conversion efficiencies for environmental and economic sustainability. For conventional Spark-Ignition (SI) engines, the quasi-hemispherical flame propagation combustion method can only be significantly optimized in combination with high excess air dilution or increased combustion speed. However, with increasing excess air dilution, this is difficult due to decreasing flame speeds and flammability limits. Pre-Chamber (PC) initiated jet ignition combustion systems significantly shift the flammability and flame stability limits towards higher dilution areas due to high levels of introduced turbulence and a significantly increased flame area in early combustion stages, leading to considerably increased combustion speeds and high efficiencies. By now, vehicle implementations of PC-initiated combustion systems remain niche applications, especially in combination with lean mixtures. This is also due to challenges regarding cold-start, combustion stability at low loads, and emissions. Nevertheless, PC ignition systems allow overall engine efficiencies &amp;gt;45%. Therefore, a market launch of an engine using globally lean mixtures ignited by a PC system is desirable. This requires a fast-running and predictive physical model to conduct robust design studies and complement existing testing methodologies (3D-CFD, experimental). This paper addresses the development of a quasi-dimensional burn rate model for PC ignition combustion systems. The presented modeling approach combines the well-established two-zone entrainment model (main-chamber) with a semi-empirical PC model that aims to detect the PC influence on the main-chamber combustion. Dedicated models predict the impact of the jet-induced turbulence and the increased flame area. The models are integrated into the so-called cylinder module developed at IFS (Institute of Automotive Engineering Stuttgart). For the model validation, measurement data of a single-cylinder research engine using different fuels (E100&lt;sup&gt;1&lt;/sup&gt;, RON95E10&lt;sup&gt;2&lt;/sup&gt;), loads (&lt;i&gt;IMEP&lt;/i&gt; = 6 − 15 &lt;i&gt;bar&lt;/i&gt;), excess air dilutions (&lt;i&gt;λ&lt;/i&gt; = 1 − 2) and compression ratios (16.4&lt;sup&gt;1&lt;/sup&gt;, 12.6&lt;sup&gt;2&lt;/sup&gt;) are used, showing a satisfactory prediction of the burn rate and pressure curve.&lt;/div&gt;&lt;/div&gt;

PD14-07 TRENDS IN MEDICARE PART D SPENDING ON MIRABEGRON AND IMPLICATIONS OF THE INFLATION

You have accessJournal of UrologyCME1 Apr 2023PD14-07 TRENDS IN MEDICARE PART D SPENDING ON MIRABEGRON AND IMPLICATIONS OF THE INFLATION REDUCTION ACT OF 2022 Brittany Berk, Elodi Dielubanza, and Thomas Hwang Brittany BerkBrittany Berk More articles by this author , Elodi DielubanzaElodi Dielubanza More articles by this author , and Thomas HwangThomas Hwang More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003261.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Mirabegron, a beta-3 adrenergic agonist indicated for the treatment of overactive bladder, is one of the costliest drugs for Medicare. In 2022, the US Congress enacted the Inflation Reduction Act, which for the first time allows Medicare to negotiate the price of certain costly drugs for Part D beneficiaries. This study analyzed trends in Part D spending on mirabegron and assessed the potential impact of the Inflation Reduction Act. METHODS: We obtained wholesale acquisition costs for mirabegron from Truven Health Micromedex as of October 2022; total Medicare Part D and per-beneficiary spending and utilization for 2016-2020 from Medicare’s 2020 Drug Spending database; estimated total rebates from SSR Health; and inflation data from Bureau of Labor Statistics. We calculated the nominal and inflation-adjusted change in prices for mirabegron since its launch in 2012, as well as the change in total Medicare Part D expenditures on the drug from 2016-2020. Finally, we compared estimated rebates in 2020 with minimum statutory discounts for negotiation-selected products under the Inflation Reduction Act. RESULTS: In 2020, Medicare Part D spending on mirabegron was $1.7 billion, ranking it among the top 10 likely negotiation-eligible drugs for Medicare under the Inflation Reduction Act in 2026. Part D spending on mirabegron increased by 3.37-times from 2016 ($518.6 million) to 2020. After accounting for estimated rebates, Part D net spending on mirabegron increased by an estimated 123.5% from 2016-2020. Since market launch in 2012, the wholesale acquisition cost for mirabegron has increased by 106.1% unadjusted and 68.9% on inflation-adjusted basis. Under the Inflation Reduction Act, the minimum statutory discount for mirabegron would be 25% if selected for negotiation in 2026, compared to an estimated total rebate level in 2020 of 65%. CONCLUSIONS: Medicare gross and net spending on mirabegron has grown significantly over the past decade, partly due to rapid price increases. Mirabegron may be one of the first medications (overall and for urology) selected for pricing negotiations under the Inflation Reduction Act. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e415 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Brittany Berk More articles by this author Elodi Dielubanza More articles by this author Thomas Hwang More articles by this author Expand All Advertisement PDF downloadLoading ...

Predicting Success for Web Product through Key Performance Indicators based on Balanced Scorecard with the Use of Machine Learning

Machine Learning (ML) can be proved as an important tool in planning better business strategies. For the purposes of the present study, the prospect for the development of an electronic platform by a technology firm providing financial services is explored. The purpose of this article is to demonstrate the ways in which a start-up can predict the success of an online platform prior to its market launch. The prediction is achieved by applying Artificial Intelligence (AI) on Key Performance Indicators (KPIs) derived from the customers’ perspective, as shown in the Balanced Scorecard (BSC). The research methodology was quantitative and online questionnaires were used to collect empirical quantitative data related to bank loans. Subsequently, KPIs were created based on the collected data, to measure and assess the success of the platform. The effectiveness of the model was calculated up to 91.89%, and thus, it is estimated that the online platform will be of great success with 91.89% validity. In conclusion, prediction was found to be crucial for businesses to prevent a dire economic situation. Finally, the necessity for businesses to keep up with technological advances is highlighted.

Information technology market research and launch of a new product — the innovative digital platform "Smart School Pro"

The article presents an assessment of the state of the information technology market, identifies business opportunities for one of the market participants — Educational Technologies LLC, and also proposes a project to bring a new product (the innovative digital platform "Smart School PRO") to the market.

Lachancea thermotolerans, an Innovative Alternative for Sour Beer Production

The interest in and growth of craft beer has led to an intense search for new beers and styles. The revival of traditional styles has sometimes been hampered by the use of microorganisms such as lactic acid bacteria. Therefore, studies on alternative yeasts for the production of this style of beer have increased. In this work and together with previous studies carried out with yeasts isolated from Madrid agriculture (from grapes, must, wine, vineyards and wineries), the capacity of 10 yeast strains, belonging to the genus Lachancea thermotolerans, for the production of sour beer has been determined. For this purpose, different fermentation scale-ups (100 mL, 1 L and 100 L) have been performed and their fermentation capacity, aroma compound production (33 volatile compounds by GC), organoleptic profile (trained tasting panel and consumers), melatonin production (HPLC) and antioxidant capacity have been studied. Beer fermented with yeast strain CLI 1232 showed a balanced acidity with a fruity aromatic profile and honey notes. On the other hand, the beer fermented with strain 1-8B also showed a balanced acidity, but less fruity and citric flavour than CLI 1232 strain. Finally, the yeast strain selected by the consumers (CLI 1232) was used for beer production at industrial scale and the market launch of a sour beer.

Commercial impact of adding real-world evidence to clinical trials at regulatory approval: a Markovian-like transition model

Objective Regulatory use of real-world evidence (RWE) has been recognized as a useful supplement to clinical trial evidence and could benefit patients by reducing time to treatment. However, commercial benefits have not been documented. The aim was to determine commercial impact of regulatory RWE, using ambrisentan as an illustrative example. Methods A Markovian-like transition model was constructed to simulate the drug development workflow across a simulation time of t = 20 years. RWE was assumed to be incorporated at pII–pIII and pII–pIII–pIV, and its multiplicative median transition rate was determined by biopharma expert opinion. Each model was subjected to “with” and “without” RWE rates. Commercial impact was estimated using potential decrease in time to launch. Time to first medicine adoption and potential lives saved were also estimated. Results Based on cumulative first prescriptions for ambrisentan among pulmonary arterial hypertension patients (N = 487), in comparison to standard drug development, RWE incorporation has the potential to expedite first medicine adoption by 10.4 weeks. The duration of market launch was estimated at 2.5–3.0 years earlier than standard, and approximately 9% of patients would benefit in survival. Potential earnings for an earlier launch would be GBP £43,597.86 per patient, with launch being brought forward from 2009 to 2007. Conclusions Regulatory RWE has the potential to increase overall survival rates and potential earnings by reducing time to launch. This study provides further support for industry efforts to generate RWE in time for regulatory approval.

Incorporating Dynamic Pricing in Cost-Effectiveness Analysis: Are Known Unknowns Valuable?

Current practice in health technology assessment (HTA) of pharmaceuticals conducts cost-effectiveness analyses (CEAs) based on a static price or the estimated price at market launch. Recent publications suggest incorporating dynamic pricing. To test the feasibility and importance of including dynamic pricing, we compared the standard static approach to four dynamic scenarios by replicating US-based HTA evaluations with dynamic pricing inputs. The four case examples included omalizumab (Xolair®) for the treatment of allergic asthma, elagolix (Orilissa®) for the treatment of endometriosis, ocrelizumab (Ocrevus®) for the treatment of primary progressive multiple sclerosis (PPMS), and dupilumab (Dupixent®) for the treatment of atopic dermatitis (AD). The primary outcome was the relative percentage change in incremental cost-effectiveness ratios (ICERs) per quality-adjusted life-year (QALY) for two dynamic pricing scenarios versus static pricing. Secondary outcomes included the absolute difference in ICERs versus base-case and an assessment of decision uncertainty. Base-case ICERs were $327,000, $102,000, $700,000, and $102,000 for allergic asthma, endometriosis, PPMS, and AD, respectively. Across scenarios and case examples, the range of ICERs versus base-case varied from decreases of 56% to increases of 232%. The absolute difference in ICERs versus base-case ranged from decreases of $120,000 to increases of $758,000. Conclusions on cost effectiveness were altered in 2/16 scenarios across the four case examples. Given the decision context that US payers face, with prices varying over time, findings suggest further research to reduce uncertainty around price trajectories, as well as conducting or updating multiple assessments over the lifecycle of pharmaceutical products.

Can innovation help existing firms resist shock from new stock issuance? Evidence from the launch of China’s STAR market

ABSTRACT The launch of China’s STAR market (officially known as the Science and Technology Innovation Board of Shanghai Stock Exchange) caused a significant drop in stock prices in existing stock markets in the Shanghai and Shenzhen stock exchanges. This study examines whether innovative firms showed more resilience to the shock caused by the launch of the STAR market. Using a sample of Chinese A-share listed firms, we find that firms with higher innovation had significantly higher stock returns during the shock period. This suggests that the STAR market launch induced investors to pay more attention to firm innovation and prompted them to reward innovations to a greater extent. This finding remains intact after an array of robustness tests. Moreover, this effect was more pronounced in non-state-owned enterprises and firms with higher product market competition. Additional analyses suggest that investors prefer firms with higher quality of innovation. Overall, this study finds that innovation plays an important role in capital markets; that is, innovation helps firms resist shock from the issuance of new shares.

Stakeholder contributions to commercialization and market creation of a radical innovation: bridging the micro- and macro levels

PurposeSuccessful commercialization is crucial to innovative firms, but further investigation is needed on how diverse stakeholders can contribute to the commercialization of a radical innovation that requires particular market creation support. This paper aims to, therefore, analyze the key stakeholders and their contributive activities in commercialization and market creation, particularly in the case of radical innovations.Design/methodology/approachThis study relies on qualitative research design including interviews with key stakeholders, such as regulators, scientists, experts, licensing partners, core company representatives and extensive secondary data. This single-case study concerns a functional food product, which is a radical innovation requiring the development of a novel product category positioned between the food and medicine categories in global market settings. Since its market launch in 1995, the involvement of multiple stakeholders was needed for its successful commercialization in over 30 countries.FindingsResults uncover the contributions of diverse stakeholders to commercialization and market creation, particularly of radical innovation. Stakeholders performed market creation activities such as regulating the marketing and labeling of food products, conducting safety assessments, revealing and validating the positive health effects of the novelty and raising awareness of healthy living and cardiovascular health. The commercialization activities included distributing the products overseas, applying the ingredient to different food products and making the products available for users.Research limitations/implicationsThis single-case study provides an overview of the positive stakeholder activities with contributions to market creation and commercialization of functional food innovations. Although the user perspective was not included in the empirical part of this study because of our focus on B2B actors, users of the innovation can contribute to R&D activities to a great extent.Originality/valueThe developed framework of stakeholders’ contributive activities in radical innovation commercialization and market creation contributes to literature discussing market creation as well as commercialization within the marketing and innovation management research fields. This work also generates practical advice for managers who commercialize (radical) innovations.

A survey on the acceptance of unattended trains

Due to increasing prices, growing environmental awareness, and resource scarcity, railway operations become increasingly more important. In today's conventional railway operations drivers are needed for driving trains. Drivers have a very responsible job to drive the trains safely. However, they work differently depending on the time of day. Due to illness and strikes, train journeys had to be cancelled in the past. Therefore, a driver takes a special role in today's railway operations. The operation in metros is different. Due to different system properties, unattended metro systems correspond the state of the art. In the future, technical developments will enable unattended operations on railway to substitute drivers, too. Although promising, several challenges need to be accomplished for a successful market launch of unattended trains. Next to several technical challenges, this could especially concern the acceptance among potential users. If a technology or a system is not accepted, it will most likely not be adopted. Most empirical literature regarding the acceptance of driverless or unattended vehicles is related to road and air, but not to railway transport. In this paper, we, therefore, present the results of an online survey that investigated the acceptance of unattended trains. The results of the survey indicate that people generally accept unattended trains. Numerous participants would use such trains. Furthermore, some sociodemographic factors, age, current usage of rail transport, and prior experience with unattended trains, affect the acceptance. However, the results show that people worry about cyberattacks. Overall, the implementation of unattended railway trains seems to be promising. This is an important finding for railway companies to drive the trend towards unattended trains.