Securing the Supply Chain

According to market research, the API market is expected to experience a compound annual growth rate of 6.7% in the forecast period of 2020-2027 (1). "The low-cost benefits of manufacturing APIs and drug products within Asia has helped to turbocharge the generic drug industry and expand global access to a range of lower-cost medication options," says Meudt. "The shift has been positive for patients, allowing consumers to benefit from lower cost drugs from US Food and Drug Administration (FDA) and European Union (EU) inspected current good manufacturing practice (cGMP) facilities while still maintaining quality, innovation, and allowing efficient drug development and commercialization routes," he says. "While manufacturing cost will always be important, pharmaceutical companies are increasingly selecting their long-term CMOs based upon other factors including security of quality and supply, regulatory track record, data control, and environmental sustainability.

Contract Testing Services Solidify Their Place in the Manufacturing Value Chain

Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies. Since the beginning of the COVID-19 pandemic, providers offering contract testing services have seen various changes and improvements to everyday processes. According to Lara Silverman, PhD, founder and principal consultant at LIS BioConsulting, it became increasingly crucial for contract testing labs to provide seamless services to clients and communicate any issues in a quick, efficient fashion. [...]corresponding services that are contracted with recognized service organizations are needed to solve technically demanding tasks.

Changing Vaccine Assessment Criteria and Focus Towards Prevention Strategies

Objectives: To understand changes to granting access to novel vaccines by NITAG and payers and how prevention has become a focus in many markets Methods: Secondary research by studying various NITAG documents and published articles followed by primary research with experts in EU4 and UK Results: For NITAG recommendations, disease burden, vaccine efficacy, vaccine safety, followed by Epidemiology and mathematical modelling are conducted by most Western countries. Published studies on efficacy, effectiveness and reactogenicity are considered as key reference. UK specifically takes into account health economic modelling outputs. Recommendations in other markets are also considered in making local decisions. For vaccine funding payers consider the efficacy, durability and dosing regimen as key drivers, followed by aspects of strain coverage, formulation and storage. Platform were not considered by payers, while physicians considered it to be very important. For cost containment reasons, many NITAGs issue a recommendation for a narrow patient population Payers in all markets indicated that there is focus or prioritization of prevention strategies from ongoing COVID-19 pandemic and are likely to remain. UK for instance has increased its prevention budgets;however, this does not mean there is higher willingness to pay. In Germany there is no ring-fenced prevention specific budget. Conclusion(s): Severity of the disease is an important criterion in assessing the burden, an influential factor in vaccine decision making. In all countries in focus, Payers anticipate that the evaluation of new vaccines launched post-COVID-19 to be faster. Structural changes in Italy (restructure of AIFA and new NITAG) and UK (new public health agency), add to uncertainties on timelines. The length of the evaluation process will depends mainly on pre-work done with availability of local data on burden, epidemiology, and cost-effectiveness modelling.Copyright © 2023

The Future of Remote Trials

According to a recent report from Frost & Sullivan, "Hybridization of Clinical Trial Designs Reviving Global CRO Market Post-pandemic;2019-2024" (https:// bit.ly/36Fquky), hybrid trials and remote patient monitoring are key trends driving the global CRO market. Frost & Sullivan further expects that revenue will be back to its original growth trajectory by 2024-2025, with a compound annual growth rate of 8.2% and $63.83 billion revenue by 2024, up from $43.03 billion in 2019. The report also suggested that adoption of hybrid trials by CRCs could increase their growth opportunities by enabling uninterrupted trials and cost savings of 15% to 20%;by focusing on long-term collaborations that offer substantial cost advantages with 8% to 13% savings across different trial phases;by leveraging new technologies, such as risk-based monitoring, eConsent, wearables, and telemedicine patient visits;and implementing direct-to-patient model clinical trial supplies.

CLINICAL TRIAL INSIGHTS

With support from large databases, informatics, technologies, and advanced analytics we're able to target highly stratified patient subpopulations-eventually at the individual patient level- resulting in smaller and faster clinical trials, fewer adverse outcomes, greater likelihood of a treatment response, higher probability of approval, and lower overall development costs. Ultimately this second movement ensures that we are measuring outcomes that are the most clinically meaningful and relevant as defined by the community living with a given disease;and promises to deliver more feasible, faster clinical trials with better enrollment and retention rates, proportional representation according to disease prevalence by race and ethnicity and other individual characteristics, fewer unplanned and unbudgeted protocol amendments, higher approval rates, and accelerated commercialization. Research conducted by the Tufts Center for the Study of Drug Development and by others indicates that drug development failure rates are the highest they have ever been;the average overall duration of a development program and of a clinical trial by phase is not getting faster-they are taking longer and the durations are less predictable;recruitment and retention rates are at their lowest in history-particularly in oncology and rare diseases (two dominant segments of the R&D pipeline);the perennial 4% to 6% increase in overall R&D spending shows no sign of slowing;and we are observing higher levels of inefficiency and performance volatility.

ASIAN BIOTECH CLINICAL TRIAL DEMAND MOVES TO THE WEST

The critical element, of course, is that there can be no compromise on trial design, execution and data collection to deliver a robust drug development package. AUM's strategy is to reverse this flow and go from Asia to the West, satisfying the need of the Asian population for innovative and affordable drug development and reducing the cost of health care in Western countries by introducing drugs at an "Asian" price point. [...]the dislocation in services from widespread lockdowns resulted in significant delays in data collection and management of research samples. Even when we could transfer them to appropriate laboratories for analysis, the staff shortages, backlog of samples, and supply chain disruption of critical reagents and parts caused troubling delays in obtaining and analyzing data.

Economics of a Health System's Direct-to-Consumer Telemedicine for Its Employees

Am J Manag Care. 2023;29(6):In Press _____ Takeaway Points The value of direct-to-consumer (DTC) telemedicine services offered by academic health systems is understudied. * DTC telemedicine services for low-acuity or minor illnesses are increasingly offered as an employee benefit, but any per-episode unit cost advantage may be offset by overuse of care. * DTC telemedicine staffed by an academic health system and offered to its employees resulted in lower per-episode unit costs for care within 7 days and only marginally increased the use of services. * DTC telemedicine staffed by an academic health system and offered directly to employees was cost-saving. _____ Employers in the United States have increasingly been offering a direct-to-consumer (DTC) telemedicine benefit for low-acuity or minor illnesses to their employees.1-3 By 2021, more than 95% of employers with 50 or more employees provided some coverage for DTC telemedicine in their largest health plan;more than 75% felt that offering telemedicine was important and nearly 20% either limited or eliminated cost sharing for telemedicine.4 Despite these trends among general employers, few health systems have directly provided DTC telemedicine to their own employees. [...]because these services are easy to access (often available immediately, around the clock, and without travel), they may induce overuse of care, especially for self-limited conditions such as viral upper respiratory infections for which the alternative to in-person care is no care at all, thus increasing the overall cost of care.5-11 Telemedicine will save money relative to in-person care if any unit price advantages are not overwhelmed by the increased use of care overall, induced by its convenience. Employers provide health insurance coverage for 158 million Americans or nearly 50% of the population. Since the COVID-19 pandemic began, telemedicine has represented a significantly larger portion of all medical claims—consistently more than 5% of all medical claims by mid-202112-15—and the estimated value of the global telemedicine industry is projected to reach a quarter of a trillion dollars by 2024.13 Yet, the future of telemedicine remains undetermined with reimbursement rates in debate,16-18 driven in large part because its economic value is understudied and uncertain. Penn Medicine is self-insured and more than 95% of employees use its only employer-sponsored plan—a preferred provider organization (PPO) plan—rather than insurance obtained individually or through a family member. Since 2017, these PPO-insured employees have been offered Penn Medicine OnDemand,19 a 24/7 DTC telemedicine benefit to employees and their adult (≥ 18 years) dependents.

Beyond Symptoms Alleviation: Population-Level Benefits of COVID-19 Oral Direct-Acting Antiviral (DAA) Treatment and Resulting Decreases in Infectivity and Transmission

Objectives: Efforts to combat COVID-19 have largely focused on vaccination and non-pharmaceutical interventions to decrease hospitalization and death and to reduce transmission. First generation COVID-19 direct-acting antivirals (DAAs) are only authorized for high-risk patients to reduce individual risk of disease progression. However, DAAs can also impact transmission by reducing viral load, thereby shortening the duration of infectivity. Next generation oral DAAs in development may have safety profiles that are amenable to broader eligibility and use. This analysis estimates the economic and clinical impact of increasing the utilization of DAAs to treat COVID-19. Method(s): A susceptible-infected-recovered-susceptible model was developed to estimate COVID-19-related outcomes based on DAA uptake. Cost-savings modeled included reduced healthcare utilization amongst individual patients and, importantly, potential savings attributable to reduced transmission. Cost inputs included treatment acquisition costs, adverse events, healthcare utilization, and productivity losses based on published literature. One million individuals were assessed with clinical and economic outcomes estimated for DAA adoption by risk level. Result(s): The model projects 402,330 new infections per 1 million individuals annually, leading to 6,000 hospitalizations and 107 deaths. By increasing DAA use by 10% in the high-risk population and 20% in the standard-risk population, infections decreased to 312,000, with 1,800 fewer hospitalizations and 34 fewer deaths. Decreases in medical encounters were driven by reduction in transmission (77% of the decrease) and reduction in severity amongst those treated (23% of the decrease). Among deaths averted, 72% were attributable to the reduction in transmission. Overall, costs decrease by 23.5% with increased treatment. Conclusion(s): This study is among the first to model the potential population-level impact of DAAs in reducing infectivity and transmission, a factor currently under-emphasized in the literature. New DAAs under development with potentially improved safety profiles may expand the uptake of treatment and substantially reduce the clinical and economic burden of COVID-19.Copyright © 2023

Maximizing the Value of Remote Monitoring

The success achieved in the creation of the coronavirus vaccines, from speedy development to speedier authorization, leaves little doubt that remote monitoring has value. The trials' uniform design, standardized data language, use of central monitoring, and the heterogeneous patient population have all contributed to that survival rate. Survey respondents said COVID-19 has caused longer enrollment times (49%), amended protocols (45%), and paused protocols (41%).6 * The Oracle survey also showed that while two-thirds of respondents were using remote data collection in their trials-patient apps, ePRO and wearables-nearly half of these professionals said a primary concern with using new sources and methods of data collection was just that;shifting gears would mean adopting a new approach to manage, review, and interpret the data. * Starting last year, said Rajneesh Patil, IQVIA's vice president, Digital Strategy and Innovation, 60% to 70% of its customers looked at incorporating these standardized, transparent, remote monitoring methods into their protocol design. Agreed, said Oracle's Jim Streeter, global vice president, Life Sciences Product Strategy.

Gastroenterology Fellowship Virtual Interviews: Applicant and Faculty Perceptions on Virtual Interview Advantages and Barriers

Introduction: During the COVID-19 pandemic, virtual interviews for resident and fellowship applicants became the standard. However, studies evaluating the experience of virtual interviews format are lacking. Accordingly, we sought to survey both gastroenterology fellowship applicants and interviewing faculty members about their experiences with the virtual interview process. Method(s): Interviewees and faculty at 13 different gastroenterology fellowship programs at academic medical centers across the United States completed a post-interview survey. The online survey was conducted during the 2020 ERAS fellowship interview season via Google Forms. The survey responses were anonymously collected and reported. Result(s): A total of 177 gastroenterology fellowship applicants and 83 faculty members completed the electronic surveys. Most participants reported a positive experience with 91% and 84% of applicants and faculty respectively, scoring at least 4 points on a 5-point scale. Eighty-8 percent and 85% of applicants and faculty respectively, reported that they had enough insight about the applicant or the fellowship program during the interview. Over 67% of applicants reported cost-savings of greater than $1,000 per interview. Thirty-6 percent of applicants reported that they missed the personal interaction with the current gastroenterology fellows in the respective programs and the experience of physically touring the facility. Twenty-7 percent and 25% of applicants and faculty experienced technical difficulties during the interview process, respectively. Thirty-one percent and 22% of applicants and faculty would like for the virtual interviews to be the standard of future fellowship interviews, while 35% and 42% of applicants and faculty would consider it in the future, respectively. Figure 1 shows the ranking process for both applicants and faculty. Conclusion(s): Virtual interviews were perceived as effective and cost-saving by both gastroenterology fellowship applicants and faculty members. The virtual experience was widely accepted by most applicants and faculty, with high potential to become the standard of fellowship interview process in the future. However, a substantial portion experienced technical difficulty. Further improvements in technology are needed to optimize the process and increase the acceptance of the virtual interview experience. (Figure Presented).

The complex evolution of information quality improvement in competitive market

Information is important market resource. High-quality information is beneficial to increase enterprise's reputation and reduce consumer's verification cost. This paper constructs a two-layer dynamic model, in which enterprises simultaneously conduct price and information game. The goal of profit maximization integrates two types of games into one system. The complex evolution of the two-layer system are studied by equilibrium analysis, stability analysis, bifurcation diagram, entropy and Lyapunov exponent. It is found that improving the information quality through regulations will increase involution and reduce stability of the market. Then, the block chain technology is introduced into the model for improving information quality of the market. It is found that increasing enterprises' willingness to adopt block chain can improve the information quality quickly and effectively, and that is verified by entropy value. Therefore, the application and promotion of new technologies are more effective than exogenous regulations for improving information quality in market.

Incentivizing at‐risk production capacity building for COVID‐19 vaccines

Our study analyzes capacity management for promising vaccine candidates before regulatory approval (i.e., at‐risk capacity building) in the presence of production outsourcing and different operational challenges: misaligned interests, possible ex post negotiations, asymmetric information between developers and manufacturers, and government involvement. We develop analytical models to compare two vaccine production modes: (1) the integrated mode (a single company determines the at‐risk capacity and produces in‐house) and (2) the outsourcing mode (a manufacturer determines the at‐risk capacity and a developer determines a funding level to share the capacity‐building cost). Our study reveals that outsourcing can achieve a higher at‐risk capacity only if it can achieve sufficient cost savings compared to the integrated mode. Our research also proves that both vaccine production modes tend to underinvest in the at‐risk capacity. Following this, we suggest measures to improve the at‐risk capacity building in both vaccine production modes. Our signaling game model reveals that a developer with high competence cannot always send credible signals of its true competence level to the manufacturer. Our incomplete contract model verifies that the relative performance of the two vaccine production modes is robust when ex post negotiation occurs under the outsourcing mode;however, the two parties may show incompatible preferences for the ex post negotiation. Our study also analyzes the optimal allocation of government financial support to development funding and capacity funding to incentivize at‐risk capacity building. We present comprehensive guidelines for the different stakeholders to collectively contribute to ramping up the at‐risk capacity of promising vaccines.

Mitigating the Impact of Covid-19 on Hiv Viral Load Access among Key Populations

Background: Monitoring of HIV-infected individuals on antiretroviral treatment requires periodic viral load(VL) measurements to ascertain adequate response to treatment. While plasmaVL is widely available in health facilities, it is difficult for use among key populations(KPs) due to their high mobility and sophisticated sample storage and transport requirements, which are not available for community VL sample collection. Use of Dried Blood Spot(DBS) VL measurement has shown promise as an alternative to plasma specimens for KPs. Studies to investigate the performance of DBSVL quantification against the standard plasma VL assay has proven to be within acceptable range. DBSVL was introduced for sample collection among KPs when it became difficult to safely and appropriately collect, store and transport samples during COVID-19 lockdown. This study assessed the usefulness of the use of DBSVL deployed by USAID to ensure access to HIV VL services among KPs in 7 states of Nigeria during COVID-19 lockdown Methods: To mitigate the impact of COVID-19 lockdown, virtual trainings were conducted for one-stop-shops and community VL champions of USAID partners providing KPs services in seven states of Nigeria on DBS sample collection, storage and transportation and remote test ordering was activated for service providers. Standard operating procedures and job aids were deployed to points of service and laboratory equipment were verified for DBSVL testing. VL sample collection rate(SCR), VL coverage(VLC), VL suppression(VLS), turnaround time (TAT) and cost savings for the program between March2019 and February2021 were compared using the two-sample independent t test pre-COVID (March2019- February2020) and during-COVID lockdown (March2020 -February2021) at 95 confidence interval and < 0.05 level of significance. Result(s): There was a significant increase (p< 0.05) in SCR from 73% to 94%, VLC 44% to 85%, and VLS 78% to 95% pre-COVID to during-COVID respectively despite increase in number of clients eligible for VL. However, the median TAT remained unchanged at 29 days. There was a 60% cost savings for the program due to reduction in consumables needed for sample collection and processing and convenience in sampling among KP clients. Conclusion(s): Implementation of DBSVL resulted in increases in both VLC and VLS with an improved TAT for KPs clients in seven states of Nigeria. KPs Program implementers should consider introduction of DBSVL sampling among KPs for a better VL access and clinical outcome.

Freight Distribution in Small Islands: Integration between Naval Services and Parcel Lockers

Freight transportation in urban areas represents an essential activity from the standpoint of economic development;in recent years, the spread of e-commerce (also accelerated by COVID-19) has contributed to increasing the demand for freight distribution over short distances. In most cities, the approaches and measures are often based on new technologies. Nevertheless, today there are contexts wherein delivery operations represent critical tasks to be solved. Furthermore, low accessibility areas, such as small islands, present further problems due to their exclusive dependence on maritime links (and often low-reliability services). This paper tackles this topic, formulating and solving a distribution problem by linking shipping services with last-mile distribution operated by means of an automatic delivery service (parcel lockers). A test application is proposed by considering the small island of Lipari in the archipelago of the Aeolian islands (Sicily, Southern Italy). The results show that such a type of service could reduce the user's waiting time when compared to traditional home deliveries.

Consumer Preferences for Smart Energy Services Based on AMI Data in the Power Sector

Advanced metering infrastructure (AMI) is becoming increasingly popular as an efficient means of energy demand management. By collecting energy data through AMI, it is possible to provide users with information that can induce them to change their behavior. To ensure that AMI continues to expand and to encourage the use of energy data, it is important to increase consumer participation and analyze their preferred service attributes. This study utilized a choice experiment to analyze consumer preferences for and acceptance of smart energy services based on AMI data. The results of a mixed logit model estimation show that consumers prefer the electricity information service for individual households and the social safety-net service among convergence services. A scenario analysis confirms that monetary compensation to offset any additional charges is important to maintain the level of consumer acceptance. These empirical findings offer insights for policymakers and companies seeking to develop policies and similar services.

Learning to Contract under Uncertainty in Strategic Alliances: The Co-evolution of a Firm's Absorptive Capacity: JMI

Firms have often used strategic alliances as a strategy to cope with increased uncertainty. This paper argues that a firm needs to learn to leverage its absorptive capacity to exploit and explore the contracting knowledge in strategic alliances so as to enhance efficiency, scope, and flexibility. It conceptually examines how a firm's contractual absorptive capacity co-evolves with its knowledge environment under uncertainty as part of learning. By integrating transaction cost economics and absorptive capacity literatures, this paper offers a rich picture of the co-evolutionary processes underlying contractual absorptive capacity in strategic alliances under uncertainty. It also incorporates a more refined (and underexplored) conceptualization of asset specificity and uncertainty, two key constructs in transaction cost economics, into the coevolutionary framework of absorptive capacity in strategic alliances. It illustrates some of the concepts with examples from the hospitality industry, where the impact of uncertainty is clearly evident - particularly in view of the COVID-19 pandemic.

SIMO Research: Where Excellence Enables the Proliferation of Engineering Expertise

The case "SIMO Research" documents the journey of an engineer-entrepreneur who created an enterprise providing safety, quality and consultancy solutions to some of the most prominent cryogenic industry and the oil and gas sector. The case also mentions roadblocks faced, business strategies and tactical interventions made, thus providing with insight as to how a budding entrepreneur may succeed in any kind of market. The researchers attempt a recommendation, to continue business excellence, guided by Porter's Five Forces Model.

Protecting the Most Vulnerable: Policy Response and Eviction Filing Patterns During the COVID-19 Pandemic

The COVID-19 pandemic and resulting economic crisis exposed the U.S. rental housing market to extraordinary stress. Policymakers at the federal, state, and local levels established eviction moratoria and a number of additional direct and indirect renter-supportive measures in a bid to prevent a surge in evictions and associated public health risks. This article assesses the net efficacy of these interventions, analyzing changes in eviction filing patterns in 2020–2021 in thirty-one cities across the country. We find that eviction filings were dramatically reduced over this period. The largest reductions were in places that previously experienced highest eviction filing rates, particularly majority-Black and low-income neighborhoods. Although these changes did not ameliorate racial, gender, and income inequalities in relative risk of eviction, they did significantly reduce rates across the board, resulting in especially large absolute gains in previously high-risk communities.