Applications of a geographic information system–based business intelligence system for decision making at Coffee Refresh

This case is designed to illustrate how to utilize a business intelligence framework and a geographic information system to make better decisions on franchise opening requests. The case started when Jong, the senior certified analytics professional, and his team were drafting a proposal presentation on a new franchise approval process to present to Tony, the director of Coffee Refresh. Currently, Coffee Refresh was experiencing a significant delay in approving franchise opening requests. In addition, the current approval process was relied on the appraisal teams’ evaluations, which involved self-judgment as to the accessibility and visibility of the store location in each franchise opening request and a manual count of the potential targeted customers at each location, which impacted how the appraisal teams estimated the expected revenue for each location. During the first meeting with Jong and his team, Tony was frustrated by the current evaluation process, resulting in a significant backlog of requests pending approval, which was far behind the target for its franchise branch expansion strategy. It had also been reported that the branches that opened during the past few years had a relatively low success ratio (losses between 4.8% and 16.5%) and that the rate of branch closures had increased from 2% to 7.5%. Currently, eight franchise opening requests were pending, and Jong had to provide a recommendation for which requests should be approved. Coffee Refresh could approve all of them instantly, approve some of them, or even decline all of them. This was a great opportunity for Jong and his team to revisit the current franchise approval process and to demonstrate how business intelligence systems could improve the request approval process as well as address the issues of the current franchises’ underperformance and the closure rates.

From Bench to the Clinic: The Path to Translation of Nanotechnology-Enabled mRNA SARS-CoV-2 Vaccines

During the last decades, the use of nanotechnology in medicine has effectively been translated to the design of drug delivery systems, nanostructured tissues, diagnostic platforms, and novel nanomaterials against several human diseases and infectious pathogens. Nanotechnology-enabled vaccines have been positioned as solutions to mitigate the pandemic outbreak caused by the novel pathogen severe acute respiratory syndrome coronavirus 2. To fast-track the development of vaccines, unprecedented industrial and academic collaborations emerged around the world, resulting in the clinical translation of effective vaccines in less than one year. In this article, we provide an overview of the path to translation from the bench to the clinic of nanotechnology-enabled messenger ribonucleic acid vaccines and examine in detail the types of delivery systems used, their mechanisms of action, obtained results during each phase of their clinical development and their regulatory approval process. We also analyze how nanotechnology is impacting global health and economy during the COVID-19 pandemic and beyond.

Platelet-rich plasma injection for tennis elbow: did it ever work?

Platelet-rich plasma (PRP) is a commonly used treatment for tendinopathies such as tennis elbow despite the questionable evidence of its efficacy. A recent Cochrane review suggests that it likely does not provide clinically meaningful benefits in people with tennis elbow. In this viewpoint, we discuss how lack of regulation allowed aggressive marketing and clinical use without normal phases of drug development and approval process or rigorous evidence of benefits. Since several phases of development were bypassed, we still do not know the optimal preparation method and dosing of PRP for tendinopathies. Furthermore, several clinical trials compared PRP with other interventions although it was unclear if PRP was better than placebo and these comparisons created distraction rather than improved understanding of its effects.

Current State of Regulatory Oversight of Biosimilars in India and Its Implications on the Quality of Drugs: A Comparative Assessment with EU and FDA Regulations

Biosimilars are biologic products that are highly similar to a licensed reference biologic, with no clinically meaningful differences in quality characteristics, biological activity, safety, or efficacy. Biosimilars can help to fulfill unmet medical needs due to their cost effectiveness while at the same time being as efficacious as the innovator drug. They can also improve patient access to otherwise costly innovator biologics. India has the largest number of approved biosimilars as compared to the US and Europe. However, the numbers of clinical studies that are conducted to prove the biosimilarity are lesser than the number of biosimilars approved, which is evident by the number of CTRI registrations done. Some studies have shown the quality of biosimilars approved and marketed in India to be inferior to the innovator drug. This raises concerns regarding the quality of the biosimilars. In this review, the similarities and differences in the guidelines, the approval process, and quality enforcement measures prevailing in the three regulatory regions of USA, Europe and India are discussed. Changes in the approval process and post approval monitoring of drugs and manufacturing facilities are recommended in order to ensure sustained quality standards of drugs entering the market.

The Judicial Fix for Forest Loss: The Godavarman Case and the Financialization of India’s Forests

In India, the setting up of large projects in forest areas can be undertaken only after government permission is obtained under the Forest (Conservation) Act (FCA) of 1980. Today, this approval process includes the enumeration and valuation of forest loss, and the financing of compensatory afforestation schemes to offset the loss. These procedures were designed through the orders and judgements of the Supreme Court of India in a set of cases that started in 1995 and continue to this day. These procedures are purportedly aimed to protect and restore forest ecologies in India. In this article we analyse the Supreme Court’s processes and orders between 1996 and 2006 which transformed the political ecology of forests in India. The judicial and expert discourses treated forest regulation and conservation as a techno-managerial exercise, separating it from social-ecological concerns such as historical dispossession of Adivasis and other forest-dependent people, and violent state suppression of diverse forms of forest management. The judicial interventions are instructive to understand the policy processes of green neoliberalism and the implications of the financialization of forests on environmental governance in India.

(DON’T) HOLD YOUR BREATH: THE SOUTH AFRICAN COVID-19 VACCINE APPROVAL PROCESS AND REGULATORY FRAMEWORK

The world seemed to sigh in relief in early November 2020, when it was announced that the Covid-19 vaccine developed by Pfizer and BioNTech showed itself to be 90 per cent effective in early data analysis. This announcement was followed by one from Moderna Inc that its vaccine in development was showing to be almost 95 per cent effective. Soon after, numerous other companies announced the efficacy of their respective vaccines and roll-out plans and policies were made and even implemented.However, this sigh of relief was perhaps premature. Although these announcements were good news on the face of it, they also brought to light some concerns. The fast pace at which the vaccines were developed and made available for human use raises various ethical and legal issues as well as questions related to the safety and efficacy thereof. The correct dosage and timing of vaccination is still not fixed, vaccine expiration periods and the discovery of new variants of the Covid-19 virus has further added to these concerns. In addition, uncertainty exists regarding the approval process that should be followed for these vaccines. This last concern forms the focus of this note.

Food and Drug Association Approval Process for Devices Used in Endovascular Treatment of Stroke

Purpose of the ReviewThis article reviews the Food and Drug Administration's (FDA’s) process for approval of new medical devices and describes the evolution of endovascular devices used for the treatment of acute ischemic stroke.Recent FindingsSeveral recent studies have established the benefit of endovascular treatment of acute ischemic stroke from emergent large vessel occlusion. This has led to endovascular treatment becoming the usual care in acute stroke management and has generated greater-than-ever interest in the development of newer and more effective devices.SummaryIn the United States, the FDA is the regulatory authority that is empowered with the approval and monitoring of new medical devices for widespread use in the population. The FDA categorizes medical devices into 3 classes based mainly on their potential risks to patients and/or users; class I devices pose the least risk and have the least stringent approval process, while class III devices pose the highest risk and undergo the most stringent and time-consuming approval process. There are 4 main pathways to approval: premarket notification, also known as the 510(k) pathway; premarket approval (PMA), de novo, and Humanitarian Device Exemption pathway. These pathways are described in detail in the article. The FDA also mandates postmarketing surveillance to identify any untoward and unexpected long-term complications.