TOWARDS A HOLISTIC RISK MODEL FOR SAFEGUARDING THE PHARMACEUTICAL SUPPLY CHAIN: CAPTURING THE HUMAN-INDUCED RISK TO DRUG QUALITY

Counterfeit, adulterated, and misbranded medicines in the pharmaceutical supply chain (PSC) are a critical problem. Regulators charged with safeguarding the supply chain are facing shrinking resources for inspections while concurrently facing increasing demands posed by new drug products being manufactured at more sites in the US and abroad. To mitigate risk, the University of Kentucky (UK) Central Pharmacy Drug Quality Study (DQS) tests injectable drugs dispensed within the UK hospital. Using FT-NIR spectrometry coupled with machine learning techniques the team identifies and flags potentially contaminated drugs for further testing and possible removal from the pharmacy. Teams like the DQS are always working with limited equipment, time, and staffing resources. Scanning every vial immediately before use is infeasible and drugs must be prioritized for analysis. A risk scoring system coupled with batch sampling techniques is currently used in the DQS. However, a risk scoring system only allows the team to know about the risks to the PSC today. It doesn’t let us predict what the risks will be in the future. To begin bridging this gap in predictive modeling capabilities the authors assert that models must incorporate the human element. A sister project to the DQS, the Drug Quality Game (DGC), enables humans and all of their unpredictability to be inserted into a virtual PSC. The DQG approach was adopted as a means of capturing human creativity, imagination, and problem-solving skills. Current methods of prioritizing drug scans rely heavily on drug cost, sole-source status, warning letters, equipment and material specifications. However, humans, not machines, commit fraud. Given that even one defective drug product could have catastrophic consequences this project will improve risk-based modeling by equipping future models to identify and incorporate human-induced risks, expanding the overall landscape of risk-based modeling. This exploratory study tested the following hypotheses (1) a useful game system able to simulate real-life humans and their actions in a pharmaceutical manufacturing process can be designed and deployed, (2) there are variables in the game that are predictive of human-induced risks to the PSC, and (3) the game can identify ways in which bad actors can “game the system” (GTS) to produce counterfeit, adulterated, and misbranded drugs. A commercial-off-the-shelf (COTS) game, BigPharma, was used as the basis of a game system able to simulate the human subjects and their actions in a pharmaceutical manufacturing process. BigPharma was selected as it provides a low-cost, time-efficient virtual environment that captures the major elements of a pharmaceutical business- research, marketing, and manufacturing/processing. Running Big Pharma with a Python shell enables researchers to implement specific GxP-related tasks (Good x Practice, where x=Manufacturing, Clinical, Research, etc.) not provided in the COTS BigPharma game. Results from players\u27 interaction with the Python shell/Big Pharma environment suggest that the game can identify both variables predictive of human-induced risks to the PSC and ways in which bad actors may GTS. For example, company profitability emerged as one variable predictive of successful GTS. Player\u27s unethical in-game techniques matched well with observations seen within the DQS

Developing systems to control food adulteration

The objective of this study is to explore the current strategies available to monitor and detect the economically and criminally motivated adulteration of food, identifying their strengths and weaknesses and recommend new approaches and policies to strengthen future capabilities to counter adulteration in a globalized food environment. Many techniques are used to detect the presence of adulterants. However, this approach relies on the adulterant, or means of substitution, being "known" and an analytical method being available. Further techniques verify provenance claims made about a food product e.g. breed, variety etc. as well as the original geographic location of food production. These consider wholeness, or not, of a food item and so do not need to necessarily identify the actual adulterant just whether the food is complete. The conceptual framework developed in this research focuses on the process of predicting, reacting and detecting economically and criminally motivated food adulteratio

Relationship development with customers on facebook: A critical success factors model

© 2015 IEEE. Social Networking Sites have been increasingly used by organizations to communicate with and manage relationship with existing and new customers. Through a review of the literature, content analysis of online discussions, and a set of interviews with SNS experts, this study has developed a critical success factor model for effective customer relationship management on Facebook. The model suggests seven critical factors: (i) Develop a strategic SNS plan, (ii) Ability to measure and monitor outcomes, (iii) Integrating SNS activities with other forms of marketing, (iv) Let the users/consumers participate, (v) Being committed to SNS task, (vi) Regular updates on the SNS, and (vii) Try to be honest and authentic during the campaign

The Legal Architecture of Virtual Stories: World Wide Web Sites and the Uniform Commercial Code

“Virtual Stores” on the Web raise a myriad of traditional legal controversies in a new forum: the “battle of the forms” among purchasers and sellers; jurisdictional concerns and conflict-of-law problems; and the enforceability of contracts. This wide-ranging article analyzes law regarding these issues, with particular emphasis on the U.C.C

Defeating the Empire of Forms

For generations, contract scholars have waged a faint-hearted campaign against form contracts. It’s widely believed that adhesive forms are unread and chock full of terms that courts will not, or should not, enforce. Most think that the market for contract terms is broken, for both employees and consumer adherents. And yet forms are so embedded in our economy that it’s hard to imagine modern commercial life without them. Scholars thus push calibrated, careful solutions that walk a deeply rutted path. Notwithstanding hundreds of proposals calling for their retrenchment, the empire of forms has continued to advance into new areas of social life: we now click to agree to more written contracts every few days than our grandparents did in their entire lives. This Article argues that the swelling scope of the empire of forms is itself a social problem, and it demands both a new diagnosis and a structural reform. Forms are everywhere in our lives because we’ve brought them with us in our pockets, and on our devices. Contract law hasn’t changed to make forms more valuable; the cost of contracting has fallen to make them ever cheaper to distribute. This makes them increasingly less valuable to firms. All the while, cheap forms externalize too many harms and threaten important legal values which we should defend. What’s needed is a remedy that cuts off the supply of cheap forms at its source and returns us to a world with fewer written contracts. I offer that reform with a proposed state law: the statute of frauds flipped upside-down. It would make low-stakes written form contracts, directed at either employees or consumers, simply unenforceable. I defend the statute against charges that it is worse medicine than the mass contracting disease it seeks to cure

Contract Lore as Heuristic Starting Points

What Professor Hillman labels as lore are better thought of as a series of heuristic starting points. I do not label them heuristics in and of themselves as they do not represent shortcuts to the ultimate answer. But, as I explain, all of the areas that Professor Hillman identifies as lore are actually quite nuanced, sometimes filled with exceptions; other times, they simply represent the first step in a long inquiry. Heuristics as a teaching device has been recognized in law and other disciplines as an effective tool in not only conveying information, but also prodding the student to conduct further inquiry. Thus, the persistence of lore may reflect nothing more than he need to have a starting point for a legal analysis, be it by a student, lawyer, or judge

The value of location in keyword auctions

Sponsored links on search engines are an emerging advertising tool, whereby a number of slots are put on sale through keyword auctions. This is also known as contextual advertising. Slot assignment and pricing in keyword auctions are then essential for the search engine\u2019s management since provide the main stream of revenues, and are typically accomplished by the Generalized Second Price (GSP) mechanism. In GSP the price of slots is a monotone function of the slot location, being larger for the highest slots. Though a higher location is associated with larger revenues, the lower costs associated with the lowest slots may make them more attractive for the advertiser. The contribution of this research is to show, by analytical and simulation results based on the theory of order statistics, that advertisers may not get the optimal slot they aim at (the slot maximizing their expected profit) and that the GSP mechanism may be unfair to all the winning bidders but the one who submitted the lowest bid