The Price of Progress: Funding and Financing Alzheimer\u27s Disease Drug Development

Introduction Advancing research and treatment for Alzheimer\u27s disease (AD) and the search for effective treatments depend on a complex financial ecosystem involving federal, state, industry, advocacy, venture capital, and philanthropy funding approaches. Methods We conducted an expert review of the literature pertaining to funding and financing of translational research and drug development for AD. Results The federal government is the largest public funder of research in AD. The National Institute on Aging, National Institute of Mental Health, National Institute of General Medical Sciences, and National Center for Advancing Translational Science all fund aspects of research in AD drug development. Non-National Institutes of Health federal funding comes from the National Science Foundation, Veterans Administration, Food and Drug Administration, and the Center for Medicare and Medicaid Services. Academic Medical Centers host much of the federally funded basic science research and are increasingly involved in drug development. Funding of the “Valley of Death” involves philanthropy and federal funding through small business programs and private equity from seed capital, angel investors, and venture capital companies. Advocacy groups fund both basic science and clinical trials. The Alzheimer Association is the advocacy organization with the largest research support portfolio relevant to AD drug development. Pharmaceutical companies are the largest supporters of biomedical research worldwide; companies are most interested in late stage de-risked drugs. Drugs progressing into phase II and III are candidates for pharmaceutical industry support through licensing, mergers and acquisitions, and co-development collaborations. Discussion Together, the funding and financing entities involved in supporting AD drug development comprise a complex, interactive, dynamic financial ecosystem. Funding source interaction is largely unstructured and available funding is insufficient to meet all demands for new therapies. Novel approaches to funding such as mega-funds have been proposed and more integration of component parts would assist in accelerating drug development

The Moderating Effect of User Engagement on User Behaviors and Impressions in Enterprise SNS

Enterprises continue to invest in social media technologies with analysts estimating organizations to invest $4.8 billion in internal social media by 2020. However, many organizations are still searching for how effective these technologies are within the workplace. The current research proposes a model to explore the impact of Enterprise Social Networking Sites (ESNS) on employee impression formation, team member preference and willingness to share. Furthermore, the research explores how employees actually engage in the technology (hedonic or utilitarian). The goal is to get a clearer understanding of how traditionally hedonic technologies such as social networking sites are used within a utilitarian environment to form perceptions of other employees

Uncovering Multiple Populations with Washington Photometry: I. The Globular Cluster NGC 1851

The analysis of multiple populations (MPs) in globular clusters (GCs) has become a forefront area of research in astronomy. Multiple red giant branches (RGBs), subgiant branches (SGBs), and even main sequences (MSs) have now been observed photometrically in many GCs. UV photometry has been crucial in discovering and analyzing these MPs, but the Johnson U and the Stromgren and Sloan u filters that have generally been used are relatively inefficient and very sensitive to reddening and atmospheric extinction. In contrast, the Washington C filter is much broader and redder than these competing UV filters. Here we investigate the use of the Washington system to uncover MPs using only a 1-meter telescope. Our analysis of the well-studied GC NGC 1851 finds that the C filter is both very efficient and effective at detecting its previously discovered MPs in the RGB and SGB. Remarkably, we have also detected an intrinsically broad MS best characterized by two distinct but heavily overlapping populations that cannot be explained by binaries, field stars, or photometric errors. The MS distribution is in very good agreement with that seen on the RGB, with ~30% of the stars belonging to the second population. There is also evidence for two sequences in the red horizontal branch, but this appears to be unrelated to the MPs in this cluster. Neither of these latter phenomena have been observed previously in this cluster. The redder MS stars are also more centrally concentrated than the blue MS. This is the first time MPs in a MS have been discovered from the ground, and using only a 1-meter telescope. The Washington system thus proves to be a very powerful tool for investigating MPs, and holds particular promise for extragalactic objects where photons are limited.Comment: 25 pages, 10 figure

Public Policy Should Foster Alzheimer’s Treatment Availability: Comment on the Draft US Medicare Decision to Limit Payment for Aducanumab (Aduhelm™) to Patients Participating in Clinical Trials

Aducanumab (AduhelmTM) was approved by the United States (US) Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease on June 7, 2021. Soon after, the approved labeling was adjusted to direct treatment to mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia reflecting the severity of cognitive impairment among participants in the clinical trials that led to the approval (1, 2). Individuals over age 65 in the US are entitled to have the cost of prescription drugs partially paid by the Center for Medicare and Medicaid Services (CMS; “Medicare”) if they participate in an approved insurance plan. Most people pay a monthly fee for this benefit. When a new agent becomes available it may be subject to a National Coverage Determination (NCD) to ascertain if CMS will pay for the drug and under what circumstances. CMS covers drugs that are considered “reasonable and necessary” for the treatment of an illness. The covered treatment must be shown to meaningfully improve health outcomes. The NCD process can lead to approval of coverage, denial for coverage, or limited coverage (3). On January 11, 2022, Medicare Issued its draft NCD on Coverage with Evidence Development (CED) for aducanumab which limits coverage to patients participating in CMS-approved randomized controlled clinical trials supported by the US National Institutes of Health (NIH) (3). This decision, if sustained, would greatly limit and delay availability of aducanumab to patients who could benefit from treatment. This decision has many foreseeable adverse consequences. The draft proposal must be understood in the context of the available efficacy data and the process of accelerated approval. These are discussed here followed by a description of the CMS proposal to limit the coverage of aducanumab to participants in trials. The proposed CED is not in the best interest of patients with early AD or the field of AD treatment development. The current decision is a draft of the proposed CED and is subject to change until a final decision is rendered on April 11th, 2022. Public comment on the decision is invited until February 10, 2022, and there is an opportunity to modify this draft determination (https://www.cms.gov/ medicare-coverage-database/search.aspx)

Enterprise Social Networking Sites and Knowledge Sharing Intentions in Virtual Teams

The use of virtual teams have become an essential component for successful organizations competing in the global marketplace. Virtual teams are formed to leverage various expertise throughout the organization, yet a challenge facing these teams is knowledge sharing. This is often due to the lack of trust and reciprocity which is traditionally formed during initial face-to-face interactions. The current research explores how the use of an Enterprise Social Networks (ESN) acts as an alternative to FtF interactions allowing individuals to form perceptions of future team members without meeting. Through the use of the Elaboration Likelihood Model, this study proposes exploring the formation of social capital perceptions through the use of ESN profiles. These perceptions are then evaluated to understand their impact on knowledge sharing intention within the team. The goal of this research is to understand how an ESN can help alleviate issues surrounding knowledge sharing in virtual teams

Susans Career Dilemma At MGR, LLC

Professionals starting their first job after graduate school want to launch a successful career. Unfortunately, some of them soon find out that performing at a high level does not always guarantee rapid promotion or success in their organization. This is a story about Susan, a highly recruited attorney, who joined an established law firm in Washington, DC, and was slow to realize that managing her boss is a critical skill needed for her survival and prosperity. Carlos, her direct supervisor and advocate of a tough love approach to management, views the effective nurturance and mentoring of new employees as his means of entr into the ranks of senior partner. Carlos and Susan are on a collision course with a potential impact on both of their careers. Susan needed to decide at the end of the case what to do to strategically manage her career