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D-Methionine Improves Spatial Navigation And Attenuates Oxidative Stress And Amyloid Pathology In A Sex-Specific Manner., Mackenzie R Peck, Jenelle E Chapman, Tiarra Hill, Kathleen Quinn, Erol D Ikiz, Angel Lopez, Erin R Hascup, Chilman Bae, Kevin N Hascup Jun 2026

D-Methionine Improves Spatial Navigation And Attenuates Oxidative Stress And Amyloid Pathology In A Sex-Specific Manner., Mackenzie R Peck, Jenelle E Chapman, Tiarra Hill, Kathleen Quinn, Erol D Ikiz, Angel Lopez, Erin R Hascup, Chilman Bae, Kevin N Hascup

Articles

Background

Oxidative stress and maladaptive neuroimmune activation contribute to cognitive decline in Alzheimer's disease (AD) and represent therapeutic targets beyond amyloid-centered approaches.

Objective

To determine whether oral D-methionine (D-Met), a redox-active amino acid, reduces amyloid pathology and lipid peroxidation and confers disease-modifying benefits in AD models.

Methods

Male and female APP/PS1 and APPNL−Fmice with advanced AD pathology received oral D-Met or vehicle. Behavioral assessments included locomotor activity and hippocampal-dependent spatial learning and memory. Amyloid burden, lipid peroxidation, peripheral metabolic, and inflammatory markers, and hippocampal microglial phenotypes were evaluated.

Results

D-Met did not alter locomotor or exploratory behavior but …


Emotional Intelligence And Teamwork In A Ship’S Bridge : A Proposed Training Framework For Upskilling, Sofia Kallou, Nikitas Nikitakos, Dimitrios A. Papachristos, Dimitrios Dalaklis, Momoko Kitada Jun 2026

Emotional Intelligence And Teamwork In A Ship’S Bridge : A Proposed Training Framework For Upskilling, Sofia Kallou, Nikitas Nikitakos, Dimitrios A. Papachristos, Dimitrios Dalaklis, Momoko Kitada

Articles

The notion that computers equipped with software and artificial intelligence (AI) applications can effectively replace human intelligence is under the existing paradigm of operations. This is the leading facilitator of task automation on board a ship to fulfill various jobs and is often supported by numerous scientists/academics who contribute to gaining today’s momentum in public opinion. The discourse of Industry 4.0 in the maritime domain, however, tends to focus heavily on technological contexts and overlooks socio-economic contexts. This gap is evident in the strong emphasis on technical and digital skills for future maritime professionals. This paper, therefore, argues that the …


Racing To Safety: Tax Policy For Ai Safety-By-Design, Mirit Eyal, Yonathan Arbel Apr 2026

Racing To Safety: Tax Policy For Ai Safety-By-Design, Mirit Eyal, Yonathan Arbel

Articles

The White House recently announced its vision of artificial intelligence (AI) policy: AI development is a race and America must win it. To that end, a new America's AI Action Plan directs federal agencies and states to remove regulatory barriers to AI development and accelerate innovation. This approach leaves limited room for regulatory measures that would address the safety risks of powerful AI systems: their behavior in novel domains remains unpredictable, their decision-making opaqueness, and their alignment with human values is uncertain. While experts warn of large-scale accidents, policymakers find themselves in a bind: Regulate AI and cede ground to …


Saturated Hierarchical Atomic Incremental Learning (Shail): A Behavioral Learning Perspective On Staged Mastery And Saturation, Ernest Fokoue Mar 2026

Saturated Hierarchical Atomic Incremental Learning (Shail): A Behavioral Learning Perspective On Staged Mastery And Saturation, Ernest Fokoue

Articles

We introduce Saturated Hierarchical Atomic Incremental Learning (sHAIL), a learning paradigm in which complex tasks are approached through a sequence of simpler atomic subtasks, each mastered to saturation before progression. The central mechanism is a saturation criterion that detects when learning dynamics enter a plateau region, triggering consolidation and subsequent ascent to a higher level of task complexity. We develop a theoretical framework for sHAIL and show that it naturally gives rise to \emph{staircased convergence}: alternating phases of rapid improvement and genuine plateau. Within each level, classical convergence guarantees apply under standard smoothness conditions, while the hierarchical transitions are driven …


Decorrelation, Diversity, And Emergent Intelligence: The Isomorphism Between Social Insect Colonies And Ensemble Machine Learning, Ernest Fokoue, Gregory Babbitt, Yuval Levental Mar 2026

Decorrelation, Diversity, And Emergent Intelligence: The Isomorphism Between Social Insect Colonies And Ensemble Machine Learning, Ernest Fokoue, Gregory Babbitt, Yuval Levental

Articles

Social insect colonies and ensemble machine learning methods represent two of the most successful examples of decentralized information processing in nature and computation respectively. Here we develop a rigorous mathematical framework demonstrating that ant colony decision-making and random forest learning are isomorphic under a common formalism of stochastic ensemble intelligence. We show that the mechanisms by which genetically identical ants achieve functional differentiation— through stochastic response to local cues and positive feedback—map precisely onto the bootstrap aggregation and random feature subsampling that decorrelate decision trees. Using tools from Bayesian inference, multi-armed bandit theory, and statistical learning theory, we prove that …


A General Weighting Theory For Ensemble Learning: Beyond Variance Reduction Via Spectral And Geometric Structure, Ernest Fokoue Mar 2026

A General Weighting Theory For Ensemble Learning: Beyond Variance Reduction Via Spectral And Geometric Structure, Ernest Fokoue

Articles

Ensemble learning is traditionally justified as a variance-reduction strategy, explaining its strong performance for unstable predictors such as decision trees. This explanation, however, does not account for ensembles constructed from intrinsically stable estimators-including smoothing splines, kernel ridge regression, Gaussian process regression, and other regularized reproducing kernel Hilbert space (RKHS) methods whose variance is already tightly controlled by regularization and spectral shrinkage. This paper develops a general weighting theory for ensemble learning that moves beyond classical variance-reduction arguments. We formalize ensembles as linear operators acting on a hypothesis space and endow the space of weighting sequences with geometric and spectral constraints. …


On The Scientific Stature Of Data Science: The Epistemological Unicorn, Ernest Fokoue Mar 2026

On The Scientific Stature Of Data Science: The Epistemological Unicorn, Ernest Fokoue

Articles

Data Science has ignited unprecedented academic, industrial, and pedagogical fervor, yet its status as a \textit{science} in the classical sense---comparable to physics or biology---remains profoundly unsettled. This article interrogates the epistemological foundations of Data Science by examining its hybrid theoretical lineage, from the Universal Approximation Theorem to the No-Free-Lunch Theorems, with special emphasis on the fundamental Bayesian optimality results for both regression and classification. We argue that Data Science is in a vigorous \textit{gestational period}, characterized not by an absence of principles but by a creative tension between empirical pragmatism and deep mathematical theory. The Cross-Validation score emerges as the …


On Fibonacci Ensembles: An Alternative Approach To Ensemble Learning Inspired By The Timeless Architecture Of The Golden Ratio, Ernest Fokoue Mar 2026

On Fibonacci Ensembles: An Alternative Approach To Ensemble Learning Inspired By The Timeless Architecture Of The Golden Ratio, Ernest Fokoue

Articles

Nature rarely reveals her secrets bluntly, yet in the Fibonacci sequence she grants us a glimpse of her quiet architecture of growth, harmony, and recursive stability \citep{Koshy2001Fibonacci, Livio2002GoldenRatio}. From spiral galaxies to the unfolding of leaves, this humble sequence reflects a universal grammar of balance. In this work, we introduce \emph{Fibonacci Ensembles}, a mathematically principled yet philosophically inspired framework for ensemble learning that complements and extends classical aggregation schemes such as bagging, boosting, and random forests \citep{Breiman1996Bagging, Breiman2001RandomForests, Friedman2001GBM, Zhou2012Ensemble, HastieTibshiraniFriedman2009ESL}. Two intertwined formulations unfold: (1) the use of normalized Fibonacci weights -- tempered through orthogonalization and Rao--Blackwell optimization -- …


Surgical Removal Of Visceral Adipose Tissue Has Therapeutic Benefit In Male Appnl-F Mice, Samuel A. Mcfadden, Yimin Fang, Kathleen Quinn, Mackenzie R. Peck, Jenelle E. Chapman, Tiarra Hill, Andrzej Bartke, Erin R. Hascup, Kevin Hascup Mar 2026

Surgical Removal Of Visceral Adipose Tissue Has Therapeutic Benefit In Male Appnl-F Mice, Samuel A. Mcfadden, Yimin Fang, Kathleen Quinn, Mackenzie R. Peck, Jenelle E. Chapman, Tiarra Hill, Andrzej Bartke, Erin R. Hascup, Kevin Hascup

Articles

Purpose:  Visceral white adipose tissue (vWAT) accumulation causes systemic inflammation, insulin resistance, metabolic syndrome, and senescent cell accumulation that are risk factors for Alzheimer’s disease (AD). Visceral fat removal (VFR) improves metabolism and reduces pro-inflammatory cytokines.  We hypothesized that VFR removal in AD mice would improve metabolism and cognition.

Methods:  Male and female APPNL-F mice underwent sham or vWAT surgical resection (periovarian or epididymal and perirenal) at 4 (pre-symptomatic) and 16 (symptomatic) months of age to understand interventional and therapeutic effects, respectively.  At 18 months of age, glucose metabolism and novel object recognition (NOR) memory were assayed followed by …


Law And The Self-Coordinating Market Idea, Sanjukta Paul Mar 2026

Law And The Self-Coordinating Market Idea, Sanjukta Paul

Articles

Much of the focus of the live Symposium was on comparing existing scholarship associated with two intellectual communities. I have no objection to that enterprise in the abstract, though I think it is a bit premature where law and political economy (LPE) is concerned and sets up an apples-to-oranges comparison to the decades-old streams of work and thinking in law and economics (L&E). But I would rather use the privilege of the space in this written Symposium to sketch what I believe is the ultimate substantive nub of contestation in this conversation about the core subject matter of “the economy” …


Untangling Ai Openness, Parth Nobel, Alan Rozenshtein, Chinmayi Sharma Jan 2026

Untangling Ai Openness, Parth Nobel, Alan Rozenshtein, Chinmayi Sharma

Articles

The debate over AI openness—whether to make components of an artificial intelligence system available for public inspection and modification—forces policymakers to balance innovation, democratized access, safety, and national security. By inviting startups and researchers into the fold, it enables independent oversight and inclusive collaboration. But technology giants can also use it to entrench their own power, while adversaries can use it to shortcut years and billions of dollars in building systems, like China’s DeepSeek, that rival our own. How we govern AI openness today will shape the future of AI and America’s role in it.

Policymakers and scholars grasp the …


Adding Family Complications To Birthright Citizenship, Scott Titshaw Jan 2026

Adding Family Complications To Birthright Citizenship, Scott Titshaw

Articles

On the first day of his second administration, President Trump issued an executive order purporting to restrict citizenship of U.S.-born children based on their parents’ citizenship or immigration status. In the process, it discriminates between mothers and fathers and adopts genetic definitions of “mother” and “father” to exclude any parent, who is not the child’s “immediate … biological progenitor.”

Courts and scholars have condemned this attempt to restrict birthplace citizenship as a violation of both the Fourteenth Amendment and the Immigration and Nationality Act. Yet there has been little, if any, discussion of the new family-based conditions in the order. …


Family Law Agreement And The New Gender Bargains, June Carbone, Brian H. Bix Jan 2026

Family Law Agreement And The New Gender Bargains, June Carbone, Brian H. Bix

Articles

The great family law divide is said to be marriage, as marriage has emerged as a marker correlated with race and socioeconomic status. This article argues that the real family law divide, inside and outside of marriage, is agreement. Family law, and the family court system that implements it, produce agreement when legal rules, societal norms, and family court procedures operate together to encourage shared understandings expressed through statuses such as marriage or parenthood, and legally enforceable agreements. In an increasingly unequal society, the family understandings of the college-educated middle class have moved apart from those much less privileged in …


Filling The Network Gap In Research Ethics: Analyzing Ethical Issues At Scale In Big Team Science, Susan Wolf, Gillian H. Roehrig, Timothy L. Pruett, Korkut Uygun, Claire Colby Mcvan, Evelyn Brister, Shawneequa L. Callier, Alexander M. Capron, James F. Childress, Rosario Isasi, Andrew D. Maynard, Kenneth A. Oye, Paul B. Thompson, Terrance R. Tiersch Jan 2026

Filling The Network Gap In Research Ethics: Analyzing Ethical Issues At Scale In Big Team Science, Susan Wolf, Gillian H. Roehrig, Timothy L. Pruett, Korkut Uygun, Claire Colby Mcvan, Evelyn Brister, Shawneequa L. Callier, Alexander M. Capron, James F. Childress, Rosario Isasi, Andrew D. Maynard, Kenneth A. Oye, Paul B. Thompson, Terrance R. Tiersch

Articles

Scientific research increasingly involves large, multidisciplinary teams networked across multiple institutions to develop new technologies. Despite the rise of complex research networks and big team science, there has been too little analysis to date of the ethical challenges facing these networks. The extensive literature on the ethical issues confronting individual researchers and small teams (the microlevel) and on the larger societal challenges flowing from research and new technology (the macrolevel) leaves a troubling gap in between, at the mesolevel of the research network involved in big team science. Yet the ability of complex networks to conduct research ethically—which is essential …


Creating A Responsible Authorship Culture In Science: Anchoring Authorship Practices In Principles Of Transparency, Credit, And Accountability, Susan Wolf, Véronique Kiermer, Sofia Adams, Kirsten Bibbins-Domingo, Kathleen Hall Jamieson, Joerg Heber, Mohammad Hosseini, Ana Marušić, Beau Nielsen, Magdalena Skipper, Geeta K. Swamy, Yensi Flores Bueso Jan 2026

Creating A Responsible Authorship Culture In Science: Anchoring Authorship Practices In Principles Of Transparency, Credit, And Accountability, Susan Wolf, Véronique Kiermer, Sofia Adams, Kirsten Bibbins-Domingo, Kathleen Hall Jamieson, Joerg Heber, Mohammad Hosseini, Ana Marušić, Beau Nielsen, Magdalena Skipper, Geeta K. Swamy, Yensi Flores Bueso

Articles

Authorship remains the primary currency of academic credit and a cornerstone of research integrity, yet current practices often fail to reflect the collaborative and interdisciplinary nature of modern science and questionable authorship practices persist. We argue that addressing these shortcomings is a collective responsibility shared by researchers, journals, research funders, scholarly societies, and research institutions. We examined authorship guidelines issued by journals and research institutions and found that their recommendations to researchers are highly variable. We propose that fostering a responsible authorship culture requires a shared, principle-based framework grounded in transparency, credit, and accountability. These three interconnected principles highlight when …


Need For Harmonized Terminology In Cryopreservation To Support Reproducibility, Regulation, And Translation, Susan Wolf, Lakshya Gangwar, Lowell Wolfe, Nikolas Zuchowicz, Irina Filz Von Reiterdank, Srivasupradha Ramesh, Bat-Erdene Namsrai, Joseph Kangas, Joseph Sushil Rao, Matthew Powell-Palm, Timothy L. Pruett, John C. Bischof, Korkut Uygun Jan 2026

Need For Harmonized Terminology In Cryopreservation To Support Reproducibility, Regulation, And Translation, Susan Wolf, Lakshya Gangwar, Lowell Wolfe, Nikolas Zuchowicz, Irina Filz Von Reiterdank, Srivasupradha Ramesh, Bat-Erdene Namsrai, Joseph Kangas, Joseph Sushil Rao, Matthew Powell-Palm, Timothy L. Pruett, John C. Bischof, Korkut Uygun

Articles

As cryopreservation technologies continue to develop, the need for harmonized terminology across the multitude of disciplines where cryopreservation is applied is becoming increasingly acute. Terminology in cryopreservation remains inconsistent, leading to confusion and barriers to progress. Applications of cryopreservation in medicine, food, agriculture, and conservation remain limited by this lack of consensus. Inconsistent terminology contributes to ethical, legal, and societal issues in translating and integrating new cryopreservation technologies. Here we identify the problem with examples of cryopreservation terminology that demand harmonization. We describe the need for terminological consistency by providing examples of effective terminology harmonization projects in related fields. We …


Age, Law, And Political Economy, Alexander Boni-Saenz Jan 2026

Age, Law, And Political Economy, Alexander Boni-Saenz

Articles

This Article examines the intersection of age, class, and the law. Its central claim is that age is an essential dimension for the analysis of law and political economy. There are two primary reasons why. First, age is embedded in a large body of legal rules that structure the labor market and address vulnerabilities associated with particular life stages. Child labor laws set minimum ages for entry into the workforce, while social welfare laws use age eligibility criteria to shape the material conditions for older adults. Second, age and its sibling concept, generation, indirectly shape economic and political relations by …


Expanding Astrobiology: The Case For A Lunar Biorepository, Mary Hagedorn, Lynne R. Parenti, Robert A. Craddock, Pierre Comizzoli, Paula Mabee, Bonnie Meinke, Susan Wolf, John C. Bischof, Rebecca D. Sandlin, Shannon N. Tessier, Mahmet Toner, Baptiste Journaux, Robert Ambrose, Garret Fitzpatrick Jan 2026

Expanding Astrobiology: The Case For A Lunar Biorepository, Mary Hagedorn, Lynne R. Parenti, Robert A. Craddock, Pierre Comizzoli, Paula Mabee, Bonnie Meinke, Susan Wolf, John C. Bischof, Rebecca D. Sandlin, Shannon N. Tessier, Mahmet Toner, Baptiste Journaux, Robert Ambrose, Garret Fitzpatrick

Articles

Earth’s resources are essential to support an expanding presence beyond the planet. Yet global conflicts, environmental change, and natural disasters threaten ecosystems and biodiversity, putting the integrity of Earth’s ecosystems and its resources at risk. These converging challenges underscore the urgency to develop innovative strategies to conserve Earth’s biodiversity. Astrobiology—seeking to understand life’s origins, limits, and potential beyond Earth—plays a central role in this effort, helping to preserve Earth’s species while also providing critical assets to explore and work in space. A Lunar Biorepository was proposed to hold cryopreserved samples from among the most critical species on Earth. Here, we …


Biomechanical Advancements In Hydroxyapatite, Magnesium-Substituted Hydroxyapatite, And Strontium-Substituted Hydroxyapatite In Clinical And Non-Clinical Studies For Maxillofacial Bone Tissue Engineering: A Review, Elham Zafarrazzaghnia, Stuart Hampshire, Aran Rafferty, Dermot Brabazon, Eamonn Debarra, Maura Kelleher Jan 2026

Biomechanical Advancements In Hydroxyapatite, Magnesium-Substituted Hydroxyapatite, And Strontium-Substituted Hydroxyapatite In Clinical And Non-Clinical Studies For Maxillofacial Bone Tissue Engineering: A Review, Elham Zafarrazzaghnia, Stuart Hampshire, Aran Rafferty, Dermot Brabazon, Eamonn Debarra, Maura Kelleher

Articles

Hydroxyapatite (HA) is a bioceramic known for its bioactivity and osteoconductivity, which should make it an ideal candidate for maxillofacial bone regeneration. However, its brittleness limits its suitability for load-bearing applications. Over recent decades, substantial efforts have focused on enhancing its performance, particularly through ionic substitution, including magnesium-substituted HA (Mg-HA) and strontium-substituted HA (Sr-HA). This review summarises the available information on the structural, physical and mechanical properties of facial bones (maxilla, mandible, zygoma and frontal bone). The crystal structure, physical, and mechanical properties and in-vitro biological responses of dense and porous HA, Mg-HA and Sr-HA ceramics are described, with particular …


Bending Energy Schemes For Discrete-Spring-Network Structural Modelling Of Red Blood Cells, Osayomwanbor Ehi-Egharevba, Mingzhu Chen, Fergal Boyle Nov 2025

Bending Energy Schemes For Discrete-Spring-Network Structural Modelling Of Red Blood Cells, Osayomwanbor Ehi-Egharevba, Mingzhu Chen, Fergal Boyle

Articles

Red blood cells (RBCs) undergo large structural deformation, including bending, when passing through capillaries. They also exhibit a range of complex shapes such as stomatocytes, discocytes and echinocytes that form due to altered blood pH and salt levels, ingested drugs and adenosine triphosphate depletion. Discrete-spring-network structural models of RBCs employ different numerical treatments of the continuum bending energy. This affects bending accuracy and the prediction of accurate RBC shapes. This research compares three representations called bending energy scheme (BES) A, B and C to evaluate their accuracy in shape predictions. BES A, seen throughout the literature, is based on the …


New Judicial Federalism And The Establishment Clause: Classroom Ten Commandments As A Case Study In State Constitutional Protection, Caroline Mala Corbin Nov 2025

New Judicial Federalism And The Establishment Clause: Classroom Ten Commandments As A Case Study In State Constitutional Protection, Caroline Mala Corbin

Articles

Louisiana recently enacted a law requiring a Ten Commandments display in every public school classroom from kindergarten to college. Forty-five years ago, the U.S. Supreme Court ruled that a nearly identical attempt to introduce Christianity into the public schools violated the Establishment Clause—the clause in the U.S. Constitution’s First Amendment that requires some degree of separation between church and state.

Unfortunately, the U.S. Supreme Court has since reduced the Establishment Clause to a shadow of its former self. It replaced doctrinal tests that protected religious minorities with a history and tradition test that is easily manipulated and that presumes the …


Look What You Made Me Do, Russell M. Gold Oct 2025

Look What You Made Me Do, Russell M. Gold

Articles

We have understood for centuries that crime is both the product of social forces and individual choice. We know now that crime is affected by economic deprivation, addiction, trauma, and mental health issues. But American criminal legal processes hide this reality by coercing defendants into expressing a profoundly simple narrative: crime is solely individual choice to do wrong. This coerced narrative finds defendants during a plea colloquy standing up in court saying that they are pleading guilty because they are guilty and for no other reason. A defendant who goes off-script to tell the judge that they have been repeatedly …


Innovation Interrupted: Legal And Institutional Risks Of Undermining Public-Private Partnerships, Jennifer S. Fan, Xuan-Thao Nguyen Oct 2025

Innovation Interrupted: Legal And Institutional Risks Of Undermining Public-Private Partnerships, Jennifer S. Fan, Xuan-Thao Nguyen

Articles

Part I traces the development of the Bayh–Dole Act and discusses public–private partnership collaboration. Part II focuses on intellectual property generation by universities, illustrating the benefits of public– private partnership. Then Part III highlights the Trump administration’s federal funding cuts to universities that jeopardize the established public–private partnerships. Finally, Part IV details the consequences of how federal funding cuts impact the venture capital sector and the legal architecture of innovation, eroding the United States’ standing in the innovation race.


Jefferson Et Al. Reply, Osmat Jefferson, W. Nicholson Price Ii, S. Sean Tu, Saurabh Vishnubhakat, Arti K. Rai Aug 2025

Jefferson Et Al. Reply, Osmat Jefferson, W. Nicholson Price Ii, S. Sean Tu, Saurabh Vishnubhakat, Arti K. Rai

Articles

Notwithstanding Amgen’s strenuous objections, the core premise of our article should be uncontroversial to most policy analysts: biosimilar firms that simply want to manufacture an originator biologic in the manner it was manufactured at the time of US Food and Drug Administration (FDA) approval should be able to enter the market expeditiously once valid manufacturing (and other valid patents) that legitimately cover the ‘at approval’ biologic have expired. Our core premise relies on the widely accepted values of patent validity and notice. Instead of expensive litigation discovery fights over such ‘at approval’ issues, of the sort Amgen itself has spearheaded …


Artificial Ignorance: Understanding The Role Of Ai In Modern Agnotology, Amit Ray, Michael Nolan Aug 2025

Artificial Ignorance: Understanding The Role Of Ai In Modern Agnotology, Amit Ray, Michael Nolan

Articles

This paper explores the concept of agnotology, the deliberate production of ignorance, within the context of modern scientific endeavors, particularly in the corporate and technological sectors. It examines how industries use various tactics to manipulate public understanding of scientific issues, often to protect profits and limit liability. The rise of private sector funding and the increasing reliance on technologies like AI and machine learning have exacerbated this process by making scientific inquiry more opaque and less accountable. Ultimately, we argue that as knowledge production becomes more entangled with corporate interests and technological systems, traditional methods of oversight and regulation are …


The Bandages Problem, James E. Marengo, Joseph G. Voelkel, David L. Farnsworth Aug 2025

The Bandages Problem, James E. Marengo, Joseph G. Voelkel, David L. Farnsworth

Articles

A new probability problem, named the Bandages Problem, is described and solved. The problem involves repeatedly selecting and removing an item at random from a finite population that initially consists of a known configuration of single and paired items. For each selection, the probability that the chosen item is single is found. Generalizations are suggested.


Redressing The Harm Of Accelerated Approval, Laura Karas Aug 2025

Redressing The Harm Of Accelerated Approval, Laura Karas

Articles

The accelerated approval pathway of the United States Food and Drug Administration (FDA) enables drugs to come to market more quickly than would be possible under a traditional FDA approval pathway. Accelerated approval is based upon the agency's determination that changes in a surrogate or intermediate clinical endpoint are "reasonably likely" to predict a clinical benefit meaningful for patients. In essence, the pathway affords sick patients earlier access to potentially beneficial drugs while trials to confirm clinical benefit continue. Accelerated approval has been likened to a social compromise in which promising drugs enter the market sooner in exchange for a …


Constitutional Futurisms, Jeremiah Chin Aug 2025

Constitutional Futurisms, Jeremiah Chin

Articles

How do we reckon with the past? The Supreme Court’s recent embrace of originalism as a mode of constitutional analysis relies almost exclusively on a view of history and tradition that would bind us to an understanding of principles and ideals that legitimized the exclusion of minority voices. Cases such as New York State Pistol and Rifle Ass'n v. Bruen use flavors of originalism as a framework to define rights and governmental powers through their historical antecedents, but this broad standard of interpretation is notably absent in the Court’s recent discussions of histories and traditions of racism in the United …


Comparing Conventional And Alternative Mechanisms Of Discovering And Accessing The Scientific Literature, William H. Walters Jul 2025

Comparing Conventional And Alternative Mechanisms Of Discovering And Accessing The Scientific Literature, William H. Walters

Articles

This study compares the bibliographic and full-text coverage of 15 conventional and alternative discovery/access mechanisms: two multidisciplinary library databases (Scopus and the Web of Science Core Collection), five single-subject databases, the integrated library search (ILS) mechanism of Manhattan University, a scholarly search engine (Google Scholar), two web-based scholarly databases (Dimensions and OpenAlex), two academic social networks (Academia.edu and ResearchGate), and two pirate sites (Anna’s Archive and Sci-Hub). The analysis is based on known-item searches for 875 target documents in chemistry, materials science, cardiology, public health, economics, education, and psychology. Overall, Google Scholar, OpenAlex, and the ILS are the most comprehensive …


Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman Jul 2025

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …