cometadata/datacite-rtg-text-other-reclassification-records huggingface dataset:
A Special Issue of the Journal of Regulatory Science on Genetically Modified Organisms
Creators: name: Molins, Ricardo
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: genetically modified organims
regulatory science
editorial
genetically modified organisms

description: The Journal of Regulatory Science, now in the first year in continuous publication mode, is proud to publish its first Special Issue, which examines some proposals from industry to facilitate the structuring of a more widely accepted, science based, standardized future international regulatory framework for approval of genetically modified organisms. doi: 10.21423/jrs-v09i1molins
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Toward a Taxonomy of Media Capture
Creators: name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2017
Subjects: Economics
Press
Democracy

description: Preventing capture, and ensuring that the media can perform their societal function, requires an understanding of the myriad and sometimes subtle ways the media can be compromised by the very actors they are supposed to monitor. To that end, this chapter proposes four somewhat overlapping forms of capture–(a) ownership, (b) financial incentives, (c) censorship, and (d) cognitive capture– arguing that a broader view of what constitutes capture usefully highlights less obvious but equally insidious threats to journalistic independence.
Can Mass Spectrometry Analysis of In Vitro Digestion Products Improve the Assessment of Allergenic Potential of a Newly Expressed Protein?
Creators: name: Wang, Rong
name: Houston, Norma
name: Cheever, Matthew L.
name: Geng, Tao
name: Gillikin, Nancy
name: McDonald, Justin
name: Serrano, Hector
name: Shippar, Jeffrey
name: Tetteh, Afua
name: Wang, Yanfei
name: Liu, Lucy
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: genetically modified crops
allergenicity assessment
in vitro digestion
mass spectrometry

description: The rigorous safety assessment conducted on genetically modified crops includes an evaluation of allergenic potential for an associated newly expressed protein (NEP). Since no single method is recognized as a predictor for protein allergenicity, a weight of evidence approach (WOE) has been adopted. In vitro digestion is a part of the WOE approach and is used to evaluate the susceptibility of a NEP to digestion by gastrointestinal proteases. In 2017, the European Food Safety Authority outlined additional digestion conditions and suggested liquid chromatography tandem mass spectrometry (LC-MS/MS) as an analytical method to detect small post-digestion peptides. This technical review paper focuses on the question of whether LC-MS/MS can aid in assessing allergenic potential of in vitro digestion products generated under the newly proposed conditions. After an extensive review, it was determined that LC-MS/MS can detect very small digestion products. However, the method cannot provide relevant information to differentiate whether these products are allergenic or non-allergenic. Therefore, the use of LC-MS/MS for a standard in vitro digestibility assessment provides no improvement in allergenicity prediction. doi: 10.21423/jrs-v09i1wang
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Deviations from Tri-Bimaximality and Quark-Lepton Complementarity
Creators: name: Shimizu, Yusuke
name: Takahashi, Ryo
Publisher: name: arXiv
Year: 2010
Subjects: subject: High Energy Physics - Phenomenology (hep-ph)
subject: High Energy Physics - Experiment (hep-ex)
subject: FOS: Physical sciences

description: We study deviations from tri-bimaximality (TBM) and quark-lepton complementarity (QLC) in a model independent way. The current neutrino experimental data is well approximated by tri-bimaximal generation mixing but the QLC relations are not satisfied with each data of 1$σ$ level. This means that there exist deviations from the complementarity. The same fact for the TBM might be checked in the future neutrino experiments. We discuss such deviations from the TBM and QLC, simultaneously. A new ratio between the deviations is introduced, and some interesting points are presented. We also show predicted correlations among leptonic mixing angles at the points.
description: 10 pages, 9 figures, final version
Improving security for future wireless networks through friendly jamming
Creators: name: Adams, Mark M.
Publisher: name: University of British Columbia
Year: 2017

description: As the number of connected devices and the importance of mobile communications continue to increase, a greater emphasis must be placed on security. Due to the broadcast nature of wireless communications, wireless networks are very exposed to eavesdropping. While this can be addressed above the physical layers using encryption, this still allows the attacker to receive the message and future work may allow decryption. Physical layer security is an approach to security which exploits the wireless channel to prevent the attacker from decoding the message. This thesis examines the use of friendly jamming, in which some nodes in a network broadcast white noise in order to degrade the channel between the legitimate transmitter and the eavesdropper. We address two problems related to the use of friendly jamming to improve physical layer security. The first problem is routing a signal through a network while using the remaining nodes as jammers to secure the signal. This is solved as two convex problems of allocating power to the jammers and routing the signal using those jammers to secure the transmission. This is shown to be a feasible method to increase security in a network. The second problem is estimating the self-interference channel (SIC) without using a calibration period for full-duplex jamming receivers. As the transmitter cannot transmit while the receiver estimates its SIC using a half duplex pilot signal, eliminating the calibration period can represent a significant capacity gain. Estimating the channel while receiving the desired signal causes it to act as an additional noise source, but this is shown to be overcome through the use of long estimation times. Our proposed scheme is able to increase the secrecy capacity of the system over that of calibration based estimation.
Allergy Risk Assessment for Newly Expressed Proteins (NEPs) in Genetically Modified (GM) Plants
Creators: name: McClain, Scott
name: Herman, Rod A.
name: Islamovic, Emir
name: Ranjan, Rakesh
name: Silvanovich, Andre
name: Song, Ping
name: Goodwin, Laurie
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: genetically modified
allergenicity assessment
food and feed
hazard
exposure
risk
core studies
supplementary studies

description: Based on experience and scientific advancements over the past two decades, a revised approach for the assessment of the allergenic potential of newly expressed proteins (NEPs) in genetically modified (GM) plants is warranted. NEPs are most often not native to the crop genome, and thus regulatory reviews of the safety of GM plants include an assessment of the allergenic potential of NEPs. International standards for the assessment of allergenicity first developed in the mid-1990s required a series of characterization studies to be conducted that are, to some extent, still applicable today to the risk assessment of GM plants, with most modern versions represented in the Codex Alimentarius. This standardized guidance on allergenicity assessments, including the required characterization studies, presented two primary challenges. First, there was (and still is) no defined and accepted model (animal or in vitro) for directly testing allergy potential. Second, bioinformatic analyses were prescribed using thresholds for hazard identification that were neither universal for all allergens nor tested prior to the implementation of requirements into guidance documents. Herein, risk assessment principles are applied to structure the assessment of the allergenic potential of NEPs. This allergy risk assessment is built on a foundation of: 1) identifying hazard by assessing similarity to known allergens, and 2) assessing exposure when a hazard is identified. Supplementary studies such as IgE binding may need to be performed in special cases. These recommended revisions to current approaches to the assessment of allergy potential are designed to ensure a realistic, case-by-case approach, and consider updated molecular biology, genomics, and bioinformatic techniques that were unavailable when earlier allergy risk assessment approaches were established. doi: 10.21423/jrs-v09i1mcclain
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Toxicological Assessment of Newly Expressed Proteins (NEPs) in Genetically Modified (GM) Plants
Creators: name: Roper, Jason
name: Lipscomb, Elizabeth A.
name: Petrick, Jay S.
name: Ranjan, Rakesh
name: Sauve-Ciencewicki, Alaina
name: Goodwin, Laurie
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: genetically modified
toxicological assessment
food and feed
hazard
exposure
risk
core studies
supplementary studies

description: This paper details the weight of evidence (WOE) and stepwise approaches used to assess the food and feed safety of newly expressed proteins (NEPs) in genetically modified (GM) plants, based on previously reported principles. The WOE approach is critical, as in a vast majority of cases no single assay or biochemical characteristic can identify a protein as a hazard. A stepwise approach is recommended to evaluate the safety of NEPs taking the totality of information into account. Potential triggers for the need for supplementary toxicology studies are discussed, and an alternative in vitro method for the acute toxicology study is proposed. doi: 10.21423/jrs-v09i1roper
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Countering the Power of Vested Interests: Advancing Rationality in Public Decision-Making
Creators: name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2017
Subjects: Economics
Evolutionary economics
Economic policy--Public opinion
Group decision making
Practical reason

description: Seemingly Pareto-improving reforms face more opposition than they should. In earlier work, I presented an explanation: voters correctly saw reforms as part of a long-term dynamic game, and they correctly saw how the reform affected outcomes (e.g., by affecting beliefs or coalition formation). Recent advances in behavioral economics derived from insights from sociology emphasize preference endogeneity, noting that beliefs are affected by those of others with whom one identifies and need not be consistent with rationality, as conventionally defined. Thus, individuals may have beliefs about the economic system that differ from those of economists. People may support policies which economists’ analyses suggest are contrary to their interests because they believe these policies advance their interests. Based on previous analyses of the causes of these seeming perversities, I show how economists can modify policy proposals in ways that enhance likelihood of support, e.g., with contingent provisions which are operative in the states of the world that economists know (believe) are unlikely to occur, but which enhance the wellbeing of individuals with such beliefs in those states. Those selling products that are adverse to one’s health have learned how to persuade customers to buy them. Likewise, politicians who are selling policies that are adverse to society’s wellbeing have learned how to market their ideas. Economists will similarly have to learn how to persuade citizens of the desirability of the evidence- and theory-based policies that they advocate.
Layers of Cold Dipolar Molecules in the Harmonic Approximation
Creators: name: Armstrong, J. R.
name: Zinner, N. T.
name: Fedorov, D. V.
name: Jensen, A. S.
Publisher: name: arXiv
Year: 2011
Subjects: subject: Quantum Gases (cond-mat.quant-gas)
subject: Nuclear Theory (nucl-th)
subject: Quantum Physics (quant-ph)
subject: FOS: Physical sciences

description: We consider the N-body problem in a layered geometry containing cold polar molecules with dipole moments that are polarized perpendicular to the layers. A harmonic approximation is used to simplify the hamiltonian and bound state properties of the two-body inter-layer dipolar potential are used to adjust this effective interaction. To model the intra-layer repulsion of the polar molecules, we introduce a repulsive inter-molecule potential that can be parametrically varied. Single chains containing one molecule in each layer, as well as multi-chain structures in many layers are discussed and their energies and radii determined. We extract the normal modes of the various systems as measures of their volatility and eventually of instability, and compare our findings to the excitations in crystals. We find modes that can be classified as either chains vibrating in phase or as layers vibrating against each other. The former correspond to acoustic and the latter to optical phonons. Instabilities can occur for large intra-layer repulsion and produce diverging amplitudes of molecules in the outer layers. Lastly, we consider experimentally relevant regimes to observe the structures.
description: 17 pages, 20 figures, accepted version
Galaxy Cluster Radio Relics in Adaptive Mesh Refinement Cosmological Simulations: Relic Properties and Scaling Relationships
Creators: name: Skillman, Samuel W.
name: Hallman, Eric J.
name: O'Shea, Brian W.
name: Burns, Jack O.
name: Smith, Britton D.
name: Turk, Matthew J.
Publisher: name: arXiv
Year: 2010
Subjects: subject: Cosmology and Nongalactic Astrophysics (astro-ph.CO)
subject: FOS: Physical sciences

description: Cosmological shocks are a critical part of large-scale structure formation, and are responsible for heating the intracluster medium in galaxy clusters. In addition, they are also capable of accelerating non-thermal electrons and protons. In this work, we focus on the acceleration of electrons at shock fronts, which is thought to be responsible for radio relics - extended radio features in the vicinity of merging galaxy clusters. By combining high resolution AMR/N-body cosmological simulations with an accurate shock finding algorithm and a model for electron acceleration, we calculate the expected synchrotron emission resulting from cosmological structure formation. We produce synthetic radio maps of a large sample of galaxy clusters and present luminosity functions and scaling relationships. With upcoming long wavelength radio telescopes, we expect to see an abundance of radio emission associated with merger shocks in the intracluster medium. By producing observationally motivated statistics, we provide predictions that can be compared with observations to further improve our understanding of magnetic fields and electron shock acceleration.
description: 20 pages, 15 figures, further discussion and appendix added, accepted to ApJ
Regulatory Assessment of Off-Target Changes and Spurious DNA Insertions in Gene-Edited Organisms for Agri-Food Use
Creators: name: Lema, Martin
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: Gene editing
genome editing
off-target
CRISPR-Cas
biotechnology regulation
new breeding techniques

description: Worldwide, an increasing number of regulatory systems have begun to consider applications for the authorization of activities involving gene-edited organisms for agri-food use. Although a handful of countries have made advances in establishing regulatory criteria and gathering practical experience in this regard, there is still a general need for regulatory cooperation concerning capacity building and development of harmonized criteria. Consequently, many biotechnology regulators need to quickly become more acquainted with the numerous technological possibilities enclosed under the concept of "gene editing", and to incorporate criteria for their regulatory assessment. This article contains a simplified introduction to the state of the art in genome editing, described from a regulatory perspective. In particular, two issues of higher practical importance are covered in detail, namely, off-target effects and unintended DNA insertions. The detailed review of current evidence regarding those issues serves as the basis for proposing concrete regulatory criteria to address them. doi: 10.21423/jrs-v09i1lema
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
A variational approach to dislocation problems for periodic Schrödinger operators
Creators: name: Hempel, Rainer
name: Kohlmann, Martin
Publisher: name: arXiv
Year: 2010
Subjects: subject: Mathematical Physics (math-ph)
subject: Spectral Theory (math.SP)
subject: FOS: Physical sciences
subject: FOS: Mathematics

description: As a simple model for lattice defects like grain boundaries in solid state physics we consider potentials which are obtained from a periodic potential $V = V(x,y)$ on $\R^2$ with period lattice $\Z^2$ by setting $W_t(x,y) = V(x+t,y)$ for $x < 0$ and $W_t(x,y) = V(x,y)$ for $x \ge 0$, for $t \in [0,1]$. For Lipschitz-continuous $V$ it is shown that the Schrödinger operators $H_t = -Δ+ W_t$ have spectrum (surface states) in the spectral gaps of $H_0$, for suitable $t \in (0,1)$. We also discuss the density of these surface states as compared to the density of the bulk. Our approach is variational and it is first applied to the well-known dislocation problem [E. Korotyaev, Commun. Math. Phys. 213 (2000), 471-489], [E. Korotyaev, Asymptotic Anal. 45 (2005), 73-97] on the real line. We then proceed to the dislocation problem for an infinite strip and for the plane. In an appendix, we discuss regularity properties of the eigenvalue branches in the one-dimensional dislocation problem for suitable classes of potentials.
description: 19 pages, 3 figures
Interpretation of neutrino flux limits from neutrino telescopes on the Hillas plot
Creators: name: Winter, Walter
Publisher: name: arXiv
Year: 2011
Subjects: subject: High Energy Astrophysical Phenomena (astro-ph.HE)
subject: High Energy Physics - Phenomenology (hep-ph)
subject: FOS: Physical sciences

description: We discuss the interplay between spectral shape and detector response beyond a simple E^-2 neutrino flux at neutrino telescopes, at the example of time-integrated point source searches using IceCube-40 data. We use a self-consistent model for the neutrino production, in which protons interact with synchrotron photons from co-accelerated electrons, and we fully take into account the relevant pion and kaon production modes, the flavor composition at the source, flavor mixing, and magnetic field effects on the secondaries (pions, muon, and kaons). Since some of the model parameters can be related to the Hillas parameters R (size of the acceleration region) and B (magnetic field), we relate the detector response to the Hillas plane. In order to compare the response to different spectral shapes, we use the energy flux density as a measure for the pion production efficiency times luminosity of the source. We demonstrate that IceCube has a very good reach in this quantity for AGN nuclei and jets for all source declinations, while the spectra of sources with strong magnetic fields are found outside the optimal reach. We also demonstrate where neutrinos from kaon decays and muon tracks from tau decays can be relevant for the detector response. Finally, we point out the complementarity between IceCube and other experiments sensitive to high-energy neutrinos, at the example of 2004-2008 Earth-skimming neutrino data from Auger. We illustrate that Auger, in principle, is better sensitive to the parameter region in the Hillas plane from which the highest-energetic cosmic rays may be expected in this model.
description: 28 pages, 10 figures. Substantial clarifications, such as on definition of "sensitivity" and model description
Disitamab Vedotin: First Approval
Creators: name: Deeks, Emma D
Publisher: name: Adis Journals
Year: 2021
Subjects: subject: Medicine
subject: 111299 Oncology and Carcinogenesis not elsewhere classified
subject: FOS: Clinical medicine

description: Declarations
Funding The preparation of this review was not supported by any external funding.
Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Emma Deeks is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.
Additional information about this Adis Drug Review can be found here

AbstractDisitamab vedotin (Aidixi®) is an antibody–drug conjugate comprising a monoclonal antibody against human epidermal growth factor receptor 2 (HER2) conjugated via a cleavable linker to the cytotoxic agent monomethyl auristatin E. Disitamab vedotin is being developed by RemeGen for the treatment of solid tumours, including gastric cancer. In June 2021, disitamab vedotin received its first Biologics License Application (BLA) approval in China for the treatment of patients with HER2-overexpressing (defined as IHC2+ or 3+) locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two systemic chemotherapy regimens. Disitamab vedotin as monotherapy or combination therapy is also in clinical development for the treatment of other solid tumours globally, including urothelial cancer in China and the USA, and biliary tract cancer, non-small cell lung cancer and Her2-positive and low-expressing breast cancer in China. This article summarizes the milestones in the development of disitamab vedotin leading to this first approval for locally advanced or metastatic gastric cancer.

© Springer Nature Switzerland AG 2021
Artificial Intelligence and Its Implications for Income Distribution and Unemployment
Creators: name: Korinek, Anton
name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2017
Subjects: Economics
Artificial intelligence
Income distribution
Unemployment
Economic development

description: Inequality is one of the main challenges posed by the proliferation of artificial intelligence (AI) and other forms of worker-replacing technological progress. This paper provides a taxonomy of the associated economic issues: First, we discuss the general conditions under which new technologies such as AI may lead to a Pareto improvement. Secondly, we delineate the two main channels through which inequality is affected – the surplus arising to innovators and redistributions arising from factor price changes. Third, we provide several simple economic models to describe how policy can counter these effects, even in the case of a “singularity” where machines come to dominate human labor. Under plausible conditions, non-distortionary taxation can be levied to compensate those who otherwise might lose. Fourth, we describe the two main channels through which technological progress may lead to technological unemployment – via efficiency wage effects and as a transitional phenomenon. Lastly, we speculate on how technologies to create super-human levels of intelligence may affect inequality and on how to save humanity from the Malthusian destiny that may ensue.
Universal nonequilibrium quantum dynamics in imaginary time
Creators: name: De Grandi, C.
name: Polkovnikov, A.
name: Sandvik, A. W.
Publisher: name: arXiv
Year: 2011
Subjects: subject: Other Condensed Matter (cond-mat.other)
subject: Quantum Physics (quant-ph)
subject: FOS: Physical sciences

description: We propose a method to study dynamical response of a quantum system by evolving it with an imaginary-time dependent Hamiltonian. The leading non-adiabatic response of the system driven to a quantum-critical point is universal and characterized by the same exponents in real and imaginary time. For a linear quench protocol, the fidelity susceptibility and the geometric tensor naturally emerge in the response functions. Beyond linear response, we extend the finite-size scaling theory of quantum phase transitions to non-equilibrium setups. This allows, e.g., for studies of quantum phase transitions in systems of fixed finite size by monitoring expectation values as a function of the quench velocity. Non-equilibrium imaginary-time dynamics is also amenable to quantum Monte Carlo (QMC) simulations, with a scheme that we introduce here and apply to quenches of the transverse-field Ising model to quantum-critical points in one and two dimensions. The QMC method is generic and can be applied to a wide range of models and non-equilibrium setups.
description: 8 pages, 3 figures. Expanded, final published version
Core and Supplementary Studies to Assess the Safety of Genetically Modified (GM) Plants Used for Food and Feed
Creators: name: Brune, Phil
name: Chakravarthy, Suma
name: Graser, Gerson
name: Mathesius, Carey A.
name: McClain, Scott
name: S. Petrick, Jay
name: Sauve-Ciencewicki, Alaina
name: Schafer, Barry
name: Silvanovich, Andre
name: Brink, Kent
name: Burgin, Kristina
name: Bushey, Dean
name: L. Cheever, Matthew
name: Edrington, Thomas
name: Fu, Huihua
name: Habex, Veerle
name: Herman, Rod A.
name: Islamovic, Emir
name: Lipscomb, Elizabeth A.
name: Motyka, Shawn
name: Privalle, Laura
name: Ranjan, Rakesh
name: Roper, Jason
name: Song, Ping
name: Tilton, Gregory
name: Zhang, John
name: Waters, Stephen
name: Ramos, Adela
name: Hendrickson Culler, Angela
name: Hunst, Penny
name: Gast, Rachel
name: Mahadeo, Debbie
name: Goodwin, Laurie
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: genetically modified
safety assessment
food and feed
hazard
exposure
risk
core studies
supplementary studies
regulatory harmonization

description: Genetically modified (GM) plants used for food and feed have an established history of safe use over more than 25 years of their commercialization. Developers and regulatory authorities have accumulated extensive experience in evaluating their safety over time. The studies required for the safety assessment of GM plants used for food and feed should now be re-defined to leverage this experience and increased scientific knowledge. This paper, a companion paper for Waters et al. also published in this issue, presents a systematic approach for the safety assessment of newly expressed proteins (NEPs) in GM plants by evaluating the two components of risk: hazard and exposure. Although the paper focuses on NEPs, the principles presented could also apply to other expression products that do not result in a NEP. A set of core studies is recommended, along with supplementary studies, if needed, to evaluate whether the GM plant poses risk. Core studies include molecular and protein characterization and hazard identification encompassing toxicity and allergenicity. In the absence of hazard, core studies are sufficient to conclude that GM plants are as safe as their conventional counterparts. Depending on the GM trait and intended use, supplementary studies should be performed to characterize hazard and exposure when a hazard is identified. Problem formulation should be used to identify hypothesis-driven supplementary studies. Acute toxicity studies, compositional assessment, and dietary exposure assessment are recommended to be hypothesis-driven supplementary studies. Further discussion on the current food and feed safety assessment landscape for GM plants and the use of problem formulation as a tool for identifying supplementary studies can be found in the companion paper [62]. doi: 10.21423/jrs-v09i1brune
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Data Transportability for Studies Performed to Support an Environmental Risk Assessment for Genetically Modified (GM) Crops
Creators: name: M. Bachman, Pamela
name: Anderson, Jennifer
name: Burns, Andrea
name: Chakravarthy, Suma
name: Goodwin, Laurie
name: Privalle, Laura
name: Song, Shuang
name: Storer, Nicholas
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: data transportability
environmental risk assessment
genetically modified plants
agroclimate
regulatory harmonization

description: Laboratory and field data generated on genetically modified (GM) plants in one country can inform the environmental risk assessment and support regulatory decision-making for GM plants being cultivated in another country. Well-designed studies that test clear risk hypotheses and that follow well-established methods allow for conclusions to be made about potential environmental effects from cultivation of a GM plant relative to its conventional counterparts. Following the principle of data transportability, if no biologically relevant differences between a GM plant and its conventional counterparts are observed in one country or region, data from these studies can be used to inform the risk assessment in another country, regardless of agroclimatic zone. Similarly, if biologically relevant differences are observed in studies conducted in one country, these data can be used to assess potential environmental harm in another country. Gathering additional data for the ERA in a different country or in expanded regions may increase the weight of evidence of environmental safety, but additional field study data are only warranted if specific hypotheses of risk remain after assessing risk based on the existing data, and if they would affect the outcome of decision-making. Transportation of product data across regions has been successfully used by multiple countries to eliminate redundancy, create regulatory efficiencies and enable timely realization of the benefits of GM plants. doi: 10.21423/jrs-v09i1bachman
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Associated Press-NORC Center for Public Affairs Research/CNBC Poll: Finding a Job: Americans’ Experiences with Interviewing
Creators: name: CNBC
name: Research, The Associated Press-NORC Center For Public Affairs
Publisher: name: Roper Center for Public Opinion Research
Year: 2019

description: Most recent job interview (1); questions asked during job interview (6); respondent has/has not lied or embellished during job interview or on job application (5); job interview experiences (6); reaction to being asked about current salary in interview (1); importance of various factors when considering whether to accept job offer (6).
Additional file 1 of Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice
Creators: name: Reardon, Tessa
name: Ukoumunne, Obioha C.
name: Violato, Mara
name: Ball, Susan
name: Brown, Paul
name: Ford, Tamsin
name: Gray, Alastair
name: Hill, Claire
name: Jasper, Bec
name: Larkin, Michael
name: Macdonald, Ian
name: Morgan, Fran
name: Pollard, Jack
name: Sancho, Michelle
name: Sniehotta, Falko F.
name: Spence, Susan H.
name: Stallard, Paul
name: Stainer, Jason
name: Taylor, Lucy
name: Williamson, Victoria
name: Day, Emily
name: Fisk, Jennifer
name: Green, Iheoma
name: Halliday, Gemma
name: Hennigan, Ciara
name: Pearcey, Samantha
name: Robertson, Olly
name: Creswell, Cathy
Publisher: name: figshare
Year: 2022
Subjects: subject: Medicine
subject: Biotechnology
subject: Sociology
subject: FOS: Sociology
subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: Science Policy

description: Additional file 1: Supplement 1. SPIRIT Checklist.
A New Recursion Relation for the 6j-Symbol
Creators: name: Bonzom, Valentin
name: Livine, Etera R.
Publisher: name: arXiv
Year: 2011
Subjects: subject: General Relativity and Quantum Cosmology (gr-qc)
subject: Mathematical Physics (math-ph)
subject: FOS: Physical sciences

description: The 6j-symbol is a fundamental object from the re-coupling theory of SU(2) representations. In the limit of large angular momenta, its asymptotics is known to be described by the geometry of a tetrahedron with quantized lengths. This article presents a new recursion formula for the square of the 6j-symbol. In the asymptotic regime, the new recursion is shown to characterize the closure of the relevant tetrahedron. Since the 6j-symbol is the basic building block of the Ponzano-Regge model for pure three-dimensional quantum gravity, we also discuss how to generalize the method to derive more general recursion relations on the full amplitudes.
description: 10 pages, v2: title and introduction changed, paper re-structured; Annales Henri Poincare (2011)
Stacked Trait Products Are As Safe As Non-Genetically Modified (GM) Products Developed By Conventional Breeding Practices
Creators: name: Goodwin, Laurie
name: Hunst, Penny
name: Burzio, Luis
name: Rowe, Laura
name: Money, Stephanie
name: Chakravarthy, Suma
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: stacked trait product
breeding stack
GM event
GM trait
single event
genetically modified plant
regulatory harmonization

description: International safety assessments and independent publications conclude that stacking genetically modified (GM) traits (events) through conventional breeding poses no greater risk to food or feed safety than stacking multiple non-GM traits by conventional breeding. Stacked trait products are not substantially different from their conventional comparator or their GM parent plants. Additional safety assessment of a stacked trait product produced by conventional breeding should not be required unless there is a plausible and testable hypothesis for interaction of the traits. However, the different approaches employed for the regulation of stacked trait products between countries results in asynchronous approvals, increasing the potential for trade flow disruptions, and adds to the regulatory burden for product developers. Considering their proven safety and benefit over the past 20+ years, regulatory authorities in some countries do not regulate stacked trait products, while others have simplified the approval process based on experience and sound science, reducing or eliminating the need for additional regulatory oversight. Countries that choose to regulate stacked trait products should consider integrating the more than 20 years of safety assessment experience, history of safe use, and global regulatory experience, in their approach to reduce redundancy, simplify regulations, and minimize the likelihood for trade disruption. doi: 10.21423/jrs-v09i1goodwin
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
A Theory of Pseudo-Wealth
Creators: name: Guzman, Martin
name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2016
Subjects: Economics
Labor supply
Wealth
Macroeconomics

description: Recent events in the US and Europe have witnessed the limitations of conventional macroeconomic models to predict and explain large economic recessions and crises, and to provide guidance for policies that attempt to resolve them.
Sustainable Development Goals and Measurement of Economic and Social Progress
Creators: name: Kanbur, Ravi
name: Patel, Ebrahim
name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2018
Subjects: Economics
Progress
Economic development
Well-being

description: The report by the Stiglitz-Sen-Fitoussi Commission raised fundamental questions about GDP as a measure of economic performance and social progress. The Sustainable Development Goals (SDGs) process put in train by the UN system proposes a number of goals and targets going beyond GDP that apply universally, to developing and developed countries alike. This chapter takes stock of the SDG process in relation to the general movement towards a broader perspective on the measurement of economic performance and social progress. Three central themes emerge. First, the inevitable and enduring tension between the pull to broaden and expand indicators for assessing and monitoring economic and social progress in development on the one hand, and the imperative to keep a relatively small number of top-level indicators, in order to facilitate national discourse and policy-making, on the other. The SDG list of 17 goals and 169 targets is useful as a platform from which to choose and narrow down, but choose we must at the national level. Second, National Statistical Offices must be given the governance independence and the financial resources with which to provide the framework for a data-based dialogue on economic and social progress at the national level. Third, some aspects of the measurement of progress and development are global and beyond the sole remit of any one National Statistical Office. For these exercises, and as a conduit for providing support to National Statistical Offices, the international community needs to commit resources for the provision of this global public good.
Operators whose dual has non-separable range
Creators: name: Dodos, Pandelis
Publisher: name: arXiv
Year: 2010
Subjects: subject: Functional Analysis (math.FA)
subject: FOS: Mathematics

description: Let $X$ and $Y$ be separable Banach spaces and $T:X\to Y$ be a bounded linear operator. We characterize the non-separability of $T^*(Y^*)$ by means of fixing properties of the operator $T$.
description: 20 pages, no figures
Fed Policy, Inequality, and Equality of Opportunity
Creators: name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2016
Subjects: Economics
Equality
Macroeconomics
Finance
Federal Reserve banks

description: Many are concerned that America has not been doing well in either equality of outcomes or opportunity. Our nation has obtained the dubious distinction of being the country among advanced countries with the highest level of inequality of outcomes and one of the lowest levels of equality of opportunity. This paper discusses the issue of inequality and inequality of opportunity, how Federal Reserve policies affect inequality, and what implications inequality should have for the conduct of Fed policy. I shall address both its role in macroeconomic management and in the regulation of financial markets. After a brief review of the state of inequality in the United States today, I will discuss the various channels through which the Federal Reserve affects inequality.
Streamlining Data Requirements for the Environmental Risk Assessment of Genetically Modified (GM) Crops for Cultivation Approvals
Creators: name: Anderson, Jennifer
name: Bachman, Pamela
name: Burns, Andrea
name: Chakravarthy, Suma
name: Goodwin, Laurie
name: Privalle, Laura
name: Song, Shuang
name: Storer, Nicholas
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: environmental risk assessment
genetically modified plant
problem formulation
data requirements
cultivation
Environmental risk assessment
regulatory harmonization

description: Genetically modified (GM) crops have been cultivated safely for more than 25 years, and the framework for conducting an environmental risk assessment (ERA) is well-established. Currently, there is alignment of broadly-stated protection goals across global jurisdictions; however, there is a lack of consistency for the data that are required by regulators. Risk assessors have over 25 years of collective experience assessing the environmental safety of GM crops and have conducted hundreds of ERAs to evaluate GM crop safety. This experience provides a scientific basis to help determine which data informs the ERA, and which data does not inform the safety assessment. The goals of this paper are to: 1) define the process for identifying potential pathways to harm based on robust problem formulation; 2) provide an overview of data that inform the science-based ERA for cultivation approval; 3) provide examples of data that are routinely or occasionally required but do not inform the ERA; and 4) make recommendations for harmonization of global ERA data requirements. Refinement and harmonization of data requirements across global regulatory authorities will add transparency and predictability to the ERA of GM crops globally, while ensuring that each country's protection goals are respected. doi: 10.21423/jrs-v09i1anderson
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Sovereign Debt and Joint Liability: An Economic Theory Model for Amending the Treaty of Lisbon
Creators: name: Basu, Kaushik
name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2015
Subjects: Economics
Finance
Debts, Public
Game theory

description: As the euro area crisis drags on, it is evident that a part of the problem lies in the architecture of debt within the euro area. This study argues that at least part of the debt problem could be addressed through limited cooperative action entailing appropriately structured contracts generating cross‐country liability for sovereign debt incurred by individual nations within the European Union. Such agreements are currently proscribed by the Treaty of Lisbon. We construct a game‐theoretic model demonstrating that there exist self‐fulfilling equilibria, which are Pareto superior to the existing outcome and which would come into existence if cross‐country debt liabilities were permitted.
Recommendations for Science-Based Safety Assessment of Genetically Modified (GM) Plants for Food and Feed Uses
Creators: name: Waters, Stephen
name: Ramos, Adela
name: Hendrickson Culler, Angela
name: Hunst, Penny
name: Zeph, Lawrence
name: Gast, Rachel
name: Mahadeo, Debbie
name: Sottosanto, Jordan
name: Huber, Scott
name: Shan, Guomin
name: Chakravarthy, Suma
name: Goodwin, Laurie
Publisher: name: Journal of Regulatory Science
Year: 2021
Subjects: genetically modified plant
food and feed
safety assessment
core studies
risk
problem formulation
supplementary studies
regulations
Genetically modified plant
food and feed safety assessment
regulatory harmonization

description: Since the commercial introduction of genetically modified (GM) plants in agriculture over two decades ago, technology developers and regulatory authorities have gained significant experience in assessing their safety based on assessing potential impact to humans, animals and the environment. Over 3500 independent regulatory agency reviews have positively concluded on the safety of GM plants for food and feed. Yet, divergent and increased regulatory requirements have led to delayed and asynchronous approvals, and have restricted access to innovative products for farmers and consumers. With accumulated knowledge from safety assessments conducted so far, an enhanced understanding of plant genomes, and a history of safe use, it is time to re-evaluate the current approaches to the regulation of GM plants used for food and feed. A stepwise approach using weight-of-evidence should be sufficient for the safety assessment of newly expressed proteins in GM plants. A set of core studies including molecular characterization, expression and characterization of the newly expressed proteins (or other expression product), and safety assessment of the introduced protein are appropriate to characterize the product and assess safety. Using data from core studies, and employing a “problem formulation” approach, the need for supplementary hypothesis-driven or case-by-case studies can be determined. Employing this approach for the evaluation of GM plants will remove regulatory data requirements that do not provide value to the safety assessment and provide a consistent framework for global regulation. doi: 10.21423/jrs-v09i1waters
description: Journal of Regulatory Science, Vol. 9 No. 1 (2021): Special Issue on Genetically Modified Organisms
Additional file 2 of Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice
Creators: name: Reardon, Tessa
name: Ukoumunne, Obioha C.
name: Violato, Mara
name: Ball, Susan
name: Brown, Paul
name: Ford, Tamsin
name: Gray, Alastair
name: Hill, Claire
name: Jasper, Bec
name: Larkin, Michael
name: Macdonald, Ian
name: Morgan, Fran
name: Pollard, Jack
name: Sancho, Michelle
name: Sniehotta, Falko F.
name: Spence, Susan H.
name: Stallard, Paul
name: Stainer, Jason
name: Taylor, Lucy
name: Williamson, Victoria
name: Day, Emily
name: Fisk, Jennifer
name: Green, Iheoma
name: Halliday, Gemma
name: Hennigan, Ciara
name: Pearcey, Samantha
name: Robertson, Olly
name: Creswell, Cathy
Publisher: name: figshare
Year: 2022
Subjects: subject: Medicine
subject: Biotechnology
subject: Sociology
subject: FOS: Sociology
subject: 69999 Biological Sciences not elsewhere classified
subject: FOS: Biological sciences
subject: Science Policy

description: Additional file 2: Supplement 2. Schedule of enrolment, intervention, and assessment.
Leaders and followers: Perspectives on the Nordic model and the economics of innovation
Creators: name: Stiglitz, Joseph E.
Publisher: name: Columbia University
Year: 2015
Subjects: Economics
Technological innovations--Economic aspects
International relations

description: What kinds of social and economic systems are most conducive to innovation? We formulate a simple model in which countries can close the gap with the technological leader, but where the cost of doing so may be so high that the country chooses to remain laggards. Observed disparities in productivity may be the result of a recognition that the cost of closing the gap exceeds benefit and there may therefore exist an international equilibrium in which there are leaders and followers. Even if it is granted that the United States is the leader and Scandinavia are followers, there are theoretical grounds for arguing that the Nordic model may in fact be better for innovation, suggesting that if the US adopted some of the Nordic institutions, innovations would be higher, and societal welfare would be improved even more.
Japanese Pharmaceutical Industry: Recent Perspectives and Areas for Further Research
Creators: name: Shibata, Shoyo
name: Ozaki, Koken
name: Suzuki, Takeshi
Publisher: name: Journal of Regulatory Science
Year: 2020
Subjects: Japan
pharmaceutical industry
drug pricing
regulatory science
clinical development
marketing strategy

description: The Japanese pharmaceutical market is one of the largest in the world. The Japanese government has increasingly been trying to control rising health care costs, and as a result, pharmaceutical companies are expecting that fewer opportunities will be available to command a higher price based on higher levels of innovation; this will likely lead to decreased interest in research and development (R&D) activities. With this background, the purpose of this article is to review current perspectives for R&D by the Japanese pharmaceutical industry, and to discuss the limitations and challenges for further research from the regulatory science and management perspectives. Given the substantial amount of evidence of regulatory science and management perspectives from the pharmaceutical industry outside of Japan and the limited amount of evidence from inside of Japan, it is important to review perspectives focusing on the Japanese pharmaceutical industry in comparison with those from other countries to understand the complexities of the Japanese pharmaceutical market, as well as the limitations and challenges associated with increasing productivity. https://doi.org/10.21423/jrs-v08shoyo
description: Journal of Regulatory Science, Vol. 8 (2020)