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  1. Article ; Online: I Just Can’t Get Enough (of Experts)

    MORVILLO, Marta

    European Journal of Risk Regulation

    The Numbers of COVID-19 and the Need for a European Approach to Testing

    2020  Volume 11, Issue 2, Page(s) 366–374

    Abstract: This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered ...

    Abstract This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered way, the shortage of resources seems to have acted as a driver of coordination, which is now increasingly being discussed at EU level. I will examine the legal and institutional framework supporting such embryonic coordination efforts and offer a preliminary assessment of their implications for a European approach to epidemiological knowledge-making.
    Keywords Safety Research ; covid19
    Language English
    Publisher Cambridge University Press (CUP)
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 2600871-3
    ISSN 2190-8249 ; 1867-299X
    ISSN (online) 2190-8249
    ISSN 1867-299X
    DOI 10.1017/err.2020.41
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: I Just Can’t Get Enough (of Experts): The Numbers of COVID-19 and the Need for a European Approach to Testing

    MORVILLO, Marta

    Abstract: This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered ...

    Abstract This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered way, the shortage of resources seems to have acted as a driver of coordination, which is now increasingly being discussed at EU level. I will examine the legal and institutional framework supporting such embryonic coordination efforts and offer a preliminary assessment of their implications for a European approach to epidemiological knowledge-making.
    Keywords covid19
    Publisher PMC
    Document type Article ; Online
    DOI 10.1017/err.2020.41
    Database COVID19

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  3. Article ; Online: Who shapes the CJEU regulatory jurisprudence? On the epistemic power of economic actors and ways to counter it

    Marta Morvillo / Maria Weimer

    European Law Open, Vol 1, Pp 510-

    2022  Volume 548

    Abstract: What role does the Court of Justice of the European Union (CJEU) play in holding European Union (EU) regulatory science, ie the science underpinning public regulation, to account for its epistemic quality? Since Pfizer, CJEU case law has strengthened the ...

    Abstract What role does the Court of Justice of the European Union (CJEU) play in holding European Union (EU) regulatory science, ie the science underpinning public regulation, to account for its epistemic quality? Since Pfizer, CJEU case law has strengthened the role of science in both EU risk regulation and litigation, whilst intensifying judicial scrutiny of scientific reasoning based on procedural standards. Scholars often welcome this approach as striking an adequate balance between effective judicial protection and institutional competence. Some praise the Court as an ‘information catalyst’ promoting procedures, in which epistemic quality is ensured through diligent consideration of and deliberation among all relevant voices. These debates, however, overlook the role of economic actors as information providers, in and challengers of EU risk regulation. This paper re-evaluates the modern post-Pfizer approach from a new, socio-legal perspective by studying, for the first time, the interactions between judicial review and the epistemic power of economic actors, ie their relative ability to influence what EU regulators know at the expense of other actors. We combine an epistemologically informed comparative institutional analysis with doctrinal critique of CJEU case law. Our findings show the need to rethink both legal standing and procedural review in EU risk regulation. Instead of catalysing inclusive procedures that open regulatory science to public scrutiny, the modern approach fosters an exclusive bilateral information exchange between the administration and the regulated industry. The Court reduces the function of process values, such as duty of care and reason-giving, to the protection of a small circle of actors, neglecting the public interest dimension of such values. Thus, the modern approach fails to address, and instead further entrenches the epistemic power imbalances inherent in EU risk regulation. We end by sketching out a normative and doctrinally sound vision of how CJEU review could contribute to EU ...
    Keywords administrative law ; risk regulation ; regulatory science ; epistemic power ; expert accountability ; judicial review ; Law of Europe ; KJ-KKZ
    Subject code 340
    Language English
    Publishing date 2022-09-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Role of NRAS mutations as prognostic and predictive markers in metastatic colorectal cancer.

    Schirripa, Marta / Cremolini, Chiara / Loupakis, Fotios / Morvillo, Manfredi / Bergamo, Francesca / Zoratto, Federica / Salvatore, Lisa / Antoniotti, Carlotta / Marmorino, Federica / Sensi, Elisa / Lupi, Cristiana / Fontanini, Gabriella / De Gregorio, Veronica / Giannini, Riccardo / Basolo, Fulvio / Masi, Gianluca / Falcone, Alfredo

    International journal of cancer

    2015  Volume 136, Issue 1, Page(s) 83–90

    Abstract: NRAS mutations occur in 3-5% of colorectal cancer. Differently from KRAS and BRAF mutations, the role of NRAS mutations as prognostic and predictive markers in metastatic colorectal cancer (mCRC) has been investigated to a lesser extent. A retrospective ... ...

    Abstract NRAS mutations occur in 3-5% of colorectal cancer. Differently from KRAS and BRAF mutations, the role of NRAS mutations as prognostic and predictive markers in metastatic colorectal cancer (mCRC) has been investigated to a lesser extent. A retrospective series suggested the role of NRAS mutations as predictors of resistance to anti-EGFR monoclonal antibodies (MoAbs) in chemo-refractory patients with mCRC. In our study, KRAS codons 12, 13, 61 and BRAF codon 600 mutational status were evaluated in mCRCs referred to our Institution from 2009 to 2012. NRAS codons 12, 13 and 61 mutational status was analyzed in KRAS/BRAF wt patients. We collected pathological and clinical features in the overall population and outcome data in a subset of NRAS mutated chemo-refractory patients treated with anti-EGFR MoAbs in advanced lines. NRAS was mutated in 47/786 (6%) mCRCs. NRAS and KRAS mutated tumors did not show significant differences in terms of clinical and pathological characteristics, except for a lower prevalence of mucinous histology (p = 0.012) and lung metastases (p = 0.012) among NRAS mutated tumors. In the uni- and multivariate model, NRAS mutations were associated with shorter overall survival (OS) compared to all wt patients (median OS 25.6 vs 42.7 months; univ: HR = 1.91, 95% CI 1.39-3.86, p = 0.0013; multiv: HR = 1.75, 95% CI 1.1.3-2.72, p = 0.013). None of the chemo-refractory NRAS mutated patients evaluable for response to anti-EGFRs achieved response. In conclusion, NRAS mutations have a relevant incidence in patients with mCRC and showed an association with specific clinical and pathological features. NRAS mutations affect mCRC patients' prognosis and predict lack of response to anti-EGFRs.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/pharmacology ; Antibodies, Monoclonal, Humanized/therapeutic use ; Biomarkers, Tumor/genetics ; Cetuximab ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/genetics ; Colorectal Neoplasms/mortality ; Colorectal Neoplasms/pathology ; DNA Mutational Analysis ; Disease-Free Survival ; Drug Resistance, Neoplasm/genetics ; Female ; GTP Phosphohydrolases/genetics ; Genetic Association Studies ; Humans ; Kaplan-Meier Estimate ; Liver Neoplasms/drug therapy ; Liver Neoplasms/genetics ; Liver Neoplasms/mortality ; Liver Neoplasms/secondary ; Male ; Membrane Proteins/genetics ; Middle Aged ; Mutation, Missense ; Prognosis ; Proportional Hazards Models ; Proto-Oncogene Proteins/genetics ; Proto-Oncogene Proteins B-raf/genetics ; Proto-Oncogene Proteins p21(ras) ; Receptor, Epidermal Growth Factor/antagonists & inhibitors ; Retrospective Studies ; ras Proteins/genetics
    Chemical Substances Antibodies, Monoclonal, Humanized ; Biomarkers, Tumor ; KRAS protein, human ; Membrane Proteins ; Proto-Oncogene Proteins ; EGFR protein, human (EC 2.7.10.1) ; Receptor, Epidermal Growth Factor (EC 2.7.10.1) ; BRAF protein, human (EC 2.7.11.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; GTP Phosphohydrolases (EC 3.6.1.-) ; NRAS protein, human (EC 3.6.1.-) ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2) ; ras Proteins (EC 3.6.5.2) ; Cetuximab (PQX0D8J21J)
    Language English
    Publishing date 2015-01-01
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 218257-9
    ISSN 1097-0215 ; 0020-7136
    ISSN (online) 1097-0215
    ISSN 0020-7136
    DOI 10.1002/ijc.28955
    Database MEDical Literature Analysis and Retrieval System OnLINE

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