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  1. Article ; Online: From Research to Policy: Unveiling Dementia Prevention Efforts in Switzerland.

    Mattia, Andreoletti / Blasimme, Alessandro

    Journal of aging & social policy

    2024  , Page(s) 1–21

    Abstract: Recent research has challenged the notion that dementia is an inevitable outcome of age-related cognitive decline, highlighting the possibility of preventing or delaying onset by addressing specific risk factors. This paradigm shift suggests that ... ...

    Abstract Recent research has challenged the notion that dementia is an inevitable outcome of age-related cognitive decline, highlighting the possibility of preventing or delaying onset by addressing specific risk factors. This paradigm shift suggests that prevention through lifestyle modifications and early interventions is possible, potentially averting millions of cases worldwide. This study explores the translation of scientific evidence on dementia prevention into public health policy in Switzerland. Combining the analysis of official policy documents and qualitative interviews with stakeholders, the study explores potential barriers and challenges to implementing preventive intervenions or programs, as well as opportunities for improvement. Results indicate a significant gap in incorporating emerging scientific evidence on dementia prevention into health policies and disseminating information to the public in Switzerland. This study underscores the need for a collaborative and coordinated approach to address these barriers and effectively translate scientific findings into preventive policies and campaigns. These insights can inform policy and targeted programs in Switzerland both at the federal and the cantonal level, eventually serving as a model for other countries seeking to translate evidence-based dementia prevention strategies into public health policies. By bridging the gap between research and policy, significant progress can be made in preventing or delaying the onset of dementia, providing significant benefits to individuals, families, and society.
    Language English
    Publishing date 2024-01-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 1046396-3
    ISSN 1545-0821 ; 0895-9420
    ISSN (online) 1545-0821
    ISSN 0895-9420
    DOI 10.1080/08959420.2023.2297602
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: The plasticity of ageing and the rediscovery of ground-state prevention.

    Blasimme, Alessandro

    History and philosophy of the life sciences

    2021  Volume 43, Issue 2, Page(s) 67

    Abstract: In this paper, I present an emerging explanatory framework about ageing and care. In particular, I focus on how, in contrast to most classical accounts of ageing, biomedicine today construes the ageing process as a modifiable trajectory. This framing ... ...

    Abstract In this paper, I present an emerging explanatory framework about ageing and care. In particular, I focus on how, in contrast to most classical accounts of ageing, biomedicine today construes the ageing process as a modifiable trajectory. This framing turns ageing from a stage of inexorable decline into the focus of preventive strategies, harnessing the functional plasticity of the ageing organism. I illustrate this shift by focusing on studies of the demographic dynamics in human population, observations of ageing as an intraspecifically heterogenous phenotype, and the experimental manipulation of longevity, in both model organisms and humans. I suggest that such an explanatory framework about ageing creates the epistemological conditions for the rise of a peculiar form of prevention that does not aim to address a specific condition. Rather it seeks to stall the age-related accumulation of molecular damage and functional deficits, boosting individual resilience against age-related decline. I call this preventive paradigm "ground-state prevention." While new, ground-state prevention bears conceptual resemblance to forms of medical wisdom prominent in classic Galenic medicine, as well as in the Renaissance period.
    MeSH term(s) Aging ; Humans ; Longevity ; Phenotype
    Language English
    Publishing date 2021-05-04
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2094240-0
    ISSN 1742-6316 ; 0391-9714
    ISSN (online) 1742-6316
    ISSN 0391-9714
    DOI 10.1007/s40656-021-00414-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Human stem cell-derived embryo models: Toward ethically appropriate regulations and policies.

    Blasimme, Alessandro / Sugarman, Jeremy

    Cell stem cell

    2023  Volume 30, Issue 8, Page(s) 1008–1012

    Abstract: Human pluripotent stem cells can be used to derive in vitro models recapitulating post-implantation human embryos. While useful for research purposes, such integrated embryo models raise ethical issues that need to be addressed to facilitate ethically ... ...

    Abstract Human pluripotent stem cells can be used to derive in vitro models recapitulating post-implantation human embryos. While useful for research purposes, such integrated embryo models raise ethical issues that need to be addressed to facilitate ethically appropriate policies and regulations that permit scientific ingenuity and medical progress.
    MeSH term(s) Humans ; Pluripotent Stem Cells ; Embryo, Mammalian ; Embryonic Development
    Language English
    Publishing date 2023-07-03
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2375354-7
    ISSN 1875-9777 ; 1934-5909
    ISSN (online) 1875-9777
    ISSN 1934-5909
    DOI 10.1016/j.stem.2023.06.007
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: "Tailored-to-You": Public Engagement and the Political Legitimation of Precision Medicine.

    Blasimme, Alessandro / Vayena, Effy

    Perspectives in biology and medicine

    2023  Volume 59, Issue 2, Page(s) 172–188

    Abstract: With the launch of the Precision Medicine Initiative (PMI) in January 2015, the White House granted a high degree of federal support to an emerging biomedical paradigm. What explains this level of political recognition? Based on literature and policy ... ...

    Abstract With the launch of the Precision Medicine Initiative (PMI) in January 2015, the White House granted a high degree of federal support to an emerging biomedical paradigm. What explains this level of political recognition? Based on literature and policy analysis, we reconstruct the scientific and the legislative paths that led to the political endorsement of precision medicine. First, we describe the proliferation of personalized approaches to therapy ignited by the discovery of hemoprotein cytochrome P450 polymorphism in 1988. Then, we analyze the legislative history of precision medicine, from the unsuccessful introduction of Genomics and Personalized Medicine Acts in the second half of the last decade, to the highly acclaimed PMI. However, scientific progress and political contingency alone do not explain the upheaval of precision medicine as an institutionally supported initiative. On examination, the launch of a Precision Medicine Research Cohort and the incorporation of a participatory ethos into the fabric of the PMI proved to be crucial determinants of the political support for precision medicine. Weaving together the scientific and legislative antecedents of precision medicine, we illuminate how the mutual constitution of science and social order generates political recognition for innovative biomedical paradigms.
    Language English
    Publishing date 2023-09-21
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80373-x
    ISSN 1529-8795 ; 0031-5982
    ISSN (online) 1529-8795
    ISSN 0031-5982
    DOI 10.1353/pbm.2017.0002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Accelerated drug approval: Meeting the ethical yardstick.

    Andreoletti, Mattia / Blasimme, Alessandro

    Bioethics

    2023  Volume 37, Issue 7, Page(s) 647–655

    Abstract: Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. ... ...

    Abstract Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) has recently come under scrutiny due to the U.S. Food and Drug Administration's decision to authorize Aducanumab, the first Alzheimer's disease drug. This decision attracted fierce criticism due to the allegedly insufficient evidence about the safety and efficacy of the drug. While considerable scholarly attention has been devoted to this case, the ethical aspects of the AA regulatory pathway have so far remained relatively unexplored. In this paper, we set out to fill this gap. We illustrate six conditions that should be met for AA to be ethically acceptable: moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency. We discuss such conditions and suggest practical steps to implement them in regulatory and oversight processes. Taken together, our six conditions represent a benchmark for assessing the ethical validity of AA processes and decisions.
    MeSH term(s) Humans ; United States ; Pharmaceutical Preparations ; Drug Approval ; Morals ; United States Food and Drug Administration
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2023-06-21
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632984-6
    ISSN 1467-8519 ; 0269-9702
    ISSN (online) 1467-8519
    ISSN 0269-9702
    DOI 10.1111/bioe.13191
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Sync fast and solve things-best practices for responsible digital health.

    Landers, Constantin / Blasimme, Alessandro / Vayena, Effy

    NPJ digital medicine

    2024  Volume 7, Issue 1, Page(s) 113

    Abstract: Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing ... ...

    Abstract Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing regulatory principles, oversight methods and ethical frameworks seem out of sync with digital health innovation. New governance and innovation best practices are thus needed to bring such principles to bear with the reality of business, innovation, and regulation.To grant practical insight into best practices for responsible digital health innovation, we conducted a qualitative study based on an interactive engagement methodology. We engaged key stakeholders (n = 46) operating at the translational frontier of digital health. This approach allowed us to identify three clusters of governance and innovation best practices in digital health innovation: i) inclusive co-creation, ii) responsive regulation, and iii) value-driven innovation. Our study shows that realizing responsible digital health requires diverse stakeholders' commitment to adapt innovation and regulation practices, embracing co-creation as the default modus operandi for digital health development. We describe these collaborative practices and show how they can ensure that innovation is neither slowed by overregulation, nor leads to unethical outcomes.
    Language English
    Publishing date 2024-05-04
    Publishing country England
    Document type Journal Article
    ISSN 2398-6352
    ISSN (online) 2398-6352
    DOI 10.1038/s41746-024-01105-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: A Systemic Approach to the Oversight of Machine Learning Clinical Translation.

    Vayena, Effy / Blasimme, Alessandro

    The American journal of bioethics : AJOB

    2022  Volume 22, Issue 5, Page(s) 23–25

    MeSH term(s) Delivery of Health Care ; Ethics, Research ; Health Facilities ; Humans ; Machine Learning
    Language English
    Publishing date 2022-04-27
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 2060433-6
    ISSN 1536-0075 ; 1526-5161
    ISSN (online) 1536-0075
    ISSN 1526-5161
    DOI 10.1080/15265161.2022.2055216
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Why Include the Public in Genome Editing Governance Deliberation?

    Blasimme, Alessandro

    AMA journal of ethics

    2019  Volume 21, Issue 12, Page(s) E1065–1070

    Abstract: With the birth of genetically engineered twins in November 2018, international debate about human genome editing governance has moved from an emphasis on mutual engagement among multiple stakeholders to a self-regulatory model enacted through high-level ... ...

    Abstract With the birth of genetically engineered twins in November 2018, international debate about human genome editing governance has moved from an emphasis on mutual engagement among multiple stakeholders to a self-regulatory model enacted through high-level expert groups with little or no public input. This article reconstructs this paradigm shift and suggests that inclusive public deliberation should still have a role in public decision making about genome editing.
    MeSH term(s) CRISPR-Cas Systems ; Community Participation ; Gene Editing/ethics ; Gene Editing/legislation & jurisprudence ; Genetic Therapy/ethics ; Genetic Therapy/legislation & jurisprudence ; Genome, Human/genetics ; Government Regulation ; Humans
    Language English
    Publishing date 2019-12-01
    Publishing country United States
    Document type Journal Article
    ISSN 2376-6980
    ISSN (online) 2376-6980
    DOI 10.1001/amajethics.2019.1065
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Organ chip research in Europe: players, initiatives, and policies.

    da Silva, Renan Gonçalves Leonel / Blasimme, Alessandro

    Frontiers in bioengineering and biotechnology

    2023  Volume 11, Page(s) 1237561

    Abstract: Background: ...

    Abstract Background:
    Language English
    Publishing date 2023-09-04
    Publishing country Switzerland
    Document type Systematic Review
    ZDB-ID 2719493-0
    ISSN 2296-4185
    ISSN 2296-4185
    DOI 10.3389/fbioe.2023.1237561
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: From lab to society

    Renan Gonçalves Leonel daSilva / Alessandro Blasimme

    Bioengineering & Translational Medicine, Vol 9, Iss 1, Pp n/a-n/a (2024)

    Fostering clinical translation of molecular systems engineering

    2024  

    Abstract: Abstract Over the last decade, bioengineering has seen a sustained growth in scientific publications, patents, and clinical trials. As the field attempts to bridge the gap between discovery and clinical application, a broader societal dialogue is needed ... ...

    Abstract Abstract Over the last decade, bioengineering has seen a sustained growth in scientific publications, patents, and clinical trials. As the field attempts to bridge the gap between discovery and clinical application, a broader societal dialogue is needed to build public trust and address potential ethical, societal, and regulatory challenges. In this essay, we discuss societal aspects linked to the clinical use of biomedical engineering approaches and technologies, with a specific focus on molecular systems engineering. Drawing on data from interviews with 24 scientists, we identified four key aspects for fostering societal support for translational efforts in this domain: (1) effective science communication and internal awareness; (2) open societal dialogue; (3) fair and equitable access to new technologies; and (4) adequate science and technology policies. We conclude that molecular systems engineering would benefit from anticipating future challenges with the view of building a robust bond of trust with lay publics, regulators, and society at large.
    Keywords biomedical engineering ; engagement ; molecular systems engineering ; science policy ; society ; trust ; Chemical engineering ; TP155-156 ; Biotechnology ; TP248.13-248.65 ; Therapeutics. Pharmacology ; RM1-950
    Subject code 170
    Language English
    Publishing date 2024-01-01T00:00:00Z
    Publisher Wiley
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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