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2. Possible Health Technology Assessment Pathways

Author

Carreras, Mireia Espallargues, Cuscó, Xavier Garcia, Alessandrello, Rossana, Maspons, Ramon, Serigado, Alexandre, Rousseau, Cécile F., Voisin, Emmanuelle M., Morales-Orcajo, Enrique, Viceconti, Marco, Viceconti, Marco, editor, and Emili, Luca, editor

Published
2024
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4. Possible Contexts of Use for In Silico trials methodologies: a consensus-based review

Author

Viceconti, Marco, Emili, Luca, Afshari, Payman, Courcelles, Eulalie, Curreli, Cristina, Famaey, Nele, Geris, Liesbet, Horner, Marc, Jori, Maria Cristina, Kulesza, Alexander, Loewe, Axel, Neidlin, Michael, Reiterer, Markus, Rousseau, Cecile F., Russo, Giulia, Sonntag, Simon J., Voisin, Emmanuelle M., and Pappalardo, Francesco

Subjects
Physics - Biological Physics, Quantitative Biology - Quantitative Methods
Abstract

The term "In Silico Trial" indicates the use of computer modelling and simulation to evaluate the safety and efficacy of a medical product, whether a drug, a medical device, a diagnostic product or an advanced therapy medicinal product. Predictive models are positioned as new methodologies for the development and the regulatory evaluation of medical products. New methodologies are qualified by regulators such as FDA and EMA through formal processes, where a first step is the definition of the Context of Use (CoU), which is a concise description of how the new methodology is intended to be used in the development and regulatory assessment process. As In Silico Trials are a disruptively innovative class of new methodologies, it is important to have a list of possible CoUs highlighting potential applications for the development of the relative regulatory science. This review paper presents the result of a consensus process that took place in the InSilicoWorld Community of Practice, an online forum for experts in in silico medicine. The experts involved identified 46 descriptions of possible CoUs which were organised into a candidate taxonomy of nine CoU categories. Examples of 31 CoUs were identified in the available literature; the remaining 15 should, for now, be considered speculative., Comment: Submitted to IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS

Published
2021
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9. “Artificial intelligence”: Which services, which applications, which results and which development today in clinical research? Which impact on the quality of care? Which recommendations?

Author

Adenot, Isabelle, Balague, Christine, Barthélémy, Philippe, Boubenna, Nacer, Coulonjou, Hélène, Fernandez, Xosé, Habran, Enguerrand, Lethiec, Françoise, Longin, Juliette, Metzinger, Anne, Merlière, Yvon, Pham, Emmanuel, Philip, Pierre, Roche, Thomas, Saurin, William, Tirel, Anny, Voisin, Emmanuelle, Marchal, Thierry, Diebolt, Vincent, Azancot, Isaac, and Boissel, François-Henri

Published
2019
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10. « Intelligence artificielle » : quels services, quelles applications, quels résultats et quelle valorisation aujourd’hui en recherche clinique ? Quel impact sur la qualité des soins ? Quelles recommandations ?

Author

Adenot, Isabelle, Balague, Christine, Barthélémy, Philippe, Boubenna, Nacer, Coulonjou, Hélène, Fernandez, Xosé, Habran, Enguerrand, Lethiec, Françoise, Longin, Juliette, Metzinger, Anne, Merlière, Yvon, Pham, Emmanuel, Philip, Pierre, Roche, Thomas, Saurin, William, Tirel, Anny, Voisin, Emmanuelle, Marchal, Thierry, Diebolt, Vincent, Azancot, Isaac, and Boissel, François-Henri

Published
2019
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14. A snapshot of current practices and perceptions of Public & Patient Involvement (PPI) within the Avicenna Alliance

Author

Levine, Steven M., De Cunha-Burgman, Martha, Liesbet Geris, Raphaelle Lesage, Marchal, Thierry, Mengoni, Marlène, Rousseau, Cécile F., Serigado, Alexandre, Staumont, Bernard, Thorez, Anne, Voisin, Emmanuelle, and Thinnes, Cyrille C.

Abstract

To better understand the PPI maturity level among AA members before tailoring PPI activities, the PPI TF decided to conduct an AA-internal surveyto identify current PPI practices and perceptions within the AA to serve as a guide to the newly established PPI TF for improved targeting of future content and activities in an evidence-based approach. As a secondary aim, the survey was intended to help raise PPI awareness within the AA by catalysing conversations about the topic.

Published
2023
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17. Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review

Author

Viceconti, Marco, primary, Emili, Luca, additional, Afshari, Payman, additional, Courcelles, Eulalie, additional, Curreli, Cristina, additional, Famaey, Nele, additional, Geris, Liesbet, additional, Horner, Marc, additional, Jori, Maria Cristina, additional, Kulesza, Alexander, additional, Loewe, Axel, additional, Neidlin, Michael, additional, Reiterer, Markus, additional, Rousseau, Cecile F., additional, Russo, Giulia, additional, Sonntag, Simon J., additional, Voisin, Emmanuelle M., additional, and Pappalardo, Francesco, additional

Published
2021
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18. Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

Author

Musuamba, Flora T., primary, Skottheim Rusten, Ine, additional, Lesage, Raphaëlle, additional, Russo, Giulia, additional, Bursi, Roberta, additional, Emili, Luca, additional, Wangorsch, Gaby, additional, Manolis, Efthymios, additional, Karlsson, Kristin E., additional, Kulesza, Alexander, additional, Courcelles, Eulalie, additional, Boissel, Jean‐Pierre, additional, Rousseau, Cécile F., additional, Voisin, Emmanuelle M., additional, Alessandrello, Rossana, additional, Curado, Nuno, additional, Dall’ara, Enrico, additional, Rodriguez, Blanca, additional, Pappalardo, Francesco, additional, and Geris, Liesbet, additional

Published
2021
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19. Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

Author

Ruthsatz, Manfred, Voisin, Emmanuelle, Lima, Nelson, DHondt, Kathleen, and Universidade do Minho

Subjects
regulatory policy, microbiomes
Abstract

This article describes the human microbiota and microbiomes strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical applicability. They conclude that, given the complexity of issues, a well-orchestrated, multistakeholder approach is advisable for the best chance of success., info:eu-repo/semantics/publishedVersion

Published
2020

20. Innovative medicine development.

Author

Pimpaneau, Valerie and Voisin, Emmanuelle

Abstract

BACKGROUND: In recent years the global landscape of pharmaceutical development has evolved drastically in order to adapt to innovative products such as immunotherapy, regenerative medicines and cell and gene therapy, all offering the hope to cure numerous untreated diseases. The global COVID-19 pandemic also led competent authorities in charge of approval of new medicines to implement adapted regulatory pathways allowing early access to innovative treatments and vaccines. New challenges are to be overcome, it is the short development time, or the small patient populations, or again drug product features requiring complete new production, testing and distribution strategies. OBJECTIVE: This paper provides a short overview of the different adaptations required to allow the development of such innovative medicines. METHOD: Several drug development strategies for products under clinical development or recently approved were assessed. RESULTS: Fully integrated strategies encompassing research, non-clinical, clinical and product manufacturing development along with adapted regulatory pathways, anticipation of market access and supported by risk based are important. In such fast pace, the development of relevant manufacturing processes and test methods assessing quality, safety and efficacy of new drugs falls on the critical path and requires particular attention, anticipation and detailed planning as early as possible in order to ensure successful filing and approval. CONCLUSION: Insights within innovative products approved recently reveal the importance of defining a solid chemistry manufacturing and control strategy early on as part of clinical development. Interactions with agencies at key milestones of development are also essential to reduce risks, prioritize development to support safety and allow early access to patients. [ABSTRACT FROM AUTHOR]

Published
2022
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22. Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges

Author

Musuamba, Flora T., primary, Bursi, Roberta, additional, Manolis, Efthymios, additional, Karlsson, Kristin, additional, Kulesza, Alexander, additional, Courcelles, Eulalie, additional, Boissel, Jean‐Pierre, additional, Lesage, Raphaëlle, additional, Crozatier, Cécile, additional, Voisin, Emmanuelle M., additional, Rousseau, Cécile F., additional, Marchal, Thierry, additional, Alessandrello, Rossana, additional, and Geris, Liesbet, additional

Published
2020
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23. Anticipating new regulatory hurdles; the EU's small-and medium-sized biotech companies might make strides, especially when developing drugs to treat rare and serious orphan diseases

Author

Voisin, Emmanuelle M. and Schroeder, Manfred

Subjects
European Union, Biotechnology, General interest, Health
Abstract

The potential of the biotechnology industry to provide blockbuster products is clearly demonstrated by examples like Enbrel (for the treatment of rheumatoid arthritis in adults and of active polyarticular-course juvenile [...]

Published
2004

24. « Intelligence artificielle » : quels services, quelles applications, quels résultats et quelle valorisation aujourd’hui en recherche clinique ? Quel impact sur la qualité des soins ? Quelles recommandations ?

Author

Diebolt, Vincent, primary, Azancot, Isaac, additional, Boissel, François-Henri, additional, Adenot, Isabelle, additional, Balague, Christine, additional, Barthélémy, Philippe, additional, Boubenna, Nacer, additional, Coulonjou, Hélène, additional, Fernandez, Xosé, additional, Habran, Enguerrand, additional, Lethiec, Françoise, additional, Longin, Juliette, additional, Metzinger, Anne, additional, Merlière, Yvon, additional, Pham, Emmanuel, additional, Philip, Pierre, additional, Roche, Thomas, additional, Saurin, William, additional, Tirel, Anny, additional, Voisin, Emmanuelle, additional, and Marchal, Thierry, additional

Published
2019
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25. “Artificial intelligence”: Which services, which applications, which results and which development today in clinical research? Which impact on the quality of care? Which recommendations?

Author

Diebolt, Vincent, primary, Azancot, Isaac, additional, Boissel, François-Henri, additional, Adenot, Isabelle, additional, Balague, Christine, additional, Barthélémy, Philippe, additional, Boubenna, Nacer, additional, Coulonjou, Hélène, additional, Fernandez, Xosé, additional, Habran, Enguerrand, additional, Lethiec, Françoise, additional, Longin, Juliette, additional, Metzinger, Anne, additional, Merlière, Yvon, additional, Pham, Emmanuel, additional, Philip, Pierre, additional, Roche, Thomas, additional, Saurin, William, additional, Tirel, Anny, additional, Voisin, Emmanuelle, additional, and Marchal, Thierry, additional

Published
2019
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26. New drug registration in France.

Author

Voisin, Emmanuelle M., Cheix, Francoise, Campion, Marie-Danielle, and Hoyle, Peter

Subjects
Drugs -- Laws, regulations and rules, Pharmaceutical industry -- Laws, regulations and rules
Published
1991

27. Conservation and polymorphism of mitochondrial intergenic sequences in brown algae (Phaeophyceae)

Author

Marie Voisin Emmanuelle Billard, Frédérique Viard, and Carolyn R. Engel

Subjects
Genetics, Brown algae, Mitochondrial DNA, Intergenic region, biology, Genetic marker, Uniparental inheritance, Plant Science, Aquatic Science, Laminaria digitata, biology.organism_classification, Tandem repeat locus, Intraspecific competition
Abstract

Due to their haploid nature, uniparental inheritance and apparent absence of recombination, organellar DNA markers are ideal tools for studying both intraspecific and interspecific phylogenies. Although ‘universal’ cytoplasmic DNA primers have become available for both red and green seaweeds, they are not transferable to brown seaweeds. Thus, based on the sequence of mitochondrial genome of the kelp Laminaria digitata, we developed universal-type primers for seven intergenic spacer loci and one mononucleotide tandem repeat locus. We investigated the conservation and sequence variation of these loci among nine Laminarialean and three fucoid species, as well as intraspecific polymorphism within five of these species. Six loci were conserved in at least four of the five brown algal families tested and five were polymorphic within at least one species. Although overall levels of divergence were relatively homogenous (π = 0.314 ± 0.031), a hierarchical analysis suggests there is variation in the rate of evolut...

Published
2008

30. Conservation and polymorphism of mitochondrial intergenic sequences in brown algae (Phaeophyceae).

Author

Engel, Carolyn R., Billard, Marie Voisin, Emmanuelle, and Viard, Frederique

Subjects
*MARINE algae, *DNA, *GENES, *GENETIC markers, *GENOMES
Abstract

Due to their haploid nature, uniparental inheritance and apparent absence of recombination, organellar DNA markers are ideal tools for studying both intraspecific and interspecific phylogenies. Although 'universal' cytoplasmic DNA primers have become available for both red and green seaweeds, they are not transferable to brown seaweeds. Thus, based on the sequence of mitochondrial genome of the kelp Laminaria digitata, we developed universal-type primers for seven intergenic spacer loci and one mononucleotide tandem repeat locus. We investigated the conservation and sequence variation of these loci among nine Laminarialean and three fucoid species, as well as intraspecific polymorphism within five of these species. Six loci were conserved in at least four of the five brown algal families tested and five were polymorphic within at least one species. Although overall levels of divergence were relatively homogenous (π = 0.314 ± 0.031), a hierarchical analysis suggests there is variation in the rate of evolutionary change among the six intergenic spacers. Due to their high degree of transferability, versatility and to non-coding nature, we argue that these intergenic spacer loci are highly efficient markers for within-family phylogenetic studies and for intra-specific phylogeographic studies in brown seaweeds. [ABSTRACT FROM AUTHOR]

Published
2008
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36. BioVision 2007, Immunization for all. 11-14 March 2007, Lyon, France.

Author

Voisin E

Subjects
Developing Countries, Financial Support, Global Health, Goals, Health Services Accessibility, Humans, Drug Design, Immunization Programs organization & administration, Vaccination, Vaccines economics, Vaccines standards, Vaccines supply & distribution
Published
2007

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