Deliverables
The final softwareimplemented DSS including user guide will be tested on the selected case studies on 3 representatives nanomaterials Lipidots PACA and gold nanoparticles The accompanying documentation will include data from the DSS application to the study cases At least 20 prospective DSS users will be invited to a workshop for targeted training selected in interaction with WP6
REFINE user communitiesTwo communities of active contributors each of about 12 members strong will be established They will cocreate the DSS in particular the interface and options to add users preferences and will support WP 25 by offering methodsprocedures for the WP2 inventory andor participate in interlaboratory comparisons
First beta version DSSWe will arrange a workshop where approximately 20-25 stakeholders (regulators, industry, academia) are invited to inspect and interact with the early version of the DSS, including example data sets for input. This will give valuable feedback on adjustments of the DSS to users' needs and wishes.
Knowledge-HUB (K-HUB: Social media strategy implementation, explicit knowledge sharing repository)This online platform should provide access to all non-confidential REFINE results. The platform should be searchable and allow filtering, contributions and -if deemed useful- opportunities to engage in online discussions. We will make use of the glossary of terminology to appeal to various stakeholder communities.
REFINE final KECAn international event with participation form all relevant stakeholder communities nonEU world regions and policy makersresearch funding programmes
We will arrange a workshop where approximately 20-25 stakeholders (regulators, industry, academia) are invited to inspect and interact with the early version of the DSS, including example data sets for input. This will give valuable feedback on adjustments of the DSS to users' needs and wishes.
Progress report on the use of the whitepaper in community discussions, in particular the Knowldege Exchange Conferences, and the feed in to various knowledge bases used for regulatory purposesWe will review whether the whitepaper works as kernel for a sustained dialoge of regulators scientists and developers
Two workshops with strong participation from regulatorsTwo workshops will be organised with at least 15 external participants each, from regulatory bodies and expert-level scientific committees related to regulatory bodies, plus additional high-level participants from research and development.
Reflection DocumentA reflection document will present the outline of the methodology to design intelligent testing strategies, considerations regarding populating the repository and ranking methods according to product and measurand, current observations on CQAs, as well as approaches and structures intended for the DSS. This document will serve both as an internal orientation and as a foundation for interaction with external stakeholders as it will feed into the whitepaper-drafting in WP1.
Guidance Manual for stakeholdersThe Guidance Manual will include the methodology to design intelligent testing strategies the inventory of testing methods and procedures and the CQA recommendations The development of the DSS will also be described The format will be targeted towards all relevant stakeholders
Report outlining the transferability of the in silico approach together with the linked in vitro assaysThe report outlines the outcome of the test for transferability of the in silico approach together with the linked in vitro assays which is based on an interlaboratory comparison The report also includes the comprehesive statistical analysis of all the results together with the collection of the SOPs of the in silico approach and of all standardised in vitro assays used in this context
First draft of whitepaperThe draft whitepaper will propose a catalogue of information requirements and needs for harmonisation (e.g. to address borderline products that fall under different legislature in different world regions). It will propose a gap analysis, where scientific state of the art and regulatory practice seem out of step (e.g. present a list of major adversities of administered NBMs described in the scientific literature, that are hard to predict by current standard testing methods). Thirdly the document will propose a heuristic how to assimilate new evidence in reliable and efficient way into regulatory strategies (e.g. which testing methods would deliver information that supports the modeling of an NMB-specific Adverse Outcome Pathway, for example for CARPA ).
Report on inventory of testing methods and -proceduresThe statusquo of the repository with integrated ranking Task 22 will be reported in this deliverable This deliverable marks the start of consolidating the inventory within the methodology for intelligent testing architectures at the same time the deliverables serves as check whether we inspired a critial contribution from stakeholders information about testing methods performance and access to protocols that could be used in the inventory
Report on in vitro characterization of nanoparticle distributionReport on the quantitative evaluation of key variables such as apparent permeability through various barriers systems, or uptake kinetics in key cell populations
List of requirements for any method re eligibility for regulatory acceptance/ standardisationThe report summarizes the outcome of the interlaboratory comparison which tests the transferability of the involved methods The report also includes the comprehesive statistical analysis of all the results together with the collection of the SOPs
Publications
Author(s):
Suzan M. Hammond; Annemieke Aartsma-Rus; Sandra Alves; Sven Even F. Borgos; Ronald A.M. Buijsen; Rob W.J. Collin; Giuseppina Covello; Giuseppina Covello; Michela A. Denti; Lourdes R. Desviat; Lucia Echevarria; Camilla Foged; Gisela Gaina; Alejandro Garanto; Aurélie Goyenvalle; Magdalena Guzowska; Irina Holodnuka; David R. Jones; Sabine Krause; Taavi Lehto; Taavi Lehto; Marisol Montolio; Willeke M
Published in:
Hammond , S M , Aartsma-Rus , A , Alves , S , Borgos , S E , Buijsen , R A M , Collin , R W J , Covello , G , Denti , M A , Desviat , L R , Echevarría , L , Foged , C , Gaina , G , Garanto , A , Goyenvalle , A T , Guzowska , M , Holodnuka , I , Jones , D R , Krause , S , Lehto , T , Montolio , M , Van Roon-Mom , W & Arechavala-Gomeza , V 2021 , ' Delivery of oligonucleotide-based therapeutics : c, Issue 8, 2021, ISSN 1757-4676
Publisher:
John Wiley & Sons Ltd.
DOI:
10.15252/emmm.202013243
Author(s):
Henry Pertinez; Rajith K. R. Rajoli; Saye Khoo; Andrew Owen
Published in:
Journal of Antimicrobial Chemotherapy, Issue 1, 2021, ISSN 0305-7453
Publisher:
Oxford University Press
DOI:
10.1101/2021.01.03.21249159
Author(s):
Dania Movia; Adriele Prina-Mello
Published in:
Animals : an Open Access Journal from MDPI, Issue 1, 2020, ISSN 2076-2615
Publisher:
MDPI AG
DOI:
10.3390/ani10081259
Author(s):
Kai Moritz Eder, Anne Marzi, Álvaro Barroso, Steffi Ketelhut, Björn Kemper,
and Jürgen Schnekenburger
Published in:
Cells, 2022, ISSN 2073-4409
Publisher:
MDPI
DOI:
10.3390/cells11040644
Author(s):
Rajith K. R. Rajoli; Henry Pertinez; Usman Arshad; Helen Box; Lee Tatham; Paul Curley; Megan Neary; Joanne Sharp; Neill J. Liptrott; Anthony Valentijn; Christopher David; Steve P. Rannard; Ghaith Aljayyoussi; Shaun H. Pennington; Andrew Hill; Marta Boffito; Stephen A. Ward; Saye Khoo; Patrick G. Bray; Paul M. O'Neill; W. David Hong; Giancarlo A. Biagini; Andrew Owen
Published in:
medRxiv, Issue 9, 2021, ISSN 0306-5251
Publisher:
Blackwell Publishing Inc.
DOI:
10.22541/au.158938595.50403411
Author(s):
Perugini V., Santin M.
Published in:
Frontiers in Cell and Developmental Biology, 2021, ISSN 2296-634X
Publisher:
Frontiers Media S.A.
DOI:
10.3389/fcell.2021.701842
Author(s):
Anne Marzi, Kai Moritz Eder, Álvaro Barroso, Ane Marit Wågbø, Torkild Visnes, Geir Klinkenberg, Björn Kemper, Jürgen Schnekenburger
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
Author(s):
Maiara Camotti Montanha, Alice Howarth, Doaa Ahmed Mohamed, Estelle Loier, Lauren Main, Matthias Rösslein, Christiaan Delmaar, Adriele Prina-Mello, Marco Siccardi
Published in:
Drug Delivery and Translational Research, Issue 2190393X, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s13346-022-01175-w
Author(s):
Hannon G., Prina-Mello A.
Published in:
Wiley Interdisciplinary Reviews: Nanomedicine and Nanobiotechnology, 2021, ISSN 1939-5116
Publisher:
John Wiley and Sons Inc
DOI:
10.1002/wnan.1738
Author(s):
Andreas K.O. Åslund, Rob J. Vancebriel, Fanny Caputo, Wim H. de Jong, Christiaan Delmaar, Astrid Hyldbakk, Emilie Rustique, Ruth Schmid, Sofie Snipstad, Isabelle Texier, Kai Vernstad, Sven Even F. Borgos
Published in:
Drug Delivery and Translational Research, Issue 2190393X, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s13346-022-01159-w
Author(s):
Maroua Ben Haddada; Dania Movia; Adriele Prina-Mello; Jolanda Spadavecchia
Published in:
Colloids and Surfaces B: Biointerfaces, Issue 6, 2020, ISSN 0927-7765
Publisher:
Elsevier BV
DOI:
10.1016/j.colsurfb.2020.111172
Author(s):
Gioria S., Caputo F., Mehn D.
Published in:
Nanomedicine, 2019, ISSN 1743-5889
Publisher:
Future Medicine Ltd.
DOI:
10.2217/nnm-2019-0173
Author(s):
Walker L.E., FitzGerald R., Saunders G., Lyon R., Fisher M., Martin K., Eberhart I., Woods C., Ewings S., Hale C., Rajoli R.K.R., Else L., Dilly-Penchala S., Amara A., Lalloo D.G., Jacobs M., Pertinez H., Hatchard P., Waugh R., Lawrence M., Johnson L., Fines K., Reynolds H., Rowland T., Crook R., Okenyi E., Byrne K., Mozgunov P., Jaki T., Khoo S., Owen A., Griffiths G., Fletcher T.E., the AGILE pl
Published in:
Clinical Pharmacology and Therapeutics, 2021, ISSN 0009-9236
Publisher:
Nature Publishing Group
DOI:
10.1002/cpt.2463
Author(s):
Jordi Minnema, Sven Even F. Borgos, Neill Liptrott, Rob Vandebriel, Christiaan Delmaar
Published in:
Drug Delivery and Translational Research, Issue 2190393X, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s13346-022-01145-2
Author(s):
Antje Vennemann, Daniel Breitenstein, Elke Tallarek, Yrr Mørch, Ruth Schmid, Martin Wiemann
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s13346-022-01128-3
Author(s):
Melissa Anne Tutty, Adriele Prina-Mello, Gabriele Vella
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.21203/rs.3.rs-1277778/v1
Author(s):
Hannon, Gary; Lysaght, Joanne; Liptrott, Neill J.; Prina‐Mello, Adriele
Published in:
Advanced Science, Vol 6, Iss 19, Pp n/a-n/a (2019), Issue 4, 2019, ISSN 2198-3844
Publisher:
John Wiley and Sons Inc.
DOI:
10.1002/advs.201900133
Author(s):
Singh B., Abdelgawad M.E., Ali Z., Bailey J., Budyn E., Civita P., Clift M.J.D., Connelly J.T., Constant S., Hittinger M., Kandarova H., Kearns V.R., Kiuru T., Kostrzewski T., Kress S., Durban V.M., Lehr C.-M., McMillan H., Metz J.K., Monteban V., Movia D., Neto C., Owen C., Paasonen L., Palmer K.A., Pilkington G.J., Pilkington K., Prina-Mello A., Roper C., Sheard J., Smith S., Turner J.E., Roy I.
Published in:
ATLA Alternatives to Laboratory Animals, 2021, ISSN 0261-1929
Publisher:
Fund for the Replacement of Animals in Medical Experiments
DOI:
10.1177/02611929211025006
Author(s):
Halamoda-Kenzaoui, Blanka; Baconnier, Simon; Bastogne, Thierry; Bazile, Didier; Boisseau, Patrick; Borchard, Gerrit; Borgos, Sven Even; Calzolai, Luigi; Cederbrant, Karin; Di Felice, Gabriella; Di Francesco, Tiziana; Dobrovolskaia, Marina A.; Gaspar, Rogério; Gracia, Belén; Hackley, Vincent A.; Leyens, Lada; Liptrott, Neill; Park, Margriet; Patri, Anil; Roebben, Gert; Roesslein, Matthias; Thürm
Published in:
Regulatory Toxicology and Pharmacology, Issue 3, 2019, ISSN 0273-2300
Publisher:
Academic Press
DOI:
10.1016/j.yrtph.2019.04.011
Author(s):
B. HALAMODA-KENZAOUI, H. BOX,
M. VAN ELK,
S. GAITAN,
R. GEERTSMA,
E. GAINZA LAFUENTE,
A. OWEN, A. DEL POZO, M.
ROESSLEIN, S.
BREMER- HOFFMANN
Published in:
Precision Nanomedicine, 2020, ISSN 2639-9431
Publisher:
Andover House
DOI:
10.33218/001c.13521
Author(s):
Caputo F., Vogel R., Savage J., Vella G., Law A., Della Camera G., Hannon G., Peacock B., Mehn D., Ponti J., Geiss O., Aubert D., Prina-Mello A., Calzolai L.
Published in:
Journal of Colloid and Interface Science, 2021, ISSN 0021-9797
Publisher:
Academic Press
DOI:
10.1016/j.jcis.2020.12.039
Author(s):
Valeria Perugini; Matteo Santin
Published in:
Journal of Materials Science. Materials in Medicine, Issue 3, 2020, ISSN 1573-4838
Publisher:
Springer Nature
DOI:
10.1007/s10856-020-06373-x
Author(s):
Three-dimensional (3D) liver cell models - A tool for bridging the gap between animal studies and clinical trials when screening liver accumulation and toxicity of nanobiomaterials
Published in:
Drug Delivery and Translational Research, Issue 2190393X, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s13346-022-01147-0
Author(s):
Valeria Perugini, Samuel M. Flaherty, Matteo Santin
Published in:
Journal of Materials Science: Materials in Medicine, 2022, Page(s) 33:37, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s10856-022-06658-3
Author(s):
Boffito M., Back D.J., Flexner C., Sjö P., Blaschke T.F., Horby P.W., Cattaneo D., Acosta E.P., Anderson P., Owen A.
Published in:
Clinical Pharmacology and Therapeutics, 2021, ISSN 0009-9236
Publisher:
Nature Publishing Group
DOI:
10.1002/cpt.2099
Author(s):
Kai Moritz Eder, Anne Marzi, Ane Marit Wågbø, Jolanda P. Vermeulen, Liset J.J. de la Fonteyne-Blankestijn, Matthias Rösslein, Rainer Ossig, Geir Klinkenberg, Rob J. Vandebriel, Jürgen Schnekenburger
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
Author(s):
Markova N., Cairns S., Jankevics-Jones H., Kaszuba M., Caputo F., Parot J.
Published in:
Vaccines, 2021, ISSN 2076-393X
Publisher:
Multidisciplinary Digital Publishing Institute (MDPI)
DOI:
10.3390/vaccines10010049
Author(s):
Julian A. Hiscox; Julian A. Hiscox; Saye Khoo; James P. Stewart; Andrew Owen
Published in:
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, Issue 2, 2021, ISSN 0305-7453
Publisher:
Oxford University Press
DOI:
10.1093/jac/dkab189
Author(s):
Mildner R., Hak S., Parot J., Hyldbakk A., Borgos S.E., Some D., Johann C., Caputo F.
Published in:
European Journal of Pharmaceutics and Biopharmaceutics, 2021, ISSN 0939-6411
Publisher:
Elsevier BV
DOI:
10.1016/j.ejpb.2021.03.004
Author(s):
Alex Zabeo, Fabio Rosada, Lisa Pizzol, Fanny Caputo, Sven Even Borgos, Jeremie Parot, Robert E Geertsma, Joost Jacob Pouw, Rob J Vandebriel, Oihane Ibarrola Moreno, Danail Hristozov
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.21203/rs.3.rs-1246960/v1
Author(s):
Robert Vogel; John Savage; Julien Muzard; Giacomo Della Camera; Gabriele Vella; Alice Law; Marianne Marchioni; Dora Mehn; Otmar Geiss; Ben Peacock; Dimitri Aubert; Luigi Calzolai; Fanny Caputo; Adriele Prina-Mello
Published in:
Journal of Extracellular Vesicles, Vol 10, Iss 3, Pp n/a-n/a (2021), Issue 8, 2021, ISSN 2001-3078
Publisher:
John Wiley and Sons Inc
DOI:
10.1002/jev2.12052
Author(s):
Arshad U., Pertinez H., Box H., Tatham L., Rajoli R.K.R., Curley P., Neary M., Sharp J., Liptrott N.J., Valentijn A., David C., Rannard S.P., O’Neill P.M., Aljayyoussi G., Pennington S.H., Ward S.A., Hill A., Back D.J., Khoo S.H., Bray P.G., Biagini G.A., Owen A.
Published in:
Clinical Pharmacology and Therapeutics, 2020, ISSN 0009-9236
Publisher:
Nature Publishing Group
DOI:
10.1002/cpt.1909
Author(s):
B. Halamoda-Kenzaoui, R.J. Vandebriel, A. Howarth, M. Siccardi, C.A.W. David, N.J. Liptrott, M. Santin, S.E. Borgos, S. Bremer-Hoffmann, F. Caputo
Published in:
Journal of Controlled Release, Issue 336, 2021, Page(s) 192-206, ISSN 0168-3659
Publisher:
Elsevier BV
DOI:
10.1016/j.jconrel.2021.06.016
Author(s):
Valeria Perugini, Ruth Schmid, Yrr Mørch, Isabelle Texier, Martin Brodde, Matteo Santin
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
DOI:
10.1007/s13346-022-01141-6
Author(s):
Lead beneficiary: SINTEF
Published in:
2018
Publisher:
REFINE Project
Author(s):
Lead beneficiary: GreenDecision
Published in:
2020
Publisher:
REFINE Project
Author(s):
Lead beneficiary: Joint Research Center
Published in:
2019
Publisher:
REFINE Project
Author(s):
Lead beneficiary: Joint Research Center
Published in:
2018
Publisher:
REFINE Project
Author(s):
Lead beneficiary: University of Liverpool
Published in:
2019
Publisher:
REFINE Project
Author(s):
B. HALAMODA-KENZAOUI, H. BOX,
M. VAN ELK,
S. GAITAN,
R. GEERTSMA,
E. GAINZA LAFUENTE,
A. OWEN, A. DEL POZO, M.
ROESSLEIN, S.
BREMER- HOFFMANN
Published in:
2019, ISSN 1831-9424
Publisher:
Publications Office of the European Union
DOI:
10.2760/596822
Author(s):
Valeria Perugini, Matteo Santin
Published in:
Chinese-European Societies for Biomaterials Conference, 2019
Publisher:
Chinese Society for Biomaterials (CSBM) and European Society for Biomaterials (ESB)
Author(s):
Kai Eder, Anne Marzi, Álvaro Barroso, Björn Kemper, Jürgen Schnekenburger
Published in:
Quantitative Phase Imaging VII; 116531Q, Issue Proceedings Volume 11653, 2021
Publisher:
SPIE
DOI:
10.1117/12.2577655
Author(s):
Valeria Perugini, Matteo Santin
Published in:
30th European Society for Biomaterials Conference, 2019, Page(s) III-OS10-05 page 188
Publisher:
European Society for Biomaterials
Author(s):
Kai Moritz Eder, Anne Marzi, Alvaro Barroso, Björn Kemper, and Jürgen Schnekenburger
Published in:
Imaging and Applied Optics Congress, OSA Technical Digest, Issue Imaging and Applied Optics Congress, OSA Technical Digest (Optica Publishing Group, 2020), paper JW5A.4., 2020
Publisher:
OSA
Author(s):
Kai Eder, Tobias Kutscher, Anne Marzi, Álvaro Barroso, Jürgen Schnekenburger, Björn Kemper
Published in:
Label-free Biomedical Imaging and Sensing, 2021
Publisher:
SPIE
DOI:
10.1117/12.2577232
Author(s):
Tobias Kutscher, Kai Eder, Anne Marzi, Álvaro Barroso, Jürgen Schnekenburger, and Björn Kemper
Published in:
OSA Optical Sensors and Sensing Congress 2021, Issue OSA Technical Digest (Optica Publishing Group, 2021), paper JTu5A.23., 2021
Publisher:
OSA
Author(s):
Matteo Santin (Invited Keynote Speaker)
Published in:
Tissue Engineering and Regenerative Medicine International Societies (TERMIS) 2019, 2019, Page(s) 726
Publisher:
TERMIS
Author(s):
Kemper B., Barroso Á., Eder K., Marzi A., Ritz S., Schnekenburger J., Ketelhut S.
Published in:
2021
Publisher:
Progress in Biomedical Optics and Imaging - Proceedings of SPIE
DOI:
10.1117/12.2577807
Author(s):
Björn Kemper, Álvaro Barroso, Kai Eder, Anne Marzi, Sabrina Ritz, Angelos Ntovas, Jürgen Schnekenbürger, Steffi Ketelhut
Published in:
Proceedings Volume 11786, Optical Methods for Inspection, Characterization, and Imaging of Biomaterials V; 117860I (2021), Issue SPIE Optical Metrology, 2021, 2021
Publisher:
SPIE
DOI:
10.1117/12.2592534
Author(s):
Kai Moritz Eder
Published in:
2021
Publisher:
XXX
Author(s):
Christina Giannakou
Published in:
2019
Publisher:
Maastricht University
Author(s):
Kathleen Spring, Klaus-Michael Weltring, Adriele Prina-Mello, Ruth Schmid
Published in:
Drug Delivery and Translational Research, 2022, ISSN 2190-393X
Publisher:
Springer Pub. Co.,
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