Translating innovation into access for ATMPs: third EU-Innovation network multi-stakeholder meeting

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Date

, -

Locație

Online
Rome, Italy
Live broadcast

Event summary

The EU-Innovation Network (EU-IN) and the Italian Medicines Agency (AIFA) are organising a multi-stakeholder meeting to discuss how innovation in the development of Advanced Therapy Medicinal Products (ATMPs) can be translated into effective and safe therapies at the point of care in Europe.

The objectives are:

  • seek feedback from developers on the main challenges and barriers currently encountered from early development to access,
  • provide insights on scientific and regulatory advice tools at European and national level available for developers,
  • discuss opportunities for promoting mutual exchange and interactions between stakeholders with the aim of strengthening the European Innovation Ecosystem.

The meeting provides an open forum for all stakeholders and aims to foster collaboration across the European Innovation Ecosystem.

Documents

Agenda : Translating innovation to access for ATMPs: 3rd EU-Innovation network multi-stakeholder meeting

English (EN) (185.42 KB - PDF)

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Presentation - The landscape for ATMPs in Europe 15 years after the initial introduction of the Regulation (K.Breen, EMA)

English (EN) (778.47 KB - PDF)

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Presentation - survey to gather developers' view on challenges and opportunities in ATMP development (M.Di Marzo, AIFA)

English (EN) (1.15 MB - PDF)

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Presentation - Journey of ATMPs from early development to access in EU (F.Locatelli, Bambino Gesu Childrens Hospital)

English (EN) (4.55 MB - PDF)

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Presentation - (Regulatory) Challenges in the development of a CRISPR/Cas9 edited tacrolimus-resistant regulatory T cell product (L.Amini, BeCAT Therapies)

English (EN) (3.06 MB - PDF)

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Presentation - The journey of ATMPs from early development to access in EU: challenges and opportunitiesSME perspective (A. Natz, EUCOPE)

English (EN) (383.37 KB - PDF)

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Presentation - Translating Innovation into Access for ATMPs - Industry Perspective (M.Cattani, Farmindustria)

English (EN) (622.51 KB - PDF)

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Presentation - EMA support to innovation - Translating innovation into access for ATMPs (V.Cordo, EMA)

English (EN) (1.24 MB - PDF)

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Presentation - National Competent Authorities support to innovation - Translating innovationi nto access for ATMPs (E.Agricola, AIFA)

English (EN) (1.31 MB - PDF)

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Presentation - HTA Regulation - Joint scientific consultations and joint clinical assessment (P.Rivetti di Val Cervo, AIFA)

English (EN) (1.23 MB - PDF)

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Presentation - EU4Health Programme (G.Simone, HaDEA)

English (EN) (2.61 MB - PDF)

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Presentation - Horizon Europe funding programme - ATMPs (A-P. Papageorgiou, DG Research and Innovation)

English (EN) (2.06 MB - PDF)

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Presentation - Strengthening the European innovation ecosystem (T.Humphreys)

English (EN) (9.92 MB - PDF)

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Presentation - The GMO framework (C.Beuneu, FAMHP)

English (EN) (481.12 KB - PDF)

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Presentation - Combined developments CTR, MDR, IVDR (I.Reischl, BASG)

English (EN) (1.13 MB - PDF)

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Presentation - Hospital Exemption - Non repetitive use of Advanced Therapy Medicines (S.Petraglia, AIFA)

English (EN) (1.19 MB - PDF)

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Presentation - Case studies of academic development of ATMP: ARI0001 and ARI0002h (G.Calvo, Hospital Clinic Barcelona)

English (EN) (422.95 KB - PDF)

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Presentation - Case study: Fondazione Telethon (C.Scotti)

English (EN) (745.69 KB - PDF)

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Presentation - Case study: Holoclar (M.Latella, Holostem)

English (EN) (754.84 KB - PDF)

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Presentation - Round Table discussion: Main factors affecting development and access to ATMPs in the EU

English (EN) (142.99 KB - PDF)

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Presentation - Round Table discussion: Academia no-profit perspective (G.Calvo, Hospital Clinic de Barcelona)

English (EN) (185.33 KB - PDF)

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Presentation - Round Table discussion: Academia no-profit perspective (A.Biondi, University of Milan)

English (EN) (53.19 KB - PDF)

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Presentation - Round Table discussion: Academia no-profit perspective (A.Aiuti, San Raffaele Telethon Institute for Gene Therapy)

English (EN) (160.01 KB - PDF)

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Presentation - Round Table discussion: Industry perspective (R.Ena, Federchimica Assobiotec)

English (EN) (97.12 KB - PDF)

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Video recording

Survey

We plan to present ATMP developers' views on challenges and opportunities in the ATMP field at this meeting. Please consider contributing via this survey.

With this survey we would like:

  • to get feedback from developers on the perceived challenges and potential opportunities for improvement for ATMPs development and early access;
  • to investigate developers' awareness and experience of the current available EU regulatory support tools;
  • to understand developers' expectations with regard to regulators' role in EU public and public-private funded projects.

Access the survey:

Translating innovation into access for ATMPs

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