Report of the European Medicines Agency Conference on RNA-Based Medicines.

European Medicines Agency (EMA) RNA-based medicines drug development oligonucleotides regulatory challenges

Journal

Nucleic acid therapeutics
ISSN: 2159-3345
Titre abrégé: Nucleic Acid Ther
Pays: United States
ID NLM: 101562758

Informations de publication

Date de publication:
04 Jan 2024
Historique:
medline: 4 1 2024
pubmed: 4 1 2024
entrez: 4 1 2024
Statut: aheadofprint

Résumé

RNA-based medicines have potential to treat a large variety of diseases, and research in the field is very dynamic. Proactively, The European Medicines Agency (EMA) organized a virtual conference on February 2, 2023 to promote the development of RNA-based medicines. The initiative addresses the goal of the EMA Regulatory Science Strategy to 2025 to "catalyse the integration of science and technology in medicines development." The conference focused on RNA technologies (excluding RNA vaccines) and involved different stakeholders, including representatives from academia, industry, regulatory authorities, and patient organizations. The conference comprised presentations and discussion sessions conducted by panels of subject matter experts. In this meeting report, we summarize the presentations and recap the main themes of the panel discussions.

Identifiants

pubmed: 38174996
doi: 10.1089/nat.2023.0021
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Auteurs

Falk Ehmann (F)

European Medicines Agency, Amsterdam, The Netherlands.

Andreas Kuhn (A)

BioNTech SE, Mainz, Germany.

Anna Maria Gerdina Pasmooij (AMG)

Medicines Evaluation Board (MEB), Utrecht, The Netherlands.

Anthony Humphreys (A)

European Medicines Agency, Amsterdam, The Netherlands.

Arjon Van Hengel (A)

DG Research and Innovation, European Commission, Brussels, Belgium.

Brian Dooley (B)

European Medicines Agency, Amsterdam, The Netherlands.

Brigitte Anliker (B)

Paul Ehrlich Institute (PEI), Langen, Germany.

Camilla Svensson (C)

Medical Products Agency (MPA), Uppsala, Sweden.

Daniel Capaldi (D)

Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.

David Henshall (D)

RCSI University of Medicine and Health Sciences College of Surgeons RCSI and FutureNeuro SFI Research Centre, Dublin, Ireland.

Emer Cooke (E)

European Medicines Agency, Amsterdam, The Netherlands.

Haiyan Zhou (H)

University College London (UCL), NIHR Great Ormond Street Hospital Biomedical Research Centre, London, United Kingdom.

Hilde Bastaerts (H)

European Medicines Agency, Amsterdam, The Netherlands.

Jeske Smink (J)

Silence Therapeutics GmbH, Berlin, Germany.

Joop Van Gerven (J)

Central Committee on Research Involving Human Subjects (CCMO), The Hague, The Netherlands.

Leonor Enes (L)

European Medicines Agency, Amsterdam, The Netherlands.

Lubomir Nechev (L)

Alnylam Pharmaceuticals, Inc., Cambridge, Massachusetts, USA.

Marcel Hoefnagel (M)

Medicines Evaluation Board (MEB), Utrecht, The Netherlands.

Mariëtte Driessens (M)

VSOP - Patient Alliance for Rare and Genetic Diseases, Soest, The Netherlands.

Michael Wenger (M)

BioNTech SE, Mainz, Germany.

Oriane Blanquie (O)

European Medicines Agency, Amsterdam, The Netherlands.
Department of Dermatology, University Medical Center of the Johannes Gutenberg-University Mainz, Germany.

Pawel Widomski (P)

BioNTech SE, Mainz, Germany.

Ralf Herold (R)

European Medicines Agency, Amsterdam, The Netherlands.

René Thürmer (R)

Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.

Sol Ruiz (S)

Agency of Medicines and Medical Products (AEMPS), Madrid, Spain.

Steffen Thirstrup (S)

European Medicines Agency, Amsterdam, The Netherlands.

Susan Goody (S)

ModernaCambridge, Massachusetts, USA.

Tal Zaks (T)

OrbiMed, Boston, Massachusetts, USA.

Valentina Cordò (V)

European Medicines Agency, Amsterdam, The Netherlands.

Annemieke M Aartsma-Rus (AM)

Leiden University Medical Center, Leiden, The Netherlands.

Classifications MeSH