2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (

Humans Biomarkers / analysis Cell- and Tissue-Based Therapy Vaccines / immunology Flow Cytometry Biological Assay / methods European Union White
WRIB bioanalysis biomarkers cell therapy gene therapy immunogenicity vaccine

Journal

Bioanalysis
ISSN: 1757-6199
Titre abrégé: Bioanalysis
Pays: England
ID NLM: 101512484

Informations de publication

Date de publication:
2024
Historique:
medline: 20 6 2024
pubmed: 20 6 2024
entrez: 20 6 2024
Statut: ppublish

Résumé

The 17

Identifiants

DOI: 10.1080/17576180.2024.2340961 PMID: 38899739
pubmed: 38899739
doi: 10.1080/17576180.2024.2340961
doi:

Substances chimiques

Biomarkers 0
Vaccines 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

179-220

Auteurs

Olga Kholmanskikh (O)

Belgium FAMHP, Brussels, Belgium.

Yow-Ming Wang (YM)

US FDA, Silver Spring, MD, USA.

Sarah Hersey (S)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Meenu Wadhwa (M)

UK MHRA, London, UK.

Katherine Block (K)

Genentech, South San Francisco, CA, USA.

Abbas Bandukwala (A)

US FDA, Silver Spring, MD, USA.

Matthew Szapacs (M)

Abbvie, Philadelphia, PA, USA.

Russell Weiner (R)

Takeda, Cambridge, MA, USA.

Khader Awwad (K)

Abbvie, Ludwigshafen, Germany.

Francis Dessy (F)

GlaxoSmithKline, Rixensart, Belgium.
Takeda, Cambridge, MA, USA.

Sean Downing (S)

Takeda, Cambridge, MA, USA.

Xiulian Du (X)

US FDA, Silver Spring, MD, USA.

Fabio Garofolo (F)

BRI Frontage, Vancouver, BC, Canada.

Shannon Harris (S)

HilleVax, Cambridge, MA, USA.

Victor Hou (V)

Moderna, Cambridge, MA, USA.

Jennifer Jones (J)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Sumit Kar (S)

WRIB, Toronto, ON, Canada.

Arvind Kinhikar (A)

Novartis, Cambridge, MA, USA.

Ming Li (M)

Stoke, Cambridge, MA, USA.

Joel Mathews (J)

Ionis, Carlsbad, CA, USA.

John Meissen (J)

AstraZeneca, South San Francisco, CA, USA.

Giane Oliveira Sumner (GO)

Regeneron, Tarrytown, NY, USA.

Luying Pan (L)

Takeda, Cambridge, MA, USA.

Gerard Sanderink (G)

Sanofi Pasteur, Swiftwater, PA, USA.

Ingrid Scully (I)

Pfizer, Pearl River, NY, USA.

Johannes Stanta (J)

Celerion, Stevenage, UK.

Yoichi Tanaka (Y)

Japan MHLW, Tokyo, Japan.

Stephanie Vauleon (S)

F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Leslie Wagner (L)

US FDA, Silver Spring, MD, USA.

Kai Wang (K)

GlaxoSmithKline, Collegeville, PA, USA.

Liang Zhu (L)

Moderna, Cambridge, MA, USA.

Steven Eck (S)

AstraZeneca, Gaithersburg, MD, USA.

Yi-Dong Lin (YD)

Takeda, Cambridge, MA, USA.

Mitra Azadeh (M)

Ultragenyx, Cambridge, MA, USA.

Vilma Decman (V)

GlaxoSmithKline, Collegeville, PA, USA.

Sandra Diebold (S)

UK MHRA, London, UK.

Xiulian Du (X)

US FDA, Silver Spring, MD, USA.

Polina Goihberg (P)

Pfizer, Andover, MA, USA.

Enrique Gomez Alcaide (EG)

F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Christele Gonneau (C)

Labcorp, Meyrin, Switzerland.

Michael Nathan Hedrick (MN)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Gregory Hopkins (G)

2seventy Bio, Cambridge, MA, USA.

Sumit Kar (S)

WRIB, Toronto, ON, Canada.

Jakob Loschko (J)

Pfizer, Pearl River, NY, USA.

Megan McCausland (M)

Q2 Solutions, Atlanta. GA, USA.

Luis Mendez (L)

Merck, Kenilworth, NJ, USA.

Sarita Sehra (S)

Incyte, Wilmington, DE, USA.

Erin Stevens (E)

Pfizer, Groton, CT, USA.

Yongliang Steve Sun (YS)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Shabnam Tangri (S)

Navigate, a Novartis Subsidiary, San Diego, CA, USA.

Paul C Trampont (PC)

Moderna, Cambridge, MA, USA.

Isabelle Cludts (I)

UK MHRA, London, UK.

Mark Dysinger (M)

Alexion, New Haven, CT, USA.

Uma Kavita (U)

Spark Therapeutics, Plainsboro, NJ, USA.

Hiroshi Sugimoto (H)

Takeda, Cambridge, MA, USA.

Shannon Chilewski (S)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Christine Grimaldi (C)

Regeneron, Tarrytown, NY, USA.

Yong Jiang (Y)

GlaxoSmithKline, Collegeville, PA, USA.

John Kamerud (J)

Pfizer, Andover, MA, USA.

Susana Liu (S)

Pfizer, Kirkland, QC, Canada.

Carolina Owen (C)

Pfizer, Groton, CT, USA.

Nisha Palackal (N)

Regeneron, Tarrytown, NY, USA.

Corinne Petit-Frere (C)

Fresenius Kabi, Bad Homburg, Germany.

Samuel Pine (S)

Sanofi, Ghent, Belgium.

Mohsen Rajabi Abhari (MR)

US FDA, Silver Spring, MD, USA.

Kara Scheibner (K)

US FDA, Silver Spring, MD, USA.

LaKenya Williams (L)

Bristol Myers Squibb, Lawrenceville, NJ, USA.

Tao Xu (T)

Frontage, Exton, PA, USA.

Guodong Zhang (G)

Alnylam, Cambridge, MA, USA.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › 2023 White Paper on Recent Issues in...
questionsmedicales.fr › Facteurs biologiques › Marqueurs biologiques › 2023 White Paper on Recent Issues in...
questionsmedicales.fr › Thérapeutique › Biothérapie › Thérapie cellulaire et tissulaire › 2023 White Paper on Recent Issues in...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › 2023 White Paper on Recent Issues in...
questionsmedicales.fr › Techniques d'investigation › Techniques cytologiques › Cytophotométrie › Cytométrie en flux › 2023 White Paper on Recent Issues in...
questionsmedicales.fr › Techniques d'investigation › Dosage biologique › 2023 White Paper on Recent Issues in...
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