2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (

Biological Assay Biomarkers / analysis Biotechnology Cell- and Tissue-Based Therapy Genetic Therapy Humans Research Report
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:
Mar 2021
Historique:
pubmed: 30 1 2021
medline: 30 11 2021
entrez: 29 1 2021
Statut: ppublish

Résumé

The 14

Identifiants

DOI: 10.4155/bio-2021-0005 PMID: 33511867
pubmed: 33511867
doi: 10.4155/bio-2021-0005
doi:

Substances chimiques

Biomarkers 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

295-361

Auteurs

Susan Spitz (S)

Incyte Research Institute, Wilmington, DE, USA.

Yan Zhang (Y)

Bristol-Myers Squibb, Lawrenceville, NJ, USA.

Sally Fischer (S)

Genentech, South San Francisco, CA, USA.

Kristina McGuire (K)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Ulrike Sommer (U)

Novartis, Basel, Switzerland.

Lakshmi Amaravadi (L)

Boston Pharmaceuticals, Cambridge, MA, USA.

Abbas Bandukwala (A)

US FDA, Silver Spring, MD, USA.

Steven Eck (S)

Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.

Fabio Garofolo (F)

BRI, Vancouver, BC, Canada.

Rafiqul Islam (R)

Celerion, Lincoln, NE, USA.

Gregor Jordan (G)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Lindsay King (L)

Pfizer, Andover, MA, USA.

Yoshiro Saito (Y)

Japan MHLW-NIHS, Tokyo, Japan.

Giane Sumner (G)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Linda Terry (L)

GlaxoSmithKline, Stevenage, UK.

Alessandra Vitaliti (A)

Novartis, Basel, Switzerland.

Yow-Ming Wang (YM)

US FDA, Silver Spring, MD, USA.

Christine Grimaldi (C)

Boehringer Ingelheim, Ridgefield, CT, USA.

Alison Joyce (A)

Pfizer, Groveland, MA, USA.

Rachel Palmer (R)

Sanofi, Framingham, MA, USA.

Matthew Andisik (M)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Marcela Araya (M)

Pfizer, Medford, MA, USA.

Mitra Azadeh (M)

Takeda, Cambridge, MA, USA.

Daniel Baltrukonis (D)

Pfizer, Groton, CT, USA.

Rebecca Elliott (R)

Genentech, South San Francisco, CA, USA.

Sam Haidar (S)

US FDA, Silver Spring, MD, USA.

Seema Kumar (S)

EMD Serono, Andover, MA, USA.

Andrew Mayer (A)

GlaxoSmithKline, Collegeville, PA, USA.

Florian Neff (F)

Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.

Nisha Palackal (N)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Kun Peng (K)

Genentech, South San Francisco, CA, USA.

Mohsen Rajabi Abhari (MR)

US FDA, Silver Spring, MD, USA.

Christina Satterwhite (C)

Charles River, Reno, NV, USA.

Natasha Savoie (N)

CFABS, Montreal, QC, Canada.

Catherine Soo (C)

Health Canada, Ottawa, ON, Canada.

Stephen Vinter (S)

UK MHRA, London, UK.

Jan Welink (J)

EMA, London, UK.

Weili Yan (W)

Genentech, South San Francisco, CA, USA.

Kevin Maher (K)

US FDA, Silver Spring, MD, USA.

David Lanham (D)

Eurofins Bioanalysis Services, Abingdon, UK.

Sylvie Bertholet (S)

GSK vaccines, Rockville, MD, USA.

Naveen Dakappagari (N)

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

Christèle Gonneau (C)

Covance, Meyrin, Switzerland.

Cherie Green (C)

Genentech, South San Francisco, CA, USA.

Fabian Junker (F)

F. Hoffmann-La Roche, Basel, Switzerland.

Sumit Kar (S)

CFABS, Montreal, QC, Canada.

Lisa Patti-Diaz (L)

Bristol-Myers Squibb, Mt. Laurel, NJ, USA.

Shyam Sarikonda (S)

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

Megan McCausland (M)

Q2 Solutions, Marietta, GA, USA.

Priscila Camillo Teixeira (PC)

F. Hoffmann-La Roche, Basel, Switzerland.

Vilma Decman (V)

GlaxoSmithKline, Philadelphia, PA, USA.

Jose Estevam (J)

Takeda, Cambridge, MA, USA.

Michael Hedrick (M)

Bristol-Myers Squibb, Holland, PA, USA.

Alberto Hidalgo Robert (AH)

Genentech, South San Francisco, CA, USA.

Gregory Hopkins (G)

bluebird bio, Cambridge, MA, USA.

Sandra Nuti (S)

GSK vaccines, Rockville, MD, USA.

Shabnam Tangri (S)

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

Richard Wnek (R)

Merck, Kenilworth, NJ, USA.

Suman Dandamudi (S)

US FDA, Silver Spring, MD, USA.

Arindam Dasgupta (A)

US FDA, Silver Spring, MD, USA.

Anna Edmison (A)

Health Canada, Ottawa, ON, Canada.

Patrick Faustino (P)

US FDA, Silver Spring, MD, USA.

Michael McGuinness (M)

UK MHRA, London, UK.

Gustavo Mendes Lima Santos (GM)

Brazil ANVISA, Brasilia, Brazil.

Tahseen Mirza (T)

US FDA, Silver Spring, MD, USA.

Diaa Shakleya (D)

US FDA, Silver Spring, MD, USA.

Susan Stojdl (S)

Health Canada, Ottawa, ON, Canada.

Nilufer Tampal (N)

US FDA, Silver Spring, MD, USA.

Jinhui Zhang (J)

US FDA, Silver Spring, MD, USA.

Elana Cherry (E)

Health Canada, Ottawa, ON, Canada.

Isabelle Cludts (I)

UK MHRA-NIBSC, London, UK.

Andrew Exley (A)

UK MHRA, London, UK.

Akiko Ishii-Watabe (A)

Japan MHLW-NIHS, Tokyo, Japan.

Susan Kirshner (S)

US FDA, Silver Spring, MD, USA.

Joao Pedras-Vasconcelos (J)

US FDA, Silver Spring, MD, USA.

Meiyu Shen (M)

US FDA, Silver Spring, MD, USA.

Richard Siggers (R)

Health Canada, Ottawa, ON, Canada.

Therese Solstad (T)

Norwegian Medicines Agency (NoMA), Oslo, Norway.

Daniela Verthelyi (D)

US FDA, Silver Spring, MD, USA.

Haoheng Yan (H)

US FDA, Silver Spring, MD, USA.

Lucia Zhang (L)

Health Canada, Ottawa, ON, Canada.

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Classifications MeSH

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