2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).

Biological Assay / methods Biomarkers / metabolism Flow Cytometry / methods Genetic Therapy / methods History, 21st Century Humans United States United States Food and Drug Administration / standards

Journal

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

Informations de publication

Date de publication:
Dec 2019
Historique:
pubmed: 11 12 2019
medline: 22 4 2020
entrez: 11 12 2019
Statut: ppublish

Résumé

The 2019 13

Identifiants

DOI: 10.4155/bio-2019-0271 PMID: 31820675
pubmed: 31820675
doi: 10.4155/bio-2019-0271
doi:

Substances chimiques

Biomarkers 0

Types de publication

Congress Historical Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2207-2244

Auteurs

Steven Piccoli (S)

GlaxoSmithKline, Collegeville, PA, USA.

Devangi Mehta (D)

Biogen, Cambridge, MA, USA.

Alessandra Vitaliti (A)

Novartis Pharma, Basel, Switzerland.

John Allinson (J)

Immunologix Laboratories, Tampa, FL, USA.

Shashi Amur (S)

US FDA, Silver Spring, MD, USA.

Steve Eck (S)

AstraZeneca, Gaithersburg, MD, USA.

Cherie Green (C)

Genentech, South San Francisco, CA, USA.

Michael Hedrick (M)

Bristol-Myers Squibb, Princeton, NJ, USA.

Shirley Hopper (S)

UK MHRA-NIBSC, London, UK.

Allena Ji (A)

Sanofi, Framingham, MA, USA.

Alison Joyce (A)

Pfizer, Andover, MA, USA.

Virginia Litwin (V)

Caprion Biosciences, Montreal, QC, Canada.

Kevin Maher (K)

US FDA, Silver Spring, MD, USA.

Joel Mathews (J)

Ionis Pharmaceutical, Carlsbad, CA, USA.

Kun Peng (K)

Genentech, South San Francisco, CA, USA.

Afshin Safavi (A)

BioAgilytix, Durham, NC, USA.

Yow-Ming Wang (YM)

US FDA, Silver Spring, MD, USA.

Yan Zhang (Y)

Bristol-Myers Squibb, Princeton, NJ, USA.

Lakshmi Amaravadi (L)

Shire/Takeda, Lexington, MA, USA.

Nisha Palackal (N)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Sai Thankamony (S)

Bristol-Myers Squibb, Princeton, NJ, USA.

Chris Beaver (C)

Syneos Health, Princeton, NJ, USA.

Eris Bame (E)

Biogen, Cambridge, MA, USA.

Thomas Emrich (T)

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

Christine Grimaldi (C)

Boehringer Ingelheim, Ridgefield, CT, USA.

Jonathan Haulenbeek (J)

Bristol-Myers Squibb, Princeton, NJ, USA.

Alison Joyce (A)

Pfizer, Andover, MA, USA.

Vellalore Kakkanaiah (V)

PPD, Richmond, VA, USA.

David Lanham (D)

Eurofins Bioanalysis Services, Abingdon, UK.

Kevin Maher (K)

US FDA, Silver Spring, MD, USA.

Andrew Mayer (A)

GlaxoSmithKline, Collegeville, PA, USA.

Paul C Trampont (PC)

Covance Central Laboratory, Greenfield, IN, USA.

Laurent Vermet (L)

Sanofi, Montpellier, France.

Naveen Dakappagari (N)

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

Catherine Fleener (C)

Pfizer, San Diego, CA, USA.

Fabio Garofolo (F)

Angelini Pharma, Pomezia, RM, Italy.

Cynthia Rogers (C)

bluebird bio, Cambridge, MA, USA.

Shabnam Tangri (S)

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

Yuanxin Xu (Y)

Alnylam Pharmaceuticals, Cambridge, MA, USA.

Meina Liang (M)

AstraZeneca, South San Francisco, CA, USA.

Manoj Rajadhyaksha (M)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Susan Richards (S)

Sanofi, Framingham, MA, USA.

Becky Schweighardt (B)

BioMarin, Novato, CA, USA.

Shobha Purushothama (S)

Biogen, Cambridge, MA, USA.

Daniel Baltrukonis (D)

Pfizer, Groton, CT, USA.

Jochen Brumm (J)

Genentech, South San Francisco, CA, USA.

Elana Cherry (E)

Health Canada, Ottawa, ON, Canada.

Jason Delcarpini (J)

Celldex Therapeutics, Needham, MA, USA.

Carol Gleason (C)

Bristol-Myers Squibb, Princeton, NJ, USA.

Susan Kirshner (S)

US FDA, Silver Spring, MD, USA.

Robert Kubiak (R)

AstraZeneca, Gaithersburg, MD, USA.

Luying Pan (L)

Shire/Takeda, Cambridge, MA, USA.

Michael Partridge (M)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

João Pedras-Vasconcelos (J)

US FDA, Silver Spring, MD, USA.

Qiang Qu (Q)

EMD Serono/Merck KGaA, Billerica, MA, USA.

Venke Skibeli (V)

Norwegian Medicines Agency, Oslo, Norway.

Therese Solstad Saunders (TS)

Norwegian Medicines Agency, Oslo, Norway.

Roland F Staack (RF)

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

Kay Stubenrauch (K)

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

Al Torri (A)

Regeneron Pharmaceuticals, Tarrytown, NY, USA.

Daniela Verthelyi (D)

US FDA, Silver Spring, MD, USA.

Haoheng Yan (H)

US FDA, Silver Spring, MD, USA.

Boris Gorovits (B)

Pfizer, Andover, MA, USA.

Rachel Palmer (R)

Sanofi, Framingham, MA, USA.

Mark Milton (M)

Novartis, Cambridge, MA, USA.

Brian Long (B)

BioMarin, Novato, CA, USA.

Bart Corsaro (B)

GlaxoSmithKline, Rockville, MD, USA.

Vahid Farrokhi (V)

Pfizer, Andover, MA, USA.

Michele Fiscella (M)

REGENXBIO, Rockville, MD, USA.

Neil Henderson (N)

AstraZeneca, Molndal, Sweden.

Vibha Jawa (V)

Merck & Co., Inc., Kenilworth, NJ, USA.

Jim McNally (J)

Shire/Takeda, Cambridge, MA, USA.

Rocio Murphy (R)

Merck & Co., Inc., West Point, PA, USA.

Hanspeter Waldner (H)

CRISPR Therapeutics, Cambridge, MA, USA.

Tong-Yuan Yang (TY)

Janssen R&D, Spring House, PA, USA.

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Classifications MeSH

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