Evidence map›Paper›PMID 39862111›Full record

ArticleBioanalysis2025

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation

Omar Tounekti, Sandra Prior, Sarah Wassmer, Joshua Xu, Adrian Wong, Xiaodong Fang, Ivo Sonderegger, John Smeraglia, James Huleatt, LiNa Loo and 53 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioanalysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

63 authors.

Omar TounektiHealth Canada, Ottawa, ON, Canada.
Sandra PriorUK MHRA, London, UK.
Sarah WassmerHealth Canada, Ottawa, ON, Canada.
Joshua XuUS FDA, Jefferson, AR, USA.
Adrian WongHealth Canada, Ottawa, ON, Canada.
Xiaodong FangAskBio, Research Triangle Park, NC, USA.
Ivo SondereggerTakeda, Opfikon, Switzerland.
John SmeragliaAstraZeneca, Cambridge, UK.
James HuleattGates Medical Research Institute, Cambridge, MA, USA.
LiNa LooVertex, Boston, MA, USA.
Christopher BeaverTakeda, Cambridge, MA, USA.
Jason DelCarpiniModerna, Mystic, CT, USA.
Francis DessyGlaxoSmithKline, Rixensart, Belgium.
Sandra DieboldUK MHRA, London, UK.
Michele FiscellaREGENXBIO, Rockville, MD, USA.
Fabio GarofoloBRI Frontage, Vancouver, BC, Canada.
Christine GrimaldiRegeneron, Tarrytown, NY, USA.
Swati GuptaAbbVie, Irvine, CA, USA.
Victor HouModerna, Mystic, CT, USA.
Chad IrwinHealth Canada, Ottawa, ON, Canada.
Dewal JaniTakeda, San Diego, CA, USA.
Julie JosephHealth Canada, Ottawa, ON, Canada.
Warren KalinaPfizer, Pearl River, NY, USA.
Sumit KarWRIB, Toronto, ON, Canada.
Uma KavitaSpark, Philadelphia, Pa, USA.
Yanmei LuSangamo, South San Francisco, CA, USA.
Jean-Claude MarshallModerna, Mystic, CT, USA.
Christian MayerAustria AGES, Vienna, Austria.
Johanna MoraBristol Myers Squibb, Lawrenceville, NJ, USA.
Katrina NolanMerck, West Point, PA, USA.
Kun PengGenentech, South San Francisco, CA, USA.
Nathan RiccitelliNavigate, a Novartis Subsidiary, San Diego, CA, USA.
Ingrid ScullyPfizer, Pearl River, NY, USA.
Jessica SeitzerIntellia, Cambridge, MA, USA.
Mark SternBristol Myers Squibb, Lawrenceville, NJ, USA.
Meenu WadhwaUK MHRA, London, UK.
Yuanxin XuIntellia, Cambridge, MA, USA.
Daniela VerthelyiUS FDA, Silver Spring, MD, USA.
Giane SumnerRegeneron, Tarrytown, NY, USA.
Adrienne Clements-EganLarimar, Bala Cynwyd, PA, USA.
Cecil ChenAstraZeneca, South San Francisco, CA, USA.
Boris GorovitsRegeneron, Tarrytown, NY, USA.
Albert TorriRegeneron, Tarrytown, NY, USA.
Daniel BaltrukonisPfizer, Groton, CT, USA.
George GunnGlaxoSmithKline, Collegeville, PA, USA.
Akiko Ishii-WatabeJapan MHLW, Tokyo, Japan.
Daniel KramerSanofi, Frankfurt, Germany.
Robert J KubiakAstraZeneca, Gaithersburg, MD, USA.
Garrett MullinsEli Lilly and Company, Indianapolis, IN, USA.
Luying PanTakeda, Cambridge, MA, USA.
Michael A PartridgeRegeneron, Tarrytown, NY, USA.
Johann PoetzlSandoz, Oberhaching, Germany.
Michele RasamoelisoloTeva, West Chester, PA, USA.
Federico Riccardi SirtoriEMD Serono, Ivrea, TO, Italy.
Susan RichardsSanofi, Cambridge, MA, USA.
Ola M SaadGenentech, South San Francisco, CA, USA.
Weiping ShaoAstraZeneca, Gaithersburg, MD, USA.
Yuan SongGenentech, South San Francisco, CA, USA.
Sam SongTakeda, Cambridge, MA, USA.
Roland F StaackRoche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
Bonnie WuJohnson & Johnson Innovative Medicine, Spring House, PA, USA.
Mohanraj ManangeeswaranUS FDA, Silver Spring, MD, USA.
Seth ThackerUS FDA, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 18

Indexed as

High-Throughput Nucleotide SequencingVaccinesBiomarkersCell- and Tissue-Based TherapyClinical RelevanceGenetic TherapyGenomicsHumansBiomarkersVaccinesbioanalysisbiomarkerscell therapygene therapyimmunogenicityvaccineWRIB

Identifiers

PMID39862111
PMCPMC11863570

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.