Evidence map›Paper›PMID 38441119›Full record

ArticlemAbs

Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.

Sophie Tourdot, Daniel Baltrunkonis, Sofie Denies, Viswanath Devanarayan, Joanna Grudzinska-Goebel, Arno Kromminga, Gregor P Lotz, Laurent Malherbe, Lydia Michaut, Karin N Weldingh and 7 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
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

17 authors.

Sophie TourdotPharmacokinetics, Dynamics and Metabolism, Pfizer Inc, Andover, MA, USA.
Daniel BaltrunkonisResearch and Development, Clinical Pharmacology and Bioanalytics, Clinical Bioanalytics, Groton, CT, USA.
Sofie DeniesSD Analytics, Bellem, Belgium.
Viswanath DevanarayanEisai Inc, Nutley, NJ, USA.
Joanna Grudzinska-GoebelDMPK Project Management, Pharmaceuticals R&D, Bayer AG, Berlin, Germany.
Arno KrommingaBioNTech SE, Mainz, Germany.
Gregor P LotzRoche Pharma Research and Early Development (pRED), Roche Innovation Center Munich, Hoffmann-La Roche Ltd, Penzberg, Germany.
Laurent MalherbeLilly Research Laboratories, a Division of Eli Lilly and Company, Indianapolis, IN, USA.
Lydia MichautNovartis Biomedical research, PK Sciences, Basel, Switzerland.
Karin N WeldinghDepartment of Clinical Immunogenicity Analysis, Novo Nordisk A/S, Maaloev, Denmark.
Joao A Pedras-VasconcelosDivision of Biotech Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Laura I Salazar-FontanaLAIZ Regulatory Science, Lausanne, Switzerland.
Sebastian SpindeldreherIntegrated Biologix GmbH, Basel, Switzerland.
Zuben SaunaDivision of hemostasis, Office of Plasma Protein Therapeutics; Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Veerle SnoeckTranslational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
Daniela VerthelyiDivision of Biologics Research and Review III; Ofrfice of Biotechnology Products; Center for Drug Evaluation and Research; Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, MD, USA.
Daniel KramerGlobal Scientific Advisor Immunogenicity, Translational Medicine & Early Development, Sanofi Aventis Deutschland GmbH, Frankfurt am Main, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biologics have revolutionized disease management in many therapeutic areas by addressing unmet medical needs and overcoming resistance to standard-of-care treatment in numerous patients. However, the development of unwanted immune responses directed against these drugs, humoral and/or cellular, can hinder their efficacy and have safety consequences with various degrees of severity. Health authorities ask that a thorough immunogenicity risk assessment be conducted during drug development to incorporate an appropriate monitoring and mitigation plan in clinical studies. With the rapid diversification and complexification of biologics, which today include modalities such as multi-domain antibodies, cell-based products, AAV delivery vectors, and nucleic acids, developers are faced with the challenge of establishing a risk assessment strategy sometimes in the absence of specific regulatory guidelines. The European Immunogenicity Platform (EIP) Open Symposium on Immunogenicity of Biopharmaceuticals and its one-day training course gives experts and newcomers across academia, industry, and regulatory agencies an opportunity to share experience and knowledge to overcome these challenges. Here, we report the discussions that took place at the EIP's 14

Indexed as

Biological ProductsAntibodiesDrug DevelopmentHumansRisk AssessmentAntibodiesBiological ProductsAnti-drug antibodyclinical relevanceimmunogenicityrisk assessment

Identifiers

PMID38441119
PMCPMC10936655

What OpenQuestion holds

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LicenceCC BY-NC
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 OpenQuestion graph.