Evidence map›Paper›PMID 39862107›Full record

ArticleBioanalysis2025

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (

Nicoletta Bivi, Danielle Graham, Laura Joglekar, Kristina McGuire, Jeroen Stoop, Jad Zoghbi, Brian Baker, Abbas Bandukwala, Sarah Bond, Alessandra Buoninfante and 54 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. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

64 authors.

Nicoletta BiviEli Lilly and Company, Indianapolis, IN, USA.
Danielle GrahamBiogen, Cambridge, MA, USA.
Laura JoglekarBristol Myers Squibb, Lawrenceville, NJ, USA.
Kristina McGuireRegeneron, Tarrytown, NY, USA.
Jeroen StoopJanssen, Leiden, Netherlands.
Jad ZoghbiBiogen, Cambridge, MA, USA.
Brian BakerRegeneron, Tarrytown, NY, USA.
Abbas BandukwalaUS FDA, Silver Spring, MD, USA.
Sarah BondAlnylam, Cambridge, MA, USA.
Alessandra BuoninfanteEU EMA, Amsterdam, Netherlands.
Jeff ChenAstraZeneca, South San Francisco, CA, USA.
Mark DysingerAlexion, New Haven, CT, USA.
Jörg EngelbergsGermany PEI, Frankfurt, Germany.
Michele FiscellaREGENXBIO, Rockville, MD, USA.
Fabio GarofoloBRI Frontage, Vancouver, BC, Canada.
Shirley HopperUK MHRA, London, UK.
Barry JonesCrinetics, San Diego, CA, USA.
Lindsay KingPfizer, Groton, CT, USA.
Rocio MurphySanofi, Swiftwater,PA, USA.
Rachel PalmerSanofi, Cambridge, MA, USA.
Gerard SanderinkSanofi, Cambridge, MA, USA.
Agnes SeydaBristol Myers Squibb, Lawrenceville, NJ, USA.
Huaping TangGlaxoSmithKline, Collegeville, PA, USA.
Andrea Van TuylBioMarin, Novato, CA, USA.
Leslie WagnerUS FDA, Silver Spring, MD, USA.
Karl WalravensGlaxoSmithKline, Rixensart, Belgium.
Kai WangGlaxoSmithKline, Collegeville, PA, USA.
Hilke ZanderGermany PEI, Frankfurt, Germany.
Liang ZhuModerna, Cambridge, MA, USA.
Ming LiAlexion, New Haven, CT, USA.
Yi-Dong LinTakeda, Cambridge, MA, USA.
Mahwish NataliaNovartis, Cambridge, MA, USA.
Nathan StandiferTempest, South San Francisco, CA, USA.
Steven EckAstraZeneca, Gaithersburg, MD, USA.
Polina GoihbergPfizer, Andover, MA, USA.
Katharine GruganJohnson & Johnson Innovative Medicine, Spring House, PA, USA.
Michael Nathan HedrickBristol Myers Squibb, Lawrenceville, NJ, USA.
Greg HopkinsRegeneron, Cambridge, MA, USA.
Sumit KarWRIB, Toronto, ON, Canada.
Steve KellerAbbvie, San Mateo, CA, USA.
Shannon McGrathModerna, Cambridge, MA, USA.
Bill O'GormanGenentech, South San Francisco, CA, USA.
Chad StevensPfizer, Andover, MA, USA.
Erin StevensPfizer, Groton, CT, USA.
Grzegorz TerszowskiNovartis, Basel, Switzeland.
Paul C TrampontModerna, Cambridge, MA, USA.
Shuyu YaoGlaxoSmithKline, Collegeville, PA, USA.
Alison JoycePfizer, Andover, MA, USA.
Seema KumarPioneering Medicines, Cambridge, MA, USA.
Carolina OwenAbbVie, Worcester, MA, USA.
Samuel PineSanofi, Ghent, Belgium.
Graham YearwoodBristol Myers Squibb, Lawrenceville, NJ, USA.
Liching CaoSangamo, South San Francisco, CA, USA.
Valerie ClausenAlnylam, Cambridge, MA, USA.
Kelly CobleBoehringer Ingelheim, Danbury, CT, USA.
Andria CulbertSpark Therapeutics, Philadelphia, PA, USA.
Shalini GuptaAmgen, Thousand Oaks, CA, USA.
Richard HughesResolian, Greater Cambridge Area, UK.
Susana LiuPfizer, Montreal, QC, Canada.
Kun LuRegeneron, Tarrytown, NY, USA.
Rita MartelloEMD Serono, Darmstadt, Germany.
Kimberly J ReeseGlaxoSmithKline, Collegeville, PA, USA.
Kay-Gunnar StubenrauchF. Hoffmann-La Roche Ltd, Roche Pharma Research & Early Development (pRED), Basel, Switzerland.
Yi WenEli Lilly and Company, Indianapolis, IN, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on "IVDR Implementation in EU & Changes for LDT in the US" and on "Harmonization of Vaccine Clinical Assays Validation" were the special features of the 18th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2024 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2024 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers in the Part 2A the recommendations on Biomarkers/BAV, IVD/CDx, LBA and Cell-Based Assays and in Part 2B the Regulatory Inputs on these topics. Part 1 (Mass Spectrometry Assays and Regulated Bioanalysis/BMV) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 17 of Bioanalysis, issues 5 and 3 (2025), respectively.

Indexed as

Flow CytometryGenetic TherapyBiomarkersCell- and Tissue-Based TherapyHumansUnited StatesBiomarkersbioanalysisbiomarkerscell therapygene therapyimmunogenicityvaccineWRIB

Identifiers

PMID39862107
PMCPMC11866642

What OpenQuestion 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 OpenQuestion graph.