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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).

Olga KholmanskikhYow-Ming WangSarah HerseyMeenu WadhwaKatherine BlockAbbas BandukwalaMatthew SzapacsRussell WeinerKhader AwwadFrancis DessySean DowningXiulian DuFabio GarofoloShannon HarrisVictor HouJennifer JonesSumit KarArvind KinhikarMing LiJoel MathewsJohn MeissenGiane Oliveira SumnerLuying PanGerard SanderinkIngrid ScullyJohannes StantaYoichi TanakaStephanie VauleonLeslie WagnerKai WangLiang ZhuSteven EckYi-Dong LinMitra AzadehVilma DecmanSandra DieboldXiulian DuPolina GoihbergEnrique Gomez AlcaideChristele GonneauMichael Nathan HedrickGregory HopkinsSumit KarJakob LoschkoMegan McCauslandLuis MendezSarita SehraErin StevensYongliang Steve SunShabnam TangriPaul C TrampontIsabelle CludtsMark DysingerUma KavitaHiroshi SugimotoShannon ChilewskiChristine GrimaldiYong JiangJohn KamerudSusana LiuCarolina OwenNisha PalackalCorinne Petit-FrereSamuel PineMohsen Rajabi AbhariKara ScheibnerLaKenya WilliamsTao XuGuodong Zhang
Published in: Bioanalysis (2024)
The 17 th Workshop on Recent Issues in Bioanalysis (17 th WRIB) took place in Orlando, FL, USA on 19-23 June 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17 th 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 "EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with these NEW Regulations" and on "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were the special features of the 17 th 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 2023 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 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons.This publication (Part 2) covers the recommendations on Biomarkers, IVD/CDx, LBA and Cell-Based Assays. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 16 of Bioanalysis, issues 9 and 7 (2024), respectively.
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