2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Johanna MoraRachel PalmerLeslie WagnerBonnie WuMichael Partridgenull MeenaIvo SondereggerJohn SmeragliaNicoletta BiviNaveen DakappagariSandra DieboldFabio GarofoloChristine GrimaldiWarren KalinaJohn KamerudSumit KarJean-Claude MarshallChristian MayerAndrew MeltonKeith MerdekKatrina NolanSerge PicardWeiping ShaoJessica SeitzerYoichi TanakaOmar TounektiAdam VigilKarl WalravensJoshua XuWeifeng XuYuanxin XuLin YangLiang ZhuDaniela VerthelyiRobert J KubiakKelly CobleSwati GuptaMohsen Rajabi AbhariSusan RichardsYuan SongMartin UllmannBoris CalderonIsabelle CludtsGeorge R GunnShalini GuptaAkiko Ishii-WatabeMohanraj ManangeeswaranKimberly MaxfieldFred McCushChristine O'DayKate PengJohann PoetzlMichele RasamoelisoloOla M SaadKara ScheibnerSophie ShubowSam SongSeth ThackerPublished in: Bioanalysis (2024)
The 17 th Workshop on Recent Issues in Bioanalysis (17 th WRIB) took place in Orlando, FL, USA on June 19-23, 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 3) covers the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 2 (Biomarkers, IVD/CDx, LBA and Cell-Based Assays) are published in volume 16 of Bioanalysis, issues 8 and 9 (2024), respectively.
Keyphrases
- cell therapy
- gene therapy
- transcription factor
- stem cells
- mesenchymal stem cells
- high throughput
- mass spectrometry
- risk assessment
- healthcare
- mental health
- quality improvement
- palliative care
- primary care
- emergency department
- clinical practice
- dna methylation
- single cell
- systematic review
- genome wide
- health information
- gene expression
- randomized controlled trial
- high resolution
- bone marrow
- copy number
- climate change
- human health
- tyrosine kinase
- study protocol
- advance care planning