第17届生物分析近期问题研讨会(第17届WRIB)在奥兰多举行,FL,2023年6月19日至23日,美国。代表制药/生物技术公司的1000多名专业人士,CRO,和多个监管机构召开会议,积极讨论生物分析的最新主题。第17届WRIB包括3个主要研讨会和7个专业研讨会,这些研讨会跨越了1周,以便详尽而彻底地涵盖生物标志物生物分析中的所有主要问题。免疫原性,基因治疗,细胞疗法和疫苗。此外,关于“EUIVDR2017/746对全球生物标志物社区的实施和影响:如何遵守这些新法规”和“美国FDA/OSIS远程监管评估(RRA)”的深入研讨会是第17版的特别节目。和往年一样,WRIB继续聚集了广泛的国际,行业意见领袖和监管机构专家致力于小分子和大分子以及基因,细胞疗法和疫苗,以促进专注于提高质量的分享和讨论,提高监管合规性,并在生物分析问题上实现科学卓越。这份2023年白皮书涵盖了研讨会期间广泛讨论中提出的建议,旨在为生物分析界提供有关主题和问题的关键信息和实际解决方案。为了实现科学卓越的进步,提高质量和更好的监管合规性。由于它的长度,由于编辑原因,这份全面白皮书的2023版分为三个部分。本出版物(第2部分)涵盖了关于生物标志物的建议,IVD/CDx,LBA和基于细胞的测定。第1A部分(质谱分析和调节生物分析/BMV),P1B(调控输入)和第3部分(基因治疗,细胞疗法,疫苗和生物治疗免疫原性)发表在《生物分析》第16卷中,问题9和7(2024),分别。
The 17th Workshop on Recent Issues in
Bioanalysis (17th 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 17th 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 17th 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.