2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody <u>(PART 1A</u> – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis <u>PART 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)
Mike Baratta, Wenying Jian, Shawna Hengel, Surinder Kaur, Jennifer Cunliffe, Jason Boer, Nicki Hughes, Sumit Kar, John F. Kellie, Yeoun Jin Kim, Michael E. Lassman, John T. Mehl, Ling Morgan, Joe Palandra, Hetal Sarvaiya, Jianing Zeng, Naiyu Zheng, Jian Wang, Long Yuan, Allena Ji, Christopher J. Kochansky, Lin Tao, Yue Huang, Estelle M. Maes, Luca Barbero, Kévin Contrepois, Luca Ferrari, Yunlin Fu, Jay Johnson, Barry Jones, Monika Kansal, Lu Yang, Noah Post, Honglue Shen, Yongjun Xue, Yiyue Zhang, Gopa Roy Biswas, Seongeun Cho, Anna Edmison, Kimberly Benson, Lee Abberley, Mitra Azadeh, Jennifer Francis, Fabio Garofolo, Shalini Gupta, Iordanka Ivanova, Akiko Ishii‐Watabe, Shane Karnik, Sean Kassim, Olga Kavetska, Steve Keller, Elham Kossary, Wenkui Li, Fred McCush, Dulcyane Neiva Mendes, Mohsen Rajabi Abhari, Kara Scheibner, Timothy W. Sikorski, Roland F. Staack, Edward Tabler, Huaping Tang, Katty Wan, Yow‐Ming Wang, Emma Whale, Yang Li, Jennifer Zimmer, Abbas Bandukwala, Xiulian Du, Olga Kholmanskikh, Sonja Kwadijk‐de Gijsel, Meenu Wadhwa, Joshua Xu, Alessandra Buoninfante, Isabelle Cludts, Sandra S. Diebold, Kimberly Maxfield, Christian Mayer, João Pedras-Vasconcelos, Mohsen Rajabi Abhari, Sophie Shubow, Yoïchi Tanaka, Omar Tounekti, Daniela Verthelyi, Leslie Wagner
Abstract
The 17th Workshop on Recent Issues in Bioanalysis (17th 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 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 this NEW Regulation” 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 covers the recommendations on Mass Spectrometry Assays, Regulated Bioanalysis/BMV (Part 1A) and Regulatory Inputs (Part 1B). Part 2 (Biomarkers, IVD/CDx, LBA and Cell-Based Assays) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 16 of Bioanalysis, issues 7 and 8 (2024), respectively.