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The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global 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 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

Accessing patient samples using a whenever/wherever paradigm is needed to enable a better understanding of human biology and disease. The technology for convenient self-collection of blood samples by patients at home is quickly becoming available. The potential benefits of patient-centric sampling far outweigh the short-term challenges associated with implementation of this disruptive approach. This is especially true given we are amid a global pandemic and enabling patients to sample at home would help not only clinical trials, but healthcare in general. This perspective article aims to convince the reader that patient-centric sampling is a reality and that we are on the cusp of an information revolution in clinical trials that will be enabled by patient-centric (e.g., at home) sampling.

In this paper we show the application of the Tasso OnDemand™, a novel automated sample collection device, in conjunction with volumetric absorptive microsampling (VAMS) for the development of gefapixant, a P2X3 receptor antagonist currently under clinical development for the treatment of refractory and unexplained chronic cough and endometriosis-related pain. A LC–MS/MS bioanalytical method was developed and validated using VAMS to support this development program. This method was utilized in a drug–drug interaction study to establish a mathematical bridging relationship with data obtained from a validated plasma assay used to support the program. The VAMS bioanalytical method and the predictability of the mathematical relationship is reported and discussed here.

Increasingly diverse large molecule modalities have driven the need for complex bioanalysis and biotransformation assessment involving both traditional ligand-binding assays (LBA) and more recent hybrid immunoaffinity LC–MS platforms. Given the scientific expertise in LBA and LC–MS typically resides in different functions within the industry, this has presented operational challenges for an integrated approach for bioanalysis and biotransformation assessment. Encouragingly, over time, the industry has recognized the complementary value of the two platforms. This has not been an easy transition as organizational structures vary widely within the industry. However, there are tremendous benefits in adopting fully integrated strategies for biopharma. This IQ consortium paper presents current perspectives across the biopharma industry. It highlights the technical and operational challenges in current large molecule bioanalysis, the value of collaborations across LBA and LC–MS, and scientific expertise for fully integrated strategies for bioanalysis and biotransformation.

This Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this 3-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program is a mixture of lectures, interactive discussions and a poster session. This report summarized the presentations at the 16th Annual Conference. 6th Annual Land O'Lakes Bioanalytical Conference, Fluno Center Madison, WI, USA, 13–16 July 2015

The Boston Society hosted the 7th Applied Pharmaceutical Analysis (APA) conference in Cambridge (MA, USA) from September 12th to 14th 2011. The overarching theme for this year’s meeting was ‘Smaller and Smarter’ covering a variety of topics on how qualitative and quantitative analysts are creatively using novel and emerging techniques to improve analytical sensitivity, which affords the use of smaller sample volumes while striving to meet the ever-increasing regulatory expectations, as well as cost, resource and time constraints.

The 12th Annual Symposium on Chemical and Pharmaceutical Structure Analysis (CPSA 2009) was held on 26–29 October 2009 in Langhorne, PA, USA. This annual meeting began in 1998 and was the first industry-led event to focus on the specific needs of industry researchers. The goal of CPSA is to provide an indepth review of innovative technology and industry practices through open discussion of industry-related issues and needs. Education and specialized training are the foundation of all CPSA events: ‘Where Technology and Solutions Meet’.