How The Bioanalytical Scientist Plays A Key Role in Interdisciplinary Project Teams in The Development of Biotherapeutics – A Reflection of The European Bioanalysis Forum

Abstract

The bioanalytical scientist plays a key role in the project team for the drug development of biotherapeutics from the discovery to the marketing phase. Information from the project team members is required for assay development and sample analysis during the discovery, preclinical and clinical phases of the project and input is needed from the bioanalytical scientist to help data interpretation. The European Bioanalysis Forum target team 20 discussed many of the gaps in information and communication between the bioanalytical scientist and project team members as a base for providing a perspective on the bioanalytical scientist's role and interactions within the project team.

Update to the European Bioanalysis Forum Recommendation on Biomarkers Assays; Bringing Context of Use Into Practice

“…The bioanalytical scientist must remain integral to the conversation, ensuring engagement with stakeholders and demand the COU in order to develop the right assay to answer the question that is being asked. Being an integral part of interdisciplinary teams and having the right conversations with the relevant individuals should not be underestimated [21] and is not only applicable to the conversation around biomarkers but to all assay types. Communication is critical to understand how the data will be used and interpreted, and the decisions being made with the data.…”

“…In order to have meaningful and engaging discussions, the bioanalytical scientist must be at the heart of the discussions and part of or at least be involved with project teams [21]. Too often, the bioanalytical scientist is informed that an assay is needed yet no interaction takes place on the reason for the assay, the use of the generated data and the decisions that will be made.…”

Qualitative and quantitative characterization of protein biotherapeutics with liquid chromatography mass spectrometry

“…The importance of bioanalysis in the initial discovery and preclinical/clinical developments of biotherapeutics has been well‐recognized (Dudal et al, ). Accurate, sensitive, selective, robust, and high throughput quantification is essential to obtain fundamental temporal data for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) analyses (Dudal et al, ; Zhang, Olah & Zeng, ; Chilewski & Jiang, ).…”

“…The importance of bioanalysis in the initial discovery and preclinical/clinical developments of biotherapeutics has been well‐recognized (Dudal et al, ). Accurate, sensitive, selective, robust, and high throughput quantification is essential to obtain fundamental temporal data for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) analyses (Dudal et al, ; Zhang, Olah & Zeng, ; Chilewski & Jiang, ). Ligand‐binding assays (LBAs) and liquid chromatography mass spectrometry (LC/MS/MS)‐based strategies represent the mainstream analytical methods to collect such data, and their quantitative performances have been comprehensively reviewed in previous reports (Ezan & Bitsch, ; Hoofnagle & Wener, ; An, Zhang, & Qu, ).…”

Proposal for A Harmonized Descriptive Analyte Nomenclature for Quantitative Large-Molecule Bioanalysis

“…Here, we propose a descriptive nomenclature for large-molecule analytes based on functionality. This might aid in the clarification of the exact nature of the drug fraction that is being analyzed among bioanalysts and within multidisciplinary drug development teams [1]. For large-molecule bioanalysis, drug quantification assays also referred to as PK assays have always been an essential part of preclinical and clinical drug development.…”