title: 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.
authors: Roche Innovation Center Basel; DMPK & Bioanalytical R&D; Pharmaceutical Sciences, Switzerland.
authors: Sherri
authors: S
authors: Dudal
authors: Roland F
authors: RF
authors: Staack
authors: Daniela
authors: D
authors: Stoellner
authors: Marianne Scheel
authors: MS
authors: Fjording
authors: Eva
authors: E
authors: Vieser
authors: Marie-Hélène
authors: MH
authors: Pascual
authors: Margarete
authors: M
authors: Brudny-Kloeppel
authors: Michaela
authors: M
authors: Golob
mesh_terms: D004341:Drug Evaluation / Q000592:standards; D005060:Europe; D020416:Outsourced Services; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000378:metabolism / Q000592:standards; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations
keywords: assay development; bioanalysis; bioanalytical process; biotherapeutics; clinical; drug development; large molecules; preclinical; project team; sample analysis