How the bioanalytical scientist plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum

Author:

Dudal Sherri1,Staack Roland F2,Stoellner Daniela3,Fjording Marianne Scheel4,Vieser Eva5,Pascual Marie-Hélène6,Brudny-Kloeppel Margarete7,Golob Michaela8

Affiliation:

1. Roche Innovation Center Basel; DMPK & Bioanalytical R&D; Pharmaceutical Sciences, Switzerland

2. Roche Innovation Center Penzberg, DMPK & Bioanalytical R&D; Pharmaceutical Sciences, Germany

3. Novartis Pharma AG; Novartis Institute for Biomedical Research, DMPK Biologics, PO Box, CH-4002 Basel, Switzerland

4. Novo Nordisk A/S; Novo Nordisk Park, DK-2760 Måløv, Denmark

5. AMGEN Research (Munich) GmbH; Bioanalytics - PK/PD, Staffelseestr. 2, 81477 München, Germany

6. Sanofi; Biomarkers & Biological Analyses Group Disposition, Safety & Animal Research, Sanofi Recherche & Développement, 3 Digue d’Alfortville, 94140 Alfortville, France

7. Bayer Pharma AG; Drug Metabolism & Pharmacokinetics, Bioanalytics & Nonclinical Pharmacokinetics, CRO Monitoring Bioanalytics, Müllerstr. 170–178, 13342 Berlin, Germany

8. Merck Serono; DMPK Institute of Drug Metabolism & Pharmacokinetics, Am Feld 32, D-85567 Grafing, Germany

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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