Over the last decade, metabolite profiling and quantification in support of Early Development drug R&D decision making has increased exponentially. Both industry and regulators have provided scientific and regulatory guidance on some key aspects on when and why initiate experiments. However, in recent years, we have seen an overconsumption of metabolite experiments in some areas of our industry. As a consequence, it makes sense to bring the key players and stakeholders involved in generating and interpreting metabolite profiling and quantification data together and share current practices and agree on future best practices to cover scientific and regulatory project requirements for metabolite work.
AIM OF THE WORKSHOP
The aim of the workshop is to share current practices in drug R&D related to metabolite profiling and quantification in early drug R&D and discuss best practices combining scientific and regulatory project requirements. In addition, the discussions at the workshop aim at creating a synergy between the key stakeholder involved in this discussion and agree not only on the ‘When, What and Why’ of metabolite profiling and quantification, but also on ‘Who and How’ so we can make best use of expertise and resources on the different teams/disciplines involved in this work.
WHO SHOULD ATTEND?
Scientists and managers from Pharma and CRO involved in metabolite profiling and quantification (DMPK and bioanalytical scientist) and the key stakeholders involved in making project decisions when interpreting these data (preclinical and clinical PK project representatives).