Mette is Managing Director of "PIP Adviser" which provides expert regulatory advice on PIPs and PSPs. She has a background in authorities & industry. In the Danish Medicines Agency (2000-2006), she was nonclinical assessor of MAAs and EU Scientific Advice. She was member of the SWP, Gene Therapy WP, Biosimilar WP and PGWP and a rapporteur for CHMP and ICH guidelines. As Scientific Officer in EMA, Mette handled PIP procedures with PDCO, was in the FDA-EMA paediatric cluster and established the PDCO Nonclinical Expert Group. In Novo Nordisk (2009-2017), Mette lead all PIP/PSP procedures, was paediatric strategy advisor across the company and was in the EFPIA paed group. Mette also spent a year as Senior Director in Shionogi, London.

Dr Karres is a Scientific Officer in the Paediatric Medicines Section at the European Medicines Agency in London, UK since 2009. Her main focus is currently on paediatric clinical drug development in the area of endocrinology/diabetes and pre-clinical development supporting the use of medicinal products in children. Dr Karres holds a M.Sc. degree from the University of Massachusetts, Amherst (US) in Molecular and Cellular Biology (2002) and a joint PhD in Molecular Biology from the University of Heidelberg and the European Molecular Biology Laboratory in Heidelberg/Germany (2007). Dr Karres is author of several scientific articles in high impact journals indexed by Medline.