Mette Due Theilade Thomsen

Founder,
PIP Adviser ApS

Mette is the founder of “PIP Adviser ApS” which provides expert regulatory advice on all aspects of paediatric drug development, in particular EU PIPs, US pediatric study plans and global paediatric drug development. In PIP Adviser ApS, Mette advises on a very high amount of PIPs – in particular within the advanced therapy space- for an optimal PDCO procedure.

Mette has a background from authorities and industry. In the Danish Medicines Agency (2000-2006), Mette was a nonclinical assessor of MAAs and of EU Scientific Advices. She was the Danish delegate in several CHMP working parties, e.g. Nonclinical Working Party and Gene Therapy Working party, and was rapporteur for several CHMP and ICH guidelines.

During her later role as Scientific Officer in the EMA (2007-2009), Mette handled PIP procedures with PDCO, was in the FDA-EMA paediatric cluster, and established and ran the PDCO Nonclinical Expert Group for support to the PDCO on nonclinical development in paediatric plans.

During her time in Novo Nordisk (2009-2016), Mette lead all PIP/PSP procedures within a large therapy area, was paediatric strategy advisor across the company, and was a member of the EFPIA paediatric group.

Mette also spent a year as Senior Director in Shionogi, London.