At the BIO International Convention in San Diego this June, Emer Cooke settled onto a sofa in front of a room she could not see the end of and made a small confession. She is used to working in places where everybody knows who she is, and this was not one of them. For the executive director of the European Medicines Agency, whose network decides which medicines reach 450 million people, that is a bruising piece of market research. For the founders in the audience with 20 employees and one promising candidate, it was an opportunity, because a regulator who worries about being insufficiently famous badly wants to hear from you.
You have roughly nine months to take her up on it. Cooke told the European Parliament’s public health committee earlier this month that this was her last appearance before them, with her mandate ending in April next year. Her second term was never going to run the full five years, since the EMA management board extended her appointment only to April 30, 2027, the date she reaches pension age.
So the European Commission is shopping for the agency’s fifth executive director, who will inherit a rulebook rewritten by global competitive pressures and new EU legislation.
Cooke took on the role as the EMA’s chief on November 16, 2020, the first woman to hold it, arriving at the precise moment the first COVID-19 vaccine efficacy data landed on regulators’ desks. What followed is now folklore, from rolling reviews to joint procurements that reached 27 EU member states at once.
Six years later, the EMA has powers it did not have in 2020, including statutory emergency and shortage bodies, a role in medical devices, and a clinical trials system that replaced 27 national front doors with one.
Stability Is A Strategy
The contrast with Washington is hard to miss. While Europe quietly extended a mandate to keep the same person in the chair until she retires, the US FDA has been cycling through leadership at a pace that would exhaust some football clubs (not looking at you, Chelsea). CBER is on its sixth leader since January 2025, the commissioner resigned in May this year, and the acting heads of both CDER and CBER changed within a week of his departure. Sponsors have learned to read the FDA’s organizational charts the way traders read the yield curve.