Blog Big Molecule Watch November 17, 2020

Emer Cooke takes office as first woman head of EMA

Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical unit of the European Commission and EMA and was the Director responsible for all medical product-related regulatory activities at the WHO in Geneva from 2016 to November 2020. Ms. Cooke was at WHO in 2017 when it created a pilot project intended to encourage manufacturers to submit biosimilar versions for prequalification. Ms. Cooke stated that “[b]iotherapeutic products have shown added value in terms of treating many diseases, particularly cancers and other non-communicable conditions. But they are prohibitively expensive and out of reach of numerous countries. ‘Similars’ of these products are cheaper, but we must ensure that they are good quality, safe and effective. The aim therefore, is to increase the number of affordable quality biotherapeutics for international procurement.”

On her first day of office, Ms. Cooke said that she “take[s] up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” but stressed that the Agency will also have to tackle other major challenges, including antibiotic resistance, supporting new waves of innovation and making the most of the opportunities provided by digitalization for medicine discovery and development.

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