Committee for Orphan Medicinal Products: Chair and Vice-chair re-elected

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Committee for Orphan Medicinal Products: Chair and Vice-chair re-elected

Bruno Sepodes and Lesley Greene appointed for new three-year mandate

Bruno_ Leslie and Lesley GreeneAt its October 2015 meeting, the European Medicines Agency's (EMA’s) Committee for Orphan Medicinal Products (COMP) voted to renew the mandates of Professor Bruno Sepodes and Ms Lesley Greene (both pictured) as chair and vice-chair respectively. Both of their terms have been prolonged by three years, beginning this month.

Professor Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon. He became a member of the COMP in 2008 and has served as chair of the committee since 2012. Ms Lesley Greene joined the COMP in 2009. She is a volunteer patient representative for Eurordis and has a long history in patient advocacy, having established a patient organisation for rare metabolic diseases in 1981. Since the establishment of the committee in 2001, the vice-chair has always been a representative of a patient organisation. This highlights the importance of the contribution of civil society to the work of the COMP.

Accepting his re-election, Professor Sepodes said, “It is an immense privilege to be given the opportunity to serve the COMP for a further three years. The COMP is a data-driven scientific committee, and looking ahead, I would like to maintain our scientific mission as the main driver of our work, thanks to the expertise of our committee members and their commitment to addressing the unmet medical needs of patients with orphan diseases. The increasing levels of complexity of new applications for medicines call for deeper cooperation between the COMP and other EMA committees, particularly in the areas of advanced therapies and paediatric medicines. In this way, we can ensure that we catalyse orphan drug development. I look forward to playing a key role in these interactions.”

Professor Sepodes sees two key priorities for the COMP:

  • continuing support for the active participation of patients’ representatives, not only as full members of the COMP, but also as observers and experts; and
  • strengthening interactions with multiple stakeholders and regulatory authorities globally.

The COMP is the committee at EMA responsible for reviewing applications from people or companies seeking orphan designation. Orphan designation can be granted early in the development process to substances that are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 people in the European Union or that would not be developed without incentives.

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