Marisa Papaluca, MD

Dr. Marisa Papaluca was appointed as senior scientific advisor in the Research and Development Division at the European Medicines Agency (EMA) in March 2015. Since September 1, 2016, she moved in to the advisory function of Scientific Committees Regulatory Science Strategy.

In her new position, Dr. Papaluca has the following main activities ongoing: establishment of the EMA Regulatory Science Observatory, a new matrix function aiming at informing strategies for the support of successful development of innovative medicines and modernization of regulatory tools. She is also the co-chair of the E.U. Innovation offices network with the focus on strengthening the overall E.U. regulatory support to early innovation and especially to academic innovators. She also collaborates with European and international partners and stakeholders on emerging science, technologies and regulatory tools for patient-centered medicines for the benefit of patients and society as a whole.

Papaluca has her medical degree in internal medicine. She joined the EMA in October 1994.

Dr. Papaluca served as deputy head of Quality Sector until 2002, of the Efficacy and Safety Sectors until 2009, and head of office until 2015. Dr. Papaluca pioneered regulatory science work, at the European and international levels, to support emerging therapies and technologies with open discussions with innovators, involving of the best expertise available from partners and stakeholders and planning ahead for effective and efficient regulatory science work.

Her main achievements include: the initiation and establishment of innovative regulatory science platforms and processes (e.g., Innovation Task Force, Business Pipeline Project, biomarkers and novel methods qualification) to support innovation, regulatory preparedness and strategic EMA Road Maps; the initiation and establishment of specialized expert groups and working parties covering emerging therapies (e.g., gene and cell therapy working parties – prior to the establishment of the Committee for Advanced Therapies), pharmacogenomics, biosimilar medicines, nanomedicines); the initiation and establishment as of 2009 of the EMA Specialised Scientific Support Office focusing on:

  • Specialised Disciplines support to the Committees in multidisciplinary areas (statistical methodology, non–clinical drug development, environmental risk assessment, clinical pharmacology);
  • Reinforced functionality of the Business Pipeline function and of the Innovation Task Force, transitioning and expanding functions of the latter into the current E.U. Innovation Offices Network.