Marisa Papaluca, MD, Specialist in Regulatory Science and Innovation, Former EMA Senior Scientific Advisor Scientific Committees Regulatory Science Strategy; Visiting Professor, Imperial College, School of Public Health, London, January 2020 Marisa, graduated MD at the State university La Sapienza in Rome (Italy) and then spent few years (1978-1994) in clinical immunology scientific research and clinical activity as internal medicine specialist, closely linked to the Academic clinical environment.
Marisa joined in 1984 the Pharmaceuticals Department of the Italian Ministry of Health as medical director and since pioneered regulatory science work contributing to the creation of innovative approaches and tools including: the establishment in 1986 of the first Italian database to support pharmacovigilance Adverse Drug Reactions evaluation, in 1989 the format for National Assessment reports, in 1990 the Italian Office for Centralised Community Procedures (OCCP) to strengthen the participation to EU activities, and in 1993 the first multinational scientific advice for large clinical trials in EU.
Marisa joined the EMA in October 1994. Contributing to Agency foundations she drafted and implemented the main EMA centralised procedure for the preparation of the scientific opinions recommending the granting of Marketing Authorisations for the entire EU, along with the European Public Assessment Reports (EPARs).
She convened and contributed to conferences for reinforcing international cooperation with other authorities and stakeholders, internationally leading on EMA behalf regulatory science in pharmacogenetics, cell and gene based novel therapies, nanotechnology based medicines.
Marisa launched in 2001 “safe harbour” platforms for medicines developers and innovators such as the EMA's Innovation Task Force (ITF) and the Business Pipeline function (https://www.ema.europa.eu/documents/leaflet/business-pipeline_en.pdf) to stimulate early dialogue with innovators and secure regulatory preparedness.
In 2005 Marisa led the launch of the Biosimilars policy with profound impact on availability of biologicals to patients and in 2007 the scientific qualification process for novel biomarkers and methodologies.
Marisa has been involved in a number of activities in collaboration with European Commission DG R&I Health at the forefront of Patient-centred and Personalised medicine and on the international landscape she worked closely with colleagues from the US FDA CBER and CDER and from the Japan PMDA.
After having covered various management positions1 in July 2015 Marisa was appointed as the Senior Scientific Advisor of the European Medicines Agency and till retirement on 1 st April 2019, played a major role in the establishment of the European Innovation Offices Network (EU-IN), the methodology for the pilot EMA Regulatory Science Observatory2 and the elaboration of the Regulatory Science Strategy 2025.
1 Marisa acted as deputy head of sector Quality of Medicines, deputy head of sector Safety and Efficacy and Head of Specialised Disciplines Office (covering pre-clinical drug development, Environmental Risk Assessment clinical pharmacology, clinical trials methodology).
2 Data mining, first filtration, case studies impact assessment on the regulatory standards, different partners and stakeholders interviews, public consultation (modified Delphi approach)