How can access to innovative medicines for patients be accelerated?
New scientific approaches to innovative medicines are often conceived in academic research. However, unlike pharmaceutical companies, academic medicines developers often do not have the necessary regulatory support in their own teams. For this reason, there is a need in many EU member states to close these information gaps concerning regulatory aspects in medicines development and to actively encourage the dialogue between academic research and national medicines authorities.
In a co-ordinated European approach, the Coordination and Support Action (CSA) project "STARS – Strengthening Training of Academia in Regulatory Science" initiated by the EU commission pursues the aim of developing and providing a systematic advice and training programme for the establishment of scientific and regulatory knowhow. The purpose of the concept is to familiarise academic medicines developers with the regulatory requirements as early as in the funding stage of a project. The implementation of research results in medicines for clinical practice requires regulatory knowledge and a suitable technical environment for the preparation of products, including medicines. These prerequisites can, as a rule, be fulfilled in pharmaceutical companies, however, not in public research institutes.
The STARS project intends to bridge the gap between the academic world and national medicines authorities. It integrates stakeholders relevant throughout Europe, including academic clinical centres, scientists working in clinical research, and funding establishments from Germany such as the Federal Ministry for Education and Research (Bundesministerium für Bildung und Forschung, BMBF), the German Research Society (Deutsche Forschungsgesellschaft, DFG), and the German Cancer Aid (Deutsche Krebshilfe). Also included are European networks from the areas of clinical research, patient advocacy groups, and the European Medicines Agency (EMA). The project, which is planned for a period of three years, is coordinated jointly by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut (PEI).
In the recently published whitepaper "Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap" Dr Manja Burggraf from the Paul-Ehrlich-Institut jointly with other STARS project members, describes the communicative inadequacies between regulatory authorities and academic researchers. The team also shows approaches to bridging these gaps. "That way, innovative medicines shall reach patients faster,"
explains Dr Burggraf. "STARS is an important project enabling the development of medicines to be accompanied along the entire value-creating chain efficiently at the highest regulatory level"
, adds the project leader, Bettina Ziegele with regard to Paul-Ehrlich-Institut’s strong interest and commitment to the project.
Within the STARS project, 40 funding institutes, 88 academic institutes, 449 academic researches, and 21 regulatory authorities participated in survey by the European Union (EU). The results of the surveys permitted to record the current status of the yet to be extended supply with scientific and regulatory knowhow, and to develop steps of improvement.
The first stakeholder workshop took place on 3 and 4 November 2020 with around 100 participants from all over Europe. Subjects in the focus of the discussion included the selection of suitable channels of communication, possibilities of early integration of regulatory support into the funding projects, and the improvement of education and training for academic researchers in regulatory affairs.
The figure outlines fields of action in the STARS project with the aim of improving the dialogue and flow of information between regulatory authorities and academic researchers.
Source: Source: V.Starokozhko, et al. „Strengthening regulatory science in academia: STARS, an EU initiative to bridge the translational gap”
Updated: 24.11.2020
