STARS: ‘A matter of bringing worlds together’
June 2022 marked the finalisation of the three year period of STARS (Strengthening Training of Academia in Regulatory Science). Project leader and manager Wiebke Löbker and Anne Heβ recap and reflect on the goals and results of the project. “It’s a matter of bringing worlds together.”
New medicines, or possibly promising drug candidates are developed throughout research institutes at universities or in labs at startup companies. However, the chances that these innovations reach the patient are sometimes limited. This has several reasons, leading from the science itself to financial hurdles. But an important factor is also lack of knowledge of regulatory requirements and of regulatory processes. This delays these promising tracts, or even leads to cancellation of research.
During the 2022 MEB Science Day last February Viktoriia Starokhozko (clinical assessor at the Medicines Evaluation Board and project member of STARS) already mentioned a so called ‘valley of death’. “We see a gap between the developmental and clinical practices phases. The so called ‘valley of death’”, she explained. “STARS primary goal is to turn that valley into a valley of success.”
STARS is an EU funded Coordination and Support Action (CSA), started in 2019. Crossing the knowledge gap is a major goal. “The major aims were to improve the general level of regulatory knowledge in the academic world, but also strengthening the support in regulatory processes and to stimulate the dialogue between stakeholders. Our first goal was to analyse the state of regulatory knowledge in the field of academia, and to enhance those regulatory knowledge levels by improving training and education”, Anne Heβ explains.
Mapping challenges and hurdles
To get a grasp of the current situation, STARS conducted several comprehensive surveys. “We aimed to map the state of the current regulatory landscape, the knowledge gaps ánd which tools and initiatives were already in place in Europe. It gave an overview of what was there, and what was needed, and which challenges and hurdles there are”, Anne continues.
The result: a broad overview of both what is lacking and what kind of support is in place. Wiebke: “What’s interesting is that in Europe there are several support activities in place, provided by regulators. For example, here at BfArM we have our Innovation Office. We offer so called kick-off meetings. Those are opportunities for researchers and startups to obtain regulatory guidance and orientation at an early development stage. Looking at the STARS data, we noticed that academic groups do not make much use of the innovation meetings which are offered by agencies across Europe, because that target audience wasn’t really aware of these offers. The results from several surveys show that although European regulators provide various regulatory support tools, less than half of the responding academic researchers were aware of these tools. An interesting outcome.”
Pilots and best practices
Besides mapping the current status of regulatory knowledge, STARS also focused on practical use and improvement. “We’ve conducted several pilot projects. For example on transferring best practice examples from one country to another, or the initiation of novel support activities”, Wiebke explains.
An example in this category is the one-stop-shop principle that the colleagues at the Spanish Agency of Medicines and Medical Devices (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) tested. Anne: “The ‘shop’ supplied a collection of all necessary contents – documents, guidelines and frequently asked questions – but also a portal to submit questions. The overall goal was to provide a platform with a low level threshold, enabling researchers to get the right information, regardless of the level of complexity.”
“It’s not that information isn’t present on websites of regulatory authorities, it’s just that the target audience isn’t always aware of all wording and abbreviations used. So the one-stop-shop helps improve communication and timely response.”
Education and training
Of course, the STARS consortium also honours its acronym and has an important focus on strengthening training. Anne: “We’ve developed a comprehensive curriculum, which focuses on regulatory awareness for scholars. It can be used by universities to provide (graduate) students with the key knowledge about the regulatory field.” Use of the curriculum was the third major pilot project in STARS, giving researchers access to the programme materials.
Starting in 2019, the project had a 3 year duration. So on paper, STARS is finished. Literally on paper, since STARS has delivered a common strategy document containing all conclusions and recommendations. But it definitely doesn’t end here, Wiebke stresses. “Our tasks and ambitions are not over. Sustainability of the STARS goals is important, to really make those improvements work.”
The common strategy document contains a set of 21 recommendations, for all stakeholders or target groups, and in the different strategic areas. “These recommendations are set to further improve awareness and knowledge and competence of academic researchers. And to adapt, improve and optimize regulatory processes.” Recently, these recommendations were also highlighted in Nature Reviews Drug Discovery.
Bringing stakeholders together
But STARS is not just about educating researchers. Anne: “This works both ways. It focuses on both knowledge increase in the academic research world, but also on creating more awareness on the side of regulators. It’s a matter of bringing worlds together. We noticed that researchers are reluctant to ask ‘small’ questions. We aimed to bring them together, facilitating open discussions.”
STARS organised two workshops and one conference to do so. “Unfortunately, due to COVID, we had to do the meetings in a remote way”, Wiebke explains, “but we did manage to bring all the stakeholders to one table, from research, regulatory authorities and funding.”
Funding bodies shouldn’t be forgotten. “We’ve seen that several governmental funding bodies give advice to academic researches, to get in touch with the national competent authorities to get regulatory advice, but there is no systematic approach. STARS opted for development of scientific advice in the pre-funding phase.
To carry forward the knowledge and learning from STARS even further, we are getting involved in other projects, such as the REMEDI4ALL initiative, which can benefit from early consultations and interaction between regulators and researchers.”
What STARS has delivered? “The information is here, as well as recommendations to implement and improve. Now it’s up to all stakeholders to stay in touch, and collaborate with an open mindset. What many of the recommendations in the common strategy document boil down to is exactly that: clear and open-minded communication and interaction between regulators, funders, academic researchers and entrepreneurs. We’re convinced that will work out, since all stakeholders see the needs to do so!”
Dr. Wiebke Löbker & Dr. Anne Heβ
Wiebke Löbker (PharmD) joined BfArM six years ago. At the scientific advice department she focused on advice for academic researchers and startups, a target group of young and ambitious people that lack concrete knowledge of regulatory processes, she noticed. In 2017 she started as the lead for the newly setup Innovation Office, which eventually merged with the change management organization into the unit for Scientific Advice, Innovation and Change Management at BfArM, which Wiebke now leads.
Wiebke is also a member of the European Innovation Network (EU-IN), in which the national competent authorities exchange ánd foster knowledge on innovation. It is in that network where STARS was born.
Anne Heβ holds a PhD in Medical Biology. She has been the project manager for STARS in the past three years. Her focus is on supporting academic research groups and start-ups and providing orientation in the regulatory jungle. Anne also performs horizon scanning, which is a foresight method used for discovering early signs of potential change. Together with Wiebke she repesents the BfArM in the EU-IN. Before joining BfArM in 2019, Anne worked as a post doc in research, where she became aware of the regulatory ‘lack’ of knowledge amongst scientists that work in the field of medicinal research and development.
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte ) is the German Federal Institute for Drugs and Medical Devices. BfArM is an independent federal higher authority, which is responsible for licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.
Strengthening Training of Academia in Regulatory Science (STARS) is a coordination and support action (CSA) comprising 21 partners from 18 countries. It includes most of the European national competent authorities (NCA’s) and the European Medicines Agency (EMA). The project was funded by the European Commission.
More information: www.csa-stars.eu