- Evaluate intellectual property (IP) challenges of the market introduction of advanced therapy medicinal products (ATMPs) and personalized medicine systems, particularly the NANOSPRESSO value proposition (Leiden University).
- Assess the regulatory readiness of the system for authorizing nucleic acid therapies in Europe, identifying key regulatory hurdles for approval (Utrecht University).
- Develop health economic evidence to define the NANOSPRESSO value proposition, supporting its integration into patient care and demonstrating its cost-effectiveness and potential benefits (Erasmus University).
- Analyze stakeholder perspectives on the development and adoption of emerging nanomedicine technologies, ensuring alignment with both industry needs and public health priorities (ETPN).
Leader of WP4
Prof. Marieke de Bruin
Prof. Drug Regulatory Science – Utrecht University
Short bio: Prof. Dr. Marieke De Bruin was trained as a pharmacist at Utrecht University and as an epidemiologist at Erasmus University Rotterdam. Since 2008, she has combined academic research with regulatory roles, serving both nationally as a pharmacovigilance expert for the Dutch Medicines Evaluation Board (2008–2016) and internationally as an independent scientific expert appointed by the European Commission to the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency (2012–2018).
Other Involved Partners
Results
We are collecting results that will be posted here soon. Stay tuned.
