The one year ALADDIN Research Fellowship provided me with a unique opportunity to immerse myself in the dynamic and challenging field of paediatric oncology drug development. Collaborating with the ACCELERATE FAIR (Fostering Age Inclusive Research) Working Group, I engaged in impactful discussions and established significant collaborations with key stakeholders, including industry representatives and regulators. This experience not only broadened my knowledge but also enhanced my ability to contribute meaningfully to this critical area of research.
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Maria Inês Alves, Paediatric Oncologist
This fellowship consisted mainly in the development of a research project focused on drug development in adolescents and young adults (AYA) with cancer, taking into account both the regulatory and practical aspects. The key components could be divided in three major groups:
- Current Landscape of Access to Trials: This aspect is crucial as it addresses the practical aspect of drug development. Understanding the accessibility of clinical trials, especially for innovative drugs, is vital for ensuring that AYA patients have opportunities to access cutting-edge therapies.
- European Regulation and Approvals: Delving into the European regulatory landscape concerning drug approvals for the adolescents added depth to the research since it showed awareness of the specific regulatory frameworks (Paediatric Investigation Plans) that impact drug accessibility and availability for this population.
- Information on Drug Labels: Analysing what important information is available on drug labels approved by regulatory bodies like the EMA and FDA provided insights into the transparency and safety considerations for AYA patients and healthcare providers.
Enrolling in this fellowship has empowered me to meet distinct goals: acquiring in-depth knowledge of regulatory and strategic sciences, developing a holistic understanding of the complex drug development dynamics within paediatric oncology, and forging impactful collaborations with key stakeholders beyond academia, including regulators, industry representatives and patient advocates. It has been wonderful to witness first-hand how a multi-stakeholder team collaborates towards a paramount common goal: improving patient care in this tremendously challenging medical field.