aPODD review of the 7th ACCELERATE Paediatric Oncology Conference, Brussels
This annual conference organised by the ACCELERATE Platform which brings together academia, industry, patient advocacy groups and regulators took place at the Wiltcher’s Steigenbuerger Hotel, Brussels.
This conference is a multi-stakeholder platform that challenges the current ways of working. Asking the difficult questions to achieve the objectives of improving drug development and bring about more effective therapies for children with cancer.
The aim of this year’s conference was to share updates on last year’s achievements, share and discuss community updates and set objectives for the coming year. Attending from aPODD were trustees Cesare Spadoni and Evgenia Mengou as part of their involvement in the FAIR Trials Working Group. Whose focus is to foster age inclusive research and the participation of adolescents and young adults in early stage cancer drug trials.
Some observations on the topics discussed at this year’s conference included
A recognition that ACCELERATE Platform is becoming more ‘international’ every year, this is very appropriate for drug development and even more so in the paediatric field.
Implementing ‘Mechanism of Action’ based drug development: which will focus on three key deliverables
o Identify and build consensus on what constitutes unmet medical need.
o Develop models for a smart and efficient development, within the regulatory constraints, of several agents of the same class.
o Create a platform to share regulatory experience e.g. Precedence of ‘flexibility’ in regulatory decision making, including paediatric plans approved in both EU and USA.
And finally, academic research data usage for registration purposes. A lofty aspiration that attempts to gain agreement that all academic research is carried out with the ‘end in mind’ – where the ‘end’ will be an update of labelling. Thus, raising the level of academic research to standards acceptable to regulators and make academic data usable for labelling purposes (and thus on label wider use).
The three areas that we feel were reinforced during the conference, when it comes to accelerating paediatric drug development, are:
1. Collaboration and open communication among key stakeholders is essential, i.e. regulators, academics, patient advocacy groups and industry.
2. Materialising public-private partnerships/ workable financial models for entities to focus and deliver new paediatric cancer drugs, which are still elusive.
3. Implementation of the new US legislation which necessitates consideration and interaction with the FDA about paediatric drug development earlier in the development stages will impact the US environment but also inadvertently the European one which already required much earlier regulatory interactions.
For aPODD it was great to be part of such an inspiring group of people whose aim matches ours. To get children access to kinder more effective drugs as quickly as possible.
Trustees Dr Cesare Spadoni and Evgenia Mengou