ACCELERATE in collaboration with the European Medicines Agency and with the participation of the Food and Drug Administration
6th Paediatric Strategy Forum for Medicinal Product Development of CAR T-cells in Children and Adolescents
16-17 November 2020
European Medicines Agency, Amsterdam, Netherlands
The 6th Multi-stakeholder Paediatric Strategy Forum, organised by ACCELERATE in collaboration with the European Medicines Agency (EMA) and with the participation of the U.S. Food and Drug Administration (FDA) will focus on CAR T-cells in children and adolescents.
Background: Paediatric Strategy Forums have been created to evaluate the current state of the science, facilitate dialogue and provide an opportunity for constructive discussions between relevant stakeholders (patient advocates, clinicians, academics, biotechnology/pharmaceutical companies and regulators) on specific topics in an open forum to assure development of medicines in the best interests of children and adolescents with cancer. The goal of these meeting is to share information, to facilitate the development of innovative medicines and ultimately their introduction into the standard-of-care of children with malignancies.
The summary of the first 5 Paediatric Strategy Forums held in January and November 2017, September 2018, April 2019 and January 2020 on ALK inhibition, mature B-cell malignancies, and checkpoint inhibitors in combination, acute myeloid leukaemia and epigenetic modifiers respectively can be found here.
Chimeric antigen receptor T cells (CAR T-cells) have been a major advance in the field of cancer therapy. To date the predominant focus has been on haematological malignancies and there are currently many clinical trials and many products being evaluated in adults and children.
Cellular immunotherapy with CD19-directed CAR T-cells is a promising approach for the treatment of B-cell acute lymphoblastic leukaemia (ALL) the most advanced area at present. However, there are many unanswered questions regarding the use of developed products and the development of new products. The role of CAR T-cells in both leukaemia and solid tumours will be addressed. More details on the content of the Forum is available here.
Forum Goals: to summarise the current status of the development of CAR T-cells in paediatrics; identify current challenges, future directions and ascertain the best strategies to accelerate their development and their availability to children.
Forum Output: publication of a summary and manuscript from all participants addressing the challenges and documenting the conclusions of the meeting. Potentially further specific meetings relating to areas which require more in-depth discussion will be arranged.
Participation: possible only by invitation and by submitting an Expression of Interest (see below) before the deadline of 6 July 2020. Invited participants will be informed in due time.
Submit your Expression of Interest:
The Forum Programme Committee will continually monitor the COVID-19 situation and modify plans if required.
ACCELERATE is generously supported by The Andrew McDonough B+ Foundation