ACCELERATE - Five years accelerating cancer drug development for children and adolescents.

Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term side-effects for children and adolescents with cancer. The international multi-stakeholder organisation ACCELERATE was created to advance the timely investigation of new anti-cancer drugs. ACCELERATE has enhanced communication and understanding between academia, industry, patient advocates and regulators. It has promoted a mechanism-of-action driven drug development approach and developed Paediatric Strategy Forums. These initiatives have facilitated prioritisation of medicinal products and a focused and sequential strategy for drug development where there are multiple potential agents. ACCELERATE has championed the early assessment of promising drugs in adolescents through their inclusion in adult early phase trials. ACCELERATE has strongly supported alignment between the European Medicines Agency and the US Food and Drug Administration and identification of unmet medical needs through multi-stakeholder collaboration. Early engagement between all stakeholders in the development of new drugs is critical. Innovative clinical trial designs are required, necessitating early discussion with sponsors and regulators. Amplifying the patient advocate voice through inclusion across the drug development continuum will lead to better, patient-centric trials. By these means, children and adolescents with cancer can maximally and rapidly benefit from innovative products to improve outcomes and reduce burdensome sequelae.
Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: PCA is an employee of Sanofi. EB is an employee of Day One Biopharmaceuticals. HC is an employee of Hoffmann-La Roche and owns stock of Hoffmann-La-Roche. SGD has consulted for Bayer and received travel expenses from Loxo, Roche and Salarius. LG has been an unpaid advisor to Amgen, Janssen, Kura, Novartis, OnKure and Pfizer and owns stock in Amgen, Sanofi Paris and Mirati. MK is an employee of Day One Biopharmaceuticals. KarstenNysom has consulted for Y-mAbs and has been an advisor to EUSA Pharma, Y-mAbs and Bayer and provided teaching to Y-mAbs and Bayer. ADJP has consulted for Lilly, Norgine and Developmental Therapeutics Consortium Limited and been an advisor for Amgen. RR is an employee of Gritstone Oncology, Inc. JS is an employee of INOVIO Pharmaceuticals, Inc. DW is an employee of Janssen Research & Development. All remaining authors have declared no conflicts of interest.
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