Sandbox | A place, area, or environment that provides opportunities for variation and experimentation in a way suggestive of children playing in a sandbox. A controlled environment supervised by a regulatory authority within which existing regulations are relaxed to allow stakeholders to more freely experiment with new products and service.
Canadian Pediatric Oncology Innovation Sandbox | An adaptable risk-based framework to provide Canadian access to promising, internationally approved pediatric oncology therapies for children and teenagers fighting cancer that has not responded to rational treatment options.
In Canada, over 86% of children under 15 with cancer are expected to survive 5 years after diagnosis. However, when survival rates are broken down by cancer type, is clear that advances have been extraordinary in some areas (e.g., >91% for Hodgkin’s lymphoma) other cancer types have survival rates closer to 60% and/or reduced survival upon metastatic disease – for example the 5-year estimated survival rate for Rhabdomyosarcoma drops from 83% to 45% if the child has metastatic disease.
Despite promising treatment options being developed globally, many Canadian children and teens with cancer are unable to access innovation new treatments due to systemic barriers and exhaust all available treatment options upon multiply relapsed disease.
Compared to other countries, Canada does not get full access to pediatric oncology clinical trials and the innovative therapies they offer.
Existing regulatory frameworks were largely designed with adult patients in mind, overlooking the unique needs of younger populations.
Canada lags behind the U.S./FDA in terms of the number of new drugs approved for pediatric oncology, and the turn around time to approval.
The provincial nature of Canada’s healthcare system results in fragmented regulations and inconsistent access to innovative drugs after they receive approval to be marketed in Canada (Health Canada NOC).
IMC has published that on average (across all indications and patient age categories) the time from NOC to access is 736 days.
These challenges compounded by limited trial infrastructure, geographic barriers in rural and remote areas, restrictive eligibility criteria, and the underrepresentation of marginalized groups continue to hinder equitable access to emerging therapies for children and teens in Canada.
The goal of the Innovation Sandbox is to establish a collaborative, flexible, and accelerated regulatory and access pathway that expands availability of novel and emerging therapies for children and teens with cancer in Canada while seeking an improved regulatory experience for pharmaceutical companies working in the Canadian pediatric oncology therapeutic area.