Passionate Childhood Cancer Advocate

Patrick Sullivan, Chair, Childhood Cancer Canada

You Have To Recognize A Problem To Address It

• Proportion of pediatric trials in oncology has been decreasing over time, especially for those which are investigator-led (rather than industry-sponsored)

The Access Problem In Canada

3

2010 2014 2018

Total # of CTAs 827 806 791

Total pediatric CTAs 136 109 134

% oncology 19.9% 16.5% 11.9%

Academic-sponsored oncology 14.0% 12.8% 4.5%

Industry-sponsored oncology 6.6% 3.7% 7.5%

We Are Collectively Working Hard to Address The Access Problem• Excellent working relationship with Clinicians & C17• Excellent working relationship with Health Canada

• Efforts to modernize Clinical Trial regulatory structure• Change in approach to off-label drugs in Clinical Trials• Continue to meet with informally

• Reminding everyone that we need to start with Why and then move to what and how

• $30 Million Federal Government Commitment To Pediatric Cancer• Continuing to diagnose the problem

Way(s) Forward to Further Address What An Access Gap That I Believe Will Get Worse• Embed patients in the international regulatory cooperative efforts that

Alysha spoke to• Keep the focus on Why• Drive a respectful sense of urgency• Think the problem differently

• Use the Accelerate forum to combat the Law of Unintended Consequences• Develop relationships with Payors• Understand both the problems and the opportunities from the perspective

of Industry • Play to our strengths and embrace the possibilities inherent in an

International Pediatric Oncology Regulatory Sandbox

Thank You!