The American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) recorded a listening session on May 27, 2020 for patient advocates to learn more about cancer clinical trials during COVID-19. The session is about 45 minutes, with the pediatric questions at about minute 25.5, minute 37, and minute 41. FDA Listening Session: Oncology and Covid-19
Read morePosts archive for May, 2020
CAC2 Webinar–What is a Pediatric Study Plan?
Our May CAC2 All-Member webinar focused on how pediatric cancer study plans are developed. CAC2 Member Kelli Wright (CureSearch) introduced Dr. Brenda Weigel from University of Minnesota’s Masonic Cancer Center and Dr. Samuel Blackman of Day One Biopharmaceuticals as they addressed: What is a Pediatric Study Plan (PSP)? How is it created and by who? How does FDARA/RACE for Children impact PSP development? Where in the process are the opportunities to create better PSPs? Currently, regulatory agencies require that a pharmaceutical or biotechnology company submit a Pediatric Study Plan (PSP) to confirm the suitability of drug usage in the pediatric [...] Read more
Day One Biopharmaceuticals
Day One Biopharmaceutical, a start-up biotech company founded with a focus on developing therapies for children with cancer through drug repurposing announced its debut in the market last week. Its first agent, DAY101, licensed from Takeda Pharmaceuticals, is a targeted treatment for children with low grade glioma, a type of brain cancer. DAY101 is a Phase 2-ready RAF inhibitor that also shows strong potential for other pediatric and adult indications. The company is co-founded by Chief Medical Officer Dr. Sam Blackman (who offered our May webinar) and Acting CEO Julie Grant from Canaan Partners. You can read more here. Please look for a […]
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Phase III Pediatric Brain Tumor Clinical Trial Collaboration
Everybody is worried these days. We have witnessed toilet paper hoarding and other behaviors that make us feel vulnerable and alone. That's why we would like to hold up and highlight some fabulous Member Collaborations. One recent collaboration between two CAC2 members really brings this story of hope in the midst of worry during Coronavirus as these two organizations, The Taylor Matthews Foundation and the Pediatric Brain Tumor Foundation found a way to support funding for a Phase III clinical trial. Here's the story in their words: "As you may recall, The Taylor Matthews Foundation first linked arms with PBTF [...] Read more