All posts tagged: Drug Development

CC Community News Digest (May 25-31)

Assorted news from the last week: FDA issues its final guidance on the RACE Act and specifies when sponsors must conduct pediatric studies for new cancer drugs as well as when those requirements can be waived or deferred. CAC2 Supporting Organization Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN), a clinical-stage biopharmaceutical [...]

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 [...]

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 […]

Accelerating Drug Development for Children and Adolescents with Cancer

We were pleased to invite CAC2 members, associate members, student members, supporting organizations to our December CAC2 All-member webinar where Susan Weiner (Children's Cancer Cause) hosted Dr. Gilles Vassal, chair of ACCELERATE, an international nonprofit. Dr. Vassal discussed ACCELERATE and its fresh approach to addressing the complex challenges of developing innovative pediatric cancer [...]

Understanding and Enhancing the Role of Children with Cancer and their Parents in Pediatric Oncology Drug Development

This month's webinar was presented by Stacy Crane, Predoctoral Fellow at Indiana University School of Nursing.  She described the experience of participating in a Phase I clinical trial from the perspective of the parents of children battling cancer. While overall, parents do not regret their child participating in a phase I clinical trial [...]