CAC2 Webinar–The Art and Science of Navigating the Clinical Trials Landscape for Childhood Cancer

June 18, 2020
Webinars No comments yet
Our June CAC2 All-Member webinar explored the world of clinical trials and helped us understand the important role of clinical trial navigation, a topic that is growing in importance as the number and variety of options for pediatric and adolescent oncology patients has begun to grow. Brenna Carswell, Clinical Trials Navigator at Alex’s Lemonade Stand Foundation, and Michael Wenger, Vice President of Patient Engagement at Trialscope, covered the basic trends in trial enrollment and the challenges and solutions to improving access to clinical trials for children and teens with cancer.  Both Brenna and Michael are cancer survivors! Read more

FDA Approves Gemtuzumab Ozogamicin for CD33-Positive AML in Pediatric Patients

June 16, 2020
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On June 16, 2020, the Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARGTM, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.   Read More Here On June 16, 2020, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Read [...] Read more

AACR Sponsored Listening Session with FDA

May 27, 2020
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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

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CAC2 Webinar–What is a Pediatric Study Plan?

May 27, 2020
Webinars No comments yet
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

May 21, 2020
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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

May 3, 2020
Collaborative Achievements No comments yet
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

CAC2 Webinar–Cancer in Children with Birth Defects: What Can We Learn from Population-Based Studies 

April 29, 2020
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Our April CAC2 All-Member webinar hosted by Donna Ludwinski (Solving Kids Cancer) introduced Drs. Jeremy Schraw and Philip Lupo of Baylor College of Medicine who spoke about their research on nonchromosomal cancer predisposition. Studies show that birth defects are one of the strongest risk factors for cancer in children, but who is at risk and why? To address these questions, the presenters performed the largest investigation of cancer risk in children with birth defects to date. They discussed how a child’s risk of cancer relates to the type and number of birth defects they are diagnosed with, evidence for possible genetic and [...] Read more

Joint Webinar Presentation: The Pandemic’s Impact on the Pediatric Cancer Research Landscape

April 28, 2020
Collaborative Achievements No comments yet

Solving Kids’ Cancer and Max Cure Foundation offered a joint webinar: The Pandemic’s Impact on the Pediatric Cancer Research Landscape Timothy P. Cripe, Chief of Hematology and Oncology at Nationwide Children’s Hospital moderated the session that featured an all-star line-up: Peter Adamson, MD – former Chair, Children’s Oncology Group (COG) and current Global Head, Oncology Development & Pediatric Innovation, Sanofi Mark Kieran, MD, PhD – Pediatric Clinical Trial Lead, Bristol Myers Squibb Jeffery J. Auletta, MD – Director of the Blood and Marrow Transplant (BMT) Program and the Host Defense and Immunocompromised Infectious Diseases Program at Nationwide Children’s Hospital. Carol Thiele, Ph.D, […]

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CAC2 Member Guide to Navigating Covid19

April 1, 2020
CAC2 News No comments yet
If you want to know what the $2.2 trillion CARES Act economic relief package means for nonprofits, donors, and individuals, have asked yourself "what can I do?" want to brush up your leadership skills or explore ideas to help with fundraising in a crisis, or just need accurate and reliable information, then the CAC2 Member Guide to Navigating the Covid-19 crisis may help.  Members have worked together to build this document to help organizational and individual members during this unprecedented crisis.     If we have overlooked an essential resource, let us know here:  Suggest a Resource for the Guide.   You [...] Read more
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