All posts tagged: Drug Development

CAC2 Webinar–Hearing Loss from Cisplatin—Multiple Perspectives on the New FDA Preventative Treatment Option

December 1, 2022
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Children who receive cisplatin as part of their cancer treatment are at risk for progressive and/or permanent hearing loss as a result of their treatment.  This treatment effect can influence speech and language development, educational achievement, and social-emotional development.  Recently, the FDA approved Pedmark, a Sodium Thiosulfate Injection created by Fennec Pharmaceuticals, as a treatment to help reduce the risk of ototoxicity associated with cisplatin.  November’s CAC2 All-Member webinar provided key information about this important breakthrough in improving the quality of life for childhood cancer survivors who received cisplatin. Attendees learned about the importance of this specific drug approval, the [...] Read more

Guest Blog–The Fit for Filing Group at ACCELERATE

November 14, 2022
Blog Posts, Community News, Explainer Post, Guest Blogs No comments yet

Blogged with permission and thanks by the ACCELERATE Fit for Filing Working Group   The ACCELERATE PLATFORM’S Fit for Filing (FFF) group was formed in 2019 to explore the issues of academic-led trials that typically do not produce data that is fit-for-filing to gain marketing approval by regulatory agencies.   The scope of Fit for Filing (FFF) is to develop best principles on how to design and deliver an academic or academic & industry collaborative trial with a dataset that can be included in a package for regulatory filing.Objectives of the FFF working group are: Define the barriers and propose solutions to ensure […]

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FDA Public Meeting: Rare Disease Day 2022

February 14, 2022
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FDA will host a virtual public meeting on March 4, 2022 to join the global observance of Rare Disease Day. The theme for FDA’s Rare Disease Day is “Sharing Experiences in Rare Diseases Together.” Patients, patient advocates, researchers and medical product developers may benefit from attending this public meeting on rare disease product development. During presentations and panel discussions various stakeholders will share their perspectives on and experiences in rare disease product development.

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CAC2 Webinar–Why Childhood Cancer Foundations are Adopting the Venture Philanthropy Approach

January 24, 2022
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In our January CAC2 All-Member webinar CAC2 invited the following panelists to speak on Venture Philanthropy: Dean Crowe - Rally Foundation For Childhood Cancer Research, Steve Giusto - Pediatric Cancer Research Foundation, Joe McDonough - The Andrew McDonough B+ Foundation and Dena Sherwood - Arms Wide Open Childhood Cancer Foundation. Venture Philanthropy is a growing trend across many important social issues. For the childhood cancer community, one case study of venture philanthropy is with Oncoheroes Biosciences. Since October 2019, 12 childhood cancer nonprofits have invested in this biotech company that is developing new therapies for children with cancer. In this webinar, [...] Read more

Guest Blog–How Collaboration is Advancing Research and Clinical Care in Pediatric Cancer

April 1, 2021
Blog Posts, Collaborative Achievements, Community News, Guest Blogs No comments yet

By Guest Blogger Dr. Lynne Davies, Operations Manager, International Cancer Research Program   It is with great excitement that I write to let you know about the upcoming webinar scheduled for Monday, April 19th at 10am ET, which aims to capture the very essence of why the International Cancer Research Partnership (ICRP) was created.   ICRP is a unique alliance of cancer organizations working together to enhance global collaboration and strategic coordination of research.  This webinar, entitled “How collaboration is advancing research and clinical care in pediatric cancer,” is jointly organized by ICRP, National Cancer Research Institute Children’s Group and Events […]

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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

CAC2 Webinar–What is a Pediatric Study Plan?

May 27, 2020
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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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CAC2 Webinar–Accelerating Drug Development for Children and Adolescents with Cancer

December 11, 2019
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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 therapies in the new regulatory environment. View the webinar below. Read more

CAC2 Webinar–Non-Profit Driven Pediatric Oncology Drug Development

May 25, 2016
Webinars No comments yet
In this All-Member webinar for May 2016, CAC2 welcomed Dr. Cesare Spadoni, Chairman and Co-Founder of Accelerating Paediatric Oncology Drug Development. Parents and non-profit entities can play a strong role in driving drug development and thus accelerate the availability of more innovative drugs for children with cancer. But to do, so they must adopt new operating models and collaborate more effectively with other stakeholders. https://youtu.be/GZVCYn-Rmek Read more
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