All posts tagged: Industry Perspective

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

CAC2 Webinar–The Blood-Brain Barrier: What If You Could Get Drugs Across?

January 26, 2017
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In this January 2017  CAC2 All-Member webinar, we provided an opportunity to our members, associate members, student members, and supporting organizations to learn about emerging technology using ultrasound and microbubbles to deliver therapeutic agents across the blood-brain barrier.  Clay Larsen, President & CEO and Rhodemann Li, Founder, EVP Strategy & Finance, both of Vesselon, presented about their plans for this technology in the pediatric brain tumor population. The blood-brain barrier (BBB) is the body's natural defense mechanism to prevent toxins from entering the brain.  Unfortunately, it also prevents 99% of all therapeutic molecules from getting to their target to treat many diseases, [...] Read more

CAC2 Webinar–Basics of a Clinical Trial in Pediatrics: A Sponsor’s Perspective

August 19, 2016
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In this All-Member and all-community webinar for August 2016, CAC2 welcomes Drs. Michael Trigg, Brigid Bradley-Garelik, and Greg Plautz from Bristol-Myers Squib, speaking on the clinical trial process. These three esteemed industry experts provided an overview of the clinical trial process, particularly from an industry-sponsored trial perspective and cover topics such as clinical trial designs, different required FDA phases of drug development, data monitoring committees, general principles of pediatric trials and special considerations of pediatric trials, industry obligations to pediatrics and personalized medicine. This presentation was not recorded. Read more

CAC2 Webinar–Non-Profit Driven Pediatric Oncology Drug Development

May 25, 2016
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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

CAC2 Webinar–Dr. Jeffrey Skolnik, Basics of Pediatric Drug Development

November 17, 2014
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On Wednesday, November 12, CAC2 had the privilege of hosting Jeffrey Skolnik, MD, US Medical Affairs Leader, Oncology, GlaxoSmithKline and Attending Physician, Children’s Hospital of Philadelphia. He presented our November All-Member webinar about the industry perspective in pediatric oncology drug development.   The views he expresses are his personal observations and not the official position of GSK or any other pharmaceutical company. https://youtu.be/Txrak33zR60 Read more
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