Fostering Pediatric Oncology Drug Development

Amy Cheung, Senior Director of Integrated Drug Development, Certara
Larissa Wenning, Scientist, Quantitative Pharmacology and Pharmacometrics, Merck & Co., Inc.
Lynne Georgopoulos, Vice President, Regulatory Strategy, Certara
Date: July 30, 2020
Time: 11:15 am ET
Duration: 1 hour

In 2020 approximately 11,000 children in the US under the age of 15 will be diagnosed with cancer. After accidents, cancer is the second leading cause of death in this population. The most common cancers in children younger than 15 are leukemia, brain, and central nervous system tumors.

The Pediatric Research Equity Act (PREA) gives the US FDA the authority to require biopharmaceutical companies developing drugs for adults to also develop them for children. However, most cancer drugs have not been subject to PREA requirements. Thus, most cancer drugs approved in the last couple of decades have not had any pediatric labeling information.

In addition, pediatric cancer drug development presents multiple challenges. Pediatric cancers include multiple rare tumor types. A substantial proportion of pediatric cancers have genomic alterations that are not shared with common adult cancers. Therefore, there is a small pediatric patient population that can be studied in clinical trials. In addition, pre-clinical models of pediatric cancer are limited. Finally, developing pediatric oncology drugs requires considering both potential developmental and long-term toxicity.

Who should attend this webinar?
  • Regulatory Affairs
  • Scientific Affairs
  • Research and Development
  • Clinical Development
  • Clinical Pharmacology/Pharmacometrics
  • Anyone interested in advancing the future of pediatric oncology
By attending this webinar, you will learn:
  • Why the Research to Accelerate Cures and Equity (RACE) for Children Act is critical to the advancement of pediatric cancer research
  • What are the implications for the pharmaceutical industry come August 18, 2020, when the RACE for Children Act goes into effect
  • How modeling and simulation can empower pharma companies to make informed decisions to accelerate developing pediatric cancer therapies

About Our Speakers

Amy Cheung.jpg
Amy Cheung is a Senior Director of Integrated Drug Development at Certara. She has over a decade of experience of clinical development in the pharmaceutical industry. Dr. Cheung earned her PhD and completed a postdoc at the University of Manchester on structural identifiability and mechanistic modeling. Prior to coming to Certara, she was a senior clinical pharmacometrician and project manager of pediatric working group at AstraZeneca. Dr. Cheung is currently the Chair of the IQ consortium Clinical Pharmacology and Translational and ADME Sciences Leadership Groups PBPK Pediatric Working group.

Larissa Wenning is a Distinguished Scientist in Quantitative Pharmacology and Pharmacometrics at Merck & Co., Inc. and is Vice Chair of the ASCPT Global Health Community. She has worked across a broad spectrum of drug development. Prior to joining Merck, Dr. Wenning received undergraduate degrees in History and Chemical Engineering from the University of Notre Dame, a doctorate in Chemical Engineering from the University of Wisconsin, Madison, and conducted post-doctoral research at Northwestern University.

Lynne Georgopoulos is Vice President, Regulatory Strategy at Certara. Lynne has over 30 years of diverse biopharmaceutical and CRO industry experience developing and providing strategic guidance and clinical and regulatory advice at all stages of product development. She has spent the last several years promoting innovative methods to accelerate pediatric drug development as VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm.

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