Fit for Filing Academic Clinical Trials: An Industry Perspective

For decades, academic clinical trials consortia have collaborated to optimize outcomes for childhood cancers through evaluating incremental improvements in conventional multi modality treatment regimes. There are now increasing opportunities to partner with industry to test new medicines in academic-sponsored trials, but these collaborative studies rarely contribute to marketing authorizations. Under the auspices of the multistakeholder platform ACCELERATE, a working group of representatives was convened from clinical academia, the pharmaceutical industry, the European Medicines Agency, US Food and Drug Administration, and patient advocacy to explore why this is the case and to seek solutions to enable academic-sponsored trials to directly contribute to the licensing of new medicines. This presentation summarizes the group's findings and provides an industry perspective on how to move forward.Dr. Barry is a board-certified pediatrician and pediatric hematologist/oncologist with over 15 years of experience in drug development. Prior to joining Day One in 2021, she was the Global Clinical Lead for Pediatric Oncology at Pfizer, as well as Head of Pfizer’s Pediatric Oncology Leadership Team where she oversaw more than 10 pediatric oncology clinical programs. She has also held previous roles at Genzyme and Millenium/Takeda focused on the development of oncology therapeutics in adults. Dr. Barry serves on the Industry Advisory Council for CureSearch and is a member of the ACCELERATE Platform Steering Committee. She is also a co-chair of the Children’s Oncology Group Industry Relations Council. Dr. Barry is a graduate of the pediatric hematology/oncology fellowship program at the Dana Farber Cancer Institute and Children’s Hospital Boston, and the pediatric residency program at Tufts. She received her M.D. at Yale University School of Medicine and also obtained a Masters in Medical Science degree from Harvard Medical School.