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Evolution of Novel Registration Endpoints as Diseases Become Chronic
Session Chair(s)
Irene Nunes, PHD
VP, Head of Regulatory Affairs, Flatiron Health, United States
Recent advances in medicine have rendered once-acute diseases into chronic burdens, but serious unmet medical needs remain for these patients. Addressing these unmet medical needs with novel therapies requires new and flexible endpoints acceptable to global regulators. This session tackles possible approaches to address the endpoint gap using the immunooncology development paradigm as a case study.
Learning Objective : Describe endpoint gaps for long term diseases; Evaluate alternative endpoint approaches using immuno-oncology as a case example.
Speaker(s)
Irene Nunes, PHD
VP, Head of Regulatory Affairs, Flatiron Health, United States
Evolution of Novel Efficacy Registration Endpoints to Quantitate Improved Long Term Survial Effects of New Drugs
Rajeshwari Sridhara, PHD
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Challenges in Evaluating Immuno-Oncology Products
C. Ola Landgren, MD, PHD
Professor of Medicine and Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center, United States
Endpoint Minimal Residual Disease Used for Novel Multiple Myeloma Therapies
Marc Theoret
Office Deputy Director, Office of Oncologic Diseases, OND, CDER, FDA, United States
Regulatory Considerations for Novel Endpoints in Immuno-Oncology
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