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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)
Evolution of Novel Efficacy Registration Endpoints to Quantitate Improved Long Term Survial Effects of New Drugs
Irene Nunes, PHD
Flatiron Health, United States
VP, Head of Regulatory Affairs
Challenges in Evaluating Immuno-Oncology Products
Rajeshwari Sridhara, PHD
FDA, United States
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA
Endpoint Minimal Residual Disease Used for Novel Multiple Myeloma Therapies
C. Ola Landgren, MD, PHD
Memorial Sloan Kettering Cancer Center, United States
Professor of Medicine and Chief of Myeloma Service
Regulatory Considerations for Novel Endpoints in Immuno-Oncology
Marc Theoret
FDA, United States
Office Deputy Director, Office of Oncologic Diseases, OND, CDER