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Wednesday, June 21 • 10:30am - 11:45am
#317: Evolution of Novel Registration Endpoints as Diseases Become Chronic

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-17-530-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Describe endpoint gaps for long term diseases; Evaluate alternative endpoint approaches using immuno-oncology as a case example.


Irene Nunes, PhD


Evolution of Novel Efficacy Registration Endpoints to Quantitate Improved Long Term Survial Effects of New Drugs
Irene Nunes, PhD

Challenges in Evaluating Immuno-Oncology Products
Rajeshwari Sridhara, PhD

Endpoint Minimal Residual Disease Used for Novel Multiple Myeloma Therapies
C. Ola Landgren, MD, PhD

Regulatory Considerations for Novel Endpoints in Immuno-Oncology
Marc Theoret


Irene Nunes

Executive Director, Global Regulatory Affairs, Daiichi Sankyo Co., Ltd.
Irene Nunes is a 13yr physician scientist with experience in drug development and global regulatory affairs. She has been a project lead for consortia projects for the last 10 yrs and actively working on the clinical qualification of novel kidney safety biomarkers for drug development... Read More →

avatar for C. Ola Landgren

C. Ola Landgren

Professor of Medicine and Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center
Dr Ola Landgren has designed studies to define biological mechanisms of transformation from myeloma precursor disease to myeloma. He has developed (1) early interventional clinical trials for patients with high-risk smoldering myeloma to delay/prevent transformation; (2) modern intervention... Read More →
avatar for Rajeshwari Sridhara

Rajeshwari Sridhara

Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products in the Oncology Center of Excellence and Center for Drug Evaluation and Research. As a leader in the field, she routinely... Read More →

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA
Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Session