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  1. Oncology Center of Excellence

Patient-Focused Drug Development

The Oncology Center of Excellence PFDD program fosters collaboration between FDA Centers and external stakeholders involved in patient outcomes research in cancer populations. The program focuses on three key areas:

  • Actively engaging with patients and advocacy groups.
  • Fostering research into measurement of the patient experience.
  • Generating science-based recommendations for regulatory policy.

Cancer patients experience disease symptoms and symptomatic treatment side effects that can impact their ability to function and other aspects of their health-related quality of life. The PFDD Program is working to identify rigorous methods to assess the patient experience that will complement existing survival and tumor information to provide additional evidence about the effects of cancer therapies on patients.

photo of Paul Kluetz, M.D.

Paul G. Kluetz, M.D.
Oncology Center of Excellence

Paul Kluetz is a medical oncologist and the Deputy Director of the Oncology Center of Excellence at the U.S. FDA. In addition to his broader role in OCE’s strategic oversight and management, Dr. Kluetz founded the OCE’s PFDD program and continues to support its strategic mission. He has engaged the global cancer drug development and health outcomes community in leading a sustained effort to advance patient reported outcomes (PRO) data, wearable technologies, and other methods to obtain rigorous patient experience data in both the clinical trial and “real-world” settings.


Photo of Vishal Bhatnagar, M.D.

Vishal Bhatnagar, M.D.
Oncology Center of Excellence

Vishal Bhatnagar, MD, is a medical oncologist/hematologist and the Associate Director for Patient Outcomes in the OCE. His interests include patient reported outcomes, patient preference and incorporation of patient experience in oncology trials. His work focuses on the operational management of the OCE’s Patient-Focused Drug Development program. Additionally, Dr. Bhatnagar has a strong clinical interest in multiple myeloma and has previously served as an Office of Hematology and Oncology multiple myeloma scientific liaison. Dr. Bhatnagar received his BA in Political Science and his medical degree at the George Washington University. He completed his internal medicine residency and hematology/oncology fellowship at the University of Maryland.


photo of Bellinda King-Kallimanis, Ph.D.

Bellinda King-Kallimanis, Ph.D.
Senior Staff Fellow
Oncology Center of Excellence

Bellinda King-Kallimanis is a Senior Staff Fellow in the Oncology Center of Excellence at the FDA. She has a PhD in psychometrics and works on patient-focused drug development initiatives that focus on using clinical outcome assessments (COAs) in cancer clinical trials. Her current projects involve looking at open label response bias, understanding responsiveness of physical function measures and investigating current COA strategies being submitted to the agency to learn how these can be improved. Bellinda has been working in the field of COAs for the past 11 years across both academia and industry. She has investigated how patients’ responses to questionnaires can shift over time using structural equation modeling and worked on qualitative projects developing new patient-reported outcome instruments.  


photo of Janice Kim

Erica Horodniceanu, MPH
Oncology Center of Excellence

Erica Horodniceanu contributes to policy development and research within the OCE’s Patient-Focused Drug Development program at the FDA. Over the past 18 years, Erica has provided healthcare research, health education, health communications, and project management services to pharmaceutical, biotech, and medical device companies. She has previously held positions in industry within consulting firms focused on outcomes research and has been working in the field of COAs for the past 8 years. Erica holds a Bachelor of Science degree in Health Science Education, with a concentration in Health Promotion from the University of Florida and a Master’s in Public Health degree in Public Health Practice and Policy from the University of Maryland.


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