SITC Thanks FDA Leaders for Their Service

By Keegan Mager posted 03-31-2025 15:31

  

Dear SITC Members,

The Society for Immunotherapy of Cancer (SITC) would like to thank Peter Marks, MD, PhD, Marc Theoret, MD, and Paul Kluetz, MD, of the U.S. Food and Drug Administration (FDA) for their significant contributions across the field of oncology and their positive impact on public health. The development of cancer immunotherapy as we know it today - serving as first-line treatment for numerous cancer types - represents one such advance in oncology that would not have been possible without the tireless work ethic, collaboration, and determination of these individuals to improve cancer patient outcomes and save lives.

Peter Marks, MD, PhD, who served as Director of the Center for Biologics Evaluation and Research (CBER), has made significant contributions not only in oncology, but also across global health. Concerning oncology, he helped shepherd evaluation of multiple novel modalities, including the initial approvals of CAR-T therapies in 2017 as well as the initial approval for treating solid tumors with adoptive cellular therapies in 2024. These advances now represent a key pillar and future foundation for immunotherapeutic treatment of cancer. His willingness to collaborate, educate, and innovate has provided immense benefit to numerous cancer patients and has driven the field of oncology to new heights. Beyond cancer, he has also provided immeasurable impact on the world by leading the rapid evaluation and approvals of COVID-19 vaccines that saved countless lives during the pandemic.

Marc Theoret, MD, has been an integral collaborative partner and friend of SITC since 2013. In addition to serving as Deputy Center Director of the Oncology Center of Excellence (OCE), as well as an Associate Director at the Office of Oncologic Diseases (OOD) within the Center for Drug Evaluation and Research (CDER), he has also served as SITC’s direct liaison with CDER and OCE. As part of this role, he was an ex officio member of our Board of Directors and has provided numerous contributions and leadership across SITC initiatives, both educational and scientific in nature. He has been a true partner with SITC and the field of oncology in ensuring that immunotherapy continues to advance into the clinic at speeds that ensure maximal patient benefit.

Paul Kluetz, MD, through his role as Deputy Center Director of OCE, as well as Associate Director at OOD within CDER, has worked to modernize drug development to better serve cancer patients across the globe. Not only has he led evaluation of numerous cancer therapeutics, he has also championed reinvention of the drug development process as a whole. His work on decentralizing trials, digital health technologies, and incorporating real-world evidence into oncology drug evaluation is highly synergistic with advances that SITC has emphasized throughout various efforts and initiatives as the future of cancer immunotherapeutic drug development.

SITC looks forward to continuing our work with these innovative leaders, the FDA, and other individuals to advance novel, safe, and effective cancer immunotherapies into the clinic well into the future. Our members and cancer patients understand that oncology research must have sustained momentum in order to make the word “cure” a reality for cancer patients everywhere. 

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