For more than 4 decades, the University of Chicago Cancer Research Foundation’s Simon M. Shubitz Cancer Prize and Lectureship has honored an internationally renowned individual for his or her exceptional contributions to cancer research and clinical care. The recipient of this year’s award is Richard Pazdur, MD, Founding Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), where he is leading an effort to develop and execute an integrated regulatory approach to further improve the cross-center coordination of the clinical review of oncology products.
“Who knows better about treatment adverse events than actual patients receiving those treatments? We think it’s important to hear directly from the patient experiencing the events.”— Richard Pazdur, MD
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Due to the ongoing COVID-19 pandemic, the Simon M. Shubitz Lecture and Prize ceremony was held virtually on October 19, 2020, and attended by the University of Chicago Comprehensive Cancer Center administration, cancer research and clinical faculty, fellows, and students. Despite its virtual nature, accepting the award and delivering his keynote address was like a homecoming for Dr. Pazdur, a Chicago native.
“This award has special meaning for me since I’m originally from Chicago and I completed my medical training at the University of Chicago Hospitals and Clinics. I have a personal relationship with the city. Most of my family still reside in Chicago, so receiving this award was more than just professional recognition. It was a homecoming, albeit virtual,” said Dr. Pazdur. “I left Chicago in 1982, and nearly 40 years later I returned to accept this award.”
‘A Watershed in the History of Precision Medicine’
Dr. Pazdur’s long career at the FDA began in 1999 when he was named Director of the Division of Oncology Drug Products. He later served as Director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research. As Director of OHOP, Dr. Pazdur coordinated oncology activities across all FDA centers and engendered collaboration between the FDA and the National Cancer Institute, as well as cancer-related organizations both inside and outside the government.
Under Dr. Pazdur’s leadership, the FDA has accelerated precision medicine approaches in oncology, including FDA approval, in 2017, of the first tumor-agnostic drug, the PD-1 inhibitor pembrolizumab, in the treatment of patients with unresectable or metastatic, microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed following prior treatment and who have no viable treatment options. The journal Nature Reviews Drug Discovery called this approval “a watershed in the history of precision medicine.”1 Since then, the agency has also approved the first bevacizumab biosimilar, ABP 215, and the first chimeric antigen receptor (CAR) T-cell therapy, tisagenlecleucel.
Incorporating the Patient Voice Into Drug Development
During his keynote address, Dr. Pazdur recounted the progress made in oncology care over the past 4 decades and the evolution of drug development over that time. “Oncology is the most active area of drug development for the pharmaceutical industry, reflecting 40% of total pharma activity,” Dr. Pazdur told the audience. “A total of 40% to 50% of our Breakthrough Therapy designations given by the FDA are in the area of oncology. We have not only a large number of drugs being developed, but these drugs hold the potential for significant therapeutic advances.”
Dr. Pazdur also talked about a recently launched online pilot program called Project Patient Voice (www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice). It is designed to provide patients, caregivers, and health-care providers with patient-reported symptom data collected from cancer clinical trials for marketed treatments.
“In oncology, we have a significant interest in incorporating patient-reported outcomes in clinical trials and, when feasible, into product labeling. Who knows better about treatment adverse events than actual patients receiving those treatments? We think it’s important to hear directly from the patient experiencing the events,” said Dr. Pazdur.
Dr. Pazdur also talked about how the Oncology Center of Excellence is developing regulatory science in oncology, including a new initiative looking at the use of seamless clinical trial designs that eliminate the conventional division of phase I, II, and III trials that may delay drug development but does not compromise patient safety. “Instead of concluding a clinical trial after each phase and constructing the trial’s next phase, which causes significant delays, a seamless trial compresses the traditional three phases of drug development into one continuous process. And we have approved drugs on the data submitted on seamless trial designs,” explained Dr. Pazdur in an interview with The ASCO Post.
Looking to the Future
What might the next 4 decades bring in advances in oncology care? “Progress in cancer will come from our ability to rely on biomarkers to find cancer before the tumor becomes radiographically detectable. And treatment will center on immunotherapies that activate the immune system to fight this early disease,” said Dr. Pazdur. “I imagine a time when cancer will be detected from a blood test given during patients’ annual physicals, and we will have immunologic drugs that will activate the body’s immunologic defense to eradicate those very early malignant cells. This is my aspirational hope for the future.”
In addition to the Simon M. Shubitz Cancer Prize and Lectureship, Dr. Pazdur is the recipient of numerous other honors, including ASCO’s Service Recognition Award, ASCO’s Public Service Award, and the American Association for Cancer Research Distinguished Public Service Award. In 2015, Dr. Pazdur was named one of Fortune magazine’s World’s 50 Greatest Leaders, and, in 2017, he was named one of the leaders who defined global business in The Bloomberg 50, a ranking of 50 individuals with “the ability to move markets or shape ideas and policies.”
1. Looney AM, Nawaz K, Webster RM: Tumour-agnostic therapies. Nature Reviews Drug Discovery, January 28, 2020. Available at www.nature.com/articles/d41573-020-00015-1. Accessed October 22, 2020.