First person profile: Richard Pazdur, MD: The founding director of the FDA's Oncology Center of Excellence has long spearheaded major initiatives to improve oncology drug development.

Abstract

“When I began my career in 1979, there were approximately 30 to 40 oncology drugs in total. Now every year we approve about 14 to 16 new molecular entities per year. The field has just exploded,” he says. “About 40% of all drug development in the world today is in the area of oncology. And not only do we have a lot of drugs, but about half are breakthrough therapy drugs that are really significant advances in treating diseases such as myeloma, melanoma, and lung cancer.” Dr. Pazdur has served as the founding director of the FDA's Oncology Center of Excellence since its launch in 2005 and is widely credited with paving the way for many of the successes in drug development. The office's mission is to consolidate the FDA's review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer as well as hematologic diseases and for medical imaging. As director, he also oversees ongoing collaborations with the National Cancer Institute and many other cancer organizations. Before his term as the Oncology Center of Excellence director, he served as director of the FDA's Office of Hematology Oncology Products from 1999 to 2005. “Friends of cancer research refer to him as ‘the oncology drug tsar,’” says Melanie Royce, MD, PhD, a medical reviewer in the FDA's Office of Oncologic Diseases, who first met Dr. Pazdur in 1997 when she was a fellow and he was a professor at the University of Texas MD Anderson Cancer Center in Houston. “To see his huge accomplishments in the oncology world, all you have to do is look at the number of drug approvals compared to when he started in 1999. I absolutely believe that his leadership has made a difference.” In recognition of his achievements, Dr. Pazdur has received numerous awards and honors, including the 2015 American Association for Cancer Research Distinguished Public Service Award; the 2013 American Society of Clinical Oncology (ASCO) Public Service Award; a spot in Fortune Magazine's 2015 listing of Top 50 World Leaders; and recognition by OncLive as a 2019 Giant of Cancer Care for Community Outreach, Education, and/or Cancer Policy, among many others. He has published more than 400 articles, book chapters, and abstracts. Teaching has been a key interest of Dr. Pazdur's since his childhood, which he spent in South Side Chicago's Calumet City, near the Indiana border. Growing up in this tightknit, largely Polish community, he attended the same grade school and high school that his mother and her family had attended. Because his parents both came from large families, he also had an abundance of uncles, aunts, and cousins in the area and still considers himself “a Chicago person.” “I remember sitting on my bedroom floor during my junior year in high school, looking at the academic catalogue from the Northwestern University School of Medicine and seeing all the professors. I said, ‘I want to be like these people—they have to be the best doctors because they're actually teaching others,’” he says. Moving to Chicago's North Side for college, Dr. Pazdur graduated from Northwestern University in Evanston in 1973. He had a particularly strong interest in sociology and ethnicity issues because of the social unrest at the time, which sprang largely from the Vietnam war. Upon graduation from Northwestern, Dr. Pazdur attended the Loyola University Stritch School of Medicine in Chicago, a program that was particularly appealing because it was a 3-year program instead of a 4-year program. “Not many people know this, but my father became blind very early in life, and that put a lot of economic pressures on our family,” he recalls. At the time, Dr. Pazdur was not very interested in the relatively new discipline of oncology. Loyola University had a large cardiology center, and his plan was to enter that field. Working in the cardiac catheterization laboratory in the hospital's basement during his residency, however, he quickly discovered that injecting dye into patients' hearts was not the career for him. Instead, he began to consider oncology. “I went to the hospital gift shop and got $10 worth of quarters, and just started dialing all the oncology fellowship programs in the country. Lo and behold, there was an opening at Rush-Presbyterian-St. Luke's Medical Center because a friend of mine had just dropped out there,” he says. Rush, also in Chicago, had one of the largest oncology programs in the country at the time, with 12 oncologists. Not only did the fellowship turn out to be an excellent professional decision, but it also led him to the love of his life. On the very first day, Dr. Pazdur met his future wife, Mary, an oncology nurse practitioner. “She was my partner in my whole career, and any success I have had I really owe to her,” he says. “She was the greatest professional and emotional support that I could have had.” Mary died of ovarian cancer approximately 5 years ago. “Even though she passed away,” Dr. Pazdur says, “I consider myself lucky in the sense that I had such a special person throughout most of my life.” After completing an additional year of a hematology fellowship, he spotted an ad in The New England Journal of Medicine (NEJM) for a medical oncology position at Wayne State University in Detroit, Michigan, which had a very large oncology program. He accepted the position and married Mary on a rainy day in Chicago just before moving. After 6 years in Detroit, Dr. Pazdur came across another NEJM ad, this time for a position at MD Anderson Cancer Center, where he would stay for 11 years, serving as a professor of medicine, director of educational programs, and assistant vice president for academic affairs, among other roles. Continuing his interest in medical education, he ran the fellowship program and focused on gastrointestinal oncology (particularly colorectal cancer) as well as new drug development and phase 1 clinical trials. In 1999, Dr. Pazdur spotted an ad, once again in NEJM, for an oncology division director at the FDA. He believed that all of his experience working with pharmaceutical companies on clinical trials would make him a great candidate, and the FDA agreed. When he started at the FDA, the agency had 12 oncologists on staff who were generalists. Today, the division has grown to nearly 100 oncologists in highly specialized areas. Among his many accomplishments at the FDA, Dr. Pazdur is most proud of creating a high degree of transparency. “I really do believe that academic investigators and pharmaceutical companies need to have a thorough understanding of what the FDA wants—that there shouldn't be any guessing games,” he says. “I've told our staff to communicate to our stakeholders exactly what their plans are.” Dr. Pazdur is particularly proud of some of the novel programs he has instituted. Project Orbis, for example, enables a collaborative review process between the United States, Canada, Australia, the United Kingdom, and Brazil in order for oncology drugs to be approved much earlier in those countries than they would be otherwise. Other programs include Project Facilitate, which helps walk practitioners through the process of obtaining compassionate use approval for certain drugs in treating individual patients; Project Community, an outreach program to underserved populations; and Project Equity, which examines ways to improve participation of underrepresented populations in clinical trials. He also initiated a joint educational program with the American Association for Cancer Research and the American Society of Clinical Oncology to educate fellows and other interested practitioners about the FDA and its review process. In terms of future challenges, Dr. Pazdur points to the need to balance between innovation and commercial interests. “We've been spending billions of dollars on drug development, and there's a considerable amount of duplication,” he says. “I really question whether there needs to be more national leadership on how our drugs are developed and where our resources are dedicated.” For example, Dr. Pazdur believes that there is no need for 6 different PD-1 drugs. Although he wonders if there should be national leadership on this issue, he adds that neither the FDA nor the National Institutes of Health control the pharmaceutical industry. “Basically, you have a commercial enterprise running the scientific industry,” he says. “I think with the pandemic that we've learned some important lessons on how to coordinate between government and pharmaceutical firms. It might be a silver lining in a bad situation.” Outside of work, Dr. Pazdur loves to take long walks. Although he can no longer run because of joint issues, he regularly rises at 5 am to walk 6 miles or more before starting his workday. “Walking is really an underappreciated form of exercise,” he says. “It just clears your head to be outside in the sun, even in cold weather.” His true love, however, is mentoring others. Dr. Royce, a long-time mentee of Dr. Pazdur's, attributes much of Dr. Pazdur's success to his leadership philosophy of focusing on the people who work for him. Far from being a micromanager, she explains that Dr. Pazdur selects good people and provides them with a supportive environment in which to perform. Dr. Royce recalls an early encounter with Dr. Pazdur when she was a fellow preparing to attend her first conference in Amsterdam. “It was the first time a supervisor told me, ‘Don't just sit in the conference room and listen to the talks—mingle and network, and also take the time to see Amsterdam,’” she says. “He's the epitome of what a mentor should be because he thinks about people as individuals and teaches them about life habits and goals.” “I think a common theme throughout my career has been an interest in the people who've worked for me and who I've been assigned to mentor,” says Dr. Pazdur. “I really take great pride in their accomplishments.”