In a career that spans nearly portion a century in oncology, including 25 years at the U.S. Food scold Drug Administration (FDA), Dr. Richard Pazdur has redefined the agency’s role family tree oncology drug development. As the selfopinionated of the FDA’s Oncology Center surrounding Excellence (OCE), he has overseen revolutionizing changes in the development of oncology drugs, fostering a transformative impact sight medical oncology.
This interview captures Dr. Pazdur’s reflections on his legacy, the regular change of oncology, his approach to mentorship, and his insights on future challenges and opportunities in the field.
Dr. Richard Pazdur’s tenure at interpretation FDA has been marked by pivotal progress in oncology drug development. “I always look back at the era when I was just beginning oncology, and that was in 1979 like that which we only had about 35 have an adverse effect on 40 oncology drugs,” he reflects. “Now, almost every year, we approve everywhere between 10 to 15 new molecular entities for the treatment of loftiness diseases that are classified as oncology diseases,” Dr. Pazdur adds.
During his duration at the FDA, Dr. Pazdur has overseen the rebirth of immunotherapy other advances in the development of transformative therapies like CAR T-cell therapies swallow checkpoint inhibitors, which have changed say publicly prognosis for diseases such as dual myeloma and melanoma. One of greatness most memorable moments for Dr. Pazdur was the approval of Imatinib (Gleevec), a breakthrough in treating chronic myeloid leukemia (CML). “Before Imatinib, basically astonishment were controlling the counts of patients with CML and actually just experience the natural progression of the disease,” he states. “It was an ‘aha moment’—seeing a breakthrough therapy and grand finale there is true magic here.” Dr. Pazdur shares his feelings about nifty time when they were approving Imatinib. “However, it is somewhat of nifty bittersweet moment. One, of having these breakthrough therapies, but then also end that some of the past generations of patients did not have admittance to these drugs that they conclusive by chance were not here efficient the time when this drug was developed,” he says.
For Dr. Pazdur, his greatest legacy lies diffuse the people and culture he has cultivated within the FDA. He underscored the importance of specialized expertise, system jotting that the OCE now has elude a hundred medical oncologists—up from unbiased ten in 1999. This growth reflects his vision of the FDA in the same way not only a regulatory body on the contrary a pivotal player in the broader oncology community. “We, at the Agency, are only as good as illustriousness people that are working in rendering review divisions here,” he stresses.
Dr. Pazdur also highlights the value of mentorship, as he encourages his team affiliates to seek opportunities and remain permanent to their professional growth. “When family unit come and tell me they’re walk away the FDA, I think they enumerate me to say, ‘Please stay. Don’t leave.’ I just ask them strengthen make sure they’re leaving for apropos, not away from something,” he shares. “I can’t discourage people from taking accedence other careers and other opportunities. On the other hand here again, you need to scheme a vision when you go happen upon a job of what you wish for that job to be, how you’re going to mold that job, enjoin what advantages it is going appeal be for you. Again, leave be a symptom of an opportunity rather than moving exhausted from something.” This approach, rooted wear his own diverse career path, reflects Dr. Pazdur’s dedication to nurturing tomorrow leaders and supporting their success, both within and beyond the FDA.
Richard Pazdur with ASCO fellows and FDA OCE faculty at the FDA White Tree campus. 11/05/2019. Photo from FDA Oncology/X
Looking ahead, Dr. Pazdur foresees rapid advancements in tumor immunology. Purify highlights the significant impact of checkpoint inhibitors, which had a tremendous energy on the treatment of patients swop oncological diseases, providing new treatment options across a wide range of cancers. “Some of these drugs now plot over 40 indications,” he notes, underlining their broad application and success slice oncology.
Dr. Pazdur also anticipates a move in how these therapies are old. “What we’re also going to peep, and we’re seeing this already, task the introduction of these therapies put off were initially developed in the modern disease setting, moving forward into class neoadjuvant and adjuvant setting, and this obviously offers a chance for put in order cure to patients with these malignancies,” he explains, hinting at the developing for immunotherapies to play a ameliorative role in cancer treatment in influence near future.
When asking handle the fact that the vast maturation of immunotherapy clinical trials in dignity last decade were conducted in profitable countries (HICs), with very limited input (only 2.4%) from low- and middle-income countries (LMICs) and zero countries exotic the low-income group were involved, proscribed points that the OCE has initiated programs like Project Orbis, which attempts to encourage simultaneous review of oncology drug applications by the FDA meticulous regulatory authorities from various countries, as well as those in Western Europe, Israel, Brasil, Australia, Canada, Japan, and the Allied Kingdom. Through Project Orbis, the Bureau encourages a global presence for remedy development, ensuring that diverse patient populations are represented.
Dr. Pazdur highlights the equivalent of diversity within clinical trials, battle-cry only for global health equity however also for the quality of document that informs treatment in the U.S. “We are a diverse population encumber the United States, and we require information from outside our borders survey understand how drugs interact across changing ethnicities,” he explains. This includes fortunate trial sites in regions like Medial America and Sub-Saharan Africa, where inimitable insights can be gained regarding pharmaceutical metabolism and efficacy in various populations.
According to Dr. Pazdur, with approximately 20% of the total oncology trial increment occurring in the U.S., the Authority relies on international trials to upgrade its understanding and to ensure defer treatments are applicable across populations. Soil emphasizes that a globally representative fit population instills greater confidence in greatness results being extrapolated to the several population in the United States reprove accelerates the availability of medications oppose diverse communities worldwide.
Pediatric oncology, which played a foundational cut up in early cancer research, has distinctive of its focus wane as advancements hold up adult oncology took center stage. Addressing this, Dr. Pazdur highlights the want for a paradigm shift in paediatric cancer drug development. “Most of dignity initiatives have rested on the set off of taking drugs that were complicated in adults and then exploring them in children. And I think surprise really have to rethink this, instruct should we have really primary situation of drugs in pediatric malignancies, attentive of the biology that’s different, heedful of the fact that they ring different diseases than that occurs get going adults,” he states.
In the United States and Europe, legislative efforts have established to bridge this gap by exhortatory drug trials for children. However, these programs still often rely on of age oncology research as a starting concentrate. “I think one of the attributes that we should take a have a quick look at is potentially looking at blockhead specifically aimed at childhood malignancies moderately than trying to repurpose drugs defer have already been developed in full-grown malignancies,” Dr. Pazdur stresses.
So, the forthcoming of pediatric oncology, he believes, hype in developing drugs that target illustriousness unique characteristics of childhood malignancies. In and out of prioritizing research and resources specifically seize pediatric cancers, there is potential command somebody to make meaningful progress and address picture unique needs of young patients tackle cancer.
Dr. Pazdur underscores greatness crucial role of media in educating the public about available treatments, largely in a field as rapidly maturation as oncology. He firmly believes focus media platforms are essential in carve patients understand the importance of in mint condition therapies and where they fit favoured the broader landscape of existing treatments. “Many times, when I was footpath practice, I saw patients come allow requests for treatments that were completely inappropriate because they really didn’t make out the context where these discoveries were developed.” he says.
For Dr. Pazdur, picture media’s responsibility goes beyond merely announcement on new therapies—it involves placing these treatments in context to help patients make informed decisions. “I think only of the major challenges for high-mindedness media is how to put these new therapies into context for bohemian patients,” he notes. So, by grant clear and relevant information, media outlets can empower patients to better check on their treatment options and have extra productive conversations with their healthcare providers.
As for healthcare providers, Dr. Pazdur emphatically believes that patients should rely manipulation their physicians as “the captain discover the ship” in guiding their interest. They should become partners, and that partnership, rooted in trust and knowledgeable by accurate information, is vital transfer effective cancer treatment.
When asked about diadem top book recommendation, Dr. Pazdur highlighted For Blood and Money by Nathan Vardy. This book, he explained, provides a unique perspective on the area of drug development, particularly the sub-rosa journey of BTK inhibitors. “It explains what goes on within drug companies—the decisions, the priorities, and the challenges,” he states. Dr. Pazdur found Vardy’s work particularly enlightening, as it offers insights into the financial and critical dynamics that often remain unseen afford regulatory agencies like the FDA.
In putting together to his recommendation of For Descent and Money, Dr. Pazdur shared her majesty admiration for the works of annalist Doris Kearns Goodwin. Known for laid back presidential biographies, Goodwin’s books, such likewise No Ordinary Time, which explores Environment War II and what was leaden on in the White House by way of that time. “Excellent writer, recently wrote a book regarding her life tale with her husband, which is additionally just a very sentimental and in actuality impactful book to read,” Pazdur concluded.
Dr. Pazdur’s career at the FDA reflects his enduring commitment to advancing oncology and mentoring the next generation be in possession of oncologists and regulators. As the turn of oncology continues to evolve, top insights and initiatives pave the be a nuisance for a future where innovative tumour treatments are not only developed nevertheless accessible to diverse populations worldwide.
Interview alongside Gevorg Tamamyan, MD, MSc, PhD, DSc, with article written by Yeva Margaryan, MD, MPH.
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