Abstract
In 2020, the FDA’s Oncology Center of Excellence, in collaboration with the American Association for Cancer Research, launched a novel educational partnership known as the FDA-AACR Oncology Educational Fellowship. This year-long program is aimed for hematology/oncology fellows, scientists, and early-career investigators, offering an in-depth exploration of the regulatory review process by blending didactic learning with practical cases discussing oncology drug approvals. The fellowship has been met with enthusiastic feedback, with participants lauding its role in demystifying the regulatory landscape and enhancing their professional careers. This article reflects on the experiences of four alumni, showcasing the program’s transformative impact across diverse oncology career paths in government, academia, and industry.
Introduction
In 2020, the Oncology Center of Excellence at the FDA and the American Association for Cancer Research (AACR) launched a new collaborative educational initiative called the FDA-AACR Oncology Educational Fellowship (1, 2). This is a year-long program in which hematology/oncology fellows, scientists, and early-career investigators with advanced scientific degrees (DO, MD, MD/PhD, PhD, etc.) gain an in-depth understanding of regulatory review through a combination of didactic learning and small-group case-based discussions of approved oncology therapies. Topics span across several disciplines, including pharmacology and toxicology, manufacturing, cellular therapies, statistics, clinical pharmacology, and clinical review. The fellowship culminates with a mock Oncologic Drugs Advisory Committee discussion based on a drug that was discussed previously at an advisory committee (3).
Since its launch, 69 participants have completed the fellowship. The feedback has been enthusiastically positive, and many note that this fellowship helped solidify their understanding of the regulatory review process. In this perspective, four former alumni reflect on how the educational fellowship impacted their career development in government, academia, and industry.
Government: FDA (T. Patel, MD)
My participation in the FDA-AACR Oncology Educational Fellowship has been a transformative chapter in my journey as a medical oncologist at the FDA. The program is meticulously crafted to deepen participants’ grasp of regulatory science, the complexities of oncology drug development, and the thoroughness of the review process. This comprehensive approach has profoundly sharpened my skills and bolstered my effectiveness in my current role as an FDA clinical reviewer.
A key part of the fellowship was the unique opportunity to dive deep into the regulatory review process. Working closely with experienced FDA reviewers and directly evaluating new cancer drugs helped me develop a detailed understanding of how drugs are assessed for safety and efficacy. This direct involvement clarified the regulatory process for me, giving me the knowledge needed to effectively deal with its challenges. Consequently, I have become better at helping move forward and critically evaluate the risk/benefit assessment of new and innovative cancer treatments.
Furthermore, the fellowship has greatly expanded my professional network. Connecting with other oncologists, researchers, and regulatory professionals has opened new avenues for collaboration and dialogue. These relationships have proved invaluable, allowing for the exchange of ideas, sharing of best practices, and fostering collaborations that extend beyond the duration of the fellowship. This network serves as a vital resource for navigating complex regulatory challenges and advancing the field of oncology.
I currently serve as the primary clinical reviewer for investigational new drugs and for new drug applications/biological licensing applications in the field of gastrointestinal cancers and melanoma. I also collaborate with a team of FDA experts to advise commercial sponsors on their drug development strategies. My research interests focus on evaluating methods to modernize clinical trials and evidence generation, especially through decentralized and pragmatic cancer trials. I have been fortunate to serve on the FDA Decentralized Trials Guidance Working Group and participate as a group lead in the White House Cancer Cabinet’s Data and Innovation Task Force.
Academia: Early Drug Development (C. Chen, MD)
Prior to medical school, I had worked as a bench scientist as well as in health policy and economics research. I was drawn to each of those disciplines for its potential to push the boundaries of medicine in very different ways. As I thought about my future career, I wondered how one could incorporate these three interests—clinical care, laboratory science, and policy and economics—into a single job.
I found this intersection in early-phase oncology drug development. As a physician, I have found that administering experimental therapeutics to patients with refractory cancer in hopes of a breakthrough is both extraordinarily rewarding and challenging. No medical textbook exists for navigating these drugs; there is no level 1 evidence that provides a clear answer to how to manage the inevitable patient issues that arise. As a scientist, I get to work with brilliant laboratory colleagues to bring new molecules forward. Finally, navigating protocol issues and regulatory requirements in hopes of bringing a drug all the way to formal marketing approval requires regulatory and policy expertise.
The chance to work in all three areas, in pursuit of better drugs and a better future for patients with cancer, is immensely joyful and perpetually fascinating. Given the skills involved, however, a diverse training experience is essential in preparation for such a career. As a trainee, I sought out opportunities to educate myself in the drug development process, and a key aspect of that was the FDA-AACR Oncology Educational Fellowship.
The fellowship expanded my key knowledge base about the drug development process. Even more valuable, however, was the chance to learn from experienced drug regulators how to conceptualize regulatory challenges. Just as the best clinical training programs teach young doctors not only a foundation of knowledge but also how to think critically through complex medical situations, the FDA fellowship taught me how to analyze and approach regulatory problems in a sophisticated way. This has made me a better doctor, clinical trialist, and drug developer.
Bringing more effective drugs to the clinic is the very heart of medical oncology. We live in an extraordinary time, in which the pace of science has vastly accelerated, and the potential for breakthroughs springs eternal. The FDA fellowship has helped cement my journey, and I encourage all trainees to consider this training opportunity. After graduating from my fellowship, I joined the Stanford University School of Medicine faculty, where I am a gastrointestinal medical oncologist and director of the Early Drug Development program for the Stanford Cancer Institute. The Early Drug Development program runs high-risk first-in-human phase I clinical trials and biomarker-driven, multihistology phase II clinical trials for patients with advanced solid tumors.
Academia: Malignant hematology (S. Al Hadidi, MD)
The FDA-AACR Oncology Educational Fellowship was an excellent investment that helped me pursue an academic career in malignant hematology. During my fellowship training at Baylor College of Medicine, I realized the crucial importance of regulatory processes, including clinical trial design, data analysis, and submission requirements for approving new cancer therapies. Such knowledge is rarely taught but is vital to making a difference in the lives of patients with cancer and advancing cancer care.
Malignant hematology is a fast-paced field, and multiple new drugs have been developed to help patients in immediate need of better therapeutics. Due to my interest in malignant hematology, particularly in multiple myeloma and cellular therapies, I wanted to gain a deeper understanding of the regulatory processes required for drug approvals, including cellular therapies. The FDA-AACR Oncology Educational Fellowship provided me with professional skills, valuable resources, and a better understanding of what is necessary to get drug approvals for patients in the future.
The fellowship also allowed me to network and collaborate with other fellows and experienced FDA staff, which was an enriching experience. By completing the fellowship, I improved my knowledge of the regulatory landscape and my ability to navigate complex regulatory processes. This experience made me a more competitive candidate for academic positions, and I was fortunate enough to secure a job in my area of interest—multiple myeloma and cellular therapies—at the Myeloma Institute at the University of Arkansas for Medical Sciences.
Developing new cancer drugs for patients with blood cancers is a lengthy and complex process that requires extensive research, clinical trials, and regulatory approvals. In my experience, the FDA-AACR Oncology Educational Fellowship has been an invaluable tool for navigating the regulatory approval process. I would highly recommend this fellowship to individuals interested in pursuing academic careers in the field of malignant hematology. It equips fellows with the knowledge and skills required to understand the regulatory landscape and navigate complex processes, such as clinical trial design, data analysis, and submission requirements for drug approvals. The fellowship provides an excellent opportunity to network and collaborate with experienced FDA staff and other fellows, ultimately facilitating successful drug approvals and improving patient care.
Presently, I lead several clinical trials as the principal investigator, concentrating on plasma cell disorders and cellular therapies. My research is primarily dedicated to multiple myeloma and other precursor plasma cell dyscrasias, with a particular focus on advancing drug development, cellular therapy, and immunotherapy; promoting health equity; and enhancing medical education. Additionally, I hold a position as a specialty board member for the hematology board at the American Board of Internal Medicine, and I serve as core faculty for the Hematology and Medical Oncology Fellowship Training Program at the University of Arkansas for Medical Sciences.
Industry (Y. Kadry, PhD)
As a bench scientist studying cancer, I have always wanted to make an impact on the lives of patients with cancer. However, we often do not get the opportunity to follow our developments at the bench as they move toward the clinic; we also typically do not have enough knowledge to navigate the regulatory/clinical trial landscape to understand how we can improve our science. As I transitioned to working in industry (pharmaceutical R&D) from my academic post doc, I found that the broad toolbox of clinical and regulatory knowledge that I was able to equip myself with as a fellow to be truly invaluable for guiding my science, my work, and my career every day.
At the time of entering the FDA/AACR Oncology Education Fellowship, I was a postdoctoral fellow at the University of Pennsylvania working in a laboratory studying the molecular underpinnings of lung cancer. Although my research in the laboratory was going well, I started to think deeply about my future goals as a scientist, and one thing was clear: I really want to make an impact on the lives of patients. The FDA/AACR Oncology Education Fellowship equipped me with the knowledge and insight that I needed to be able to take my scientific career to the next level and pursue a career in industry in which I could do just that.
As a fellow, I was able to see firsthand just how preclinical and clinical data are interpreted by FDA regulators, spanning all the way from functional data in vitro with proteins to late-stage clinical trial data. I was able to get a firsthand view of just how rigorous and important the regulatory review process is, which really helped put my daily bench science into context and perspective. This was valuable for not only encouraging me to pursue a career path in industry but also in helping me to get my “foot in the door.” Through the fellowship program, I have made invaluable connections with other fellows in my cohort and with FDA staff. Being able to navigate the world of regulatory review and clinical trials after participating in the fellowship has opened the horizons for me as an industry scientist who wants to make an impact on the lives of patients, and I truly think that all scientists can benefit from this fellowship.
After completing the fellowship, I joined GlaxoSmithKline as a scientific investigator, where I work in target discovery and collaborate with other scientists and clinicians to find, validate, and prosecute new drug targets across multiple disease areas.
Conclusion
The FDA-AACR Oncology Educational Fellowship is structured to promote scientific progress through exchange of scientific knowledge in oncology education, collaborative learning, and research. Through a series of carefully curated educational programs and interactions with experts from the AACR and the FDA Oncology Center of Excellence, fellows increase their familiarity and experience with oncology drug development and the regulatory review process. The hope is the fellowship bridges knowledge gaps with regard to how the FDA operates and the factors it considers when making a benefit: risk assessment for regulatory decisions. The fellowship program has been successful and provided an important experience to clinical and basic scientists who went on to successful careers in academic, government, and industry positions.
We invite prospective candidates, including international fellows and scientists, to reach out and apply for consideration. The application window generally opens in the summer, with the announcement of selected fellows occurring in the fall. For more information, please refer to the FDA-AACR Educational Fellowship website (4).
Authors’ Disclosures
C. Chen reports grants from Kinnate, ADC Therapeutics, ORIC Pharmaceuticals, Gilead, Genentech, Rain Oncology, Seattle Genetics, Mersana Therapeutics, Riboscience, Merus, Takeda, Palleon Pharmaceuticals, Revolution Medicines, and Tango Therapeutics and personal fees from Boxer Capital and Guidepoint Global outside the submitted work. S. Al Hadidi reports personal fees from Pfizer and Sanofi and grants and personal fees from Janssen outside the submitted work. No disclosures were reported by the other authors.