This [Oncology Center of Excellence] builds upon the collaborative work that the oncology team at the FDA has been working toward.— Richard Pazdur, MD, FACP
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On June 29, 2016, Robert M. Califf, MD, MACC, the Commissioner of the U.S. Food and Drug Administration (FDA), announced the selection of Richard Pazdur, MD, FACP, as Acting Director of the FDA’s newly created Oncology Center of Excellence. The center was created in response to the overarching goal of the National Cancer Moonshot Initiative to accelerate cancer advances and accomplish in 5 years what would normally take 10 years. It aims to streamline product evaluations, eliminate redundancies in the application for a new treatment, and develop new clinical trial designs.
The formation of the Oncology Center of Excellence builds on the FDA’s integrative approach to medical product development instituted by Dr. Pazdur in 2005, when he became Director of the FDA’s newly formed Office of Hematology and Oncology Products, which was launched to consolidate the review process of oncology products within the FDA’s Center for Drug Evaluation and Research. Since 2010, the Office of Hematology and Oncology Product’s consolidated product review process has led to the approval of 61 new molecular entities in the treatment of a variety of cancers.
The ASCO Post talked with Dr. Pazdur about the Oncology Center of Excellence, how such a center coordinating the FDA’s clinical efforts may improve oncology care, and how having an integrative approach to cancer treatment development can help achieve the Cancer Moonshot goal of accelerating treatment advances.
Launch and Development
What is your vision for the initial launch and development of the Oncology Center of Excellence?
I am honored to be selected by Commissioner Califf as the Acting Director of FDA’s new Oncology Center of Excellence in support of the National Cancer Moonshot Initiative. The center will leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices, including diagnostics, to help expedite the development of oncology-related medical products. It emulates both academia and cancer care centers, which are increasingly organized in multidisciplinary models to enhance collaboration, which is so essential when confronting a complex disease like cancer.
Enhancing collaboration and focusing our work in disease-specific teams was one of the first things I did when I became the Director of what was then the Division of Oncology Products in the Center for Drug Evaluation and Research, and I think the Oncology Center of Excellence is a continuation of that concept across medical products. This center builds upon the collaborative work that the oncology team at the FDA has been working toward. For example, one model that has worked well in the past is holding cross-center monthly meetings to discuss key oncology issues, establishing collaborative workshops and programs, and working together on research and scientific publications.
Certainly the key to the center’s future success will be in leveraging the talents of the staff at the FDA. The very first thing I plan to do as Acting Director is to meet with those involved in oncology medical product development and review across centers to hear their ideas for the Oncology Center of Excellence and how we can work together to enhance our efforts across the agency.
Staged Approach
What is the framework of the Oncology Center of Excellence, and how will the new center streamline regulatory processes and foster collaboration among researchers?
In my role as the Acting Director, I will help chart a course for developing and executing an integrated program for oncology product clinical review and for providing clinical advice and guidance to the Commissioner, center directors, and other executives on FDA oncology-related issues.
I look forward to guiding the FDA through this initial phase of the Oncology Center of Excellence, building our cross-disciplinary review staff, providing external outreach to diverse stakeholders, and streamlining administrative processes to ensure rapid review of important cancer products for the American public.— Richard Pazdur, MD, FACP
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Establishing a Center of Excellence in a disease-management area like cancer across drugs, biologics, and devices requires a thoughtful approach and is an ongoing process. Working closely with the center directors, we will develop a staged approach for establishing the new center as quickly as possible, while ensuring the work across centers continues without disruption.
Judging by the past few years, in particular, it’s clear that innovation in oncology is only increasing across drugs, biologics, and devices. It’s essential that the FDA be prepared for where the field is headed. By bridging the various medical product centers, the Oncology Center of Excellence will be ideally suited to support innovation and to address the recognition that multiple treatment and diagnostic options are in the best interest of patients.
Improving Care
Do you think a center coordinating all of the FDA’s clinical efforts in cancer will improve oncology care?
Ultimately, as a scientific and public health agency, the FDA is responsible for promoting and protecting the health of the American public. Our goal in oncology is to provide safe and effective medical products as quickly as possible, and we make our regulatory decisions in the best interest of patients. I often ask my review team to keep this one question in mind as they do their daily work: “Will the American public be better with or without this drug, based on the evidence provided?”
By coordinating across drugs, biologics, and devices, we will continue this mission in patient-focused regulation through disease-focused teams that mirror how patients are treated in practice. The Oncology Center of Excellence will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease, which touches so many American families.
Voice of the Patient
How will the new center incorporate the voice of the cancer patient?
At the FDA, the patient voice is an integral part of our regulatory decision-making based on professional responsibility and personal experience. This will continue to be valued in the work of the Oncology Center of Excellence across oncology-related products.
A large part of my role will be to serve as one point of contact to help facilitate engagement externally with oncology stakeholders, including patient-focused advocacy groups, professional associations, industry, academia, sister agencies such as the National Institutes of Health, and international regulatory agencies. The FDA has incredibly strong partnerships in oncology that we look forward to building upon through the Center of Excellence.
Accelerating Advances
Will having this type of integrated approach at the FDA help achieve the Cancer Moonshot goal of accelerating cancer advances?
It’s difficult to predict exactly what the future holds regarding where science and discovery will take us in the treatment and diagnosis of cancer over the next few years. But as Vice President Biden said so poignantly at the recent Cancer Moonshot Summit, we know the world is counting on us.
As scientists, clinicians, and, ultimately, regulators here at the FDA, we also know that innovation is accelerating in the field of oncology, and we must be prepared for what is to come in the next 20 years, let alone the next 5. We strongly support the level of enhanced focus, collaboration, and sense of urgency that the Cancer Moonshot has provided, and we are dedicated to serving the needs of the patient and health-care communities.
I look forward to guiding the FDA through this initial phase of the Oncology Center of Excellence, building our cross-disciplinary review staff, providing external outreach to diverse stakeholders, and streamlining administrative processes to ensure rapid review of important cancer products for the American public. ■
Disclosure: Dr. Pazdur is Acting Director of the FDA’s Oncology Center of Excellence.
