Richard Pazdur, currently the director of the FDA Office of Hematology and Oncology Products, will serve as acting director of the newly formed FDA Oncology Center of Excellence.
The exact structure, budget and staffing for the program will be determined in an ongoing process, Pazdur said to The Cancer Letter.
“Because I will be working to develop the structure of the OCE with input across all centers, it would be premature to speculate about what the ultimate structure of the OCE will be,” Pazdur said. “The framework of the OCE will evolve over time, so as not to disrupt the ongoing work in each center.”
Pazdur spoke with Matthew Ong, a reporter with The Cancer Letter.
Matthew Ong: Does this announcement mean that the Oncology Center of Excellence will no longer be virtual? Will the OCE be real—i.e., will it actually have authority to make meaningful decisions?
Richard Pazdur: I think the question people are asking is what the structure of OCE will be and how other staff at FDA will be involved—and that is exactly what my role will be as the acting director: to 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 oncologic-related programs and issues.
But because I will be working to develop the structure of the OCE with input across all centers, it would be premature to speculate about what the ultimate structure of the OCE will be. The framework of the OCE will evolve over time, so as not to disrupt the ongoing work in each center.
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.
I look forward to guiding the agency through this initial phase in support of the National Cancer Moonshot Initiative, and our objective is to move as quickly as possible toward establishing the OCE, while ensuring the work across centers continues without disruption.
MO: What was your vision for FDA regulation of oncology products when you first joined the agency in 1999? How does the OCE fulfill that vision in creating a seamless and effective regulatory pathway for oncology products?
RP: I’ve always had a vision to enhance collaboration and focus our work in oncology here at the FDA in disease-specific teams. That was one of the first things I did when I became the director of what was then the Division of Oncology Products in CDER, and I think the OCE is a continuation of that across medical products.
This OCE builds upon the collaborative work that the oncology team at 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, collaborative workshops and programs, and working together on research and scientific publications.
I am also honored 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 OCE.
Anyone who knows me knows that two things at the heart of what I try to bring to the table are the patient voice, and fostering innovation.
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 OCE across oncology-related products.
At FDA we support innovation and believe that multiple treatment and diagnostic options are in the best interest of patients. I look forward to continuing to support the agency’s mission in this regard.
MO: Now that you have the authority to chart the course with the FDA leadership and other centers, what will be your first order of business?
RP: The very first thing I plan to do in my role as acting director of the OCE is meet individually with those involved in oncology medical product development and review across centers to hear their ideas for the OCE, and how we can work together to enhance our oncology efforts across the agency. I want to understand where they believe we can make the biggest impact.
The only way to build a successful OCE is collaboration, by taking the best ideas from across centers, industry, and the patient and physician communities to help shape the OCE from the ground up.
I look forward to working with the center directors from CDER, CBER and CDRH to formalize an innovative, yet seamless cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics and medical devices.
MO: I know that the details have not been hashed out, but generally, can patients, industry and other stakeholders expect drugs, devices and biologics—related to cancer or that pose oncologic risks—to eventually become subject to review, in one way or another, under OCE?
RP: You’re right that we are still working through the details, but what we do know is that the OCE will leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices, including diagnostics.
This center of excellence will help expedite the development of oncology-related medical products and support an integrated approach in:
• Evaluating drugs, biologics, and devices for the prevention, screening, diagnosis, and treatment of cancer;
• Modernizing existing business processes and enhancing IT systems to enable an outcome-focused operating model and establish a regular cadence of delivering value and measurable outcomes;
• Supporting the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer; and
• Developing and promoting the use of methods created through the science of precision medicine.
More details on approval processes will be shared once the structure is established. I’m really looking forward to working closely with others here at the FDA to bring this vision to life.
MO: Since you are on detail for the OCE, how will the Office of Hematology and Oncology Products be managed?
RP: An acting director of the Office of Hematology and Oncology Products will be appointed to take over my previous responsibilities. More details about that transition will be shared once that selection has been made.
MO: Is there a tentative timeline for when FDA expects to launch a full-fledged OCE?
RP: We are working expediently toward our goal of establishing the OCE as quickly as possible. For example, we have already held listening sessions and heard valuable input from patient and physician communities, as well as industry and internal audiences.
The reason for my appointment as acting director is to accelerate the integration of various disciplines involved in the clinical review of oncology products at the FDA.
MO: Did I miss anything?
RP: I want to thank everyone who has supported me and the FDA in our work to get the OCE up and running. As Vice President Biden said at the Cancer Moonshot Summit this week, we have a lot of work ahead of us, but we have a lot of people working with us to change cancer as we know it.
At the FDA, we are dedicated to serving the needs of the patient and health care communities and we will get this right.