Interview
Harnessing the Power of Collaboration
Interview with Richard Pazdur, MD
review resources within the FDA to
promote the more rapid completion
of marketing for drugs for which
there is an urgent need.
The FDA currently has
several approval pathways
to help move these types
of therapies through the
regulatory process (i.e.,
breakthrough-therapy
designation and fast-
track designation). How
will the OCE’s operations
complement these
pathways?
ASH Clinical News spoke with Richard Pazdur, MD, director
of the U.S. Food and Drug Administration’s (FDA) Oncology
Center of Excellence (OCE), about the scope of the new center
and its efforts to accelerate the drug approval process.
In January 2017, the FDA
formally established the
OCE as part of the national
Cancer Moonshot Initiative.
Can you describe the OCE’s
responsibilities, as well as
your role as its director?
The OCE unites experts across
the FDA and its agencies (includ-
ing the Office of Hematology
and Oncology Products [OHOP],
the Center for Devices and
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ASH Clinical News
Radiological Health [CDRH], and
the Center for Biologics Evaluation
and Research [CBER]) to expe-
dite the development of medical
oncology products. Its operations
support an integrated approach
to the clinical evaluation of drugs,
biologics, and devices for the treat-
ment of cancer.
As the director of the OCE, I
work in close coordination with
the FDA commissioner and the
directors of the various centers to
make this happen – and to help pa-
tients get faster access to safe and
effective cancer treatments. I also
continue to serve as acting director
of OHOP. These positions are a
natural complement to each other;
the majority of the FDA’s oncolo-
gists work in OHOP, and OHOP
oversees most of the applications
for products that treat cancer. In
these dual roles, I am able to bring
together experts in OHOP with
other cancer experts across the
agency to help advance the goals of
the new interagency center.
One way in which the new OCE
organization can affect cancer drug
development is that I, as the director,
can mobilize and deploy internal
The OCE’s scope includes the clini-
cal review of applications for prod-
ucts undergoing expedited review,
such as those granted breakthrough-
therapy designation, accelerated
approval, or priority review.
Trial sponsors will submit
product applications to the same
relevant FDA product center as
in the past: CBER, CDRH, or the
Center for Drug Evaluation and
Research (CDER). If an applica-
tion is granted expedited review,
the OCE will form a clinical
review team comprising repre-
sentatives from OCE, OHOP,
and the relevant product center.
The review team will make its
recommendations on the clinical
portion of the application and, as
OCE director, I will review and
approve their recommendations.
Once approved, the application
will be returned to the product
center, where other aspects of
review – such as quality, toxicol-
ogy, statistics, manufacturing,
and facilities inspection – will
take place and the final approval
determination will be made.
The OCE carefully weighs the
risks and benefits of new products
prior to approval, including
obtaining external consultation
at an Oncologic Drugs Advisory
Committee meeting or with
special government employees
(patients and clinicians who have
undergone conflict-of-interest
screening and who can provide an
opinion about the new product)
on an as-needed basis.
July 2017