ASH Clinical News July 2017 V2 - Page 38

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 36 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