Dr. Paul Kluetz, Medical Oncologist, Deputy Director of the Oncology Center of Excellence (OCE at the US FDA, Attending Georgetown University Hospital.

Paul Kluetz is a medical oncologist and Deputy Director of the Oncology Center of Excellence (OCE) at the U.S. FDA. In addition to contributing to the strategic leadership and operational oversight of the OCE, he holds a leadership role in the Office of Oncologic Drugs overseeing the regulatory review of solid tumor drug indications within the Center for Drug Evaluation and Research. Dr. Kluetz founded and leads several initiatives including creation and direction of the OCE’s patient-focused drug development program; OCE’s real-world evidence program; trial modernization efforts including pragmatic and decentralized trial designs; use of digital health technology; the OCE’s Oncology labeling program; and support of the OCE’s extramural research portfolio. He remains clinically active, caring for patients and supervising medical residents at the Georgetown University Hospital.

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Objectives:

1.Explain FDA’s role in cancer product development and regulation.
2.Contrast strengths and limitations of cancer trial design and endpoints to generate evidence for approval.
3. Examine emerging Drug development challenges and ways to address them.

FACULTY DISCLOSURES:

Dr. Kluetz has indicated that he has no relevant financial relationships with commercial interest.

Dr. Lekakis has indicated that he has no relevant financial relationships with commercial interests.

All the relevant financial relationships for these individuals have been mitigated.

TARGET AUDIENCE:
Faculty, Primary Care Physicians, APRNs, PharmD

ACCREDITATION:
The University of Miami Leonard M. Miller School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION:
The University of Miami Leonard M. Miller School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.