Inside FDA’s Oncology Center of Excellence - Webinar Recording/Transcript

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Inside FDA’s Oncology Center of Excellence: What Regulatory & Quality Professionals Need to Know

Cancer therapies have a new friend at the FDA. The year-old Oncology Center of Excellence is tasked with expediting development of oncology and hematology medical products — drugs, biologics and devices — and supporting an integrated approach to clinical evaluation of cancer treatments.

If your company is involved with cancer treatment and you are regulated by the FDA, you owe it to yourself to find out more about how this still-new FDA activity might benefit you.

Dr. Richard Pazdur, OCE director, and Dr. Amy McKee, deputy director, pull back the curtain on the OCE. Over the course of a fast-paced hour and a half, they’ll share the insider view on:

  • OCE structure: Where this Center of Excellence sits within the FDA and how it interacts with other agency Centers of Excellence
  • The regulatory role, encompassing nuances such as formation of clinical review teams for oncology products
  • Who does what: Roles of OCE staff, including outreach, immune-oncology, targeted therapy, cellular therapy and bioinformatics
  • OCE research, including real-world-evidence research and the NGS laboratory
  • OCE outreach, including interactions with professional societies and patient or advocacy groups
  • And much more!

Knowledge is power. Knowledge of the inside workings of this Center of Excellence, still only a year old, will pay off in getting products to market faster and gaining competitive advantage.

Drug/biologics makers, devicemakers, CROs and pharma consulting firms — every FDA-regulated company involved with oncology therapies — can find benefit in this illuminating look inside this still-new FDA activity. Specific job titles include:

  • Regulatory affairs
  • Quality control/GMP
  • Medical directors
  • Strategic planners
  • Drug and oncology development specialists

Richard Pazdur M.D. is director of the FDA's Oncology Center of Excellence (OCE), tasked with expediting development of novel drugs, biologics and devices to treat cancer by leveraging the combined skills of the FDA's regulatory scientists and reviewers. Dr. Pazdur leads agency efforts to develop and execute an integrated regulatory approach that enhances the cross-center coordination of oncology product clinical review.

Amy McKee M.D. is Deputy Center Director, OCE, with a background in pediatric hematology/oncology and neuroblastoma research. At the FDA she reviews new molecular entities for marketing approval in oncology, including presenting these applications at the Oncologic Drugs Advisory Committee.