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

Wednesday, June 13, 2018 · 1:30 p.m. - 3:00 p.m. EDT

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.

Mark your calendar for Wednesday, June 13, when 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. But you can’t benefit unless you sign up — so do it today!

Register now.

BONUS: Order the webinar plus audio recording/transcript or the 24/7 encore plus audio recording/transcript for $487, and receive a FREE copy of Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation (retail value $397).

Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation
In this book noted FDA law expert Jim O’Reilly lays out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it.


Who Will Benefit

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

Webinar plus Audio Recording/Transcript with BONUS
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$487

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Webinar only
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$287

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24/7 Encore plus Audio Recording/Transcript with BONUS
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$487

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24/7 Encore Presentation
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$287

add to cart

Audio Recording/Transcript
Learn more

$287

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Meet Your Presenters

Richard Pazdur M.D.

Director
FDA's Oncology Center of Excellence (OCE)

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.

Deputy Center Director
FDA's Oncology Center of Excellence (OCE)

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.

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