Wednesday, September 14, 2011

Oncologic Drugs Advisory Committee

Posted by Eric Zhao at Wednesday, September 14, 2011

SILVER SPRING, Maryland - Oncology experts from around the nation gather in the FDA's White Oak Conference Center to evaluate the new drug application for Ferriprox (deferiprone) and to discuss trial design for the development of products to treat patients with non-metastatic prostate cancer. It's 8 o'clock in the morning and the Chair of the Oncologic Drugs Advisory Committee (ODAC) meeting begins the Call to Order for this all-day meeting. The ODAC consists of 13 voting members to review and evaluate safety and efficacy data for oncology drugs and makes recommendations to the Commissioner of Food and Drugs, CDER, and CBER.

Their view:

The Great Room in the White Oak Conference Center
FDA White Oak Campus, Building 31

Meanwhile, in Indianapolis, I park myself in my desk chair, log on to the Lilly corporate system, and break out my headphones. Inside my bag, I pack two caffeinated beverages with my lunch to prepare for today's 8:00 a.m. to 5:00 p.m. meeting. My assignment today consists of analyzing and interpreting how the FDA thinks. Think of it like the industry playing chess against the FDA.

My view:

The closed captioning didn't make sense all day.

Ferriprox (deferiprone) [8:00 a.m. - 12:00 p.m.]

Iron Man's Kryptonite

Submitted by ApoPharma, Inc., deferiprone is proposed for the treatment of patients with transfusional iron overload, when current chelation therapy is inadequate. During the meeting, ApoPharma, Inc. presents their case, and then afterwards, the FDA presents their case (are we in court??). Following this, the public delivers their testimonials and opinions about the magic of deferiprone. Finally, the ODAC answers questions, discusses any issues, and casts a final vote. In this case, they voted 10-2 to support an application for accelerated approval.

Non-Metastatic Prostate Cancer Study Design [1:00 p.m. - 5:00 p.m.]
Currently, there are no products approved for the following indications:
  1. Non-metastatic, PSA-only recurrent prostate cancer who have not received androgen deprivation therapy (ADT)
  2. Non-metastatic castration resistant prostate cancer (NM-CRPC) who have a rising serum level of prostate-specific antigen (PSA) despite currently receiving ADT
The afternoon session of the ODAC meeting discusses possible patient populations, trial designs, and suitable clinical endpoints for studies intended to support a product for these unmet medical needs. The session begins with an FDA presentation and two speaker presentations for background, and I feel like I'm in lecture again. For the next 3 hours, however, the committee argues about the pros and cons of trial endpoints until they finally hit 5:00 p.m.--with a split conclusion. I'm sure my preceptor is going to loooove this result.

The Food and Drug Administration

FDA stands for Full Day Agenda

Today was definitely a test of endurance, but a great experience nonetheless. I wish I requested a clerkship rotation with the FDA, because after attending this meeting, I realize how valuable that experience would have been. If you're interested in the industry, having been at the FDA will truly give you a leg up. Write that down...

-Eric Zhao

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