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

FDA!

Posted by Rebecca Lalani at Sunday, September 04, 2011

Day 1 of my only away rotation. I arrived at Baltimore Washington International Airport Sunday morning, excited about the prospect of spending the next 4 weeks working for the FDA! Today was my prep day: I would set up my new digs, buy supplies, stock the fridge and of course, do my pre-rotation research (Go in prepared!) But as I found out upon my arrival at my sublet, even the best laid plans can go awry. My first day in Maryland was marred by the lingering effects of Hurricane Irene that struck the area only the night before. My landlord informed me that the power had been out since the previous night, with restoration nowhere in sight. “It’s daylight” I think as I march towards the closest grocery store and RiteAid location. Much to my chagrin, everything is shutdown. There isn’t a place I can even grab food. Hungry, tired and devoid of even the most basic of necessities, I shuffle my way back to my new place. I hope the power company can accomplish the miracle I’m praying for: I would REALLY appreciate some electricity! I spent the evening sitting in the dark, chatting with my new roommate and although my wishes were eventually fulfilled, it would not come to pass until the following day. So Day 1 of my only away rotation… was spent at home.

Day 2 of my only away rotation. That was much more exciting! I’m in the Office of Compliance under the auspices of Dr. Ilisa Bernstein. I’ve been assigned to work for the nascent Drug Integrity and Security Program, addressing the increasing drug imports that find their way to the American consumer. All rotation students are also given a lecture schedule that involves a variety of topics pertinent to pharmacy at the FDA. As far as my mentors go, I couldn’t have asked for a more supportive group. I’m pleased to report then that I am 2/2 for amazing rotation experiences. Working with Dr. Rozelle Hegeman-Dingle (Pfizer, Medical Outcomes Specialist) during rotation 1 was an absolute delight. With this track record, I’m looking forward to what rotation 3 has to offer!