(Non Traditional) Pfizer Canada

Posted by Hussein at Monday, January 16, 2012

Pfizer Canada

(click to see Pfizer Canada)

After an interesting array of rotations that included Oncology, Cardiology, Infectious Disease and Transplant, I find myself now out of the hospital and behind the scenes. But even here the preceptor is a U of M Graduate! He completed his residency in pharmacokinetics, and is a big Wolverines fan. From football to pharma, you’ll learn quite a lot. This rotation site develops your experience with the inner workings of a pharma company. We often hear a lot about industry, but when do we actually get to experience some of it!

If you’ve ever wondered about what is on that label you’re reading in the pharmacy, or had to check a product monograph for information, or wondered why drugs are manufactured in certain amounts or concentrations, this rotation will tell you. Have you ever thought about how a product lands on the shelf at CVS et al., or where on that shelf it lands, or even how big that shelf must be? The simple answer is: for every pharma question, there is an Act, a law, a rule or a regulation that covers that information. And if there isn’t, chances are a company (with whom you may do business) has an already established policy.

(Click on the picture to learn about the new Pfizer logo)

At this Pfizer rotation, students are provided with their own office, and access to all of Pfizer’s resources – which is tremendous. Students are part of the department of Scientific and Regulatory Affairs, under Pfizer Consumer health. The department applies for new and maintains registrations for drug products, ensures that products and their marketing comply with Canadian regulatory requirements, and conducts regulatory vigilance. This department acts as a liaison between various departments like marketing, and regulatory bodies such as Health Canada and the FDA.

My time here so far has been too short, but amazing. And if you are not from Toronto a major benefit of this rotation – aside from the learning experience - is the ability to see and experience Toronto! It’s something the preceptor encourages and Toronto amazing and vibrant city!

Random Fact: Did you know that Pfizer Canada is Pfizer’s second largest affiliate? It’s larger than China and all of the EU combined!

Hussein

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

Caught Up In The Regulations

Posted by Eric Zhao at Friday, September 02, 2011

Once again, I find myself in the pharmaceutical industry (surprise!). This time, however, I am with Eli Lilly and Company...in the Regulatory Affairs Department, no less.

Eli Lilly and Company, Indianapolis, IN

If you remember from my previous adventures, I spent a summer in regulatory affairs at Abbott in Advertising and Promotion. You're probably thinking, what's the point of doing two regulatory affairs positions? I had the same thought, believe me.

What I didn't know was that I would be working on the complete opposite spectrum of the drug development process. At Abbott, I dealt with the regulations after the FDA approved a drug. At Lilly, I deal with the regulations before and during FDA approval. Yup, I'm working with Investigational New Drug (IND) applications and New Drug Applications (NDA).

I'm currently wrapping up a journal club presentation for this upcoming Tuesday on a competitor's newly approved biologic drug and will finish the rest of the clerkship gathering intelligence on a project that's under Double Secret Probation. I wish I could say more, but these industry folk like to keep to themselves.

I'm sure I'll come up with interesting topics to blog about that won't compromise my employment status, but for now, enjoy a picture of Lilly's entrance fountain.

Best,
Eric

Developing Drugs (and skills)

Posted by Jim Stevenson at Thursday, April 28, 2011

My non-traditional elective was in the drug industry with a consulting company called United BioSource. United BioSource works with a number of pharmaceutical companies to provide guidance and input during a drug’s development. For the most part, United BioSource positioned me with one of their clients, Esperion Therapeutics. Esperion has an interesting background – it started as a small pharmaceutical company in 1998, then was bought up (for a handsome sum) by Pfizer in 2004, and then split off once again in 2008. Esperion’s area of interest is in basic metabolism-related conditions. Their CEO, Dr. Roger Newton, was co-discoverer and champion of Lipitor while at Pfizer.

While I was working with Esperion, they were designing a Phase 2B trial for a drug they are developing. Interestingly, they were investigating the same compound for multiple indications. My work entailed reviewing literature on the actions and development of similar compounds. The published manuscripts of phase 2 trials for similar drugs were invaluable resources. For example, a power calculation needed to be performed for the phase 2 trial I was assisting with. The magnitude of effect of various biomarkers and the duration of similar trials were major considerations. Also, the study population was a major discussion point. With an unproven drug, it becomes an ethical dilemma to perform a long placebo-controlled trial in patients with active disease (as half will be on placebo therapy and half will be treated with an unproven drug).

It was a very interesting experience to learn about all of the considerations that must be made during a drug’s development. There is an incredible amount of consequences to consider with each decision. In a world where a small difference in p-values or a single rare adverse event can cost billions of dollars, there is spirited discussion about every aspect of a drug’s development. Perhaps one day I will see use of (or even use myself) the compound that I worked on this winter.