The Bright Side of the “Dark Side”

Posted by Tony Lin at Friday, June 29, 2012

This rotation was so fascinating I had to write two blogs about it.

In the last entry I briefly mentioned what pharmaceutical industry is and a little bit about Aastrom. I never told you what I did so here it is.

My preceptor was the head of the regulatory affairs but what does that mean? Does she work for FDA or Aastrom? Well, last time I asked she was on Aastrom payroll. So a good answer would be “Aastrom.”

Regulatory Affairs, as serious and critical as it sounds—it is. This aspect of the pharmaceutical industry serves as the interface for both the company (aka sponsor) and FDA. For example, FDA communicates their comments and concerns about your latest clinical study, you had better be able to interpret it correctly—all 100% of it. Vice versa. Whenever the sponsor wants to communicate with FDA to ensure it is following all the rules and regulations, it is best to have reliable personnel to deliver and translate your intents correctly. Every word, every punctuation and every tone in a message or verbal conversation can be misinterpreted for the undesired.

In fact, being in regulatory affairs is all about reading between the lines and extrapolate. In the few seemingly “simple” documents that I was supposed to summarize you know what I did? Well, I summarized it…in a traditional fashion that would have gotten me an A on a school paper but probably an F (for “you are Fired”) if I were doing a real job. Compared to my preceptor’s versions, she had extrapolated all sorts of conclusion from simple sentences that I would never even think of. But, they made sense. They absolutely made sense. The analytical skills and nuances that take place in the regulatory affairs world are nothing we ever see or learn in pharmacy school.

Just when I was wondering why some say you can’t learn everything in pharmacy school…

My main project at this rotation was to make a presentation to the employees during a Lunch & Learn session. With much assistance from my preceptor in selecting topic and analyzing available information, I delivered my presentation titled “Prochymal--Paving the Way for Stem Cell Products.”

Aastrom’s Ixmyelocel-T represents an unprecedented stem cell therapy that has not been caught on by most of the industry and regulatory authorities. The technology is cutting-edge and the science is exceptional. Knowing the right things to do in clinical trials and the important things that FDA looks for are tricky…did I mention the word “unprecedented” already?

That’s why I chose to present on Prochymal, a self-claimed “world’s first approved stem cell drug product” in Canada just last month. I researched in details and established parallels on the similarities and differences between Prochymal and ixmyelocel-T to see how this groundbreaking drug product got on the market despite our knowledge of stem cells are still in its infancy.

Two things I can tell you based on this presentation: 1) it was not easy for Prochymal to get on the market but rest assure the focus of the pharmaceutical industry is about to shift, 2) companies from all areas do this all the time—research and analyze similar types of products in order to learn from different experiences in the pathway to getting regulatory approval. .

The past 5 weeks have been a phenomenal experience. Perhaps my blogs have cleared up your stereotype of the pharmaceutical industry or maybe I dug an even deeper hole for the industry in your eyes. My conscious choice of selecting Aastrom over a large pharma was a good one. I had interactions with personnel from manufacturing to engineering, programming to finance. My presentation on Prochymal was deemed important enough that I even got to present it to the executive leadership team.

I enjoy presenting and I loved my first 5 weeks. The bar is set high and I wonder what the next 7 rotations will bring.