Greetings from Lake County, Illinois!

OK, so the locale isn't as exotic as some of my previous bloggers, however I promise the experience is just as interesting. My work this summer was in the pharmaceutical industry, as a Quality Intern at Abbott Laboratories. For those of you that think you have never heard of Abbott Labs, if you have ever heard of the biologic rheumatoid arthritis medicine Humira, been prescribed erythromycin, seen Similac baby formula, eaten a zone bar, needed an IV bag, known someone that needed a heart stint; well then you have probably had contact in some form with Abbott Labs.

As a part of Abbott Pharmaceuticals Division I was in Global Pharmaceutical Regulatory Affairs, a department that is a member of Abbott International and deals with regulatory agencies in the more than 120 countries Abbott markets its products. The two agencies I had the most experience with are the two major regulatory agencies in the world; the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA).

My first and main project was a study on biosimilars, an extremely hot topic in the US and a sensitive one for innovator pharmaceutical companies. Biosimilars are an attempted generic medicine for biologics, which are any drug derived from living tissues. Because a different cell bank is used to create a biosimilar the protein is inherently different, and thus the biosimilar is a different medicine than the originator biological product. Currently in the US there is no approval pathway for biosimilars, however in Europe there is an established pathway with several guidelines and product-specific annexes. I examined four originator products and their totalled 13 approved biosimilars in Europe in terms of all the Phase I, II, and III clinical trials they needed for approval. (As a quick side note: Phase I trials involve healthy volunteers; Phase II a small group of the target population; and Phase III a large, randomized trial with the target population). I utilized EMEA approval documents, FDA approval documents, Package Inserts, and Perscribing Information to determine all of the trials conducted for each of these products and put them into tables. I then used these tables to create my six key Comparison Charts that condensed this wealth of data and allowed for the differences in the originator and biosimilar products to be observed side by side.

This document I presented to our Vice President, who presented it to Commercial and some of her superiors. I also did a twenty-five minute departmental presentation to everyone in Global Pharmaceutical Regulatory Affairs, which I was the most nervous about. These people work with these products daily, and I was presenting information that I was worried they may know more about. Interestingly enough, they did not. I finally completed an Intern Poster Presentation on this project as well, where I set up my poster with other Quality, Science, and Environmental Interns and the displays were open to everyone in Abbott to discuss our projects with us. Because of the sensitive nature of biosimilars, the Vice President of my group would not allow me to hand out any information at either the departmental presentation or the poster presentation, I had to have my poster board approved by the Vice President, and my board was destroyed after the project. I have to say that I am the only intern I know that had their board destroyed.

With half the summer gone on that project, I started my second of three assignments. This project involved monoclonal antibodies, and companies that had developed surrogate antibodies for preclinical toxicology testing. Monoclonal antibody products are very specific to human receptors, and in some cases cannot be tested in the rodent. For these products, a company may develop a surrogate antibody, i.e. an antibody that acts the same way as the product but is specific to the rodent. This process, however, is extremely expensive, and not all companies create a surrogate. For toxicology studies, however, it is important to have two species (usually a rodent and a non-human primate) for a full toxicology profile. Again turning to FDA and EMEA approval documents as well as scientific literature (studies are normally published), I examined all products that had developed a surrogate and their rationale for doing so. This topic is important because in a few cases, the FDA has asked a company to develop a surrogate before moving into clinical trials. I also examined a few experimental drugs for this study, but I cannot really talk about that ;)

Then, because my preceptor unexpectedly resigned to take a Deputy VP position at PhRMA, I was switched from the Central Nervous System and Pain group to Labeling. The 5 projects I conducted with this group involved internal label comparisons, i.e. the US, European, Canadian, South African, and Australian labels for a single drug and determining similarities and discrepancies; as well as external comparisons, where an Abbott product label was compared to the labels of its competitors. A label project like the latter I completed was presented to the CEO as part of a presentation in regards to changes requested by the FDA and in comparison to the competitors.

I feel as if this blog has become rather long, and I congratulate you for having read this far. There are some perks to being an Intern at a large company other than the chance to meet students from all over the US; we had dinner with the CEO of Abbott, social events such as Amazing Race Chicago, and the opportunity to learn a vast amount of both an industry and cutting-edge science. I could go into many of my lessons learned, but as stated this reflection is already a tad lengthy. I will leave you with this: Did you know that it is possible for one manufacturer to create a product and conduct clinical trials on that product, and then sell that product and the rights to the trials to different companies that market the same drug under several different names? And that each of the mentioned drugs has a different approval document, although the clinical trials are exactly the same? I did not.


I look forward to seeing everyone next week!


--Colleen