Hello all! The conclusion of the first week of classes motivated me to write my thoughts here.
I'm working at some of the requirements for the IBH major, which include calculus II, organic chemistry, and of course the first IB Honors class: the evolution of molecules and cells. My first IB 270 class surprised me in how different the class was from any other I had taken before. Having about 18 students makes a surprising difference in that we're given options that just aren't possible for larger classes. Take, for example, the fact that we were all given keys to the IBH rooms. I hadn't bought the textbook for the class by the time the first reading was assigned, so after dinner on Tuesday I walked to the Natural History Building, unlocked a door, and got to work using one of the textbooks present in the same room I would be lectured in the next day. As I was nearing the end of the reading, a girl called Phoebe joined me and got to work as well. The next day, the lecture material wasn't as intimidating as I had thought it would be; it was review from previous biology classes I had taken but now there was a different approach: why is this important? I feel science majors sometimes get the label of just memorizing countless facts from their textbooks and regurgitating them for exams. Here, though, our lecture was placed in the context of the scientific thought of the time and how ideas progressed from Darwin's suggestion that "gemmules" accumulated in gametes and how phenotypes were blended to our current understanding of chromosomes and exceptions to Mendelian genetics. Ok, ok, so that wasn't all in one lecture but by the end of Friday's lecture I felt that I understood not only the material but also why it was important. My intimidation, I suppose, was made up for with the research project we have for the semester. Producing novel, interesting, and important original genetics research seems quite scary for someone who not too long ago was one of the youngest students at the university (excluding those crazy-smart 8-year olds who go on to become doctors before they can drive). Original research always seemed so far away, like something I'd be doing during grad school or maybe even later. But maybe I feel this way only because I have nothing to base these ideas on. Maybe it's intimidating only because I've never really tried. We'll see. Outside of the academics, though, I'm excited for the community feel that IBH has. On the first day, Dr. Cheeseman introduced us to the room we were in (and had keys to), pointing out things like the printer, the speakers that could play iPod music if someone was studying in the room, the projector that could technically play DVDs if we wanted.... I feel like IBH is much more than just classes. I'm looking forward to getting to know better the students who surround me during lecture and who I will very soon share a lab with. I know three people who are also in CHEM 236 with me, so IBH study sessions are imminent. The possibilities abound... Looks like it'll be a good year. -Matt
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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 forbiosimilars, 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 EMEAapproval documents, FDA approval documents, Package Inserts, andPerscribing 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, andEnvironmental Interns and the displays were open to everyone in Abbott to discuss our projects with us. Because of the sensitive nature ofbiosimilars, 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 EMEAapproval 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 Greetings from Dublin, Ireland! It’s getting near the end of the summer (already!), so I thought it past time to fill you all in on my experiences abroad. I’ve spent the duration of this summer at the University College Dublin (UCD) through a program known as CoBiD-UREKA. It’s a research-based program which accepts students from around the world for a 10 week, allexpense-paid research internships. They tend to pick students who are about to enter their senior year – so current juniors, I’d look to see if they’re offering it again next summer! This year the program accepted 11 students: 3 from Ireland, 6 scatteredaround the USA, 1 from Brazil, and 1 from Colombia. While we all arrived at UCD not knowing a single person, we quickly forged friendships and have had an amazing time together! Of course, a lot of our time Mon-Fri is spent working on our research projects. These projects span a wide range of topics, including plant genomics, limnology, paleobotany, vertebrate palaeontology, soil ecology, ecological modelling (that’s mine!), and BioControl. We’ve all gained valuable research experience, whether it was designing your own protocol for studying the setae of earthworms, goingelectrofishing to survey the fish of a certain region, creating a model of ocean currents, designing primers to study plant DNA, putting nylons (yep, women’s tights!) on plants to act as dust and study the effects, or creating pterosaur wing models and using a wind tunnel to test their aerodynamics. My own research project has focused on the study of deep-sea chitons and habitat connectivity. We’re especially interested in the dispersal of these chitons, which mainly takes place during their free-floating larval life stage. We’ve been using Argo oceanography data and a program called Matlab to map out the ocean currents of the Central Indo-Pacific near our populations of interest. With this data, we have been able to model larval transport, to determine where larvae from our source populations would disperse to. Through this project we’ve determined how far the larvae are able to travel before metamorphosing into adults, allowing us to better understand the dynamics of chiton metapopulations – something which is heavily understudied as of yet. Of course, it wasn’t ALL about the research! We’ve had the weekends to ourselves, and we’ve made the most of it. We’ve traveled throughout the country to see many famous and beautiful places, such as the Aran Islands, the Cliffs of Moher, the Blarney Castle, the Giant’s Causeway, and Killarney National Park (amongst many others). And of course, we’ve spent endless amounts of time exploring all that Dublin has to offer. Between the beautiful botanic gardens, the Dublin Zoo, the massive Phoenix Park, the theatre, the nearby markets, the gorgeous shoreline, the nightlife, and of course the friends, it has been a trip to never forget! Dubliners tend to be friendly people in general, which was a big help in getting around the city at first.Even on our first bus ride, someone happily told us which stop we’d need to get off at, as well as narrated all of the local sites we were passing! TodayDublin is a fairly worldly city, so while it’s not as typically “Irish” as most of the other cities are, it’s still a great place to explore. It also has some killer Indian restaurants! And of course there’s also a great nightlife! And for anyone who has seen the movies Once or P.S. I Love You (yep sappy romances but of course we all had to watch them after being here!)… yep we’ve been to a lot of those sites! Even more lovely in person than they appear in the movies! This whole summer has just flown by, just like it has for Josie! I’m leaving a week from today, and it seems way too soon!There’s somuch more I could still do and see here, my ten weeks was not enough to encompass it all. It’ll be a bittersweet homecoming, as all trips are. I’ll be glad to see my friends and share my experiences, but it will be hard parting from my new-found friends. Still, thanks to the wonders of the internet, we’ll all still be in close contact for years to come! And if anyone wants a look at pictures -http://irishescapades2009.shutterfly.com/. Cheers, Katie IBH class of 2010
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IBH StudentsIBH students travel the world, publish research papers, and do all sorts of amazing things Archives
November 2016
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