Tuesday, August 6, 2013

A Whirlwind

It's hard to believe that nearly 8 weeks have gone by since I began my internship at Novo. I still meet new people every day and have been expanding my horizons even within other departments recently. No one shies away from my questions or puts down my curiosity here!

Last Thursday, I was sitting at the "other" building a few miles away for their rendition of the weekly "dollar barbecue" event. I had ventured over there with a few other employees after they lured me with the appeal of "better food" and "unlimited creampuffs". Not one to deny unlimited creampuffs, I traveled over to the packed cafeteria and eventually found a seat. Soon, I saw a man looking for his own place to eat and offered a, "You can sit here!" (a la Forrest Gump). He sat down and we proceeded to describe his life as an endocrinologist, adjunct professor of medicine, and director of a department involved with research here at Novo! In the end, after I confessed that he has what I would consider one of my dream jobs, he invited me to meet with him to discuss an upcoming study as I would offer unique insights from my perspective living with diabetes.

I met with him yesterday and feel good that I was able to give him tangible assistance and identify several ways to improve the study for the participants and researchers alike. It was quite nice to be able to answer questions that no one else in the room could satisfy. As an intern, there isn't much in the way of solid, scientific information I can offer up to anyone. As a narrator, however, I am the best at telling my own story.

At the end of the meeting, he asked if I was going to return as an intern next summer.
Admittedly, I hadn't thought that far ahead. Would I like to return to Novo next year? Absolutely! I'd like to work in a different department to experience even more of the pharmaceutical industry, just as I've tried to expose myself to as much as possible within Health Economics.

Thursday, August 1, 2013

Flying Time and Ropes Courses

The weeks have been flying by! I’ve been working on yet another project and will be able to finish it before my internship ends. Without giving away too much information, I am basically pulling scientific data from research trials over several pharmaceutical drugs and then comparing their outcomes in several ways. Once this is complete, we will be able to make direct, across-the-board comparisons between the drugs and see what areas we need to focus our marketing resources on as well.

Yesterday all of the interns went to Ironwood Outdoor Center in Lumberton, NJ. After an hour on the bus, we did teambuilding activities on high and low ropes courses throughout the day. Although heights and mosquitos aren’t quite my cup of tea, it was a good time all around.

Monday, July 15, 2013

Business/Science Dichotomy

If my blogs lately and in the near future are a bit lacking/sound somewhat robotic, you must forgive me. I’ve been working recently on many, many essays for secondary medical school applications and my creativity has about run dry.

I learn a lot through hands-on experience by shadowing folks around the building, and asking questions whenever they arise. Yet I seem to thoroughly enjoy the “car talks” that my mentor and I have when we are motoring together from one meeting to another.

As an ex-Ivy league professor, he may harbor a tinge of bitterness toward the general attitudes of his past students. With an extreme focus on securing certain letter grades versus gaining knowledge about statistics, he has told me some great tales about being bullied, cursed, and threatened because a student refused to attend class, didn’t do any work, or a plethora of other unreasonable excuses.

“You know those kids who get straight 75’s throughout high school and college? They are still somewhere out there. They have jobs too- and it is probably not on the scientific side of the pharmaceutical industry.” While he was not assuming that scientists are all high-achieving geniuses, he was making a point about the dichotomy between scientific and business rationale when making decisions within a pharmaceutical company.

“Morons with molecules!” he says. The problem is that businessmen with no scientific background do not make the best decisions regarding drug development. Their bottom line is obviously going to be related to a profit margin. Likewise, scientists with no business knowledge are not fit to make executive decisions, as they would likely approve development of a novel, $300 million asthma medication due to its innovative pharmacokinetic properties rather than consider the fact that it would cost so much and only serve a very small subset of the population with asthma.

The power of having both a scientific foundation and business education cannot be understated for many industries. I suppose I did not consider this before- as a biology student, some of the economic data I’m encountering is befuddling and forces me to agreeably disagree with decisions made about clinical development and marketing propositions. On the other hand, it confirms the value of my presence here as this financial and business expertise is something I likely will not encounter again in the near future while steeped in medical school.

Just as science and business are necessary backgrounds for powerhouse pharmaceutical decision making, they are also necessary for diligent policy making. Hopefully I can continue to increase my awareness of health economics in the future to prepare me for this public health role.

As a random note, I've been wondering about the difference between a systematic review and a meta analysis for awhile....   A systematic review is a thorough, comprehensive, and explicit way of interrogating the medical literature. It typically involves several steps, including (1) asking an answerable question (often the most difficult step), (2) identifying one or more databases to search, (3) developing an explicit search strategy, (4) selecting titles, abstracts, and manuscripts based on explicit inclusion and exclusion criteria, and (5) abstracting data in a standardized format.

A "meta-analysis" is a statistical approach to combine the data derived from a systematic-review. Therefore, every meta-analysis should be based on an underlying systematic review, but not every systematic review leads to a meta-analysis.

Sunday, July 7, 2013

Down the Shore or Up the Cape?

After several days spent with my lovely roommate and hilarious family members checking out the sites in D.C., VA, and MD, I've reached the near-end of the 4th of July break from Novo. It's funny that when I talk about it in casual conversation, I tend to say, "Yeah, I have to go back to work tomorrow..." in that typical back-to-school groan, as if I dread waking up to go in on Monday. But each time I do this, I catch myself, realizing that I'm actually quite excited to go in to work and I'll probably fight myself to get to work at 9 a.m. and leave by 5 p.m. instead of going in at 7 a.m. when the building opens and staying until 6 p.m. closing.

The Dossier project should start to dominate my agenda by the end of this coming week. Until then, Neil has graciously taken the time to nitpick through some published trial data with me so I know what to look out for with the Dossier literature search results. Basically, we kick this project off by skimming through hundreds of abstracts and flagging them for significance. Neil is teaching me how to determine if a study is airtight, whether its subject pool is too narrow, if the testing methods are consistent and leave little room for random variables to affect the outcomes, etc.

I realize this might sound quite dry thus far. While it may seem boring to the reader, I assure you that I could not be in a better place! This entire department is completely out of my typical element- as a biology major used to taking more abstract science courses based on pictures of cells and qualitative data, now I am faced with people who work almost entirely in the quantitative realm. I'm forced to think in numbers now and test the hard data using p values, confidence intervals, etc and then consider its economic outcomes (Will payers buy into this drug? Does it compete well with the other drugs in its class? Will Novo make a profit?) as well.

Friday, June 28, 2013

After a long series of meetings yesterday (some involving free BBQ or cupcakes…others simply “croissandwiches”), I picked up another project that will allow me great responsibility with just the right amount of pressure to do the work effectively yet in a timely manner. My mentor and I have been tasked with updating the AMCP Dossier for a drug. This incredibly lengthy document is a single source for all clinical, safety, economic, and other data involving a pharmaceutical. It must be updated every few years or as new data is released which may affect its distribution in some way- in this case, we believe the latest data will give our drug a leg-up on its comparator and thus increase its market value.
At this time, we’re having meetings with information/library database staff to figure out how to find every piece of literature involving our drug that has been published since the last dossier and is relevant to our goal.

Monday, June 24, 2013

1st Day, 2nd Week

Today, the first day of my second week, I learned just how brutal the corporate world can be. My lunch, in all of its microwaveable Tupperware glory, is MIA. I checked three refrigerators- no dice. Someone has taken it upon themselves to consume the strange mix of beets, onions, kale, romaine, teriyaki chicken, poppy seeds, horseradish, green lentils, and salt substitute. Perhaps they thought they were doing me a favor by taking care of such an unorthodox lunch assembly. Either way, I’ll miss my Tupperware. If there is anything college has taught me thus far, it is to spare everything! Nothing goes to the garbage unless it is spoiled or useless otherwise….and this includes my Tupperware, which has no plans to degrade in any landfill within the next million years.

What a diverse group of folks I work with- Danish, Thai, Mexican, Chinese, New Jerseyan (ha!), and plenty more outside my department. I hear several different languages every day. A good portion of the employees I encounter while refilling my coffee are amicable if not willing to strike up a casual conversation. This makes my slew of questions much easier to quench as I have several people to ask with various knowledge bases and backgrounds to pull from.

Though I’m still getting started and haven’t quite ramped up the workload aside from the initial papers I’ve been given to analyze for my mentor, I’m already busy! Trying to get my mind into the thought-processes behind health economics and outcomes research is a task in itself. I’ve got to constantly consider the strategic issues and imperatives at hand, the potential market access of the drug, our target value plan, and how we are going to form our health economic plan. There are currently more abbreviations and acronyms than I can shake a stick at, but I will slowly conquer them as I settle in here.

Wednesday, June 19, 2013

Day 2

Phase I, II, and III trials are part of the “clinical development” world which exists to establish the drug as one that is functional and relatively safe for human use. Phase I trials are often done with animals or groups of around 20 people to determine what dose might end up being harmful or even lethal. Phase II trials are generally 50-80 people and occur in two stages. IIa trials focus on safe dosage as it relates to body response. IIb trials are larger and focus on drug efficacy. Finally, Phase III trials determine efficacy endpoints- if the drug shows weight loss, for example, then how much weight can one be expected to lose? These trials also seek to determine if the drug is more efficacious than a competitor. These trials cost hundreds of millions of dollars to complete, so pharmaceutical companies want to develop drugs that are novel and proven to be effective so they have the best chance of distributing them.
As a side note, my email here is AMYJ@novonordisk.com. Some random four characters from your first and last name end up comprising your email account, and out of all the other employees stuck with "DJOH" or "TYLA" or "PLEB", "AMYJ" is a pretty solid stroke of luck!

Novo Beginnings...

“Holy Cannoli!” I thought as I stepped through the glass doors and into the expansive lobby. As an intern at the North American headquarters for Novo Nordisk in New Jersey, I am already blown away by the opportunities that lie ahead for learning and engaging in new experiences. To begin, our building is newly overhauled and designed in a rather unorthodox, sleek, Danish style that promotes collaboration and tranquility. It rests on a lake with an outdoor patio and rooftop terrace and has mostly clear glass windows and walls to promote an open feel. Brimming with Ikea-esque furniture, the building is much longer than it is wide and has “pantries” every few hundred feet. These house a free soda vending machine, eating area, refrigerator/microwaves, combination bean grinder and coffee drink machine with more buttons than one could shake a stick at, bowl of fresh fruit, and more. Health and wellness are integral to the Novo Nordisk way and this is evident throughout the building. The cafeteria offers almost entirely healthy options which are minimally processed. There is even an exercise facility! More importantly today though, I met my manager, Sheldon Kong, and mentor, Neil Wintfeld, as they guided me through the building and attempted to describe our department in a nutshell.

Health Economics and Outcomes Research (HEOR) is a part of the Clinical, Medical, and Regulatory unit of Novo. It serves as a liaison between the objective, scientific pharmaceutical research and the marketing folks tasked with convincing “payers” or “reimbursers” (code for insurance companies) to buy into the drug and thus offer its coverage to patients. Neil has already positioned himself as a professor-of-sorts, encouraging my endless curiosity and answering my questions with the help of his whiteboard. At this time I’m focused on improving my understanding of the process of drug development and exactly what HEOR does to ensure we connect the dots from the world of clinical development to the realm of patient access. For a payer to cover a drug, especially within the highly competitive and widespread Type 2 diabetes market, it must demonstrate its efficacy and worth as a product by its dosage, cost to acquire, implications for further healthcare costs, etc. On the other hand, Novo aims to develop a product that is not only profitable but also distinguishable from its comparators.

Though I’ve only been on the job for 6 hours, I’ve already sat in on a 2-hour teleconference with consultants from Copenhagen, Denmark (Novo’s world headquarters) and Belgium! We strategized with our research consulting group to design trials and collect data appropriate to re-launch a metabolic drug. Because another indication has been proven (another effect of the drug, such as weight loss), the publishing of this data will greatly add to the market base to improve reception with insurance companies. Although I took a statistics course during my first year of college, I am currently “Googling” many terms I seem to have forgotten which are going to be valuable when discussing these trials and what to make of their results. In the end, this will develop my critical eye when reading popular medical journals to determine the true value of the data presented in light of the publisher’s goal, sample population, and study parameters.

In the future, I’d like to be involved in making public health policy decisions in some capacity- be it as a city councilmember, member of a nonprofit board, or state representative. Combined with the medical degree I am pursuing in the near future, this internship will give me a perspective on healthcare and related decisions outside of one that is strictly anatomical and physiological.