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 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.