Courtney Carlson BUS 345-01

This week we dove head first into the world of clinical trials. I think being able to understand how vast and extensive the process actually is, is something that as pharmaceutical business majors we need to know. Clinical trials are what drives the industry and they themselves open up many industries that branch off. Both of our speakers took separate approaches to the trials but they connected on some topics. Rolland from Pfizer talked more about the aspect of how many business decisions are made through each phase and how critical they can be. Dr. Bose of the on the other side spoke of all the approvals that drugs have to go through during these phases and how they can tell the future of a drug. Rolland brought in a more practical taste to the class when he was talking about the industry. I have learned a lot about clinical trials and what they entail through each phase so I will not re-preach these aspects. Rather I wanted to focus on what Rolland taught me. As a project manager ...

Three Interesting Things: 1.) I find it interesting that if a drug is trying to be imported into the U.S. from an outside country, they can try to get around requirements of the FDA by filing for an IND. Sometimes drugs need to be imported in order to complete trials or studies but the FDA has a lengthy list of requirements and protocols to do so in terms of labeling, naming, and formula but if an IND is filed then they can get around these aspects in order to expedite the process. 2.) The advance in technology that we have been touching on for the last three weeks is coming up again. We have talked about how it is taking jobs away from professionals in order to improve the industry's efficiency as a whole. This reading talked about how RWD is improving the system drastically in terms of electronic data and systems to provide the data so that it is being compiled faster and in high volumes in order to improve trials. 3.) Finally I think that it is interesting that the 21st Ce...

Three Interesting Things: 1.) I had no idea that the term "Clinical Research" only applied to studies and trials done on humans rather then animals or other test subjects. When grouping them all together you tend to have a broader or less abstract view of what the study actually entails but breaking down the term makes you start to separate the trial in your mind ahead of time. 2.) I think it is interesting that the FDA approves and regulates drug advertising but yet some companies still get away with falsifying their information about a drug when advertising it. There have been a multitude of law suits where patients experience a side affect or undesired outcome due to advertisements lacking certain information. With the most regulatory group approving all of this it is funky that some still slip through the cracks. 3.) I think that when it comes to naming drugs there is a laboratory name and then a manufacturing name. Its basically further splitting up the industry in...

This week we had some really good conversations about the readings we did outside of class and how it applied to our speakers. The speakers we have are meant to not just lecture us but generate knowledge on the industry and inform us of what we need to know in order to make it through. Our first two speakers, Dean Spooner and Dean Welch, had presentations regarding the industry itself and how it functions on a day to day basis but our last speaker, Dr. Kennedy, took a more scientific approach and focused on drug discovery today. I thought all of them tied in well and created broadened my knowledge. On Tuesday we dove in deeper of what we read and learned the week before. We were assigned the readings "Next-generation member engagement during the care journey" and "Top health industry issues of 2019".  These readings had things in common with one another as well as multiple connections to what our speakers last week talked about. The first article preached the idea...

Three things I found interesting: 1.) I think it is interesting that the Clinical Path Initiative is including the aspect of "establishing standards for clinical trial data and its management; fully automating trials data and its management; improving the clinical trial quality management system; and modernizing FDA oversight of the clinical trial process". I believe this because of my research recently on the Clinical Trial Data Management Services which is an industry on the rise and could be used in this factor. If the FDA potentially made it mandatory for clinical trials to have a CTMA system for their trials, if would improve trial safety and efficiency as well as both the healthcare and CTMS industry. 2.) I find it interesting that the FDA Critical Path article stated that one debilitating factor for drug development is the fact that so much information is stored but yet not all of it is accessible for potential drug development because it is not generalized. It say...

Three Things I Found Interesting: 1.) I think the idea of digital therapeutics or other connected devices is a great way to improve the industry, The healthcare industry is seeming to try to think more like a business rather than a compilation of services. Thinking more like a business and at their patients as consumers rather than sick beings, they are able to take into account the needs and wants of the consumer outside of health. In this day in age even with the growing elderly population, a more digital approach to life is a must. Every aspect of a consumers life is just about run by technology so allowing patients to have access to an app or online tool for their treatment for their medical condition, makes their journey more efficient and effective. If the healthcare industry continues to have this outlook they will increase their customer satisfaction as well as build a tight-knit relationship. 2.) I think that is is interesting that the healthcare system is adopting ideas f...

This week we had Dr. Welch come in to speak with us and we had a presentation day. I felt that this presentation was very interesting compared to our first one. I liked that she was very blunt and practical when she spoke about professions and what they entail. Dr. Welch's approach to "lecturing" was interactive and discussion based. It was a way for every student to be able to relate their lives to the topics we were talking about or an open forum for questions. I felt like the students really drove the class and the learning because based on what we were saying, Dr. Welch then gave us information and personal experiences related to it. The reading that we had done was very plain and simple and to the point. It broke down the main professions in the healthcare industry and what their job was, the education that have to go through, and how much money they make. It then talked about other jobs in the industry that are just as important but more behind the scenes. On top of...

Three Interesting Things: 1.) The first concept that I found interesting relates to all of the major healthcare professions talked about in the Ch. 2 reading. Each profession was briefly described as to what their goals are on a daily basis as well as the education they must endure in order to reach standards. The pharmacists, physicians, physician assistants, and pharmaceutical technicians all have a very clean cut jobs in terms of what their day to day activities are as well as what is expected of them. Unlike these, when the nurses profession was described there was more talk about their emphasis on caring for the whole patient rather than what is technically expected from them. Later in the chapter it talked about patients focused care and interdisciplinary care but yet how can these topics be harped on if the nurses are the ones responsible for the patients over all experience. I guess it just baffled me how the nurses position was the last discussed but yet it is the most impo...

This week we were given a lot of information to start us off for our first guest speaker. The readings Dr. Spooner gave us were lengthy and in depth. They talked a lot about the progression of the healthcare and pharmaceutical field today as well as how it has changed drastically but yet stays concrete in some ways. The first reading, Chapter 1, talked about how the healthcare system in the United States is kind of an oxymoron or hypocritically ran. What I mean by this is the clear fact that the US has some of the most advanced medical technology and is continuing to progress but yet has a high rate of medical errors and is costing citizens so much money. The healthcare system is a solidified field and will most likely stay around forever but yet the country cannot get a grasp on it. There are issues with every citizen not receiving proper care or having access to the care that they need. This is why the concept of medicare for all is such a hot topic. Health care is something that eve...

Three Interesting things I found: 1.) I found it interesting that the U.S. is leading the way with under performance in areas such as access, patient safety, coordination, efficiency, and equity due to the fact that there are health worker shortages and the ratio of healthcare clinicians to patients (physicians, nurses, physician assistants, pharmacists, and community/public health workers). With this Chapter 1 states that medical errors and problems ensued by them costed the U.S. $19.5 billion in 2008. Since the U.S. powers over other countries in terms of technological advancements and access to such great health care, they are still misusing their resources and allocated funds in the wrong places which is costing the country it's financial state as well as their reputation. 2.) A connection that I made that I thought stood out was that on page 6 of Chapter 1, the reading stated that currently in the U.S., despite their vast advancements and intelligence, health care technolog...