Weekly Reflection 9/29
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 there are many decisions that have to be made in order to allow the trial to run smoothly. Each phase comes with new challenges and as they go on, they become more critical. Rolland emphasized the fact that he is someone that looks at the patients as actual people rather then just numbers. He said that the old mantra of trials was to find a cure but now it is more focused on helping the patients with their symptoms and making their daily life a little bit better. These individuals have a disease that alters their lives and they are looking for hope. They are more inclined to trust the R & D companies if they know what the expectations are at the end of the trial. There is more room for disappointment if all trials are focused on curing because that only leaves you two outcomes; cured or not cured. When you focus more on symptoms then there are many more outcomes that gives patients a more positive outlook. I felt that this connected to what Dean Welch talked about when the industry is trying to become more inter-connected in order to improve the quality of care of patients in order to have more positive outcomes that benefit both the patients and the professionals at the same time. The patients are the center of the industry and more focus needs to be put on them. This also plays into clinical trials because the industry wants to get drugs to market fast in order to help patients but they want them to be as safe an effective as possible. This trickles down to business decisions because each phase the business individuals have to sell their trial to the governance board in order to prove that it will provide the standard of care for patients. The clinical trial itself is the business teams product and they have to market it to the regulatory boards because the clinicians wont be able to. The regulatory committees only want to know about money, time and scope. They want to know how much it will cost, will it meet the needed profit, how long will it take, and will it be worth it to put it to market. All of this relies on the business decisions that occur behind the scene and individuals like Rolland must be on top of their game in order to make sure that their product sells and succeeds. Like Rolland said clinical trails are "monolithic entities".
Dr. Bose's presentation was much less intuitive about the business approach but informative about how much goes into getting a drug approved. When going into a clinical trial you have to file an investigational new drug application which is basically your proposal to move forward with a molecule and lead compound that you believe will be viable for a clinical trial. The IND is split up in between multiple groups who specialize in different aspects that will each have to approve the application in order for it to move forward. This means that the clinicians and the business team need to work hand in hand in order to make sure that all of the boxes are checked off. Once it is approves then the trial moves on until it reaches the end of Phase 3. This is when a NDA has to be filed which is a new drug application when all the phases have been completely thoroughly and correctly. After this is approved then the drug is sent to market. After it is sent to market there can actually be changes made to the drug that do not call for a fresh start. A SNDA can be filed which is if there are small changed such as dosage or a label change. If there is a change in anything larger then an ANDA must be filed such as is the drug is going from brand to generic within the same company. All of these applications are what makes the drug approval process so rugged. They are put in place in order to make sure that the safest and most effective drug is being put on the market. One other thing I took away from his presentation was the talk of RWE and RWD. I have known of them for a little while but was not aware of how regular they are becoming. I think RWD/RWE are extremely important to clinical trials and the health care industry in general. It provides healthcare professionals information about the current patient population that will help them better shape their trials and studies. Dr. Bose mentioned that RWE is mostly used later in the clinical trials but now regulatory boards are making its usage become more involved in the early phases of the trials in order to speed them up and make them more cost effective. Data and information like this is revolutionary and it can help the industry become much more solidified.
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 there are many decisions that have to be made in order to allow the trial to run smoothly. Each phase comes with new challenges and as they go on, they become more critical. Rolland emphasized the fact that he is someone that looks at the patients as actual people rather then just numbers. He said that the old mantra of trials was to find a cure but now it is more focused on helping the patients with their symptoms and making their daily life a little bit better. These individuals have a disease that alters their lives and they are looking for hope. They are more inclined to trust the R & D companies if they know what the expectations are at the end of the trial. There is more room for disappointment if all trials are focused on curing because that only leaves you two outcomes; cured or not cured. When you focus more on symptoms then there are many more outcomes that gives patients a more positive outlook. I felt that this connected to what Dean Welch talked about when the industry is trying to become more inter-connected in order to improve the quality of care of patients in order to have more positive outcomes that benefit both the patients and the professionals at the same time. The patients are the center of the industry and more focus needs to be put on them. This also plays into clinical trials because the industry wants to get drugs to market fast in order to help patients but they want them to be as safe an effective as possible. This trickles down to business decisions because each phase the business individuals have to sell their trial to the governance board in order to prove that it will provide the standard of care for patients. The clinical trial itself is the business teams product and they have to market it to the regulatory boards because the clinicians wont be able to. The regulatory committees only want to know about money, time and scope. They want to know how much it will cost, will it meet the needed profit, how long will it take, and will it be worth it to put it to market. All of this relies on the business decisions that occur behind the scene and individuals like Rolland must be on top of their game in order to make sure that their product sells and succeeds. Like Rolland said clinical trails are "monolithic entities".
Dr. Bose's presentation was much less intuitive about the business approach but informative about how much goes into getting a drug approved. When going into a clinical trial you have to file an investigational new drug application which is basically your proposal to move forward with a molecule and lead compound that you believe will be viable for a clinical trial. The IND is split up in between multiple groups who specialize in different aspects that will each have to approve the application in order for it to move forward. This means that the clinicians and the business team need to work hand in hand in order to make sure that all of the boxes are checked off. Once it is approves then the trial moves on until it reaches the end of Phase 3. This is when a NDA has to be filed which is a new drug application when all the phases have been completely thoroughly and correctly. After this is approved then the drug is sent to market. After it is sent to market there can actually be changes made to the drug that do not call for a fresh start. A SNDA can be filed which is if there are small changed such as dosage or a label change. If there is a change in anything larger then an ANDA must be filed such as is the drug is going from brand to generic within the same company. All of these applications are what makes the drug approval process so rugged. They are put in place in order to make sure that the safest and most effective drug is being put on the market. One other thing I took away from his presentation was the talk of RWE and RWD. I have known of them for a little while but was not aware of how regular they are becoming. I think RWD/RWE are extremely important to clinical trials and the health care industry in general. It provides healthcare professionals information about the current patient population that will help them better shape their trials and studies. Dr. Bose mentioned that RWE is mostly used later in the clinical trials but now regulatory boards are making its usage become more involved in the early phases of the trials in order to speed them up and make them more cost effective. Data and information like this is revolutionary and it can help the industry become much more solidified.
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