I thought Natalie's discussion over clinical trials was rather interesting. I did not realize that it takes between 15-17 years for each drug that works and is placed on the market to go through all of the necessary stages and procedures. Also, I did not know that for cardiovascular studies they used pigs to test on and for the immune systems they use lab rats. I was curious how one comes about a job like this? For Natalie, I know it was just pure luck and being in the right place at the right time, but I was wondering how long it takes for the average person wanting to go into this field how long it actually takes to get there. I understnad that one has to go through several stages of not as good of jobs in order to move on up into the clinical trials. Another thing that I found interesting was her academic history, because she was just an average student and that is one thing that I can really relate to. I work really hard for every grade that I get and sometimes it's not exactly what I want, but I get through my classes. It just gives some of us who are in that same boat hope that things will work out in the end. Overall, I found her to be a great speaker and it was interesting to her what she is currently working on and I will be curious to see how the trial about H1N1 works out.
Notes
Steps to Marketing Drug/Treatment
1. Discovery of Drug and/or Drug manipulation
2. Pre-Clinical experiments usually with Animal models
3. IND Application-Get approval to use drugs on people-Patent process also starts here
4. Phase 1-Use a healthy patient to adminster the drug. Monitor patient 24/7 and try to find optimum drug dose
5. Phase 2-Outpatient-use drug in patients with the disease the drug is intened to treat in a hospital setting. Tests for efficacy-if you take drug exactly by the label/directions, how effective is the drug.
6. Phase 3-Geographic Distribution-Diverse subject population to use drug on.
7. NDA-New Drug Application-FDA takes about 2 years to approve drug and get it to the market.
8. Phase 4-This step is not required-involves giving out free trials to people who could use/be treated in hopes that they will beg doctors for the drug. This step tests for effectiveness-The effectiveness of the drug in the real world where people may not take the drug as stated on the label.
Sponser-Like pfizer-holds patents for drugs and selects doctors to conduct research
IRB-duh
CRO-Contract Research Organization-Tell doctors how to do study and monitors the progress of the study and collects data and sends it to head honcho/stat guys-natalie does this stuff
