Stacpoole’s Presentation

As director of the Clinical Research Center, Dr. Stacpoole is responsible for much of the clinical and translational research that occurs at SHANDS.  Most of the translational research is focused on the agents of disease and production of new medical devices. Clinical research is mostly hypothesis driven and takes a mechanistic approach to treatment schemes.  There is usually no therapeutical goal for the patients.

He then went over the steps in getting a medicine approved by the FDA.

1. Pharmacological trials

2.  Mainly for information on efficacy

3. Double-blind trials for dozens to 1000’s of individuals

4. Post marketing surveillance

The Orphan Drug Act was instituted to streamline FDA approval, thus lowering costs, for diseases that don’t make up a significant amount of the market base.

Lastly, he went over many of the notable orphan drug research that has been going on here in Gainesville (see slides 7-9). The patient base for many of the orphan diseases draws from a wide geographical net because they are so infrequent in the population.  Also, these trials in particular, are done in a protected environment, away from the concerns of insurance and hospital administration. If anything you see interests you, the best way to getting research experience would be to directly contact the lead investigator on a project and ask them if they need any help.

The GCRC is on the third floor of SHANDS.  Every summer, they have a 10 week program for medical school students to undergraduates working in the hospital.  Generally 6-10 undergraduate students are chosen to participate in the program.  Dr. Stacpoole’s email is stacpool@gcrc.ufl.edu if you would like to contact him about some of the summer positions.

Here is his presentation.