Claudia Mickelson, Deputy Dir. & Special Advisor to the VP for Rsrch, EHS
| Jan/29 | Wed | 10:00AM-12:00PM | 68-181 |
Enrollment: http://ehs.mit.edu/site/content/iap-course-registration
Limited to 35 participants
The process of translating laboratory discoveries into clinically relevant therapeutics takes a long time, costs a great deal of money, and had a high failure rate. This is partly due to the complex nature of the process and the FDA regulations and the fact that researchers are not familiar with the various steps in the process and what must be done at each step. This is a dynamic process in those issues and adverse events observed in past clinical trials are used to inform decisions about ongoing and new clinical trials. This class will give an overview of the steps, the requirements and submissions needed to obtain FDA permission to conduct a phase I clinical trial in the U.S. Examples from various different human gene therapy clinical trials will be discussed.
Sponsor(s): Environment, Health and Safety Office
Contact: Jessica Van, N52-496, 617 452-3233, JVAN@MIT.EDU