Topics | Fall 2021
Topics for CSTR include:
Working with the FDA
Approval process for medicines
- Investigational New Drugs
- Orphan disease designation
Approval process for devices
- Investigational Device Exemption
Consulting with the FDA before you apply
Institutional review boards (what they do and how to get approval)
Good manufacturing practice (GMP)
What is this?
Who sets the rules and who regulates the GMC facility?
Human clinical trials
Phase I, Phase II, Phase III, and Phase IV trial design
Trials in children (How does this differ from adult trials)
First in human trials
Preclinical data needed to begin a human trial
Data safety monitoring board (what is this and do you need one)?
Ethical considerations in trial design
Health related software development
How is this regulated?
How is it tested?
How do you sell a health related app?
From academia to industry
Balancing academic appointments as you start a company
Deciding to leave academia for industry
Returning to academia once you leave
Working with industry as an academic physician scientist
Patenting your ideas
When do you file a patent?
Who files a patent?
What is a disclosure and how does this affect patents?
Licensing your patented ideas
Why would you do this?
Who gets the money?
Starting a company
How do you do this?
Advantages and disadvantages
How much do you need to start a company?
Where does that money come from?
What can be supported by the NIH or other grant agencies? (SBIR, R01, other grants)
Evaluating market size
Please also consider the impact of racial disparities, socioeconomic disparities, and vulnerable populations
Clinical trial design
Drug targeting, dosing, marketing, and pricing
Equity in the availability of therapies (local, regional, global)
Medical bioinformatics, decision making, and apps
Informed consent (language choices, cultural considerations)