Better Understanding the Approach Towards Post-Trial Access

Time: 10:30 am
day: Pre-Conference Day Track B 2


As these programs are expensive to set up and operate, there is a risk to your company if the drug isn’t commercialized. An exit strategy must be clearly defined.

Attend this discussion for answers on the following:

• What are the options when ending a program in a country where the drugs won’t be commercialized?

• How do you communicate upfront to investigators your plan when the study ends?

• When a clinical study is done, to what extent is a company obligated to keep giving the drug?

• How do you maintain ethical responsibility to patients that’d benefitted from the program?