FDA Basics Webinar: Biologic Drugs

[jspotila]

For anyone interested, FDA is offering an FDA Basics webinar on Monday, June 17 at 1pm EDT on Biologic drugs. Rituximab and Ampligen are two examples of therapeutic biologics. The webinar will provide an overview of these kinds of projects. No registration is required, and you can join the webinar through a link on this page:

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm355978.htm

 

[Chris]

Jennie, thanks for this info--sounds interesting, since I don't really understand how either of these drugs work. Chris

 

[Sherlock]

It was a nice primer, around 20 minutes. The audio is supposed to be up in 2 days. The next one on biosimilars is August 19th. Thanks to jspotila for the alert on this webinar.

As always, the question/answer period afterwards was disappointing because of what questions get chosen, such as "will the slides be available?" (the link to the slides was right there before the webinar, right next to the very link that you had to use to get to the webinar presentation page). http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM356666.pdf

 

[Sherlock]

Jennie, thanks for this info--sounds interesting, since I don't really understand how either of these drugs work. Chris

Hi, Chris. Nothing was said about how they work, which varies a lot anyway. It was mainly about the difference in complexity... also in size and shell life, etc.

FYI, the rituximab antibodies work like tiny little flags that are engineered to attach to the B-cells, and they signal other parts of the immune system to come kill this thing. The same could be done for invading bacteria, e.g.

 

[Chris]

Sherlock, thanks for this--I managed to miss it--having a low day. Sounds as if I did not miss too much, anyway. Now on to see how the planned Rituximab studies work out--I wish us all good luck! Chris