Biotech Values

[gofishmarko]

NCI/NIH Video link

http://videocast.nih.gov/

The link above says there will be an archive available in PastEvents ( wherever that is ) for on-demand viewing. The title to look for is : "Bringing Therapeutic Cancer Vaccines and Immunotherapies Through Development to Licensure".

I only caught bits and pieces myself and will probably try to listen to the archive version too. If I find a separate link , I'll post it.

I'd like to think that FDA policies are reasonable enough so that combo therapy trials of new HCV antivirals could move ahead unimpeded , and I agree that the odds of a particularly nasty interaction are low and would likely be discovered early.
However , in the final panel discussion yesterday it was very clear to me that the concerns I outlined are real among the drug development community ( which formed the bulk of the audience ) , and are likely impeding progress in certain cases , at least. There was much talk about getting a "safe harbor" assurance from the FDA , and the FDA response was , basically , " Don't hold your breath."

The issues were much more complex than we've discussed here , and include legal liability issues as well as regulatory vulnerability issues , and in the cancer immunotherapy area it involves the use of , for example , adjuvants like IL-12 that will never be approved on a stand-alone basis.

Overall , it's just becoming clear to me that the regulatory mechanisms are not working efficiently and fixing it will require more than a tweak here or there.

Of course , I feel that way about government in general. )

Let the Revolution begin !!