Hey Guys, Just thought I'd start posting here instead of sending mass emails. Anyways, one thing that I found out about in my genomes class and online is that there are regulations against human germ line genetic therapy. I'm looking further into this - I just wanted to keep you guys updated!
Here's a link to some of the stuff FDA regulates:; http://www.fda.gov/cber/genadmin/octgtprocess.htm
yeah, so from what I understand, the FDA regulates what types of protocols, and trials and such are allowed - and the NIH has it's own guidelines for research that it funds.
Hey i have been looking up at some web pages trying to get some topic to help us get started but there's really not a lot out there. i found some restrictions that the FDA has put on the kind of viruses that can be employed in the gene therapy process but this wasnt a lot. i thought i should you you guys know.
Yeah, viruses seem to be at the core of gene therapy. I know it's really hard to employ that kind of research, on humans at least, but I feel that if a patient has some kind of terrible/terminal genetic disease, is informed about the therapy and risks involved, s/he should be allowed to make the decision to, well, be the 'guinea pig' for the test. I mean, it's his/her life they're putting on the line.
Hey Team, I've been reading up on gene therapy and indeed i am finding that not much legislature is in place to regulate both the clinical trials and manufacturing facilities. I've found that many us biotech companies who's primary focus is on gene therapy outsource to China and other countries perhaps to avoid regulation...there have also been reports od patient deathes linked to, or caused by adverse reactions to gene therapy...the link below gives a little background (from 1992) I thought it was interesting how lightly this subject was treated just several years ago http://www.newscientist.com/article/mg13318050.900.html
When do you think we can meet and start working on it together? Maybe we should also talk to Dr. Fagan after our meeting, so she can tell us if there is anything wrong with our presentation.
The time for meeting Tanya suggested - next Wed @ 10:30 - works for me; I say we each bring some materials and suggestions and assign responsibilities / develop our strategy for the next couple of weeks ;)
Hey guys i found this site as i continued to get something useful for our topic. i thought i might be helpful. http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml#5
12 comments:
Hey Guys,
Just thought I'd start posting here instead of sending mass emails. Anyways, one thing that I found out about in my genomes class and online is that there are regulations against human germ line genetic therapy. I'm looking further into this - I just wanted to keep you guys updated!
Here's a link to NIH guidelines that relate to our topic:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
And here's a more general page,
which also has some interesting info that relates to which of the higher ups oversee this kind of stuff:
http://www4.od.nih.gov/oba/rac/cover.htm
Here's a link to some of the stuff FDA regulates:;
http://www.fda.gov/cber/genadmin/octgtprocess.htm
yeah, so from what I understand, the FDA regulates what types of protocols, and trials and such are allowed - and the NIH has it's own guidelines for research that it funds.
Hey i have been looking up at some web pages trying to get some topic to help us get started but there's really not a lot out there. i found some restrictions that the FDA has put on the kind of viruses that can be employed in the gene therapy process but this wasnt a lot. i thought i should you you guys know.
Yeah, viruses seem to be at the core of gene therapy. I know it's really hard to employ that kind of research, on humans at least, but I feel that if a patient has some kind of terrible/terminal genetic disease, is informed about the therapy and risks involved, s/he should be allowed to make the decision to, well, be the 'guinea pig' for the test.
I mean, it's his/her life they're putting on the line.
Hey Team, I've been reading up on gene therapy and indeed i am finding that not much legislature is in place to regulate both the clinical trials and manufacturing facilities. I've found that many us biotech companies who's primary focus is on gene therapy outsource to China and other countries perhaps to avoid regulation...there have also been reports od patient deathes linked to, or caused by adverse reactions to gene therapy...the link below gives a little background (from 1992) I thought it was interesting how lightly this subject was treated just several years ago
http://www.newscientist.com/article/mg13318050.900.html
Hey Guys,
When do you think we can meet and start working on it together? Maybe we should also talk to Dr. Fagan after our meeting, so she can tell us if there is anything wrong with our presentation.
The time for meeting Tanya suggested - next Wed @ 10:30 - works for me; I say we each bring some materials and suggestions and assign responsibilities / develop our strategy for the next couple of weeks ;)
Hey guys i found this site as i continued to get something useful for our topic. i thought i might be helpful.
http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml#5
This is interesting.
http://www.ncsl.org/programs/health/genetics/Geneticshealthins.pdf
hey guys!
I think this is a VERY useful link for info on current legislature: DEF check it out:
http://www.wired.com/science/
discoveries/news/2007/11/genomics_sidebar
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