The FDA is holding its first 2016 stem cell meeting today.
How’s the meeting going?
The meeting start awfully early for us West Coast folks (5:30am) so I didn’t get to see the first few talks. Did anyone else see those and if so, what was your impression?
From the talks I have seen, this meeting is very scientifically focused so far. There has been a lot of clinical trial data presented, which for me as a scientist I really appreciate.
We’ve heard about promise, but also many challenges. One gestalt from the meeting up to this point is that there are a lot of complexities with developing and testing cellular therapies, and the utmost care must be used in this kind of clinical research. It’s not amenable to being rushed. At the same time I think it was Irv Weissman who pointed out that if we are going to see stem cell therapies help many of the patients in need within our lifetimes then there likely need to be some changes.
In the panel discussion before the lunch break, a question from the audience asked about the REGROW Act, but we didn’t hear very much from the panel about in reply that I could gather. If I heard someone on the panel correctly they referred to trying to answer that question as similar to “sticking one’s hand into a bucket of crabs”. However, a few people did indicate they have major concerns on REGROW.
I believe we are going to hear much more about policy in the afternoon session.