Understanding Operation Trialblazer, with Dr Harpreet Singh

Let's talk a little bit about this clinical trial modernization initiative.

So as you say, part of the impetus here is the competition, global competition that's increasing.

I'm sure most people hear that and think China, but it's bigger than just China, right? People are doing...

They're taking their trials all over the world.

Our system produces very robust results, but it's also more cumbersome and expensive in a lot of ways for researchers.

So what are some of the proposals baked into this initiative to make clinical trials in the United States possible? better, easier, more up to date with what we can do.

Yeah, thanks for the question.

And I appreciate that you're commenting that it's not just about China.

The document talks about Australia, and I don't think they actually talk enough about Europe.

There's fast starting countries in Europe, France and Spain.

And whether it's China, Australia, or some parts of Europe, Each of these regions can be more cost effective than conducting trials in the United States.

So as I mentioned, Operation Trial Blazer is really an HHS-wide initiative that to help keep early drug development or accelerate early drug development in the United States, making it less burdensome, more technology-enabled, while, of course, maintaining safety and scientific rigor.

So let's start with the FDA.

And I found some of this quite interesting.

The idea with speeding first in human studies through is to have more clear IND requirements.

And these are not actually heavily focused on the clinical protocol, meaning things like the eligibility criteria and DLT and washout periods, although that is part of this process.

They're actually very heavily focused on CMC and toxicology expectations because there seems to be a mismatch between what bio and pharma believe is required by FDA versus what FDA actually requires for CMC.

We're also seeing a push for reduced animal testing, greater use of NI or alternative methods, and then this idea that could we have an expedited IND, this would be a pilot that is being proposed, through a type of rolling FDA review.

So instead of having the classic and current system which is a pre-IND meeting, which is very optional for companies, and getting some preliminary answers and then submitting a formal IND that's meant to fit in that 30-day window, making it of a more iterative process so that issues and questions are worked out over time.

And so I think that that's an interesting piece, and that's within FDA's purview, certainly.

I mean, and so that's the FDA piece, and we can talk a little bit more about that.

And I think it's really interesting to understand, again, the HHS pieces.

They also talk about major bottlenecks, one of them being IRB review.

And there's this idea that I really like, which is, you know, how would this be pursued? They talk about potentially rulemaking.

And it would be interesting to understand what avenues there are to pursue having perhaps a central or single IRB for trials that are being conducted at multiple institutions.