NIH offers two paths for biotech startups: traditional Phase I and II funding, or Fast-Track that combines them. Phase I budgets around $314k with 30-40% advancing to Phase II ($2M), while Fast-Track offers comparable odds without the sequential wait. Program officers can help identify high-interest topics and secure larger awards.
Chapters
go for a Phase II, or during the Phase II, you can ask for a project period of 1 to 2 years and can ask up to a little more than $2 million and change for your project period. And then the NIH has something called the Fast-Track Program, where instead of applying for a Phase I, waiting to get that, carry it out, apply for a Phase II, wait for that, and carry along, you can actually accelerate that process and have Phase I plus Phase II combined for a project period of 1 to even 3 years. So this is a really attractive track for a lot of people that have an idea what is their commercialization potential and strategy and have strong preliminary data. So, and the interesting thing, the success rate for a Phase I is very similar to a Fast Track. So if you're not sure, you don't have a lot of good data yet and you're still trying to figure out what your go-to-market is, a Phase I is a good fit. But if you're further along, you have a little bit of a bigger team, you understand what your next 2 to 3-year goals are, a Fast Track could be something to consider. If you are a Phase I awardee, your chances of getting a Phase II jumps up to about 30 or 40%, which is really exciting. And so keep that in mind if you are a Phase I awardee, it's much easier to get a Phase II than if you're going for a Phase I. Now, although those are the budget limits that I proposed here. There's something called a budget waiver where we can actually ask even more money than our allocated proposal budget. Has anyone heard of the NIH budget waiver before? Even though online it says the proposed budget for a Phase 1 is about $314,000, there is a list of really interesting topics that the NIH really is looking for to fund. And if you talk to the program officer and hit one of those budget criteria between the agencies, you might even— you can jack up that budget even $400,000, even $500,000 of non-diluted funding for a Phase 1, which is really exciting.