AIDS Vaccine Panel Discussion [Minutes]

7-APR-97 PACHA AIDS VACCINE PANEL DISCUSSION - p. 33

DR. FAUCI: We do have government/industry collaboration within our granting process.
For example, our National Cooperative Vaccine Development Groups, similar to our
National Cooperative Drug Discovery Groups, have consortia with industry so that
when funding goes through the usual peer review system, either for a grant or a
contract, it does not exclude government de facto at all. In fact, actually, it does not
exclude industry. Industry can be an important part of that and is an important
partnership.
So it isn't as if the NIH gets money and it's just NIH. As Bill said, that gets
distributed throughout academia and industry as part of that.
DR. LU: If I may, there is a funding program for the small business innovation grant called
SBIR. It's very generous funding. The chance of getting that funding is much higher
than an R-01, it is my understanding. The funding is the following: Phase I is where
you just get $75,000 for 6 months, after which, if you are successful and you complete
your goal, you are invited to go for the Phase II, which is $750,000 in the span of 3
years. The chance to get that is very hard.
The most difficult part is that Phase I to Phase II, because the amount of
money, as you can imagine, for Phase II is very limited in the NIAID. It's quite easy to
get Phase I. For example, I wrote four of them, and my success rate so far has been 70
percent, 80 percent. But that amount of money is not near enough for you to produce
your product in the grade that we call GMP [good manufacturing practice] grade to
put into the human.
So here comes the chicken-and-egg issue. If you don't have the money, you
cannot produce it; if you cannot produce it, you cannot tie it to the human; you cannot
tie it to the human without doing the work. But without this data, you cannot convince
the study section to give you that money to go ahead with it. So here is the dilemma
we're facing.
MR. FOGEL: Does Dr. Sadoffhave anything to add?
DR. SADOFF: Well, making vaccines is a staged process, and like many other manufacturing
processes or other industries, although the early work seems to be expensive, it really
gets much more expensive as you go up. To build a factory, for example, could cost
hundreds of millions of dollars.
So, therefore, there have to be very hard-nosed decisions and criteria for what
goes forward and doesn't go forward, and what the biotechnology groups are talking
about is trying to get products to that point where a decision could be made that
something should go forward into the really expensive part of the endeavor, where you
want to have as low a risk as possible and as high a possibility of having success.