AIDS Vaccine Panel Discussion [Minutes]

7-APR-97 PACHA AIDS VACCINE PANEL DISCUSSION - p. 49

so much information in 5 minutes -- that there is existing talent within the government
who has been working in this field already to coordinate at both a scientific and at a
developmental level. The problem is, I don't think there's any one human being who's
probably equally good at attending to the research issues and to the development
issues.
All of the issues that were discussed by Dr. Fauci -- about liability, and
preparation of field trials, and making sure that you have communities that are prepared
to participate in trials, and that there's an appropriate incidence and follow-up, and that
you have all of the infrastructure necessary to conduct clinical studies, and the reality of
getting a product that's GMP produced that can be used, and that you can export and
import it -- those are development issues aside from the research issues. I think they
both have to be attended to efficiently to move vaccines into the development pipeline.
So I would see this as having some sort of a mechanism of overseeing and
coordinating. It would take two people, one with a strength in research, one with a
strength in development, but both of those people should have a clear understanding of
the importance of the other.
DR. LEVINE: Dr. Lu, and then we'll go to the Council.
DR. LU: I agree 100 percent with Dr. Baltimore and Dr. Fauci in the sense that basic
scientists have formed the "dream team" you could ever find in this world to perform
the basic science. There's no need to add another layer or to coordinate that activity.
Leave that alone. The Baltimore Committee has the best protein chemists,
retrovirologists, immunologists in the world. Everybody recognizes that. Leave the
science to the scientists.
What I suggest is that the one thing missing here is that we should pursue in
parallel the practical side of it that involves the biotech industry and the drug companies
and get necessary help from the government. That's what I meant that we do need a
coordinator here to coordinate, to be the liaison officer. We need a CEO if you want
this type of approach, because you are dealing with the industry.
DR. LEVINE: Ms. Miramontes?
MS. MIRAMONTES: I want to add my appreciation for the participants on the panel being
here with us and putting themselves kind of on the hot seat when it comes to this issue.
As you well know, this is probably the most controversial issue in HIV that we've had
for a long time.
I need to tell you that I have been one of those people on this panel that have
pushed for vaccines from the moment I was appointed in December and will continue
to push and hold your feet to the fire whenever necessary.