AIDS Vaccine Panel Discussion [Minutes]

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7-APR-97 PACHA AIDS VACCINE PANEL DISCUSSION - p. 7
It leads to proof of concept of a vaccine, proof of efficacy, and ultimately to licensure
and applications. Both of these arms are absolutely critical to the development of a
vaccine. They're the yin and the yang of vaccine development. Without these, there
will be no vaccines.
To the next frame, I just wanted to give you the perspective of HIV vaccine
development more from a developer's approach than from a basic researcher's
approach. We view that once a candidate vaccine has been selected for development,
it's necessary to purposefully and incrementally advance it through a step-wise system
of trials, starting with safety and immunogenicity assessments, ultimately leading up to
proof of concept of the vaccine's efficacy. This must be done in a prospective way,
through the definition of a development plan with time lines and milestones that, when
milestones are met, you continue to advance products forward.
The importance of basic science in this realm is to tell us if what we're doing
makes absolutely no sense. If there is compelling information for HIV that tells us the
approach we're taking is nonsensical, then we should either amend or stop the
development plan. But if that data is not there, I think that at this point it's incumbent
upon us to move these products forward in a purposeful, incremental way.
We view that development and basic research are interdependent and should
occur concurrently with each other. Each informs the other. In fact, clinical research
in the realm of HIV and many other diseases where we don't know the correlates of
immunity for the disease or we don't have adequate animal models must be viewed as
primary scientific-generating information. It's hypothesis-testing clinical research.
Some people are uncomfortable with this concept, that doing these large-scale
evaluations in humans is clinical research, is testing a hypothesis, but that is a fact.
These trials are generating information that will lead us to certain directions, either
continuing down the same pathway, learning what does not work is as important as
what does work, and moving on to new areas.
We also believe that we should be pursuing proof of concept under the most
advantageous conditions that are available to us, which takes a phenomenal amount of
coordination both in the field sites with the vaccine developers and with all international
partners who are participating in the partnership.
The schematic on the bottom gives you an idea of how we view the vaccine
development process. I think-the most important point to get out of this slide is that it
takes many years of basic research to result in an idea that can be translated into a
candidate vaccine. That information comes out of basic studies of virology,
immunology, molecular biology, and studies in animal systems, and it leads us to
candidate vaccines which we then have to manufacture by certain regulatory practices
and conditions, and it could take anywhere from 1 year to 3 years to have a candidate