[Email to David Baltimore from Bruce Weniger with Draft of PACHA Recommendations]

the specific objectives, responsibilities, strategies and
outcomes for the implementation of the plan. It is
essential that the plan reflect the integration of the
special skills and expertise of all appropriate federal
agencies, non-governmental organizations, and the
international community, as well as set forth a process
for collaboration among the various participants. Some
of the issues which must be addressed include: (1) how
to coordinate the relationships and form partnerships with
other major industrialized nations, UNAIDS, and
nongovernmental organizations; (2) funding and financial
incentives; (3) management controls; (4) clear milestones
and target goals; (5) regulatory issues; (6) intellectual
property rights; (7) liability issues; and (8) defining the
roles of the various U.S. Federal agencies, taking
advantage of established programs and experience in
field testing of candidate vaccine products.
Basic Science Research
A major area which must be addressed within
the comprehensive plan concerns basic scientific
research. The National Institutes of Health (NIH), the
world's premier biomedical research agency, should
maintain it's essential role in promoting basic research
in virology, immunology, behavioral, and related
sciences which provides the knowledge base for
vaccine development. However, NIH should utilize more
of its in-house experience and expertise in vaccine
development for this effort. NIH experts outside of the
Division of AIDS could provide much needed knowledge
and advice in vaccine development.
The establishment of the proposed [AIDS] Vaccine
Center within NIH may facilitate expansion of basic
scientific knowledge. It is essential that the director of
this Center be an accomplished vaccinologist, and that
this director have full responsibility and authority to allocate,
prioritize, and manage all NIH funding designated as
"AIDS vaccine" research. Additionally, NIH must
substantially increase the amount of AIDS research funds
allocated to vaccines.
Vaccine Development Approach
There is a serious lack of candidate AIDS
vaccines in the "pipeline" to test in clinical trials, and it
is imperative to overcome this lack. Basic science
research may not reveal, within the desired timelines,
all the answers to the complex mechanisms of immune
control of HIV-1 to permit the rational design of an AIDS
vaccine certain to work in advance of human testing.
Without knowing the "correlates of protection" (the
human immune responses to a vaccine that indicates
protection from HIV-1 if exposed), and without having a
laboratory animal that closely mimics human HIV
infection, it will be necessary to test various traditional
and novel vaccine design strategies in human clinical
trials to assess safety, immune response, and efficacy.
This process of "thoughtful empiricism", a hallmark in
the history of vaccine development, may provide vitally

needed answers. The risk that a tested vaccine may
fail to work is a reality, but the benefit for future studies
from the knowledge gained may outweigh the time,
cost, and effort in determining a vaccine unsuccessful.

Product Development