PACHA Recommendations for Achieving the AIDS Vaccine Goal (Draft)

2. PRODUCT DEVELOPMENT

Product development must be differentiated from
basic science research. Product development is the
translation of promising concepts from laboratory and
animal experiments to actual vaccine products approved
by the FDA for human testing. There is a serious lack
of candidate AIDS vaccines in the "pipeline" to test in
clinical trials, and it is imperative to overcome this
bottleneck. Product development may require the
government to subsidize private industry, to commission
targeted applied research, and to address a host of
related issues, such as intellectual property rights,
financial incentives for the government vaccine purchase
market, international vaccine development and purchase
funds, tax rebates, patent extensions, liability, etc.
The existing basic science research system is not
structured to address these issues. Therefore:
* The Vice President should meet privately with
interested biotechnology and pharmaceutical
firms - to hear their candid assessments of
obstacles to their investment in AIDS vaccine
product development and suggestions how
government can assist.
* The White House should oversee the preparation
and implementation of a comprehensive
document/plan to address AIDS vaccine product
development. It should address: (1)
relationships with and roles for other major
industrialized nations (e.g., the G-7),
UNAIDS, and non-governmental organizations
like IAVI; (2) funding and financial
incentives; (3) management controls; (4)
regulatory issues; (5) intellectual property
rights; (7) liability, and (8) governmentsponsored product field testing through
expanded involvement of all competent
government agencies (e.g., NIH, DOD, CDC).

3. PRELIMINARY CLINICAL TRIALS