Part 1. U.S. Government’s History of HIV Vaccine Development

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T-617 P.03/05 Job-316

* Establish a "facilitator" to connect each private sector vaccine developer
who has reached Phase I with "the government". That person, an expert in the
field of vaccines, would be responsible to link a company with assistance
(financial, clinical, regulatory, political);
* Appoint a vaccine finance/support officer who works with the facilitators to
connect financial support options (public and private) to vaccine developers.
Part I!1. Alternative funding strategies for Government support Of Phase I. II and
II1 studies (see table)
I am looking here for a flexible way through which the pubic and private sectors
can interact using a variety of alternatives.
This part compares the classic vaccine development paradigm where the
manufacturer supports all clinical studies to what I call the New Standard and
the New Accelerated approaches where there is shared responsibility.
The basic description of these three examples is as follows:
New Standard: Full government support of all activities through established
review and funding sources. May require additional resources. Manufacturer
supplies vaccine and other small miscellaneous items.
New Accelerated: Manufacturer and Government share financial responsibilities
- new money from manufacturer, existing structures from ongoing funding of
government programs. Expedited government committee review since studies
rely on existing resources. Facilitator carries the proposal through the
government approval process.
Classic: This is the usual approach where the manufacturer has responsibility
for everything.