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products and capabilities required to address our public health needs, the U.S. Government
will
reduce its fixed costs while providing itself with greater flexibility in stockpiling and enhanced
agility in responding to unexpected threats.
Because multi-use approaches have the potential to yield commercially appealing products, industry
already has an inherent motivation for exploring this space. Industry is currently constrained
however, because such technological leaps are generally outside of the accepted risk portfolio for
large pharmaceutical firms, and the smaller biotech companies (that drive much of the innovation in
the life sciences) have difficulty in acquiring capital for such risky endeavors without a wellcircumscribed end market. Therefore, we must also find ways to increase investment in such highrisk/high-reward approaches. The U.S. Government will assess whether incentives such as research
and development tax credits and transferable priority review vouchers would increase collaborations
between large pharmaceutical firms and smaller companies developing innovative technology. The
U.S. Government will also consider establishing an independent, not-for-profit venture-capital
entity that spurs innovation by providing critical early-stage investments in multi-use approaches.
'A model for an entity that addresses national security needs while supporting the development of
multi-use products already exists in the form of In-Q-Tel, which was launched by the Central
Intelligence Agency (CIA) in 1999 as a private, independent, not-for-profit organization. Rather
than seeking single-solution custom products, In-Q-Tel engages with companies that build
successful technology solutions that can be sustained by the commercial market. Meeting the
demands of the commercial market stimulates continued product development and enhancements
with added value for the Intelligence Community (IC).!
AlthoughlHeneeforward] the U.S. Government will adopt credible multi-use capability as a high
Priority goveming principle for future investments in medical countermeasures, fx adopting met
tit
ple
ver, we will not jeopardize current success nor
tie the hands a government to act in the best ltercets of the American people. Going forward, the
extent to which we apply the principle to legacy programs and investments will be determined on a
case-by-case basis.
IL. Collaborations, Partnerships, and Cooperatives
The pharmaceutical industry too often relies on anachronistic technologies or practices because our
regulatory paradigm and market forces present large costs and marginal returns for many
innovations in the development and manufacturing process. It is often against the economic interest
1 Analogous to corporate strategic funds such as those found at Intel Corporation, Motorola, and Disney, In-Q-Tel
'operates for the strategic -- rather than financial -- benefit of its customers in the IC. In-Q-Tel
targets its technology
engagements based on a deep understanding of the needs of its customers in the CIA and the IC. To best serve these
customers, lr Tel plays multiple roles, serving as:
A technology accelerator, fostering development and introduction of technologies needed by the IC;
A capabilities builder, helping nascent commercial technologies mature into commercial-off-the-shelf products
the government
can buy;
'+
Anidea lab and forum for innovation, providing the IC with insight and access to both new technologies and
leading innovators
and thinkers; and
'+
A strategic investment firm, investing in companies and helping build businesses into reliable providers for the
Ic.
'Commented [a3]: I got rid of "Henceforth"
since it sounds too
such ike a royal degree and will feed the current anxieties.
I
Delieve
that we get the same effect with the way Thave changed i,
afmuci
2010-02-11 20:09:00
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Records on this page
| Record | Date | Type | Pages |
|---|---|---|---|
| reading_room:exh:00134 | — | attachment | 468 |