Are
the biggest opportunities for the U.S. biomedical industry's growth and
commercialization available outside of the U.S.?
According to CEOs, surveyed at the largest
gathering of healthcare financiers and executives, commercialization
opportunities outside of the U.S. (OUS) are very attractive.
Portland, OR, February 08, 2012 -- Biomedical
and MedTech start-up CEOs meet each year at the JPMorgan Healthcare Conference
and the OneMedForum, during the largest gathering of healthcare financiers and
executives and the biggest health care investing event of the year. Each year
attendees and investors figure out where they’re going to put their money and a
new trend evolves.
This year, that trend is that emerging, rather
than developed, markets are steering U.S. start-ups away from a burdensome and
uncertain regulatory environment in the U.S. “A large meeting of investors and
CEOs is the ideal event for international business experts to present
opportunities and build relationships in an environment designed for
networking,” says Haio Fauser, International Commercialization Principal at
acroMIS. “We use events like this conference to demonstrate the merits of early
international clinical success by presenting on-time and on-budget solutions
for clinical work and pilot trials with centers of excellence in markets
outside the U.S.”
In 2012 the conference has again grown in
size. In a time when the U.S. MedTech industry has experienced a dramatic
slowdown in the rate of growth, and venture financing dropped for the fourth
(4) consecutive year. In a November 2011 CEO Survey of one hundred (100)
biomedical companies in California, CHI-California Healthcare Institute, BayBio
and PwC US reported that eighty percent (80%) of CEOs said that the current FDA
regulatory approval process slowed down the domestic growth of their start-up.
The majority of CEOs said their companies had
to delay a research or development project in the past year due to lack of
funding, demonstrating that the pace of R&D productivity depends on the
availability of capital and a favorable regulatory framework. In this
unfavorable economic environment, CEOs need to demonstrate success in hitting
clinical and commercial milestones earlier, while investors focus on
“de-risked” later-stages companies that are profitable, cash-flow positive, or
at the very least, generate sales.
"U.S. Biomedical companies have long
relied on domestic pathways to clinical trials, but funding conditions are
shifting, timelines are shorter and companies will need to adapt to a new
budget reality. Because of limited resources to address commercial
opportunities, my clients now need to achieve milestones with less time and less
money," said Mr. Fauser. “As provisional coverage of new technologies can
be expected to become a new standard practice for private payers’ coverage
decisions in the U.S., access to international markets might be of interest to
more early stage companies."
Clinical work and first commercial success
outside of the U.S. can generate the comparative effectiveness data (CED) which
is a potential condition of coverage by private payers and Centers for Medicare
& Medicaid Services (CMS) in the U.S. Alternative sources for clinical
evidence and commercial success are available, but the new pathways to success
highlight the shifting opportunities and dynamics in the American life sciences
business.
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