Transcript Global Leadership in Medical Innovation: “Ours to

Global Leadership in
Medical Innovation:
“Ours to Lose”
America is the world leader in biopharmaceutical
research and innovation
• Roughly 70% of all R&D dollars are spent domestically
• More than 3 million jobs are supported by biopharmaceutical research
companies in America
• Congressional Budget Office: “Pharmaceutical firms invest as much as
five times more in research and development, relative to their sales,
than the average U.S. manufacturing firm.”
The effect on the economy
• While some companies certainly lost jobs during the
downturn, the sector as a whole fared better than others.
The biomedical industry grew 1.5% in jobs from 2007 to
2008, while the overall economy declined by 0.7%.
• On average, biopharmaceutical employees paid roughly
three times the federal and state taxes as employees in
the rest of the economy in 2006.
• The sector’s contribution to GDP in 2006 was triple the
average contribution in the rest of the economy.
• Direct employment in the sector grew at more than twice
the rate of the rest of the economy from 1996 - 2006.
The effect on health
• Americans generally enjoy access to
groundbreaking new medicines before the rest of
the world.
• In 2009 alone, 34 new medicines were approved
by the Food and Drug Administration.
• In the U.S., average life spans for women jumped
from 74.7 years in 1970 to 80.4 in 2005. For men,
it leapt from 67.1 years to 75.2.
Medical advances have saved millions of lives
• According to the American Cancer Society (ACS), cancer death rates
dropped 19.2% among men from 1990 to 2005 and 11.5% among
women from 1991 to 2005. The ACS partially attributed this drop to
advances in treatment.
• According to the American Heart Association, from 1999 to 2005, the
cardiovascular disease death rate dropped 26.4%, while the death rate
specific to coronary heart disease declined 34.3% during the same
period.
• Since the introduction of highly active anti-retroviral therapy in 1995, the
annual number of deaths due to AIDS has dropped by more than 70%,
according to the Centers for Disease Control and Prevention.
Many states have implemented policies
intended to grow the sector
• North Carolina was one of the first states to target the biopharmaceutical
sector for development, investing $1.2 billion to grow the sector between
1998 and 2008.
• Maryland has invested heavily in growing the sector, creating a cluster of
biopharmaceutical companies along the I-270 corridor. Governor
O’Malley has committed $1.1 billion to be invested between 2010 and
2020.
However, the federal government has not
shown the same continued initiative
• According to a recent report commissioned by the
Council for American Medical Innovation (CAMI), the
U.S. was one of the first countries to offer an R&D tax
credit to encourage innovation.
• The government has failed to continue these incentives,
just as foreign entities are increasing their efforts to woo
away America’s biopharmaceutical research companies,
and the jobs they offer.
• The paradigm should be the U.S. against foreign
governments. Instead, the lack of federal programs end
up pitting, for example, North Carolina’s efforts against
Singapore’s.
CAMI: Challenges abound for biopharmaceutical
research companies
• Increasing complexity of the science behind our
R&D is demanding and costly, and requires more
advanced technology and more complex clinical
trials.
• Regulatory review and the approval process for
new medicines is not keeping pace with scientific
advances, and has become unpredictable and
inconsistent.
CAMI: Challenges (cont’d)
• As the risk of biopharmaceutical research has increased, early financing
and private investment in R&D (such as venture capital) are becoming
harder to find. This funding is very important to early-stage research.
• The transition of early-stage research to the development of a new
medicine has been hindered by barriers to public-private partnerships.
• The U.S. talent pipeline for medical innovation – our next generation of
workers – is at risk.
How do we meet these challenges?
• We agree with CAMI that America needs a national medical innovation
agenda to help to support our companies, our potential life-saving new
medicines, and our jobs.
• As biopharmaceutical workers, this is not just about policy. This is
about our livelihood and our futures.
CAMI: The Recommended Agenda
• The report by CAMI recommends several action
items for each of the main challenges.
• The recommended agenda emphasizes additional
public-private partnerships.
• We benefit from these partnerships in many ways
and feel that a national medical innovation
agenda would be a big step toward supporting
growth of the sector.
Regulatory policy examples
• FDA funding and resources need to be increased
to better meet agency need, providing for
improved predictability and quality of review.
• The R&D process is already very risky. An
unpredictable review process can add a
burdensome level of risk.
• Other recommendations include reimbursement
policies that encourage use of new technologies
and better international regulatory harmonization.
Private investment examples
• Strengthen the federal R&D tax credit by making
it permanent and raising it to levels that would
allow it to better compete with foreign incentives.
• Encourage venture financing and investment
through a variety of incentives.
• Provide federal financing support for biomedical
infrastructure at university research parts; in many
cases, this would supplement existing state
efforts.
Translational research examples
• The early-stage research done by universities and
researchers funded by the NIH is a big part of the
R&D process.
• This work could be encouraged in a variety of
ways, including: a budget growth strategy for the
NIH; more university-industry collaboration;
enhanced support for technology transfer; funding
for the Cures Acceleration Network and its work in
rare diseases; and more.
Talent examples
• A renewed effort to improve science, technology,
engineering and mathematics (STEM) by increased
funding in our schools can help to prepare the next
generation of biopharmaceutical sector workers.
• Programs to retrain existing workers to transition to the
biopharmaceutical sector could be applied to vocational
and technical schools and community colleges. This
would create a near-term improvement in the talent
pool.
• Government incentives would increase the number of
students pursuing graduate degrees and careers in the
biosciences in the U.S.
A hope for the future
• The CAMI report includes very detailed
recommendations about the many strategies that
a medical innovation agenda could use to support
the health care sector, including
biopharmaceuticals.
• Regardless of the end result, it is important to
begin a dialogue about how our jobs can
contribute to the health of our patients and the
rebuilding of America’s economy.