Driving
Biomedical Innovation :
Initiatives To Improve Products For Patients
Because of its role as both a regulator and as a
public health agency facilitating the development of new, innovative products to
meet the needs of patients and the American public, FDA has a unique perspective
on the health of the biomedical industries that make up an important sector of
the U.S. economy.
Today, advances in science are leading toward a
fundamental change in the way medical treatments will be developed and used.
Groundbreaking discoveries in complex chemistry and biosynthesis have resulted
in promising new approaches for the development of drug candidates, advances in
cellular and molecular biologies are creating novel strategies for new biologic
therapies such as stem cell driven products, and cutting-edge electronics,
nanotechnology, and advances in materials sciences have revolutionized medical
devices.
This year, FDA has approved a number of truly novel
breakthroughs based on sound science to address critical health needs. However,
while we have seen an increase in the quality of new drug submissions, there is
a concern about a decrease in quantity. The past two decades have been marked by
steadily increasing investments in basic research and development, with more
than $95 billion in combined R&D by industry and the National Institutes of
Health (NIH) in 2010 alone. And yet, these investments have not translated into
a parallel increase in novel products submitted to the Agency for approval. For
example, last year the Agency received the lowest number of applications for
novel drugs in nearly two decades.
Medical device companies are also experiencing their
share of challenges. Venture capital for small startup companies has decreased
in the recession, and what investments are being made tend to come at a much
later stage of development leaving many companies and small businesses with
limited resources to translate great ideas from workbench to marketplace.
There is no single cause or party responsible for
this stagnation in the development of novel medical products. Rather, it
reflects a number of factors affecting multiple stages of the development
process, such as an uncertain and challenging economic and global marketplace,
increasingly complex science and products, and the imperative to ensure the
safety and efficacy of innovative medical products.
Medical Product Development Ecosystem
Translating a new idea from a discovery into a
medical product is a complex process involving an entire ecosystem consisting of
academia, industry, small businesses, payors, physicians, government agencies,
and patient and consumer groups. Each member of the ecosystem has an important
role to play in bringing a new medical product to market, and each piece of the
ecosystem is currently under stress, putting America at risk of losing its
competitive edge as the leader in scientific innovation. It is possible for the
U.S. to overcome the challenges ahead, but only by addressing each of the
underlying problems. Just as there is no single factor responsible, there is no
single solution. Innovation in medical product development transcends a single
new drug or a single new device. There is a continuum of concerns that impact
the environment for medical product innovation, including intellectual property
and patent policies, economic policies, biomedical research and medical
technology investments, regulatory reform, and reimbursement policies.
This is a holistic process that involves many
different pieces and players. As such, we must all take a comprehensive,
integrated approach toward a solution, involving the entire range of relevant
players and approaching the ecosystem as a whole. There must be a dialogue among
the various stakeholders to identify barriers to progress and better define what
steps need to be taken to overcome these obstacles. By doing this, we can work
together toward solutions that truly drive scientific innovation forward. As a
nation, we have a unique opportunity to come together to develop an overarching
strategy to spur medical product innovation.
One of the challenges of the current state of the
U.S. economy is the availability of jobs, including those in the biomedical
enterprise, that require highly technical and practical knowledge and expertise.
Many of these jobs remain unfilled, even in a time of significant unemployment,
because there are not enough qualified candidates with the necessary skill sets
to fill them. Because of the nature of the work performed at FDA, there is an
opportunity to provide these important skill sets to early and mid-career
professionals both to bring top talent into the Agency and to equip
up-and-coming professionals in the private sector with the experience and
knowledge they need to develop innovative new treatments and therapies for
American patients.
Building on the success of FDA’s Commissioner’s
Fellowship program, a competitive two-year program that provides on-the-job
training for early-and mid-career scientists and health professionals, FDA is
designing a new Future Innovators Program that will bring practical regulatory
science and policy training together to meet the scientific and technological
demands of the 21st century. Under this competitive program, FDA will hire
qualified candidates who show outstanding promise in their fields for a short
term position within the Agency.
These candidates will receive hands-on training
across multiple disciplines, including regulatory affairs, manufacturing,
diagnostics, computational science, biomedical device engineering, and design
and development of complex therapeutics such as cell-based therapies. These
Future Innovators will benefit the Agency by providing outside expertise and
perspectives, while they, in turn, will be provided with highly marketable
skills and knowledge that will equip them for highly technical jobs in a variety
of fields, such as the biotechnology/pharmaceutical industry, diagnostic or
device companies, the public health sector, academia, nonprofits, health care
administration and delivery, manufacturing, and consulting. In addition, the
retention of some Future Innovators will help ensure a pool of highly trained
personnel to sustain the Agency as the current workforce turns over or retires.
The Agency plans to create this program by working
with the Reagan-Udall Foundation, a non-profit organization affiliated with FDA,
to enhance its existing fellowship program.
Ref: FDA U.S. Department Of Health And Human
Services U.S. Food And Drug Administration
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