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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 FDAís Commissionerís 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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