21st Century Cures: Accelerating the Discovery-Development-Delivery Cycle

How can we give patients faster access to innovative treatments and cures? That’s the question the House Energy and Commerce Committee is asking our nation’s foremost medical experts and innovators through white papers, hearings, and roundtables in an initiative we call 21st Century Cures. Our collaboration includes everyone from the National Institutes of Health and the Food and Drug Administration to patients, researchers, health entrepreneurs, and other thought leaders.

Through 21st Century Cures, our goal is to keep America as the innovation capital of the world, creating more jobs here at home and ensuring patients have access to the most innovative cures and treatments available. We must close the gap between scientific knowledge and regulatory practice. We believe this will accelerate the discovery-development-delivery cycle for drugs, medical devices, and other treatments.

Discovery

The United States has long been the leader in scientific discovery, but our leadership role has been challenged by other countries in recent years. We led the way in the mapping of the human genome over a decade ago, but the Beijing Genomics Institute is now the world’s largest genetic research center. Surely we can welcome research and discovery from around the globe without relinquishing America’s leadership role. One place to begin is leveraging public-private partnerships to help advance the discovery process.

Discovery must also be informed by what scientists and doctors learn at the delivery phase. Today we have a better understanding at the molecular level of the biological mechanisms that trigger the onset or proliferation of a particular condition or disease. This knowledge should inform research for potential therapies and cures.

Development

The number of new American biotechnology companies developing the next generation of medical innovation has decreased in recent years, and in 2010, more biotechnology companies were formed in China than in the United States. The development of treatments and cures is a complex and costly endeavor, yet it continues to attract some of the world’s sharpest and most creative minds who are drawn to the challenge and opportunity that comes from saving and improving lives. The United States can work with those who translate research into reality to assess the factors that foster or deter the development process and more effectively encourage this investment here at home.

We have heard that a deterrent to faster development is the costs of clinical trials, which often must adhere to a rigid structure that does not always reflect recent scientific advances. Clinical trials can be made more effective, efficient, and affordable.

Already, the FDA has a number of new tools to encourage and allow for innovative approaches, and they are using them with some success. Congress acted in a bipartisan fashion to grant this authority, and we are interested in doing more to ensure regulatory science keeps pace with advances in personalized medicine, including diagnostics.

Delivery

To keep this cycle continuing and constantly accelerating, the delivery phase must serve as a platform for new discovery and development. Learning and investment in research should continue even after a drug or device, or combination thereof, has initial FDA approval. We must harness the power of communication technologies to contribute to this process. And we must identify and address the uncertainties or barriers in today’s post-market delivery settings.

As policymakers, we have a lot of ideas and have been heartened by the enthusiasm among experts and advocates who share a commitment to 21st Century Cures. We know we do not have all the answers, and indeed may not yet have even asked all of the right questions. But we do know our regulatory policies must keep pace with medical advances. To keep the United States at the forefront of science and innovation, we need to work together. The experts and participants here at the BIO International Convention will make a contribution. So will the patients, caregivers, loved ones, scientists, and researchers who have already shared their ideas, and will continue to do so over the next several months by submitting ideas directly to our initiative at cures@mail.house.gov. We can do this. We can develop 21st Century Cures.

Fred Upton (R-MI), Chairman, Energy and Commerce Committee

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