Our Policy Work
Accelerating Pathways For Cell Therapy in the United States
What Problem are we Trying to Solve?
Regenerative medicine and cell therapies utilize human cells to restore healthy function in the human body—representing one of the most promising areas for the next generation of groundbreaking treatments.
Regenerative medicine and cell therapies potentially will deliver effective treatments and cures in the areas of cardiology, neurology, oncology, and ophthalmology. Thousands of clinical trials are now underway that are focused on cancer, heart disease, urologic diseases, kidney disease, trauma-related burns and wounds, and diabetes. A number of clinical trials are also underway to address diseases for which there is no cure, such as Alzheimer’s, MS, and Parkinson’s disease.
Despite the benefits of these potential treatments, cell therapies are generally not available to patients. Government regulatory hurdles and funding shortages have not kept pace with scientific discoveries.
What’s the Solution?
Regenerative Medicine Foundation advocates for the following policies and actions needed to bring safe, effective regenerative medicine and cell therapies to patients:
- Increasing public education, awareness and acceptance of the emerging fields of regenerative medicine, cell therapies and stem cell research.
- Increasing and sustaining funding for regenerative medicine, cell therapies, stem cell research and clinical trials, at all levels, including the NIH, NSF, BARDA and other agencies to advance the science and the field.
- Providing encouragement and support for public/private collaborations to advance regenerative medicine.
- Defending freedom for ethical, meritorious biomedical research, including the fields of stem cells and gene therapies.
- Sustaining improvements and adaptations implemented by the Food and Drug Administration (FDA) to accelerate development, review, and authorization of new therapies during the COVID-19 pandemic.
- Increasing capacity within FDA’s Center for Biologics Evaluation and Research (CBER) to respond to the growing pipeline; provide additional education, dialogue, and technical assistance for academic and research institutions, industry innovators, and practitioners; to increase understanding of regulations; and support enforcement activities against actors that are causing patient harm.
- Advancing public and private sector payment policies that support patient access to regenerative medicine and cell therapies.
- Gaining consensus on and drive adoption of standards and best practices to support the development, manufacturing, and delivery of regenerative medicine and cell therapies.
- Expanding workforce development initiatives including within technical and community colleges, to build capacity and develop a skilled, technical workforce for the development of cell and tissue-based products. This includes development of STEM and STEAM educational initiatives.
- Expanding the evidence base through collaborative evidence development, including the development of outcomes databases that capture both cell characterization data and outcomes, to increase understanding of the correlation of different types of cells with clinical outcomes, monitor safety, drive improvements in manufacturing and delivery, and inform regulatory evaluation and payment, as well as clinical and patient decision-making.
In the absence of a supportive legal and regulatory environment, the promises of cell therapies and regenerative medicine will be delayed, thereby prolonging the anguished wait of those in need of lifesaving treatments and cures.
Regenerative Medicine Foundation has a track record fostering a supportive societal framework for advancing scientific research and accelerating regenerative medicine.
Previous Work (highlights)
In 2004-2005 Regenerative Medicine Foundation (at the time called Genetics Policy Institute) built and led a global coalition that defeated a proposed United Nations treaty that would have banned stem cell research worldwide. The grassroots coalition attracted many notable patient advocates, including Christopher Reeve.
Today we continue this essential work in partnership with Bipartisan Policy Center and other respected, nonpartisan organizations.
If you are interested in more details, or would like to discuss ways to foster a supportive legal and regulatory environment for regenerative medicine, please contact us.
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