Policy Priorities Overview
1. Funding for Clinical Trials and Evidence Development
- Significantly increase federal funding for clinical trials and research at the National Institutes of Health (NIH) and BARDA
- Expand 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.
2. Improve and Support Regulatory Evaluation
- Sustain innovations and adaptations implemented during the COVID-19 pandemic at the Food and Drug Administration (FDA) to accelerate development, review, and authorization of new therapies.
- Increase 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 and industry innovators, to accelerate bringing safe and effective therapies to patients; and
- Support enforcement activities against actors that are making false claims and causing patient harm.
3. Provide Support to Scale Manufacturing
- Provide federal and private sector support to optimize and scale manufacturing in the United States.
- Gain consensus on specifications for release of cell products.
- Gain agreement and support adoption of standards and best practices to support the development, manufacturing, and delivery of regenerative cell therapies.
4. Payment Policy
- Advance public and private sector payment policies that support patient access to regenerative medicine and cell therapies.
5. Workforce Development
- Expand workforce development initiatives including within technical and community colleges, to build capacity and develop a skilled, technical workforce for this growing field.