FDA www.fda.gov has awarded the “UCSF-Stanford Center of Excellence in Regulatory Science and Innovation” (UCSF-Stanford CERSI) https://pharm.ucsf.edu/cersi a five year grant with up to $25 million in funding.
The funding will be used to transform therapeutic products as they are developed and find better ways to assess them for safety. The research team will be able to take advantage of the latest in sophisticated computational methods and technologies to meet the safety requirements needed to upgrade FDA’s ability to evaluate and approve new medical products to help speed up regulatory decision-making.
USCF-Stanford CERSI is a joint undertaking among UCSF’s School of Pharmacy https://pharmacy.ucsf.edu and the School of Medicine https://medschool.ucsf.edu, Stanford University’s School of Engineering https://engineering.stanford.edu and School of Medicine https://med.stanford.edu and the FDA.
The UCSF-Stanford CERSI partners will use the funding to work collaboratively on projects along with foundations and commercial entities interested in the development of FDA-approved medical products.
According to Kathy Giacomini PhD, Professor of Bioengineering and Therapeutic Sciences in the UCSF School of Pharmacy, “The new funding is a vote of confidence from FDA that we are on the right path in developing new models and methods for moving drugs and other medical products such as devices and cell-based therapies from the laboratory to clinical trials not only more efficiently but with greater confidence that these products will be safe and effective.”