UCSF

Artificial kidney project led by Roy chosen for accelerated FDA program

The effort led by UCSF bioengineer Shuvo Roy, PhD, to create an implantable artificial kidney for dialysis patients has been selected as one of the first projects to undergo more timely and collaborative review at the U.S. Food and Drug Administration (FDA).

The FDA announced on April 9, 2012 that it had chosen three renal device projects to pilot a new regulatory approval program called Innovation Pathway 2.0, intended to bring breakthrough medical device technologies to patients faster and more efficiently.

The artificial kidney project, led by Roy, a faculty member in the Department of Bioengineering and Therapeutic Sciences, a joint department of the UCSF Schools of Pharmacy and Medicine, brings together 40 researchers in nine laboratories nationwide.

The effort is combining nano-scale engineering with the most recent advances in cellular biology to develop a surgically implantable Renal Assist Device (iRAD). The device would enable patients with chronic kidney failure to lead healthier lives, without external dialysis or immune suppressant medication.

With iRAD clinical trials targeted for 2017, the UCSF-led project was selected both for its transformative potential in treating end stage renal disease and for its potential to benefit from early interactions with the FDA in the approval process.

The FDA program will involve close contact between the federal agency and device developers early in the development process to identify and address potential scientific and regulatory hurdles and create a roadmap for project approval. The goal is to improve the projects’ overall chance of success and maintain safety, while reducing the time and cost of FDA review.

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About the School: The UCSF School of Pharmacy aims to solve the most pressing health care problems and strives to ensure that each patient receives the safest, most effective treatments. Our discoveries seed the development of novel therapies, and our researchers consistently lead the nation in NIH funding. The School’s doctor of pharmacy (PharmD) degree program, with its unique emphasis on scientific thinking, prepares students to be critical thinkers and leaders in their field.