|Ellen Feigal, M.D. Senior VP for |
Research & Development at CIRM
That’s why CIRM teamed up with the Alliance for Regenerative Medicine (ARM) to come up with a new step-by-step guide on how to navigate the tough regulatory waters and get approval from the Food and Drug Administration to move a therapy into clinical trials. The result is a white paper published in the journal Stem Cells Translational Medicine.
It lays out precisely what a company needs to do, when, why and how if it wants to get FDA approval.
As Ellen Feigal, MD, CIRM’s Senior VP for Research and Development and the lead author of the article, points out in the paper:
“The field of regenerative medicine is still relatively young and involves new and novel science. The products involved might be classified as a biologic - such as human cells and tissues or gene therapy- a device, a drug or combination of those. They also span a range of areas from biology to chemistry and physics and so could come under multiple regulatory agencies. All that can create uncertainty and confusion. The goal of this paper is to help companies understand the complexity of the process and how to most effectively navigate through it.”In our press release we quote Michael Werner, Executive Director of the Alliance for Regenerative Medicine, and a co-author of the study:
“Everyone involved in this process, whether it’s a company or the FDA, has a shared goal of bringing safe and effective therapies to the public as quickly as possible.”The article is comprehensive but even with this information companies will face lots of challenges along the way But by helping take some of the uncertainty out of the process we hope to make it easier for companies to get their therapies where they are needed the most, in patients.