What's the hold up? $1 Billion and an average of 12 years.
by Lisa Fritzky, on Jan 15, 2019 2:53:15 PM
But, new changes could bring stem cell therapies to you a lot sooner.
With the ability to significantly improve a person’s quality of life and treat a wide range of diseases and health conditions, we are all eager for new cell therapies to come to market. However, at the moment, the number of therapies that are FDA-approved are limited.
We are frequently asked why it takes so long for new stem cell therapies to become available to the public. This may be hard to believe, but did you know it takes an average of $1 billion dollars and 12 years for just one therapy to be approved? The approval process is extensive, but for good reason: it ensures the safety and efficacy of stem cell therapies. The below visual provides an overview of the process to move a therapy from research to clinical trials to then people in need*
You may be thinking, if the approval process is so arduous, what makes us so confident in the future of stem cells?
It may sound similar to a graduate school program placement test, but the RMAT is far from a GMAT or LSAT. The RMAT stands for Regenerative Medicine Advanced Therapy designation, which was recently created by the FDA. This program was developed to fast-track breakthrough regenerative therapies for diseases or health conditions that do not currently have any therapies available, such as for Parkinson’s disease, heart failure or spinal cord injuries.
With the FDA on our side, we feel confident that the future is bright for stem cell advancements. You can learn more about the RMAT and the 25 companies so far, that have been awarded a designated RMAT here.
Are you ready to prepare yourself for the future of medicine?
*slide presented at the International Society of Stem Cell Research’s (ISSCR) 2018 international conference.