Regenerative medicine could revolutionize healthcare by providing actual cures to so many diseases where we are currently only treating symptoms. But the field is so new that there are exceptional hurdles to getting great ideas from the bench to the clinic.
Michael May is the president and CEO of the Centre for Commercialization of Regenerative Medicine (CCRM), and he is bringing together all of the players that are needed to translate stem cell discoveries into commercial products.
“The gap between excellent science and a product that can be used in a patient is actually very large. And there are many gaps there and many challenges,” says May. “One is just demonstrating those therapies with the right kind of efficacy and dosages for effectiveness in the patient. The other is dealing with safety, and there are lots of regulatory hurdles there: how do you industrialize those products?”
On the one hand, new treatments need to go through clinical trials to be sure that they work. This process can take many years and present its own scientific challenges to overcome. But on the other hand, there are all the commercial hurdles, from scaling up production to meet demand, to the logistics of distributing the product to patients.
It’s a complex task that requires a diverse team. CCRM brings together academic and commercial partners to share ideas, infrastructure, and market research.
“What we are working on now is, how do you bring investors to play in an area where we’ve demonstrated that we have great science and we have a pathway to the market,” says May.
With all these pieces in place, CCRM hopes to accelerate promising therapies to the market, bringing true cures and major changes to healthcare.
“The promise of regenerative medicine is ultimately to provide cures. Every other medical product, whether it’s devices or drugs or biologics, treat symptoms. Regenerative medicine offers the promise of curing disease,” says May. “It will be a major shift and change in both healthcare and the economics of healthcare.”