Dr Michael May, CEO at Centre for Commercialization of Regenerative medicine (CCRM) opened the second day of World Stem Cell and Regenerative medicine Congress with a presentation titled: if You Build it will they come?
CCRM was founded in 2011 with the mission to create a hub in Canada for Regenerative Medicine products development and commercialization. More than $20M spent so far, Michael also talks about their collaboration with Cell therapy Catapult.
Two “musts” to facilitate successful regenerative medicine commercialization:
- Clinical trial support
- Flexible Regulatory environment
Michael mentioned the conditional approval of Prochymal ( now a Mesoblast’s product) in 2012.
“Canada is not a small market”, he said. Ontario has a population of 16 M people and it is the second largest buying group in North America. CCRM are looking at it like the first big customer for RM products.
Michael also stresses the importance of thinking about reimbursement early in the development of the product.
Acute myocardial infarction (AMI) has very limited headroom (that is the scope for improvement on a patient’s quality of life resulting from a treatment, relative to other potential treatments for the same indication). All cell therapies currently under clinical development to address cardiovascular diseases have a price tag which is well above the willingness to pay for these treatments.
The interesting thing is that diseases like severe sepsis, high mortality rate inflammatory disease, have a headroom which is much higher than AMI.
So, which one to advance to the clinic? The point Michael wants to make here is that, until cell therapy manufacturing is going to be so expensive, we should advance to the clinic only cell therapies that are likely to be reimbursed.
Fabio D’Agostino for Total BioPharma at WSCRM Congress, London
Fabio D’Agostino is a research engineer at the Biopharmaceutical Bioprocessing Technology centre at Newcastle University