‘Can you manufacture consistently?’ The big question in regenerative medicine
For the regenerative medicine industry, 2018 will go down as “one of the most exciting for [the industry] thus far,” due to greater investment and M&A activity, the Alliance for Regenerative Medicine (ARM) stated in its annual report.
The sector, including cell and gene therapies, and tissue engineering, attracted $13.3bn (€11.82bn) of investment – representing an increase of 73% against 2017 figures.
During 2018, M&A activity saw large pharma companies make investments in the acquisition of smaller regenerative medicines companies, such as the acquisition of June by Celgene for $9bn and AveXis being bought by Novartis for $8.7bn.
The report identified that there were 1,028 clinical trials for regenerative therapies ongoing globally, at the end of 2018.
Concerns for the industry
Despite the industry posting positive figures on the amount of investment raised in 2018, ARM’s report featured insight from Maria Fardis, CEO of Iovance Biotherapeutics, who suggested investors are concerned about manufacturing capabilities.
“I think the question [investors have] is, can you manufacture? Can you manufacture consistently?” she said. “They’re like, show me the data and let me assess the data. I also think investors are becoming savvier in that they have their own analysts.”
In the report, Christopher Vann, COO of Autolus Therapeutics, concurred with Fardis on companies in the space needing to refine their manufacturing process quickly. He stated, “The realisation today is that you need to fix your manufacturing process before you enter registration studies.”
However, Vann noted that he was encouraged by what he saw as the “maturation of the supply network”, which he believes will see ‘fast followers’ have an easier time when it comes to constructing their manufacturing processes and creating a reliable commercial supply.