Advanced therapy manufacturers should consider new payment methods to demonstrate how their therapeutic benefits are spread throughout the year, according to Miguel Forte, the MD and PhD, the chief executive officer of Bone Therapeutics.
At Advanced Therapies Live last month, Forte spoke about the history of the cell and gene therapy business. He told GEN that biomanufacturing costs are falling over time. However, they will not be higher as small molecules keeping treatment prices relatively high.
Forte, a company that has an allogeneic off-the-shelf bone cell therapy tablet, believes we are seeing a logarithmic increase in the number of batches we can make from a single donor collection.
If you have two cells, but you have a similar process, you almost half the cost, according to a doctor.
According to the author, the company may now produce dozens to a few hundred doses of cell therapy if it receives a single dose of healthy bone marrow.
We have already gone from flatbed to bioreactors with three-dimensional production, and were aiming to achieve 100,0000 doses per batch, implying that the increase in allogeneic cell therapy production is still a challenge, but they are also confident in the progress they make.
Forte believes that despite advancements across the advanced therapy industry, prices would not fall to the level of small molecule chemistry. This is due to, for example, the cost of gene delivery methods as well as raw materials, such as collecting samples from patients.
It''s not the price of a single product, but the multitude of options and procedures we assemble in order to deliver effective treatment, according to the author.
Forte believes that the industry must adopt innovative payment methods that show that cell therapies have long-term benefits.
If you correct a gene or have new cells commissioned to perform a function, you pay for two weeks, and youre done, but that type of payment must be revised, according to the author, by looking at a gene therapy to a mortgage on a property where you reduce the cost of the property while benefitting from living in it.
Forte believes that regulation is a key component in making gene therapies commercially viable. He believes that as the industry develops, regulatory approvals will be limited, enabling in part by standardizing components of the production process. For example, by changing a single gene in a gene cassette.