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| Attendees queue out of the door to hear a panel discussion on alignment with commercialization |
In a panel session on alignment with commercialization,
attendees at Cell Therapy Bioprocessing & Commercialization were quite literally
queuing out of the door to hear the discussion.
Session chair Robert Preti PhD, president of PCT, a
Caladrius Company, posed the question of whether a cell therapy product was the
process. “Yes and no,” he said. “It’s actually much more than that. But
what does define the product?”
He told attendees that a cell therapy product has to be “transformative,
have a robust manufacturing process, have the right business model, optimize
COGS, must be scalable, logistically practical, clinic friendly and
reimbursable”. “Ultimately a product has to be deliverable,” he said.
However, he stressed that cell therapy products are
difficult to deliver compared with a pill. “The benefit derived must overcome
the natural tendency to prescribe what is easier to deliver (ie a pill).”
He said one of the main challenges in creating a commercial
future for cell therapy was to change and improve the manufacturing model. “It’s
a complicated model, but we know it needs to change. It’s an enormous
challenge. A manual manufacturing process will fail,” he added.
He challenged the panel to answer how to prioritize
improvements to the process “to limit the need to go backwards and repeat
trials”.
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