Thursday, October 1, 2015

Panel discussion: what is the solution to poor process in cell therapy commercialization

Ann Daus PhD debates the priorities in the commercialization of cell therapies
By Brian Caine
Attendees at Cell Therapy Bioprocessing & Commercialization were quite literally queuing out of the door to hear a panel discussion on how to improve processes in the manufacture of cell therapy products.

Session chair Robert Preti PhD, president of PCT, a Caladrius Company, challenged panelists to prioritize improvements to the process “to limit the need to go backwards and repeat trials”. 

Phillip G Vanek PhD, general manager of cell therapy technologies at GE Healthcare named three priorities in how to industrialize manufacturing workflows. “Firstly we must simplify manufacturing environments,” he said. Secondly, he stressed the need to connect unit operations physically. And finally he talked about the importance of digitization. “We must automate,” he told attendees.

Mark Angelino, vice president of pharmaceutical sciences at Bluebird Bio, said that the industry needs to think differently and is constrained by the process.  “We must understand the process so that you can focus on the product,” he said.

“COGs are important, but margin and value proposition are more important,” he added. 

He said the current state of the cell therapy industry is very similar to biologics from the 1980s.  “Infrastructure always lags behind the science,” Angelino said. “We must be patient to allow technology to catch up with the science curve.”

As the discussion opened up, Angelino questioned what the value proposition was for the patient, asking “What is the correct price point? Pricing is based upon the indication and the effect it has on prolonging life”

Ann Daus PhD, vice president of quality assurance and quality control at PCT said: “The better you can define/characterize your product, the less the process is the product.”

She added: “Since CTs are not currently well characterized, this is the reason the  process is the product, but that should diminish go-forward.”

The discussion moved on to the point of care with Preti asking what was the best place for patients to receive treatments?

He pointed to work by Larry Couture of City of Hope who is looking into creating third-party administration centers. “The best model is not clear at this point as the current infrastructure is set up for academic/clinical administration of product, not commercial,” he added. “Making that transition is a daunting task and it will be necessary to move to an automated system,” he said.

Daus added: “We are talking about individual treatments using existing processes designed to administer treatments to thousands.  Need to change that.  An electronic approach is a must.”

“The factory of the future will look different, but right now, we don’t know what that will be,” Vanek added. “Where is automation in CT development? Its coming but, we aren’t there yet.”

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