Monday, October 5, 2015

How to make a cell therapy product commercially successful

 Cell Therapy Bioprocessing & Commercialization attendees heard from a range of speakers on getting treatments to market

By Leah Kinthaert

Novartis's Knut Niss shared his insights
 “I have been coming here since the beginning of this event, and enjoy being in a room with a group struggling with the same questions and problems,” Novartis senior technical project leader Knut Niss told attendees on day  three of Cell Therapy Bioprocessing & Commercialization 2015.

“Five years ago we were discussing Phase 1, today we have much more advanced discussions; we have moved from discussing Phase 1 to commercialization,” he said.

Having worked with Pfizer, Novartis and Biogen, Niss shared his invaluable insight into building teams at these organizations. “When people think about what success in cell therapy would look like, they answer ‘getting to the market’. For me, success is being successful in the market,” said Niss.

Describing the challenges of having a cell therapy product on the market he said: “Once you are on the market you are out of your controlled environment. [With commercialization] you need to continue to pay attention and follow the standard operating procedures.”

He detailed what some of that uncontrolled environment might entail. “A healthy donor will be very different from the patient,” he said, giving an example of how a donor might take an occasional aspirin while the patient will have potentially taken a great deal of prescribed drugs. “Be prepared for that,” he warned. He continued: “Often you cannot use the patient’s material as a process development tool. Until you hit the clinic (you only have access to) donor material.”

Niss challenged the audience to ask the question “Is this process sustainable in the marketplace?” and advised: “CMC is a critical part of clinical development. It is important that the clinical team understands CMC and vice versa. You want to build the right team; cell therapy is very different from what they usually experience.”

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