Friday, October 2, 2015

How Novartis leveraged its size to transition to commercialization

Keith Wonnaccott, Novartis
By Leah Kinthaert

Novartis director of regulatory affairs, gene and cell therapy unit, Keith Wonnaccott PhD explained to a packed room at Cell Therapy Bioprocessing & Commercialization 2015 how his organization was able to leverage their company’s large size to make the transition from an academic to a commercial manufacturing environment.

Wonnaccott described how moving from University of Pennsylvania’s facilities to Novartis’s Morris Plains site was fraught with challenges. “At University of Pennsylvania we have the donor on site, the manufacturers on site, administration on site. There is no site variability or difference in medical staffs. Once we begin to transition to commercial there are many administrative sites, many collection sites,” he told attendees.

To prepare for global development and all that comes with global manufacturing, Novartis applied what Wonnaccott described as the “tech transfer process”.  “With our step-wise tech transfer process, we can transfer all the knowledge needed to perform a given process from the transferring site to the receiving site,” he said.

Wonnaccott explained what the four key goals were needed to enhance the tech-transfer process: enhancing compliance, scalability, wide-scale distribution and process optimization.

He then went on to give reasons why the tech-transfer process was so crucial. “There is more scrutiny given to late-phase clinical trials,” Wonnaccott continued. “With early phase clinical trials you need to worry about safety, but with late-phase trials your concerns become safety and efficacy.”

He added: “University of Pennsylvania has only the US requirements, we wanted to appeal to a global market.” His discussion moved on to the list of different requirements in different countries. The group learned that not only are there different standards in the US and UK, but that the EU has an additional group of standards, and then you can add to that MHLW and ISO standards.

“All these different people are defining standards for you, it’s quite the challenge,” he said.

Wonnaccott then explained how to show comparability, one of the key needs faced with transitioning from an academic to a commercial environment. He joked about the vague answer that the FDA gives when asked “What does it take to show comparability?” (“It depends”) and went on to say “There must be robust product characterization, established assays, process consistency, predefined acceptance criteria and statistical analysis.”

Wonnaccott closed his presentation with an important point: “In the face of regulatory uncertainty, good science will make for successful development. We should do what’s right for patients.”

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